Download More time needed to recuperate the costs of bariatric surgery

BNEWS
ARIATRIC
THE NEWSPAPER DEDICATED TO THE TREATMENT OF OBESITY FOR THE HEALTHCARE PROFESSIONAL
Bariatric
surgery in
Kuwait
6
Coffee Time
Professor Mervyn
Deitel talks to
Bariatric News
about his career
and the evolution
of bariatric
surgery
8
Mini-Gastric
Bypass
Conference
A special report
from the 2nd
International
Consensus
Conference
13
Variety of factors
The impact of
bariatric surgery
on risk factors for
cardiovascular
disease depends
on a variety
of factors,
including the
type of surgery,
sex, ethnic
background, and
pre-surgery BMI
25
Country news
36
Based on projections, it
would take more than ten
years to recover the costs
of the LRYGB procedure.
Canada: Access
to surgery
Nicolas Christou discusses
access to bariatric
surgery in Canada under
the publically-funded
healthcare system
Page 17
42
between January 2003 and September
31 2009. LAGB and LRYGB claimants
were propensity score matched to two
control samples: one restricted to those
with a MO diagnosis code and one
without this restriction. The random
sample of 120,000 individuals was
provided directly from Medstat.
Propensity score matching was used
to ensure that the four groups were as
similar as possible. LRYGB patients
were matched to LAGB patients based
on patient and health plan characteristics, and on diagnoses and costs in
the year prior to the quarter before the
bariatric procedure.
Using the four matched samples,
an analysis data set was created that
included quarterly payments of total,
inpatient (both facility and physician), non-inpatient
(including payments for hospital outpatient, physician’s
office visits, and emergency department), and prescription drug claims. Each quarter represented the time
relative to (pseudo) band placement.
T
he time taken to recuperate the
costs from bariatric surgery are
more likely to be double the
5.25 years previously estimated for
laparoscopic adjustable gastric band
(LAGB), according to a study that assessed ‘The Business Case for Bariatric
Surgery Revisited: A Non-Randomized
Case-Control Study business case for
bariatric surgery’, published online in
the journal PlosOne (October 2013).
The authors conclude that the time to
recuperate the costs from laparoscopic
Roux-en-Y gastric bypass (LRYGB) would be even
greater given the procedure results in increased hospital
stay and procedure time.
The study authors state that previous studies that
have examined the cost of bariatric surgery have relied
on a comparison sample of those with a morbid obesity
(MO) diagnosis code, despite the fact that this high cost
group might not be a true reflection of patients who
eventually have LAGB or LRYGB procedures. As a
result, this study re-estimated the net costs and time to
recuperate the costs using an alternative sample that
does not rely on the MO diagnosis code.
“Regardless of the time to break even, it is worth
pointing out that the expectation for any surgical
intervention to show a return on investment is unusual
and few effective interventions reach this threshold,”
the authors state. “LAGB, however, may be one of the Results
A total of 9,631 patients (after matching), were includexceptions.”
The analysis is based on claims data from the Mar- ing in each surgical group. The groups of patients are
Continued on page 3
ketScan Commercial Claims and Encounters database
Apollo Endosurgery buys
Allergan’s obesity unit
Medicare CoE policy could limit
minority access to surgery
pollo
Endosurgery
has
completed the acquisition of the
obesity intervention division of
Allergan, which manufactures and sells
weight loss solutions comprised of the
Lap-Band adjustable gastric banding
system and the Orbera intra-gastric balloon system.
“With worldwide obesity numbers
reaching epidemic levels, the acquisition
of the Lap-Band and the Orbera technologies places Apollo Endosurgery in a leadership position to provide surgeons and
patients with innovative and less invasive
solutions in the fight against obesity,” said
Dennis McWilliams, President and CEO
of Apollo Endosurgery. “By expanding
both our product portfolio and adding
Evidence supporting or
discontinuing bariatric CoE
is ‘inconclusive’
A
Industry and product news 39
Calendar of events
Clinical comment
More time needed to recuperate
the costs of bariatric surgery
IN THIS ISSUE…
In an exclusive
interview with Dr
Salman Al Sabah
we report on the
current status of
bariatric surgery in Kuwait
ISSUE 18 | DECEMBER 2013
talent to our team, this acquisition will
be a catalyst for growth as we continue to
advance technologies in the fields of bariatric and minimally invasive surgery.”
Apollo, who announced the acquisition in October 2013, will purchase
the unit for up to US$110 million. This
total includes an upfront cash payment of
US$75 million, a minority equity interest
in Apollo by Allergan of US$15 million,
and up to US$20 million in additional
contingent consideration to be paid upon
achievement of certain regulatory and
sales milestones.
The deal comes after a year of speculation, since the Allergan announced they
were planning to sell the unit in October
Continued on page 36
T
he policy of treating Medicare
bariatric surgery patients at
high-volume hospitals designated as Centers of Excellence could
be blocking obese minorities’ access
to care, according to ‘Bariatric Surgery in Minority Patients Before and
After Implementation of a Centers of
Excellence Program’, published online
in JAMA (JAMA. 2013 310(13):1399400.).
The study, which compared rates of
bariatric surgery for minority Medicare
vs. non-Medicare patients before and
after implementation of a Medicare
coverage policy, reported a decline in
the number of minority patients with
Medicare receiving bariatric surgery
after the policy was implemented.
“The Medicare centers of excellence policy was associated with a 4.7
percentage point (17 percent) decline
in the proportion of Medicare patients
receiving bariatric surgery who were
non-white,” said Dr Lauren Hersch
Nicholas, lead author of the letter and
an assistant professor with the Department of Health Policy and Management at Johns Hopkins Bloomberg
School of Public Health. “It appears
Continued on page 3
Bariatric Surgery
Database Software
Imagine being able to track
all your bariatric surgery cases
with ease and recall any record
almost instantly…
Now you can with just a
‘click’ of a button
Dendrite’s innovative software:
St Elsewhere’s Hospital
NHS Trust
AttAch
PAtient
Sticky
here
Bariatric operation:
Pre-op weight:
109 kg
38.9 kg m-2
Pre-op BMI:
Current weight:
76.4 kg
27.2 kg m-2
Current BMI:
Total weight loss:
Excess weight loss:
Vitamins / mineral supplem
ents:
Regular monitoring
(blood test):
Clinical evidence of
malnutrition:
Weight loss and excess
120
P
F
F
F
F
F
F
F
32.6 kg
83.9 %
Yes
Yes
No
weight loss
Excess weight loss
F
Weight loss
F
FFF
F
Weight / kg
100
120
80
100
60
80
40
60
20
40
20
0
0
250
Current comorbidity
status
Type 2 diabetes:
Hypertension:
Sleep:
Asthma:
Functional:
Back / leg pain from
OA:
GORD:
PCOS:
Menstrual:
Apron:
Any other information
Current progress:
Next appointment:
Time after surgery /
500
days
Impaired glycaemia
or impaired glucose
tolerance
No indication of hyperte
nsion
No diagnosis or indicatio
n of sleep apnoea
No diagnosis or indicatio
n of asthma
Can climb 3 flights of
stairs without resting
Intermittent symptom
s; no medication
Intermittent medicat
ion
No indication / diagnos
is; no medication
Regular menstrual cycle
No symptoms
for the notes / GP
Satisfactory, as expecte
d
months
Reveal • Interpret • Improve
The Hub – Station Road – Henley-on-Thames – RG9 1AY – United Kingdom
Phone: +44 1491 411 288 – e-mail: [email protected] – www.e-dendrite.com
NHS
Gastric band (on 09 /
04 / 2008)
08 / 07 / 2009
23 / 07 / 1967
Clinic date:
Date of birth:
%
• Creates graphs
displaying Excess
Weight Loss over
time
• Links to hospital
systems to pre-populate demographic fields
• Allows the easy export of data to national/
international registries
• Simplifies the data collection process
• Maintains patient
anonymity and confidentiality (safe and secure)
Excess weight loss /
• Allows the tracking of
procedures and outcomes from
all type of bariatric procedures
(including bands, balloons,
Roux-en-Y, gastric sleeve,
duodenal switch and BPD)
• Provides detailed tracking of comorbid conditions
• Facilitates longitudinal follow-up
• Automatically identifies followup breaches
• Reduces the workload by
automating production of patient reports, operation
notes and follow-up letters
Unsatisfactory (specify)
750
0
P
RP
R
Primary
Revision as a primary
Revision
S
Planned 2 nd stage
F
Follow up
bariatricnews.net 3
ISSUE 18 | DECEMBER 2013
More time needed to recuperate the costs of bariatric surgery
Figure 1 Figure 2
Continued from page 1
predominantly female and average 44
years old at the time of surgery. Approximately 25% have diabetes and the
prevalence of comorbidities ranged from
8.4% for asthma to 44% for hypertension. Payments for the LAGB sample in
the year before the quarter before surgery
averaged US$9,971, whilst for LRYGB
patients the payment was US$10,554.
The authors note that the MO sample
is about three years older than the LAGB
sample and has a smaller percentage of
females (65.7% vs. 79.1%). They also
report that although the prevalence of
the included comorbidities is statistically lower than in the surgery samples,
the annual costs are more than US$1,500
greater for the MO sample.
“This suggests that other differences
are making this sample more expensive,” they claim.
Figures 1 and 2 (above) provide
graphical representations of the cost
trends pre- and post- (pseudo) surgery for
total, inpatient, outpatient, and pharmaceutical costs. The first (surgery) quarter,
was not included as including this would
reduce the scale to the extent that trends
would not be observable. Costs for the
LAGB and LRYGB samples in this
quarter were US$21,980 and US$29,900
for the full sample and US$22,480 and
US$31,150 for the diabetes subsample,
respectively. These figures reveal a slight
increase in costs for the surgery samples
in the run-up to surgery.
In the second quarter, the researchers
noted a reduction in costs primarily for
pharmaceutical payments such as diabetes medications.
“Costs for the MO sample immediately escalate post pseudo surgery,
largely driven by a sharp increase in inpatient costs, thus revealing significant
underlying differences between this and
the matched random sample,” the authors state. “This increase in MO costs
is driven by higher rates of admissions.
Roughly one-third of the MO sample
had an admission post pseudo-surgery,
whereas this figure is 10% for the
remaining samples.”
When compared to the MO sample,
costs for LAGB and LRYGB appear to be
fully recovered in 1.5 (CI 1.45 to 1.55) and
2.25 years (CI: 2.07 to 2.43), respectively.
Subsequently, the authors claim that these
procedures appear to generate “significant
savings” at five years: US$78,980 (CI:
$62,320 to US$100,550) for LAGB
and US$61,420 (CI: US$44,710 to
US$82,870) for LRYGB.
Some of the difference in savings
between the two procedures results
from the higher estimated surgical
costs for LRYGB (US$16,680 vs.
US$22,140). The outcomes are more
significant for the diabetes subsample,
Table 1. Time to Breakeven and Net Costs for Full and Diabetes Samples.
Time to Breakeven (Years)
5-year Net Costs (United States Dollars)
Morbid Obese Sample
Sample
LAGB
LRYGB
LAGB
LRYGB
Full sample
1.5 (1.45 1.55)
2.25 (2.07 2.43)
−78,980
(−100,550-62,320)
−61,420
(−82,870-44,710)
Diabetes subsample
1.25 (1.02 1.48)
1.75 (1.49 2.01)
−127,590
(−167,590-94,840)
−103,340
(−146,760-65,550)
Sample
LAGB
LRYGB
LAGB
LRYGB
Full sample
5.25 (4.25 10+)
10+
690 (−6,800 8,400)
18,940 (10,390 26,740)
Diabetes subsample
4.25 (3 10+)
10+
−3,060 (−13,230 7,930)
21,610 (3,330 42,570)
Random Sample
Note: LAGB = laparoscopic adjustable gastric band; LRYGB = Laparoscopic Roux-en-Y Bypass
with costs fully recovered in 1.25
(CI: 1.02 to 1.48) years for LAGB
and 1.75 (CI: 1.49 to 2.01) years for
LRYGB and even larger estimated
savings at five years; US$127,590 (CI:
US$94,840 to US$167,590) for LAGB
and US$103,340 (CI: US$65,550 to
US$146,760) for LRYGB (see Table 1).
However, when comparisons are made
to the matched random sample the estimated time to recover the costs of a LAGB
procedure increases to 5.25 (CI: 4.25 to
10+) years for the full sample. Five-year
net costs (not savings) are US$690 (CI:
$-8,400 to $6,800). For LRYGB net costs
at five years are US$18,940 (CI: $10,390
to $26,740). Based on projections, it
would take more than ten years to recover
the costs of the LRYGB procedure.
Regarding the diabetes subsample,
when compared to the matched random
sample the estimated time to recover
the costs of a LAGB procedure is 4.25
(CI: 3 to 10+) years and five-year net
costs are now negative, revealing a
savings of US$3,060 (CI: US$-7,930 to
US$13,230). For LRYGB, the net costs
remain positive (i.e., no savings) at five
years; US$21,610 (CI: US$3,330 to
US$42,570) and, based on projections,
it would again take more than ten years
to recover the costs of the procedure.
The authors state that any return on
investment for bariatric surgery depends
on three factors:
1) the cost of the surgical procedures
2) the subsequent cost profile among
those who undergo the procedure
3) what their costs would have been
Medicare CoE policy could limit minority access to surgery
Continued from page 1
that a policy intended to improve patient safety
had the unintended consequence of reduced use of
bariatric surgery by minority Medicare patients.”
Hospitals are recognized as centers of excellence
if they submitted data to a registry, have adequate
protocols for care of morbidly obese patients, and
perform at least 125 bariatric procedures annually.
Researchers examined bariatric surgery discharge abstracts from 228,136 patients undergoing
bariatric surgery in 429 inpatient hospitals in eight
states and compared the proportion of minority
patients undergoing bariatric surgery with and
without Medicare before and after implementation of the policy change. Non-Medicare patients
were used as a control group to isolate associations with the Medicare policy change relative to
trends among all bariatric surgeries over the study
period. In addition, researchers compared the
number of white patients with those from all other
minority groups.
Results
Of 228,136 patients, 18,607 (8.2%) had Medicare;
4,909 Medicare patients (26.4%) and 58,729 nonMedicare patients (28.0%) were non-white, and
54,415 non-white patients (85.5%) were black or
Hispanic.
The proportion of Medicare patients undergoing
bariatric surgery who were non-white was 27.5%
before the 2006 National Coverage Determination
and stable after the NCD (25.9%; change, −1.5
percentage points [95% CI, −4.0 to 0.87]).
However, the proportion of non-white patients
increased from 26.2% to 29.1% (change, 2.9
percentage points [95% CI, 0.88 to 5.0]) among
non-Medicare patients. After adjusting for patient
state and time trends common to all patients, the
Medicare COE policy was associated with a 4.7
percentage point decline (95% CI, −7.3 to −2.7)
in the proportion of non-white patients with vs,
without Medicare receiving bariatric surgery, representing 17% of the proportion (4.7/27.5) before
implementation of the NCD.
Earlier studies documenting better surgical outcomes at hospitals with higher procedure volume
have prompted proposals to concentrate elective
surgery in high-volume settings; these policies
have been little-used in practice.
“Policies restricting patients to Centers of
Excellence could lead to serious issues including,
reducing access for vulnerable populations,” the
authors write.
To date, bariatric surgery is the only procedure
for which the Centers for Medicare and Medicaid
Services (CMS) have experimented with restrictions to high-volume hospitals.cmS recently
decided to eliminate the Centers of Excellence
requirement after studies suggested little if any
safety benefit to bariatric Centers of Excellence.
“Morbidity and mortality associated with
bariatric surgery have declined in recent years
and safety gains from limiting hospital choice
are likely lower than they were when the national
in the absence of the surgical intervention.
“Regardless of the time to break even, it
is worth pointing out that the expectation
for any surgical intervention to show
a return on investment is unusual and
few effective interventions reach this
threshold,” the authors state. “LAGB,
however, may be one of the exceptions.”
“These results reveal that the net costs
and time to break even resulting from
bariatric surgery are less favourable
than has been reported in prior studies,”
they conclude. “Yet, even with a more
conservative and likely more accurate
comparison sample, the business case
for LAGB appears favourable. Regardless, the decision of which procedure is
right for a given individual depends on
many factors, although cost is likely to
be a significant consideration.”
The study authors were Eric A Finkelstein (Health Services and Systems
Research, Duke-NUS Graduate Medical School, Singapore, Global Health
Institute, Duke University, Durham,
North Carolina, USA), Benjamin T Allaire (RTI International, Durham, North
Carolina, USA), Denise Globe (Global
Health Outcomes Strategy and Research,
Allergan Inc., Irvine, California, USA)
and John B Dixon (Department of General Practice, School of Primary Health
Care, Monash University, Melbourne,
Australia, Human Neurotransmitters
Laboratory, Vascular and Hypertension
Unit, The Baker-IDI Heart and Diabetes
Institute, Melbourne, Australia).
coverage decision was implemented in 2006,”
concluded Nicholas. “Our findings are important
for bariatric surgery and also serve as a cautionary tale about the potential for unintended consequences if selective referral policies are extended
to other procedures.”
Viewpoint
In an accompanying Medicare Policy on Bariatric
Surgery Decision Making in the Face of Uncertainty. ‘Viewpoint’ article, Drs Sean R Tunis and
Donna A Messner, of the Center for Medical Technology Policy, Baltimore, state that the arguments
or more importantly, the evidence as to whether
CoE centres achieve better results than institutions
without accreditation is ‘inconclusive’.
“The available scientific evidence neither
proves nor refutes the hypothesis that accreditation
improves health outcomes, meaning that Medicare
will need to make its final decision by the end of
September based on other clinical and public health
considerations,” they write.
Interestingly, the point towards varied ‘evidence’
Continued on page 5
4 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013
DiaRem predicts diabetes remission following surgery
DiaRem system is based
on four readily available
preoperative patient
characteristics
R
esearchers have developed
a simple scoring system that
can predict which candidates
for gastric bypass surgery are likely to
achieve diabetes remission within five
years. The ‘DiaRem’ system, developed
by investigators from Geisinger Health
System, Danville, PA, is based on four
readily available preoperative patient
characteristics; insulin use, age, hae-
moglobin A1c concentration (HbA1c;
a measure of blood sugar), and type of
anti-diabetic drugs.
“Our novel DiaRem score will give
patients and physicians a scientifically
valid way of assessing the merits of
gastric bypass surgery for treating diabetes and deciding whether additional
measures should be taken to improve
the odds of remission”, said lead author
George Argyropoulos from the Geisinger Health System, Danville, PA. The
research paper entitled ‘Preoperative
prediction of type 2 diabetes remission after Roux-en-Y gastric bypass
surgery: a retrospective cohort study’
was published in The Lancet Diabetes
& Endocrinology journal.
To create the scoring system, the
researchers retrospectively analysed the
outcomes of 690 obese patients with
type 2 diabetes who underwent RYGB
between 2004 and 2011 at the Geisinger
Health System Clinic, 463 (63%) patients
achieved partial or complete remission.
Multiple logistic regression models
considered 259 clinical variables to
identify independent predictors of early
remission (beginning within the first
two months after surgery and lasting a
minimum of 12 months) and late remission (beginning more than two months
after surgery and lasting at least another
12 months).
Patients were assigned a weighted
DiaRem score (ranging from 0 to 22)
based on four factors that were independently predictive of remission, and
their scores were derived by assigning a
certain number of points to each of the
four factors.
The researchers found that patients
with a low DiaRem score had the highest chance of remission after surgery,
while those with a higher score were
less likely to achieve remission.
“For example, an individual with
a BMI 39 and a DiaRem score of 22
could benefit from RYGB surgery in
terms of weight loss, but would have
low probability of diabetes remission”,
said Argyropoulos. “Our score is robust
with various definitions of diabetes
remission – complete, partial, or a combination – and also predicts the probable
improvement in glycaemic control after
RYGB surgery.”
The performance of the score was
validated in two independent cohorts
totalling 389 patients based on diabetes
remission at 14 months. As in the primary
cohort, the proportion of patients achieving remission was highest for the lowest
scores and lowest for the highest scores.
Four-year-old undergoes bariatric surgery
I
n news that will surprise and shock in equal
measure, an Indian child of four years and 10
months has become the youngest person in the
world to have bariatric surgery. The child, Rishi
Khatau from Kolkata, was morbidly obese and
weighed 44.5kgs (98.1lbs) prior to surgery.
He was also diagnosed with Prader Willi Syndrome (PWS), a rare genetic disorder caused by
deletion or disruption of genes, and can result in
low muscle tone, short stature, incomplete sexual
development, cognitive disabilities, problem behaviours, and a chronic feeling of hunger that can lead to
excessive eating and life-threatening obesity.
“Rishi suffered severe difficulty in breathing
while sleeping wherein his oxygen saturation
levels dropped below 60 per cent leaving him
gasping for breath,” said Dr Mahendra Narwaria
form Ahmedabad-based, Asian Bariatrics Hospital. “Generally, we would avoid bariatric surgery
in such a young child but his problem could have
been fatal. Exercise and controlling diet was not
an option as due to his weight, he could not exercise while his genetic condition made him crave
for food.”
As a result of his condition, Rishi consumed 1,500
calories per day and he also presented with sleep apnoea and breathing problems, which became so acute
that he could not sleep lying down for more than ten
minutes as he would wake up gasping for breath.
“In obese children, the intra-abdominal pressure becomes very high, there is not enough space
for the lungs to expand to full capacity,” said
Narwaria. “This leads to less oxygen in the body.
The disturbed exchange of gases also leads to water
retention and hence more weight gain.”
According to the surgical team there were many
challenges managing such a young patient both
during operation and post-operatively.
Dr Mahendra Narwaria with Rishi Khatau
The banded gastric bypass: a new frontier or back to the future?
“Since Roux-en-Y Gastric Bypass is primarily a restriction operation, just as with VBG, it is important
that the outlet of the pouch does not stretch.” Edward Mason (Obesity Surgery 1994;4:66-72)
T
he rise in the number of banded gastric
bypass procedures underlines acceptance
by bariatric and metabolic surgeons of
the importance of the gastric reservoir size, as a
determinant of how the gastric bypass operation
effects weight loss and weight loss maintenance.
And there is now a growing body of evidence
to support banded gastric bypass procedures.
“As more patients undergo surgical intervention there will be more patients at risk of inadequate weight loss or weight regain resulting in
failure,” said Dr MAL Fobi from the Center for
surgical Treatment of Obesity, Carson, California,
speaking at the recent IFSO meeting in Istanbul.
“Putting a ring around the gastric pouch to control
the reservoir size is a good adjunct to the gastric
bypass operation for obesity.”
Failure
He began by explaining that the literature is replete
with articles documenting inadequate weight loss
and weight regain in a subset of patients after the
short limb gastric bypass.
“These account for a 25-40% failure rate
after most gastric bypass operations,” said Fobi.
“Though failure may be due to complications and
patient non-compliance, cumulative experience
have attributed failures to increase in the size of
the reservoir.”
The literature shows that the predicted
percentage of maximal weight lost after RYGB
was regained in five years, after the procedure at
different GJ stoma diameters based on the linear
regression model (Clinical Gastroenterology and
Hepatology 2011; 9:228-233).
Furthermore, endoscopic and radiological
findings show that dilated stomas, up to 4cm wide
after gastric bypass, is the cause for weight regain
Figure 1:Reservoir capacity of a gastric bypass
operation is initially the size of the tubular pouch.
Reservoir capacity (dilated reservoir) negates the
restrictive mechanism of the operation
Figure 2: Placement of a ring around the gastric
pouch controls the reservoir size
two-to-three years after gastric bypass.
Fobi explained that a dilated stoma converts the
pouch and the proximal small bowel into a neopouch – a larger reservoir that can accommodate as
much as the initial stomach – causing inadequate
weight loss and weight regain after gastric bypass.
The reservoir capacity of a gastric bypass operation is initially the size of the tubular pouch created
by the surgeon at the time of operation (Figure 1).
However, the reservoir capacity in most patients after the first year is made up of the dilated
pouch and the dilated proximal small bowel. This
increased reservoir capacity (dilated reservoir)
negates the restrictive mechanism of the operation
allowing the patient to tolerate more caloric intake
and minimising the weight loss or enhancing the
weight regain seen after the operation
Banded solution
“The placement of a Ring forces the use of a
small tubular pouch with a standard stoma,”
said Fobi. “Placed 3-4cm from the GE-junction
and at least 1.5cm above the gastro-jejunal
anastomosis and loose around the pouch
at time of banding, the Ring enhances the
restrictive mechanism of a gastric bypass by
establishing a controlled reservoir, resulting
in more weight loss in more patients, even
the super obese and also enhances weight loss
maintenance.”(Figure 2)
The literature supports this notion: Awad
et al (Obesity Surgery. 2012;15:724) reported
that there is a significant difference in %EWL
for banded patients at 36-96 month. In addition, comparative studies of the banded vs. non
“We had to use specific sleeve sizer and smaller
stapler to perform the surgery to reduce the size of
his stomach to one third,” said Narwaria. “Since he
is a growing child, we have not bypassed any portion of his intestine so that he does not suffer any
malnutrition. His stomach will grow to its normal
size as he grows up.”
At present, Rishi is on a liquid diet and able to
consume just 400 calories a day. He is using a noninvasive ventilator (BiPEP) to maintain his oxygen
levels. In time, he will receive mashed food before
being able to have the normal food. He is expected
to lose 60% to 80% of his pre-surgical weight.
The other doctors in the team who helped
managing this case were Dr Nidhish Nanavati
(paediatrician), Dr Ajay Shah (pulmonologist),
Dr Vivek Arya (endocrinologist), Dr Yogesh Tank
and Dr Parag Gohil (anaesthesiologist) and Ms
Devanshi Choksi (nutritionist).
banded gastric bypass show better weight loss
in the banded group (Bressler M. et al Obesity
Surgery 2006; Carvajal JJB et al Obesity Surgery
2006;16;225; Karcz K. Abstract Obesity Surgery.
IFO2012; Lemmens L. Abstract Obesity Surgery.
IFSO 2012).
The views of Fobi were also echoed by another
luminary of the bariatric specialty, Dr Mervyn
Deitel (Editor Emeritus of the Obesity Surgery
journal), who said at the IBC-IFSO 2013 Symposium: “If you want a long-term effective restrictive
bariatric operation – put a Ring (band) on it.”
Low complication rate
Fobi also noted that whilst there have been
recorded instances of band erosion, kinking or
slippage, and solid food intolerance, the literature
shows these occur in less than 1%, 2% and 5%
of cases and can often be treated endoscopically,
removal/replacement and by nutritional counselling, respectively.
However, also presented at the IFSO meeting, Dr Alex Heylen, The Wellness Kliniek,
Genk, Belgium, reported that in his series of 145
patients not a single instance of ring erosion in a
six year period.
In addition, Luc Lemmens reported 0.4%
instance of erosion at the same meeting, and data
from the GaBP Ring System FDA Clinical Trial
show an erosion/penetrating ulcer rate of 1.1%
(n=3/276).
“The banded gastric bypass controls the
pouch size resulting in increased weight loss and
enhanced weight loss maintenance,” concluded
Fobi. “It decreases the incidence of gastric outlet
stenosis and decreases the severity of postprandial
dumping, whilst minimising the incidence of reactive hypoglycaemia. The banded gastric bypass
is not only the “New Frontier” – it is “Back to
the Future” since now there are prefabricated,
standardised and sterilised devices available for
easy implantation for banding the pouch.”
For more information about the banded procedures,
please visit Bariatric Corporation
bariatricnews.net 5
ISSUE 18 | DECEMBER 2013
Surgical groups ‘disappointed’ as Medicare drops CoE designation
Decision based on
‘sufficient’ evidence that
certification does not
improve outcomes
T
needs of its patient population.”
This latest ruling marks a reversal of
a CMS policy enacted in 2006 that made
facility accreditation a requirement for
Medicare coverage. It also makes CMS
the only major insurer that does not
require bariatric surgical procedures be
performed at an accredited center. Blue
Cross Blue Shield, Aetna, Cigna and
United Healthcare have each embraced
and continue to support accreditation.
Medicare will continue to cover open
and laparoscopic Roux-en-Y gastric
bypass; laparoscopic adjustable gastric
banding; and open and laparoscopic
biliopancreatic diversion with duodenal
switch for Medicare beneficiaries with
a BMI >35 in those with at least one
comorbidity related to obesity who
previously have been unsuccessful with
medical treatment for obesity.
Disappointment
The American Society for Metabolic
and Bariatric Surgery and the American
College of Surgeons have expressed
their disappoint at the Centers for Medi-
Jamie Ponce
John Morton
care & Medicaid Services (CMS) recent
decision that it will no longer require
Medicare patients to undergo bariatric
surgical procedures at accredited facilities. The ruling means that eligible
Medicare patients may have bariatric
operations performed at any centre
they choose, even those facilities with
little experience in handling high-risk
patients.
“We are disappointed and in strong
disagreement with a ruling that appears
to disregard overwhelming scientific
evidence and medical opinion that bariatric accreditation programs save lives,
improve patient outcomes, and enhance
the quality of care,” said Dr Jamie
Ponce, President of the American Society for Metabolic and Bariatric Surgery
(ASMBS).
Approximately 750 inpatient and
outpatient bariatric centres throughout
the US are accredited by either the
ASMBS or ACS. In 2012, the two surgical societies combined their respective
programs and formed the Metabolic
and Bariatric Surgery Accreditation and
Quality Improvement Program (MBSAQIP), to establish a national standard
for accreditation and quality improvement that requires participating facilities
to undergo a peer-evaluation process,
follow data submission requirements,
and demonstrate experience in managing bariatric surgical patients before,
during, and after their procedures in
order to receive accreditation.
“The standards required for accreditation provide important lifesaving
safeguards for patients, particularly for
Medicare beneficiaries, who have a
higher risk of morbidity and mortality
than the general bariatric surgery population,” said Dr David B Hoyt, Executive
Maintain long-term weight loss with the
GaBP Ring
Autolock System™
The GaBP Ring is a
pre-fabricated, standardized
and sterilized silicone
device designed specifically
to control the reservoir
capacity in the gastric
bypass, gastroplasty
and sleeve gastrectomy
operations. Placement of the GaBP Ring
around the proximal
pouch results in
increased weight loss
and long-term weight
loss maintenance.
Advert
Medicare CoE policy could limit minority
access to surgery
Non-Medicare
30
25
20
Non-white (%)
he Centers for Medicare &
Medicaid Services (CMS) has
ruled it will no longer require
Medicare patients to undergo bariatric
surgical procedures at accredited facilities. The ruling means that eligible
Medicare patients may have bariatric
operations performed at any center
they choose, even those facilities with
little experience in handling high-risk
patients. The decision is effective from
25 September 2013.
The CMS based their decision on
‘sufficient’ evidence to conclude that
certification does not improve health
outcomes for Medicare beneficiaries.
Although the organisation has agreed
that there is a role for accreditation
programmes, it said that they are not
necessary to ensure safe outcomes for
Medicare beneficiaries.
“The removal of a coverage requirement does not require facilities to
discontinue practices which they find
beneficial,” according to the decision
memo. Facilities may choose to continue
with certification in order to distinguish
themselves from the competition, for
instance.
“While CMS agrees with the value
of the multidisciplinary team approach
and structure, we do not believe that
every valued endeavour needs to be
buttressed by a Medicare mandate,”
the memo states. “We expect all facilities to strive to provide the proper
equipment and services to meet the
Director of the ACS. “We encourage
Medicare patients to continue to select an
accredited centre for bariatric surgery.”
The new ruling marks a reversal of a
CMS policy enacted in 2006 that made
facility accreditation a requirement for
Medicare coverage. It also makes CMS
the only major insurer that does not
require bariatric surgical procedures be
performed at an accredited center. Blue
Cross Blue Shield, Aetna, Cigna and
United Healthcare have each embraced
and continue to support accreditation
In addition to the ASMBS and ACS,
other professional groups supporting
accreditation and opposing the new
CMS ruling are The Obesity Society,
Academy of Nutrition and Dietetics,
American Society of Bariatric Physicians (ASBP), American Association of
Clinical Endocrinologists (AACE), and
Society of American Gastrointestinal
and Endoscopic Surgeons (SAGES).
“MBSAQIP will continue to build
upon bariatric surgery’s legacy of quality improvement, which has previously
included a four-fold decline in mortality
over the past decade, by initiating a new
program in decreasing readmissions,”
said Dr John Morton, ASMBS Secretary-Treasurer and Associate Professor
of Surgery at Stanford University.
“We have made great strides in
surgical techniques, patient care, and
in identifying potential risks and managingcmplications,” Ponce wrote in a
message to ASMBS members. “But
we cannot become complacent when it
comes to patient safety and procedure
effectiveness. We are committed to
continuous quality improvement and
accreditation is the mechanism by which
we can best achieve it.”
15
10
5
0
2004
2005
2006
2007
Year
2008
2009
Figure 1: Proportion of minority patients undergoing bariatric surgery before and after the
Medicare NCD, 2004-2009
WWW.BARIATEC.COM
+1-(310)-515-3787
Continued from page 3
as to why there has been a significant improvements
in patient outcomes, specifically the move to open
to laparoscopic procedures including adjustable
gastric banding. When shifts toward safer surgical
procedures.
They also note that the number of procedures
has increased in conjunction with surgical experience, technique and technology, thereby reducing
the complication and re-operation rates, as well as
improving perioperative patient management.
“However, it is possible that some hospitals,
and perhaps many, will discontinue activities
that are currently required to obtain COE status,
and patient outcomes will worsen. This is the
strong consensus view of the bariatric surgical
community,” they conclude. “Although such
collective professional judgment usually does
not influence evidence-based policy making, its
relative importance is greater when the overall
body of scientific evidence is inconclusive as in
this case.”
The research was supported in part by the
National Institute on Aging and the Agency for
Healthcare Research and Quality.
6 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013
Bariatric surgery in Kuwait: an
interview with Dr Salman Al Sabah
With 80% of its population overweight, 47.5% obese and ranking
the 8th fattest population worldwide, Kuwait has a serious obesity
problem. This has lead to widespread practice of bariatric surgery.
Dr Salman Al Sabah, Director of Surgical Research and Academic
Program in the Department of Surgery, Consultant Surgeon at Al Amiri
hospital, Kuwait, Director of the First and Second Kuwait Bariatric
& Metabolic Surgery Conference and the First Gulf Obesity and
Metabolic Surgery Society (GOSS) Meeting which is to be held in
Kuwait on December 12-14 December 2014, talks to Bariatric News
regarding educating the region about the dangers of ‘diabesity’ and
the aims and themes of the First GOSS meeting.
T
IRAN
IRAQ
Bubiyan
KUWAIT
Faylakah
Al Jahrah
Salman Al Sabah
Kuwait
City
Persian
Gulf
he rise and prevalence of
“One of the main challenges facing
“Fast food in Kuwait, especially
Kuwait
obesity in Kuwait (and the diabetics is the lack of knowledge and after the Gulf War, flooded the malls and
wider Gulf region) has been well empowerment to take control of their the nation,” he added. “It is cheap, fast
documented with 36% of men and 48% diabetes,” said Dr Salman Al Sabah. “In and convenient. The weather is another
of women being nationally classified as 2011, The Diabetes Kuwait Resource factor in the Gulf’s weight problem. In
obese while 74% of men and 77% of Centre was established and is dedicated the summer, temperatures soar to 110F
women are overweight or obese. (Obes to provide diabetes focused education or 120F making it impossible to walk
Rev. 2011 Jan;12(1):1-13).
and support for individuals, fam- outdoors.”
SAUDI ARABIA
“Ten percent are classified morbidly ily members, and the public of Kuwait
In addition, the economic explosion
obese,” said Dr Salman Al Sabah. “Ac- thereby improving the lives of all those in Gulf region (United Arab Emirates
tually, the numbers are worse: Only 12 affected by diabetes and increasing (UAE), Saudi Arabia, Kuwait, Bahrain, every aspect of the traditional Kuwaiti with the participation of world class
percent of Kuwaitis have a BMI below overall awareness.”
Qatar, Oman), after the discovery of lifestyle, in terms of nutrition, physical regional and international faculty. Our
GOSS meeting will include workshops,
25.” According to a study published
In addition, the Dasman Diabetes oil, created the perfect breeding ground activity, and access to healthcare.
in June by the London School of
for non communicable diseases;
“Kuwaitis went from what used to be live surgery and relevant debates.
Some of the topics covered will be:
Hygiene and Tropical Medicine,
mainly obesity, diabetes, and an extremely different lifestyle of highly
using data from the World Health
hypertension. This has happened intensive physical labor, like pearl div- n Surgery for type 2 diabetes.
“Only 12 percent of Kuwaitis
Organization, Kuwait is the
due to the sudden increase in ing, to reaping the benefits of the new n Mal-absorptive operations; are they
have a BMI below 25… Kuwait is
suitable for our region.
second-most obese nation in the
socio- economical status which found natural resource – oil in the late
the second-most obese nation
n Current trend of bariatric surgery in
world, behind the US, creating the
led to population growth, drastic 1930s,” said Dr Salman Al Sabah.
the Gulf region.
need for bariatric surgery.
changes in food consumption
He explained that this dramatic
in the world, behind the US,
As waistlines in Kuwait and
patterns quality and quantity, a change in lifestyle provides the gateway n Sleeve gastrectomy; why is it
this has created the need for
becoming so common?
across the Gulf have expanded
decrease in the physical activities for a change in both physical activity as
over the last three or four years,
brought on by prosperity, and the well as dietary changes. Calories con- n Management of Sleeve gastrectomy
bariatric surgery.”
complications.
so too has the business of bariatric
trend of overconsumption and sumed started exceeding calories burnt,
Dr Salman Al Sabah
AUD
I
surgery. Ten years ago there were
over indulgence in every aspect leading to theSpresent
increase
of obesity n Revisional bariatric surgery.
n Complications of bariatric surgery.
only few bariatric surgeons in
of life.
in Kuwait. A R A B I A
Kuwait, he explained. Today, there
Nutritional transition is due
Traditional foods have been replaced n Gastric plication and Mini gastric
bypass update.
are 35 surgeons involved in bariatric Institute in Kuwait is the first research- to a change in the socio-economic by energy-dense high-fat foods. Excesprocedures (private and governmental based organization that addresses standard. The process known as “nutri- sive dietary intake and unbalanced n Adolescent bariatric surgery.
hospitals) and this number will increase. diabetes from a multi-disciplinary tion transition” is a global phenomenon diets along with sedentary lifestyles n Multidisciplinary session.
At least 6,000 people in Kuwait approach with education, treatment of affecting population diet and physical have contributed to the increase in the “As well as surgeons, we will welcome
underwent bariatric surgery last year patients, and health care professionals activity patterns in developing countries prevalence of over nutrition and the health professionals of all disciplines
(Table 1), and a paper published in on a national level.
incidence of diet related non- and policy makers, who I am sure will
“There are some initiaObesity Surgery (2013) reported that
communicable diseases such benefit greatly from this meeting. Our
“We encourage more surgeons and
vision is for this annual event to be
the country has the highest numbers of tives to raise awareness
as diabetes.
operations performed as a percentage of about diabetes and obesity,”
With regards to childhood the main bariatric surgery event in the
health professionals to join the GOSS
he added. “These are geared
national population (Table 2).
obesity, Dr Salman Al Sabah Gulf region. The meeting will rotate
and develop opportunities for career
The rise in bariatric procedures in not towards educating people
said that education is the annually between the six Gulf countries;
development, interpersonal networking,
just limited to Kuwait; the whole region on healthy eating and exerfoundation that can reverse next meeting will be in Dubai in 2014,”
he concluded. “We encourage more
is facing a dramatic rise in the number of cise. However, we still need
this trend.
involve our residents and fellows in
operations. Since 2012, over 25,000 bar- more.”
“It should start with surgeons and health professionals to join
various committees and educational
Dr Salman Al Sabah exiatric procedures have been performed
pregnant women, education the GOSS and develop opportunities
plained that the rise of obein the Gulf (Table 3).
at school level that promotes for career development, interpersonal
programmes and extend our reach
sity and diabetes are multihealthy eating and physical networking, involve our residents and
internationally.”
Diabetes
factorial, including the fact
activity, and national aware- fellows in various committees and
In addition to a rise in obesity, Kuwait that some 60-80% of genetic
ness of obesity. Patients in educational programs and extend our
Dr Salman Al Sabah
(and the wider region) has also seen a factors predispose people of
Kuwait with Type II diabetes research internationally.”
rise in the numbers of diabetics. Accord- middle-eastern descent to
are much younger compare
To find out more about the meeting, please
ing to the International Diabetes Federa- both obesity and diabetes. However, he with characteristic nutritional outcomes. to patients around the world.”
tion, Kuwait ranks 9th in the world for also stated that lifestyle plays a big role
In Kuwait, the discovery of oil opened
The biggest challenge, according to visit: gulfobesity.com
prevalence of diabetes (Table 4).
in the prevalence of obesity.
the gates to a new era, which impacted Dr Salman Al Sabah, will be addressing
Table 4
the ratio of obese and morbidly obese
Table 3: The growth of bariatric procedures in the Gulf region 2007-12 (data from industry)
Table 1: Number of bariatric surgery
individuals to the number of qualified
Adult Population (20-79)
2293.74
procedures in Kuwait 2007-12
in 1000s
surgeons. He said that policies need to
Year
Band
Sleeve
Total
be established on a national and regional
Diabetes cases (20-79) in
407.53
1000s
2007
295
234
529
level that fits the culture and the epi17.77
Diabetes National Prevademic of obesity in the region. There is a
2008
332
426
758
lence (%)
need
for
collaboration
and
support
from
2009
317
670
987
Diabetes Comparative
23.09
other health care disciplines to tackle the
2010
187
1481
1668
Prevalence(%)
problem of ‘diabesity’ in the region.
2011
119
4570
4689
2012
131
6551
6682
Table 2: Numbers of operations performed as a percentage of national
population 2011
High Frequent (%)
Low frequent (%)
Kuwait 0.1642
Japan 0.0001
Sweden 0.0899
Ukraine 0.0003
Belgium 0.0772
India 0.0004
IFSO worldwide survey of 42 countries
First Gulf Obesity Surgery Society
Meeting
“In December 2013, we will be hosting
the First Gulf Obesity Surgery Society
Meeting, and this will be an excellent
opportunity for the gulf surgeons, health
professionals, and industry to meet,
collaborate, and share their experience
as well as discussing with international
experts,” said Dr Salman Al Sabah. “We
have put together a great programme
Diabetes related Deaths
1122
Incidence Type 1 diabetes
(0-14) per 100,000
22.3
Mean diabetes related
expenditure per person
with diabetes (USD)
1886
IGT cases (20-79) in
1000s
357.86
IGT National Prevalence
(%)
15.60
IGT Comparative Prevalence (%)
17.88
bariatricnews.net 7
ISSUE 18 | DECEMBER 2013
SM-BOSS study: sleeve has fewer complications than bypass
T
ailored approach allows the
bariatric surgeon to take into account the patients’ preoperative
risk profile and will optimise the longterm results of bariatric surgery
The early results from the Swiss Multicentre Bypass or Sleeve Study (SMBOSS) have shown that laparoscopic
sleeve gastrectomy was associated
with shorter operation time and a trend
toward fewer complications than with
laparoscopic Roux-en-Y gastric bypass
(LRYGB), however, the difference
was not statistically significant. The
outcomes were published in the journal
Annals of Surgery (Early Results of the
Swiss Multicentre Bypass or Sleeve
Study (SM-BOSS): A Prospective Randomized Trial Comparing Laparoscopic
Sleeve Gastrectomy and Roux-en-Y
Gastric Bypass. 2013:258(5):690-5).
Importantly, both procedures were almost equally efficient regarding weight
loss, improvement of comorbidities,
and quality of life one year after surgery. However, the study authors from
Claraspital, Basel, Inselspital, Bern,
Kantonsspital St Gallen, St Gallen, and
University Hospital Zürich, Zurich,
Switzerland, added that the long-term
follow-up data are needed to confirm
the results
The researchers write that they
undertook the randomised clinical trial
to assess the effectiveness and safety of
the two procedures as ‘prospective data
comparing both procedures are rare’.
Indeed, they note that there have been
three (two from the same institution)
randomised clinical trials published
comparing LSG and LRYGB with small
patient numbers (16–30per group) and
limited follow-up (12–35 months).
Study
A total of 217patients were randomised
at four bariatric centres in Switzerland.
One hundred seven patients underwent
LSG using a 35-F bougie with suturing
of the stapler line, and 110 patients underwent LRYGB with a 150cm antecolic
alimentary and a 50cm biliopancreatic
limb. The mean body mass index of all
patients was 44±11.1, the mean age was
43 ± 5.3 years, and 72% were female.
The groups were similar in terms of
body mass index, age, sex, comorbidities, and eating behaviour. In addition,
there were no significant differences
with regards to comorbidities (diabetes,
hypertension, dyslipidema etc) between
the two procedural groups.
The primary end point of the study
was weight loss, which was defined by
excessive BMI loss (EBMIL), over a
period of five years. To detect a 10%
difference, we calculated a study size
of 200 patients to reach a 94% power.
Secondary end points were the rate of
perioperative morbidity and mortality,
the remission rates of the associated
comorbidities, and the change in quality
of life (QOL) in the two patient groups.
Outcomes
All patients presented for follow-up at 12
months, 112 patients completed followup at two years and 70 patients the threeyear follow-up at the time of analysis
(median follow-up of two years).
Figure 2: Reduction in comorbidity one year after surgery. No significant difference in
cure or improvement of comorbidities between LSG and LRYGB except for GERD
(*P = 0.008). GERD indicates gastro oesophageal reflux disease; OSAS, obstructive
sleep apnea syndrome; T2DM, type 2 diabetes.
The mean operative time was less for
LSG than for LRYGB (87±52.3 minutes
vs 108±42.3 minutes; p=0.003). Complications (<30 days) occurred more
often in LRYGB than in LSG (17.2%vs
8.4%; p=0.067), although the difference
in severe complications did not reach
statistical significance.
The rate of severe complications
requiring a reoperation was 4.5%
(5/110) in the LRYGB group versus
0.9% (1/107) in the LSG group (P =
0.21). The reason for the reoperation
in the LSG group was obstruction of
the gastric sleeve. The reasons for the
five revisions in the LRYGB group
were as follows: one leakage at the
gastrojejunostomy, one obstruction
of the biliopancreatic limb, two intraabdominal abscesses, and one pleural
empyema. Except for gastroesophageal
reflux disease (GERD), which showed
a higher resolution rate after LRYGB,
the comorbidities and quality of life
were significantly improved after both
procedures.
Excessive body mass index loss
at one year was similar between the
two groups (72.3%±22% for LSG and
76.6%±21% for LRYGB; p=0.2). There
was no difference regarding weight loss
or EBMIL between the 2 groups after
one year (Figures 1A, B), and there was
no further weight loss in patients who
completed the follow-up at two and
three years.
Comorbidities
The rate of comorbidities improved in
both groups (Figure 2). Except for the
remission of GERD, there was no difference between the LSG group and the
LRYGB group regarding the remission
Figure 1: A, Change in BMI (means ±
standard error). B, EBMIL (means).
of comorbidities or improvement rate.
Patients undergoing LSG experienced a
slightly higher rate of new-onset GERD
(12.5% vs 4%; p=0.12), and among
those who already presented with
GERD before the operation, the rate of
improvement was significantly lower
than those who underwent LRYGB
(50% vs 75%; p=0.008).
Patients from both groups experienced a significant improvement in
quality of life, compared with baseline
(p<0.0001) and even exceeded that of
healthy individuals who reach a score of
121 points (p<0.01).
In the LRYGB group, there was one
anastomotic ulcer at the gastroenterContinued on page 27
8 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013
with Mervyn Deitel
ff
o
ee
time
C
Bariatric News was delighted to speak with Professor Mervyn Deitel, one of
the Founders of the American Society for Bariatric Surgery in 1983 in Iowa City
and a President of the ASBS in 1995. He was one of the 13 Founders of the
International Federation for the Surgery of Obesity (IFSO) in Stockholm in 1995,
the first Executive Director of IFSO, and remains an Honorary Life Member. We
spoke about his career in bariatric surgery……
Did you always want a career in
medicine?
sufficient weight and is a healthy adult today.
Because I was treating starvation cases,
When I was really young I want to be an
in 1969 I started getting referrals of patients
artist, then a scientist, and later specifically
who were the opposite – massively obese with
a doctor. I had two older cousins who were
severe co-morbidities.
doctors and I admired what they did and
A urologist referred a female patient to me
aspired to be like them.
who had breakdowns of repairs for urinary
incontinence. She weighed over 400lbs, and
Why did you decide to specialise in
I performed a jejunoileal bypass and she
bariatric surgery, what attracted you subsequently lost a lot of weight. From then
to the specialty?
on, everyone started sending me their morbidly
When I graduated from medical school, I
obese patients.
wanted to become a surgeon. I trained in New
At first, the Chief of Staff at St Joseph’s
York in GI and Head & Neck surgery, and in
Hospital wanted to stop me performing
Buffalo in cancer surgery, and then Dallas where jejunoileal bypasses; however, he soon saw the
I performed trauma surgery. When I came back benefits of the major weight loss and referred
to Toronto, the Chief of Surgery wanted me to
his godmother to me for obesity surgery.
handle shock cases such as haemorrhagic and
The jejunoileal bypass got some bad press.
septic shock in the Trauma Unit. I soon realised I thought it was a good operation if the patient
that one of the major problems with patients
was followed closely, and its main failing was
was malnutrition, so in the 1960s for the first
the development of renal stones years later in
time in Canada, I started a treatment called
about 10% of patients.
intravenous hyperalimentation – which became
Can you tell us how bariatric
known as total parenteral nutrition.
surgery has evolved during your
As nobody in Canada had done this before,
career?
the treatment was met with some scepticism.
After the jejunoileal bypass, we started
We were putting in central lines for long periods
performing the loop horizontal gastric bypass,
of time with very high concentrations of amino
originated by Ed Mason. However, this
acids and sugar. Over time, I developed my
operation often resulted in tremendous tension
own pump, and eventually we started infusing
on the jejunal loop, and if the anastomosis ever
lipid emulsion, and later we wrote the original
leaked, the leak would probably prove fatal for
paper on liposyn concentrations (Wong KH,
the patient due to the egress of large quantities
Deitel M. Studies with a safflower oil emulsion
of bile, pancreatic and gastric juices. So the
in total parenteral nutrition. Can Med Assoc J.
Roux-en Y gastric bypass was performed: a
1981;125:1328-34).
jejunal Roux-loop was brought up to the high
GI fistulas were referred to me, and I found
that by providing nutrition centrally, the leakage gastric pouch so tension on the anastomosis
was avoided. The RYGB provides a degree
would immediately decrease, patients would
of restriction and malabsorption, and remains
gain weight, and survive.
widely performed.
I once treated a 500g premature newborn –
Subsequently, various types of horizontal
the baby was so small that the nurse’s wedding
gastroplasties were tried: patients would lose
ring would fit on the baby’s arm. I had to use
weight for the first two years, but unfortunately
the internal jugular vein which was the size of
the proximal gastric pouch and outlet would
a hair, and thread down a catheter. Within a
expand, leading to regain weight.
month, the baby could eat on his own, gained
Then, in 1982, Mason reported his results
from vertical banded gastroplasty (VBG), and this
operation became widely adopted. The weight
loss was terrific for three years, but patients then
regained weight, usually because the pouch
enlarged or the patients adapted their eating
habits. The popularity of the VBG, which was a
procedure of choice for 10-15 years, declined.
Interestingly, the published VBG results were
excellent, but the devil was in the details as noone could publish the results of patients lost to
follow-up. Many patients were too embarrassed
to return for follow-up because of weight regain.
Meanwhile, laparoscopic surgery took off
and gastric banding entered the arena. There
is plenty of talk about band failure, but if you
watch the patient and achieve regular followup, the inflatable band has been effective. In
fact, I know of many bariatric surgeons who
themselves opted to have a band placed in
them, and not one has had it removed.
The sleeve gastrectomy is on the rise, partly
because it saves the US$3,000-$4,000 cost of
the band. The sleeve costs the price of staples.
We are also seeing the rise of gastric plication,
which further saves cost, as sutures are used
instead of staplers. With regards to the sleeve,
my prognostication is that many patients will
slowly start to regain weight around years four
and five, and will eventually require a further
procedure.
The sleeve may really be a VBG without
the band, and we may be witness to a sleeve
gastrectomy hoax. I have reservations as to
the accuracy of the data reported. If you look
at the data closely, you will see that very many
patients are lost to follow-up.
I hear sleeve surgeons discussing leaks
(which are infrequent but serious) and talking
about drainage, stents, TPN, jejunostomy
tubes, etc. But they do not seem to mention
that these patients may be going through “hell”:
they have drains and tubes coming out of the
abdomen and may experience pain for months,
and are having multiple endoscopic procedures.
You founded the journal Obesity
Surgery. What do you remember
about its creation?
In 1990, a number of bariatric surgeons felt
the need for a specialized journal on obesity
surgery; many articles had been refused by the
general surgical journals because of insufficient
interest by their readers. But, there was also
opposition from a number of members of the
Handbook of Obesity Surgery
Current concepts and therapy of morbid obesity and related disease
Editors: Mervyn Deitel, Michel Gagner, John B. Dixon, Jacques Himpens, Atul K. Madan
More than 250 expert contributing authors • 480 pages • Up-to-date and comprehensive
Highlights include:
Surgical techniques, treatment of
complications, outcomes
n Gastric Banding, Band Adjustments and
Strategies
n Laparoscopic Roux-en-Y Gastric
Bypass (LRYGB) – Methods,
Complications, Results
n Complications of Gastric Bypass
Other operations, techniques
and stategies
Respiratory and Cardiac Considerations
Metabolic Considerations
Preventive Strategies
Psychological Considerations
Other Features of Obesity and
Bariatric Surgery
Bariatric Practice
For more information please visit: www.HandBookofObesitySurgery.com
Cost in Canada and USA only $30.00 Outside Canada and USA $38.00 (includes airmail)
ASBS who felt that such a journal would be
unscientific and non-academic. With difficulty, I
found a start-up publisher in Oxford, England,
who undertook Obesity Surgery, with me as
Editor-in Chief in 1991. After some difficulties,
I finally took over the publishing, including the
editing, design, printing, subscriptions, mailing
and advertising. The journal rose rapidly,
as bariatric surgery became recognized as
life-saving for individuals with refractory severe
obesity. Obesity Surgery attained an Impact
Ranking of 7th out of 149 surgical journals
for 3 consecutive years, and in 2006 Springer
Science took over as publisher.
Do you think the future for bariatric
and metabolic surgery will be in
refining current techniques or
developing newer technologies?
There will likely be many adaptations on top
of the gastric sleeve operation. I believe that
there will be salvage of restriction in many cases
by applying a silastic ring. Furthermore, various
malabsorptive techniques will likely be added
to the gastric sleeve. The duodenal switch is a
proven excellent operation. I also believe that
the mini-gastric (one-anastomosis) bypass of
Rutledge and its modifications will become
mainstream, with an understanding of the
malabsorption and its surveillance. Surgeons
are now starting to realize that the MGB is a
rather rapid, safe and effective operation, which
can be modified with the patient’s BMI, and
does not have an increased threat of cancer as
some had postulated.
Endoscopic techniques will also become
widely used for restriction as the technologies
develop. They may be limited in what they can
achieve long-term, as the stomach attempts
to re-expand. Endoscopic techniques will be
especially used in revisional surgery.
Away from surgery, how do you
relax?
The world continues to develop major
problems. My wife and I avidly keep up-to-date
with world events by watching RT America,
Euro-News, Al Jazeera, BBC World, etc. (the
mainstream media tends to have their own
agenda). I like to garden. We love to spend
time with our five grandchildren, and our two
sons, one a spinal surgeon and the other a
radiologist.
bariatricnews.net 9
ISSUE 18 | DECEMBER 2013
Photo: Courtesy The Hebrew University of Jerusalem
MetaboShield: no absorption or intestine damage
The natural C-shape anatomy of this region helps
keep the sleeve in place
R
esearchers at the Hebrew University (HU) of Jerusalem’s Biodesign programme have developed the MetaboShield, a new type of endoscopic gastric sleeve.
The device, designed to prevent the absorption of excess food in
the intestine and thus fight obesity, requires no general anaesthesia
or incisions, and results in no tissue damage. The natural C-shape
anatomy of this region helps keep the sleeve in place, blocking food
absorption without damaging the intestine.
“The mechanical prototype that does not move from place despite
the peristalsis (movement) in the intestine,” said Dr Yaakov Nahmias,
director of the HU Center for Bioengineering. “The group proved its
principle that it does not shift out of place but does block the region of
the gastroenterological system that allows the absorption of excess food.
We haven’t decided yet what type of plastic would be used to make it, but
scientists know enough today about what can be utilised without causing
rejection or other problems when left permanently inside the body.”
New type of gastric sleeve to block food absorption
and fight obesity.
The group believes that this new endoscopic procedure would
appeal to millions of obese individuals who are worried about the
complication of current gastric bypass procedures. “This is a huge
untapped market,” said Yair Timna, an MBA student leading the
project’s business development.
The MetaboShield is understood to have attracted interest from
Boston Scientific, although Nahmias conceded that the device is some
years away from general use.
Other students in the group include Dr Elad Spitzer, an orthopaedic
surgeon in Hadassah Medical Center, Gabi Menagen, an MBA student,
and Esther Feldblum, an engineering student
Biodesign is a multi-disciplinary, team-based approach to medical innovation, created by the HU and Hadassah in partnership with
Stanford University.
Biliopancreatic diversion/duodenal beats bypass
Study reports biliopancreatic
diversion/duodenal switch
improves comorbidities,
compared with bypass
Biliopancreatic diversion/
duodenal switch results in
higher earlier reoperation rates
B
iliopancreatic diversion/
duodenal switch results in
greater weight loss in superobese patients (BMI>50) compared
with gastric bypass and control of
co-existing illnesses, a study published
in the Archives of Surgery (Analysis of
obesity-related outcomes and bariatric
failure rates with the duodenal switch
vs gastric bypass for morbid obesity.
2012:147(9):847-54) has reported.
However, Dr Daniel W Nelson and
colleagues from the Madigan Army
Medical Center, Fort Lewis, Washington, also reported that the biliopancreatic
diversion/duodenal switch procedure
may be associated with higher early
risks compared with gastric bypass.
“Although the duodenal switch carries a higher relative risk profile than
gastric bypass, the absolute risk is low,”
the authors report. “Among morbidly
obese patients, the duodenal switch
results in superior sustained weight
reduction and improved comorbidity
control compared with gastric bypass,
which may outweigh early perioperative risk. The benefits of the duodenal
switch, including a significant decrease
in the bariatric failure rates, appear to be
greatest in the super-obese population.”
Despite the Roux-en-Y gastric bypass being widely acknowledged as the
gold standard bariatric procedure, the
authors note that there is some evidence
that weight loss failure and weight regain following a bypass procedure may
be more prevalent than first thought,
especially among the super-obese.
Therefore, they decided to compare
the outcomes of a large cohort undergoing biliopancreatic diversion/duodenal
switch against those undergoing gastric
bypass, using data from the Bariatric Outcomes Longitudinal Database (BOLD).
They compared 1,545 patients who
underwent biliopancreatic diversion/
duodenal switch (average preoperative
BMI 52), with 77,406 patients who
underwent gastric bypass (average
preoperative BMI 48) between 2007 and
2010. The average age of the patients
was 45 years and 78% of the patients
were female.
The main outcome measures were
weight loss; control of comorbidities including diabetes mellitus, hypertension
and sleep apnoea; and failure to achieve
at least 50% excess body weight loss.
Results
The outcomes revealed that biliopancreatic diversion/duodenal switch was as-
in the biliopancreatic diversion/duodenal
switch group (3.3% vs. 1.5%).
However, the percentage of change
in BMI was significantly greater in
the biliopancreatic diversion/duodenal
switch group at all follow-up intervals
(p<0.05). In the super-obese population, biliopancreatic diversion/duodenal
was also associated with a significantly
greater percentage of excess body
weight loss at two years, compared
with bypass (79% vs. 67%, p<0.01).
In addition, comorbidity control
of diabetes, hypertension, and sleep
apnoea were all superior in biliopancreatic diversion/duodenal switch patients
(all p<0.05).
The results also indicate that nearly
20% of bypass patients failed to lose
at least 50% of their excess BMI by
both the one- and two-year follow-ups,
compared with weight loss failure rates
of 9% and 6% for biliopancreatic diversion/duodenal patients.
“In regard to postoperative comorbidity control, the biliopancreatic
diversion/duodenal switch group saw
significantly greater resolution or
improvement in most of the wellrecognised obesity-related comorbidities, including diabetes, hypertension,
hyperlipidemia and obstructive sleep
apnoea,” the authors reported.
Although the researchers note a relative increase in the use of the biliopancreatic diversion/duodenal switch in the
US, gastric bypass is more commonly
performed.
They suggest that is likely due to
several factors, including the technical difficulty of the procedure, the
higher reported rates of short-term
complications and concerns about the
longer-term nutritional consequences
of a primarily malabsorptive procedure.
Duodenal switch
“Further studies of this procedure to
determine the optimal patient selection,
sociated with longer operative times (191 operative technique and longer-term
vs. 114 minutes), greater estimated blood risks vs. outcomes are warranted,” the
loss and longer hospital stays (2.4 vs. 4.4 authors concluded.
days), compared with bypass (all p<0.05).
Commenting in an invited critique,
Early reoperation rates were also higher ”Time for a Change in Gastric Bypass?”,
(Archives of surgery.2012;147(9):854-5)
Dr Alec C Beekley, Thomas Jefferson
University Hospitals, Philadelphia,
wrote: “Their findings and conclusions
challenge the notion that gastric bypass
is the optimal operation for the majority
of patients. As more surgeons familiarise
themselves with the operative techniques
and follow-up requirements for biliopancreatic diversion/duodenal switch
patients, it may be used more frequently
in the super-obese population.”
“Although the duodenal switch carries a higher relative risk
profile than gastric bypass, the absolute risk is low. Among
morbidly obese patients, the duodenal switch results in superior
sustained weight reduction and improved comorbidity control
compared with gastric bypass, which may outweigh early
perioperative risk. The benefits of the duodenal switch, including
a significant decrease in the bariatric failure rates, appear to be
greatest in the super-obese population.”
10 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013
Bypass surgery changes how the brain responds to food
Study could explain why bypass patients
lose more weight over the long term than
banding patients
R
esearchers from MRC Clinical Sciences Centre
at Imperial College London, UK have added further
evidence to the theory that gastric bypass surgery
changes how the brain responds to food, reducing not only
hunger but also the drive to eat for pleasure, a study has found.
The research, {{Obese patients after gastric bypass surgery
have lower brain-hedonic responses to food than after gastric
banding.||published in the journal Gut}}, helps to explain why
gastric bypass patients lose more weight over the long term than
those who undergo a gastric band operation.
“It is well established that patients after gastric bypass lose
more weight than after gastric band and we think this is because
of the different physical changes made to the gut during surgery,
which somehow have an effect on the drive to eat for pleasure,” said
Dr Tony Goldstone from the MRC Clinical Sciences Centre who led
the study.
“These findings emphasise that different bariatric procedures work
in different ways to influence eating behaviour. This may have important implications for the way we treat patients with obesity and could
help pave the way for a more personalised approach when deciding
on the choice of bariatric procedure by taking the impact on food
preferences and cravings into account.”
Previous studies in animals and humans have shown that those
who undergo a gastric bypass tend to shift away from eating highfat and sweet foods. However the effect of different types of weight
loss surgery on the brain that may be responsible for changes in food
preference has not been explored until now.
This may have important implications for the way obese patients
are treated and could help pave the way for a more personalised approach when deciding on the choice of bariatric procedure.
“Humans don’t just eat when they’re hungry – the pleasure and
rewarding feelings we get from eating play a huge role in determining
what kind of foods we eat, as well as how much,” said Professor David
Lomas, Chair of the MRC’s Population and Systems Medicine Board,
Figure 1: Whole brain comparison of activation to high-calorie foods
between obese patients after gastric bypass and gastric banding. Whole
brain group level comparison for high-calorie versus object picture
contrast to demonstrate clusters in which blood oxygen level-dependent
(BOLD) signal was lower in patients after gastric bypass (RYGB)
compared with gastric banding (BAND) surgery, adjusting for age, gender
and body mass index. No clusters showed greater activation in RYGB
than BAND groups. Colour bar indicates Z values. Cluster activation
thresholded at Z>2.1, familywise error p<0.05, overlaid onto the average
T1 scan for all subjects (n=20 per group). Co-ordinates given in standard
Montreal Neurological Institute (MNI) space. ACC: anterior cingulate
cortex, Amy: amygdala, Caud: caudate, NAcc: nucleus accumbens,
Hipp: hippocampus, MFG: middle frontal gyrus, OFC: orbitofrontal cortex,
Put: putamen. Voxel-wise differences in BOLD activation between groups
did not survive false discovery rate p<0.05 correction.
which funded the research. “This work adds to a growing body of
evidence supporting the role of the gut-brain interplay in controlling
our eating behaviour. Being able to influence this relationship may
in future play an important role in the development of non-surgical
treatments for obesity.”
Using magnetic resonance imaging (fMRI), which measures brain
activity by detecting changes in blood oxygen levels and flow, the
researchers studied 83 participants who had lost weight from either a
gastric bypass (n=30) or gastric band surgery (n=28) carried out
on average eight to nine months previously, as well as a control
group of unoperated participants (n=25). These three groups
were of similar body weight.
They found marked differences in the brain’s response to
food in patients after gastric bypass, compared to gastric band
surgery. Patients who had gastric bypass had less activity in the
brain’s reward regions when shown pictures of food compared
with those who had gastric banding.
Patients after gastric bypass also rated high-calorie foods as
less appealing to look at and less pleasant to eat, had healthier
eating habits and ate less fat in their diet than patients after
gastric banding or the unoperated control group. Both the gastric bypass and banding patients had similarly reduced hunger
compared with the unoperated group, and the findings were not
explained by differences in psychological traits between the
surgical groups.
The researchers did not find conclusive evidence of what caused
these changes, but they did observe several differences in the patients’
metabolism that could play a role. Levels of gut hormones called
GLP-1 and PYY that make us feel full after a meal were higher in the
gastric bypass group, as were levels of bile salts, which play a role in
digestion.
Patients after gastric bypass also reported more intestinal discomfort and nausea after eating foods high in fat and sugar in the early
months after the surgery than patients after banding, which may also
be influencing what foods they want to eat.
“The identification of these differences in food hedonic responses
as a result of altered gut anatomy/physiology provides a novel explanation for the more favourable long-term weight loss seen after
RYGB than after BAND surgery, highlighting the importance of the
gut–brain axis in the control of reward-based eating behaviour,” the
paper concludes.
Further work by the researchers will focus on which of these
factors may be influencing the brain’s response to food following
bypass surgery.
This research was supported by the Medical Research Council,
Wellcome Trust, National Institute for Health Research, and Imperial
College Healthcare Charity.
Study to assess whether low calorie diet can reverse T2DM
Study will recruit 140 type
2 diabetes patients who
will consume 800 calories
each day for eight to 20
weeks
U
K researchers will soon begin
a study to examine whether a
800 calorie a day diet can reverse type 2 diabetes. The £2.4 million
project, supported by Diabetes UK, will
be conducted by scientists at Newcastle
University and the University of Glasgow and involve 140 type 2 diabetes
patients. They will consume only 800
calories each day for eight to 20 weeks.
Approximately 3.8 million people
in Britain have diabetes, with type 2
making up around 90% of cases. The
figure includes about 850,000 individuals who have type 2 diabetes but are
unaware. Seven million more Britons
are at particular risk of developing the
disease.
A previous study carried out at
Newcastle University discovered a
diet of 600 calories per day could put
an end to type 2 diabetes in individuals
new to the disease. The low calorie
diet was found to decrease fat levels
in the pancreas and liver, thus boosting
insulin production. Only four of the
11 participants still had diabetes three
months on
Diabetes UK will now conduct a
more thorough study with a greater
follow up period that will delve deeper
into the long term effects of low calorie
diets.
“Type 2 diabetes will always be a
serious health condition but perhaps
it won’t always be seen as a condition
that people have to manage for the rest
of their lives and that worsens inevitably over time,” said Diabetes UK head
of research, Dr Matthew Hobbs. “The
2011 study and evidence from bariatric
surgery has shown us that it can be put
into remission. If we can do this safely,
on a bigger scale and as part of routine
care, then following a low calorie liquid diet would be a real game changer
in terms of reducing people’s risk of
devastating health complications such
as amputation and blindness.”
In the new study, study participants
will predominantly drink nutritionally complete liquid formula shakes.
They will be taught how to alter their
lifestyles for good as normal meals are
phased back in. The findings will be put
alongside the results of 120 individuals
following current slimming recommendations across a two year follow up
period.
Some of the participants will have
MRI scans that will allow researchers
to understand what is going on as the
diet influences the body.
“We are exploring uncharted territory and along the way there will be
challenges, details to unravel, and other
questions to ask,” said Professor Roy
Taylor, lead researcher at Newcastle
University. “But I believe this study
will lead to a quantum leap forward in
our understanding of how best to manage type 2 diabetes.”
bariatricnews.net 11
ISSUE 18 | DECEMBER 2013
The double balloon design
also allows for a greater
‘fill volume’
Company to submit a PMA to
the FDA in 2014 and anticipates
a launch in 2015
R
eShape Medical has announced that its REDUCE
Trial for the ReShape Duo
Intragastric
Balloon,
has met its primary
efficacy endpoints. The trial, which
reached full enrolment in less than six
months, involved eight US sites and
studied 326 patients. The company is
the first medical device company to
successfully meet its primary efficacy
endpoints in a US, randomised, shamcontrolled pivotal trial for weight loss.
“Meeting the primary endpoints is
an important accomplishment, as it convincingly demonstrates the superiority
of the ReShape procedure over diet and
exercise alone,” said Dr Jaime Ponce,
Dalton, Georgia, Principal Investigator
in the REDUCE trial. “The ReShape
procedure offers a new alternative to
help patients kick-start weight loss and
learn new behaviours. We are excited
about what this new treatment option
may do for millions of people needing to
lose excess weight.”
The ReShape Duo dual-intragastric
balloon is endoscopically placed down
the esophagus and into the stomach, with
a procedure that does not require any
incisions, sutures or fixation to the body.
The balloons are inflated with saline and
take up much of the stomach’s volume,
causing patients to eat smaller portions
and to feel full sooner. The device does
not change or alter the patient’s anatomy
and is fully reversible. During the 24
week treatment period, patients work
with dieticians, doctors and nurses to
learn healthy diet and exercise habits to
help them during and beyond the treatment period.
ReShape Duo design
“There are other technologies that
involve a single balloon, however the
ReShape Duo design has two discreet
balloons,” added Ponce. “The double
balloon design also allows for a greater
‘fill volume’ but conforms to the stomach’s natural curvature to improve
comfort, without excessively distending
the stomach wall.”
He explained that there is a risk with
single balloons deflating and migrating
Duo Intragastric Balloon meets
primary efficacy endpoints
into the intestines, potentially causing
blockages. The ReShape Duo’s double
balloons are filled with saline and a blue
indicator dye. If one balloon deflates,
the patient will notice blue urine but
Richard Thompson
there is another balloon still inflated that
prevents migration into the intestines.
The ReShape Duo is the only intragastric balloon that has an anti-migration
feature.
Prior to insertion of the device, an
endoscopic examination of the stomach
is performed to ensure that there are no
anatomical contraindications to placement of the device. The ReShape Duo
would not be placed if this examination
identified the presence of a large hiatal
hernia, significant gastritis, an ulcer or a
tumour.
of patients who received the balloon and
the group of patients who did not receive
the balloon.
“I’m encouraged about what
ReShape Duo may do for millions
REDUCE Trial
There were two primary efficacy endpoints:
n comparison of percent excess weight
loss between treatment and control
groups and;
n percent excess weight loss responder
rate in the treatment group
The first endpoint measured the percent
of excess weight loss between the group
Bariatricnews.net
News. Conference reports. Features. Opinion.
Our website, updated daily.
Over 12,500 visitors in
November 2013.
Jamie Ponce
of people who need to lose excess
weight,” said Ponce. “The ReShape
Duo is designed to initiate and maintain
significant weight loss, without the
invasiveness of surgery or potential side
effects of medication. It is used in conjunction with a comprehensive lifestyle
modification patient program to foster
long-term success.”
“While the intragastric balloon is
in place, patients are counselled by
healthcare professionals on nutrition,
exercise and behaviour change to help
them connect the value of eating small
portions with long-term weight control,”
he added. “This programme continues
following removal of the balloon to encourage new habits – and lasting results.”
Intragastric balloons
Modern intragastric balloons, used
over the last 10 years, outside of
the US, have proven to be effective
with thousands of patients studied
and reported in medical literature.
Intragastric balloons have been available in Europe for a decade, and there
is no question that they are effective in
achieving significant weight loss.
“Being the first device company to
meet its primary efficacy endpoints
in a randomised obesity trial is an
important step forward on the path to
FDA approval,” said President and
CEO of ReShape Medical, Richard
Thompson. “We saw very significant
interest in participation in this study,
and are looking forward to bringing the
first, non-surgical weight-loss device
to the US market, where ReShape Duo
has the potential to help patients lose
significantly more weight than diet and
exercise programmes alone.”
He explained that there are currently
no non-surgical options available to
patients in this market and the company
believes the ReShape procedure will be
the first, non-surgical, weight loss device
commercialised in the US market.
“Overall feedback from both the
US and European clinical work we
have done suggests that clinicians find
the device is safe and easy to insert
and remove,” said Thompson. “There
is minimal training required for those
familiar with endoscopy and the procedure can be done consistently in less
than 20 minutes.”
ReShape Medical plans to submit a
Premarket Approval application to the
FDA in the second quarter of 2014 and
anticipates a launch in mid-to-late 2015.
The device has been available in the
European Union since December 2011.
12 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013
USGI to launch ESSENTIAL endoscopic incisionless trial
European outcomes from
the POSE procedure show
excess weight loss of 62%
and total body weight loss of
19%
U
SGI Medical has obtained
conditional approval of its
investigational device exemption (IDE) application from the FDA to
launch what the company believes to
be the largest multicentre, randomised,
sham-controlled study of an endoscopic
procedure for weight loss ever conducted.
The company plans to enrol approximately 350 subjects at up to nine centres
across the US in the ESSENTIAL trial.
“Although published data show
significantly superior weight loss
results from bariatric surgery than from
diet and exercise alone, a major open
or laparoscopic operation still poses
risks and longer recovery times, and
surgery is not right for every patient,”
said Dr Thomas E Lavin, founder of The
Surgical Specialists of Louisiana and an
investigator in the trial. “Surgery for
weight loss has been studied with positive results, but this will be one of the
first major trials to prospectively compare the effectiveness of an endoscopic
procedure against a sham procedure
plus diet and exercise.
Physicians participating in the study
will use USGI Medical’s g-Cath EZ
Suture Anchor Delivery Catheter to place
tissue anchors across folds of tissue in
strategically-located parts of the stomach
to reduce its size and ability to stretch
to accommodate a meal. The company
claims that the g-Cath, which is used
extensively for general, non-obesity indications, is the first endoscopic suturing
technology proven to create a durable,
healed fold in the stomach.
“Based on preliminary studies conducted in Europe, we believe that this
new approach may help patients feel full
sooner during meals, improving satiety
and reducing hunger cravings so they can
control their portions, consume fewer
calories and lose weight,” Lavin added.
The incisionless outpatient procedure
has been performed on over 2,000
patients, mostly in Europe, where it is
known as Primary Obesity Surgery Endolumenal (POSE) procedure. The procedure is performed entirely through the
mouth without any incisions through the
abdomen. Many patients have returned
to work without any bandages or signs of
surgery within two to three days.
“If the data are positive and consistent
with smaller trials, it could mean that
tens of thousands of patients may have an
incredibly compelling option to consider
if they’ve struggled to lose weight with
diet and exercise, but aren’t prepared to
accept the risk of traditional bariatric
surgery,” said Lavin.
“The start of the ESSENTIAL
Trial represents a significant milestone
for USGI Medical and endoscopic
approaches to weight loss,” said John
Cox, Chief Operating Officer of USGI
Medical. “Our efforts to support this
study underscore our excitement about the
potential of our technology and our commitment to patient safety and outcomes.
We look forward to working with many
of the country’s leading bariatric surgeons
and advanced endoscopists, both at top
academic medical institutions and wellrespected private centres, to enrol patients
in this study. Based on our experience
to date, we believe our new incisionless
approach to treating obesity may offer
promise to patients who have struggled
The POSE procedure places tissue anchors across folds of tissue in strategically-located parts of the stomach to reduce its size and
ability to stretch to accommodate a meal
to lose weight through diet and exercise.”
European POSE results
At the recent 18th World Congress of
International Federation for the Surgery
of obesity & Metabolic Disorders (IFSO)
in Istanbul, investiagtors from Spain
reported results of two studies showing
the positive outcomes and physiological
effects of the POSE procedure.
Dr Román Turró, from the GI Endoscopy Department at the Centro Medico
Teknon, Barcelona, reported the results
of his team’s POSE experience from 137
consecutive procedures performed from
February 2011 to July 2013.
The average age of patients included
in the safety analysis was 42.8 years and
the average BMI 36.9 at the time of the
procedure. Females accounted for 74%
of the patients.
The first 22 patients who had been
followed for 12 months post-procedure
at the time of the presentation achieved
average excess weight loss of 62% and
total body weight loss of 19%.
Initial safety data were favourable
with no reported instances of hospitalisation with a surgical intervention
following the POSE procedure. One
patient developed an infection that was
treated with antibiotics and two patients
suffered intra-gastric bleeding, which
was treated endoscopically.
Endoscopies on a subset of these
patients also confirmed that the suture
anchors remained in place in the stomach
12 months after the procedure.
Also at IFSO, Dr Silvia Delgado-Aros, a
member of the Neuro-Enteric Translational
Science (NETS) Research Group at the
Institut Hospital del Mar d’Investigacions
Mèdiques in Barcelona, presented physiologic findings showing that POSE led to
weight loss, a sustained reduction in caloric
intake, normalisation of blood sugar levels
and improved feelings of fullness and satiety triggered by an improved gut peptide
response to food. In this controlled study,
patients followed for 15 months reported
mean excess weight loss of 63.7%.
A NEW range of vitamins and minerals for your bariatric patients
n Designed by
Dr David Ashton,
Medical Director,
Healthier Weight
n UK formulated and
manufactured
n Rigorously tested for
purity and stability
n Numerous advantages over competitor
products
t is widely accepted that lifelong multivitamin and mineral supplementation is
essential for patients both before and after
weight-loss surgery1. There is currently no UK
manufactured bariatric product which complies
with expert recommendations on post-operative
micronutrient supplementation. Forceval® is
a vitamin and mineral supplement commonly
prescribed for surgical weight-loss patients in
the UK and other European countries. However,
Forceval® was never specifically formulated for
bariatric patients and is deficient in a number of
important respects. The concentrations of some
essential vitamins and minerals are inadequate
for the surgical weight loss patient, whilst other
important micronutrients are missing altogether
(see comparison link below). Likewise, over-thecounter vitamins and minerals from high street
pharmacies fall well short of the needs of patients
undergoing weight-loss surgery. It was to fill this
obvious need that VitaWeight™ was developed.
VitaWeight™ delivers optimal micronutrient
support for bariatric patients, in a simple dosing
regimen and is fully compliant with expert recommendations for post-operative supplementation2.
I
Advantages of VitaWeight™
VitaWeight™ products are rigorously tested
for purity and stability and have a number of
important advantages for the surgical weight loss
patient.
n Concentrated B Vitamins. The multivitamin
contains all eight of the required B vitamins;
Thiamin (B1), Riboflavin (B2), Niacin (B3),
Pantothenic Acid (B5), Pyridoxine (B6), Biotin
(B7), Folic Acid (B9) and Cyanocobalamin
(B12). All eight B vitamins work together
in various combinations to help the body
metabolize food, protect the heart, regulate
nerve growth and boost the immune system.
Note: the high concentration of crystalline
B12 in VitaWeight™ removes the need for B12
injections in RYGBP and other patients.
n Calcium citrate. Most standard multivitamin
formulations use calcium carbonate, which
needs to combine with hydrochloric acid in
the stomach to be absorbed. Following weight
loss surgery, however, the amount of acid
in the stomach is decreased and patients are
often prescribed medication (e.g. PPIs) to
reduce stomach acid secretion even further.
For this reason we have use the citrate salt
which is well digested and absorbed, even
when stomach acid is decreased.
n Trace elements. Our multivitamin preparation includes comprehensive trace element
support, including zinc, selenium, copper,
molybdenum and chromium.
n Iron. Our iron source is ferrous bisglycinate.
This is important because the bisglycinate
salt is less irritating to the gastric mucosa
and therefore has significantly fewer side
effects such as nausea, epigastric pain and
vomiting39. In addition, we have a significantly higher dose of iron in accordance with
ASMBS recommendations (18-27mg/day).
n Vitamin D. With regard to Vitamin D,
Vitaweight has the D3 (cholecalciferol) form
rather than the D2 (ergocalciferoal). This
is because vitamin D2 has a much lower
potency and a shorter duration of action when
compared with vitamin D3. In fact, vitamin
D2 has a potency less than one-third that of
vitamin D3.
n Vitamin K2. Vitaweight™ contains both
Vitamin K1 and K2, which have distinct
functions. Vitamin K1 is involved in blood
coagulation, whereas K2 helps to direct
calcium into bone and blood, rather than
arteries, muscle or other soft tissues. Studies
now indicate that vitamin K2 also works to
prevent certain cancers and bone loss. There
are several active forms of vitamin K2: MK4,
MK7, MK8 and MK9. The most relevant to
health is the MK-7 form which is the form
included in the Vitaweight™ formula.
Procedure
Multivitamins and Minerals
(Tablets/day)
Calcium
(Tablets/day)
Gastric Band
1
1
Sleeve gastrectomy
1
3
Roux-en-Y gastric bypass
2
4
Recommended Dosage
The micronutrient needs of patients post-operatively will depend primarily upon the type of
procedure performed. The table below provides
general dosage guidelines, though results from
blood measurements may require a modified
daily regimen.
References
1.Pournaras DJ, le Roux CW. After bariatric surgery, what vitamins
should be measured and what supplements should be given? Clin
Endocrinol (Oxf) 2009; 71:322-5.
2.Aills L, Blankenship J, Buffington C et al. Bariatric Nutrition: Suggestions for the Surgical Weight Loss Patient. ASMBS Allied Health
Sciences Section Ad Hoc Nutrition Committee. Surg Obes Relat Dis.
2008;4(5 Suppl):S73-108.
How to prescribe
A comparison between VitaWeight™
and Forceval® together with detailed
product information,
scientific references
and
information
leaflets are available
at: http://vitaweight.
co.uk/medicalprofessionals
Special January
2014 Offer
If you or your
patients would like
to purchase directly
go to http://vitaweight.co.uk/buy-now and enter
the code Barinews20 for a 20% discount or call
Chrissie Twigg on Freephone 0800 073 1146
bariatricnews.net 13
ISSUE 18 | DECEMBER 2013
Mini-Gastric Bypass, 2nd International Consensus Conference, Paris. October 9 2013
Mini-gastric (one-anastomosis)
bypass becoming a mainstream
bariatric operation
Professor Mervyn Deitel Chief, Advisory Board, International Bariatric Club, Editorin-Chief Emeritus & Founding Editor of Obesity Surgery
T
he mini-gastric one-anastomosis bypass
(MGB) was conceived by Dr. Robert
Rutledge in USA 16 years ago, as a safe,
rapid and effective bariatric operation. The MGB
has slowly gained proponents throughout the
world, particularly increasing in the past 5 years. In
October 2012, an international MGB Conference of
55 experts was held in Paris, under the leadership of
Drs. Rutledge and Jean-Marc Chevallier (President
of the French bariatric society – SOFCO). Because
of international requests, a second MGB Conference was held in Paris in October 2013, with 35
MGB surgeons from 13 countries, many at the
professorial level. The Chair of the 2013 Conference was Prof. Pradeep Chowbey, immediate
Past-President of the International Federation for
the Surgery of Obesity; many see Prof. Chowbey
as the Father of both laparoscopic and bariatric
surgery in India, where the MGB is being rapidly
adopted following the excellent results reported by
Kular and others.
The MGB Consensus attendees all reported
end-to-side to the jejunum.
In the presence of a hiatal hernia, no
effort is made to address this at the
time of MGB. Experience has shown
that MGB is very effective in resolving GE reflux disease (GERD).
This is thought to be related to
traction which the GJ anastomosis
provides on the gastric pouch,
which reduces the cardia within
the abdomen, plus resolution of
the patient’s obesity. We thus have a
gastric conduit and a fat/carbohydrate
malabsorptive procedure. The pouch in
the MGB shows little dilation because there
is no outlet narrowing by a stoma or pylorus.
Modifications of the Technique
Some (but not all) MGB surgeons
vary the length of the bypass. In
super-obese (or very tall) patients, the GJ is performed
>250cm distal to Treitz’
ligament. Tacchino’s group
from Italy has performed
more than 600 MGBs;
Mervyn Deitel
Figure 1. Diagrammatic representation of the
MGB of Rutledge.
(Amended for Bariatric News by Peter Williams)
earlier SG revisions to MGB). Presenters repeatedly emphasized the need for a long gastric pouch.
Pradeep Chowbey
Robert Rutledge
prior experience with other bariatric operations –
Roux-en-Y gastric bypass (RYGB), gastric banding
(GB) and sleeve gastrectomy (SG).
Greco reported that recently they have modified
the MGB by leaving a larger gastric pouch and
constructing the GJ 300cm proximal to the ileocecal valve (i.e. leaving a 300-cm common channel).
Most of the surgeons agreed that the GJ must be
placed at least 200-300cm proximal to the ileocecal
valve, to maintain adequate nutrition. Flores from
Mexico presented the Spanish technique of Profs.
Caballero and Carbajo, where an antireflux valve is
constructed on the afferent side of the GJ; sutures
are placed between the sleeve and afferent limb to
inhibit reflux. Survey of the attendees revealed that
>80% use the Rutledge method and measurements,
10% the Carbajo antireflux method, and 5% the
Tacchino 300-cm common limb.
If ever necessary, the MGB can be modified
for inadequate or excess weight loss by moving
the anastomosis distally or proximally as a brief,
simple procedure. Bhanderi of India constructs a
longer sleeve, almost to pylorus. Prasad of India
performs the MGB using robotics.
The MGB is now being performed for weight
regain after the SG operation. All the experts emphasized that it is very important not to construct
a short gastric pouch for the MGB. The MGB
pouch is the opposite of the small proximal pouch
constructed in the RYGB. A small, short gastric
pouch in the MGB would recreate the physiology
of the old Mason loop gastric bypass and could lead
to bile reflux (as was done with some of Weiner’s
Technique
The laparoscopic operation (Figure 1) creates two
components: first, a restrictive lesser-curvature
gastric pouch; second, a 200cm or longer jejunal
bypass with a single antecolic gastro-jejunostomy
(GJ) anastomosis, which leads to significant fat
malabsorption.
Creation of the Gastric Pouch
The lesser curvature of the stomach is identified at the junction of the body and antrum. The
stomach is initially stapler-divided at a right-angle
to the lesser curvature, distal to the incisura (distal
to the crow’s foot). A 28–40 Fr bougie is passed by
the anaesthetist, and the stomach is stapler-divided
upwards parallel to the lesser curvature. With approach to the gastro-esophageal (GE) junction, the
surgeon divides the stomach lateral to the angle of
His; the cardia in the MGB is explicitly avoided
and not dissected (unlike in the SG operation).
Creation of the 200cm malabsorptive
jejunal bypass
Attention is turned to the left gutter, and the
omentum is retracted medially to identify the
ligament of Treitz. The bowel is run to ~200cm
distal to Treitz’ ligament. At this site, the distal
tip of the gastric sleeve is anastomosed antecolic
Survey Findings and Discussion
A SurveyMonkey questionnaire had been carefully
answered pre-Conference and was discussed. This
is a largely academic surgical group who carefully
records their data, because the MGB was met with
some skepticism. The Survey identified a total of
16,651 MGBs performed by the attendees. Average preoperative BMI was 46.1 ±4.1 (SD) (range
38-62). Mean operating time was 80.3 ±24.9
minutes (range 38-130). Average hospital stay was
3.2 ±1.6 days (range 1.1-6.0), and became less as
the surgeon performed more MGBs. Leaks were
reported in 0.03% (five patients), which are less
than the dreaded proximal leaks following the SG
operation. During surgery, the use of the methylene
blue or air test decreased with experience. The use
of a drain also decreased with experience. Patients
were usually ambulatory a few hours after surgery.
Diabetes had resolved at one year in 91.4
±4.9% (range 82–96). Persistent resolution of
co-morbidities and improvement in quality of life
were reported by Peraglie based on a personal experience with 1,400 MGBs, Hargroder with 1,100
MGBs, Cady with 2,500 MGBs, Chevallier with
888 MGBs, Kular with 1,200 MGBs, Musella with
1,000 MGBs, Tacchino with 600 MGBs and W.J.
Lee with >1,000 MGBs.
Preoperative GE reflux was found in 15.3
±14.2%, and postoperatively in 4.7 ±14.2%. The
experts’ opinion was that GERD improves after
MGB. Revisional surgery has become necessary in
3.2% (0.4% for bile reflux). It was very rare that
a Braun entero-enterostomy became necessary.
Marginal ulcers have occurred in 1.4 ±1.8% (range
0-5), which is less than after RYGB. Interestingly,
Spain and India have found almost no postoperative ulcer occurrence.
The %EWL was: one year 75.8, two years 85.0,
three years 78.0, four years 75.0, five years 70.2,
longer 70.0. Failure to lose >50% of excess weight
at five years occurred in 14.2 ±25.1%. Operative 30day mortality has been very low – 0.2% (33 deaths).
In the consensus survey, bowel obstruction was
very rare and had occurred in 0.15 ±0.36% (range
0–1), and none was due to an internal hernia. There has
been no intractable hypoglycemia.
Regarding marginal ulcer development, the MGB should not be performed
in smokers, those taking salicylates,
and many felt it should not be used in
those taking heavy alcohol. However,
Kular in India noted that patients in
his area of India tend to take whisky,
without problems. However, as with
the RYGB, there is more rapid absorption of alcohol, which should thus
be decreased.
Most of the surgeons prescribed a
PPI, and all ordered supplements (multivitamins, calcium – preferably dairy, yoghurt,
and Proferrin® as an iron supplement. In 5% of
menstruating women, iron deficiency develops, and
may require I.V. iron. The majority treat H. pylori
preoperatively, and many treat it if it becomes necessary postoperatively. No case of carcinoma has been
found in the gastric pouch or esophagus after MGB.
Some critics have referred to a rat study where concentrated bile in the stomach led to cancer; however,
J.D. Frantz in 1991 showed that bile led to hyperplasia and malignancy in the proximal 2/3 of the unique
rodent stomach (which is squamous cell) and not in
the glandular distal 1/3 (which corresponds to the
human stomach).
Wei-Jei Lee of Taiwan described his 10-year
comparison of MGB and RYGB, where long-term
weight loss, resolution of diabetes and elevation of
GLP-1 were slightly better after the simpler and
safer MGB.
Conclusion
There was early prejudice against the MGB by
surgeons who performed a longer, more difficult
procedure. However, the numerous surgeons
throughout the world who perform the MGB reported essentially the same results. The attendees
have found the MGB to be a rapid, technically
simple, safe, effective operation with an absence
of leaks, a single antecolic large anastomosis in
easy view, the bypassed length modifiable with
the degree of BMI, durable weight loss, easily
revisable by moving the anastomosis, and if ever
necessary, reversable.
Bibliography
Rutledge R, Walsh TR. Continued excellent results with the mini-gastric
bypass: six-year study in 2,410 patients. Obes Surg 2005;15:1304-8.
Noun R, Skaff J, Riachi E et al. One thousand consecutive mini-gastric
bypass: short- and long-term outcome. Obes Surg 2012;22:697-703.
Lee WJ, Yu PJ, Wang W et al. Laparoscopic Roux-en-Y versus mini-gastric
bypass for the treatment of morbid obesity: a prospective randomized
controlled clinical trial. Ann Surg 2005;242:20-8.
Carbajo M, Garcia-Caballero M, Toledano M et al. One-anastomosis gastric bypass by laparoscopy: results in first 209 patients. Obes Surg
2005;15:398-404.
Lee WJ, Wang W, Lee YC et al. Laparoscopic mini-gastric bypass: experience with tailored bypass limb according to body weight. Obes Surg
2008;18:294-9.
Frantz JD, Bretton G, Cartwright ME, et al. Proliferative lesions of the nonglandular and glandular stomach of rats. In: Guides for Toxicologic Pathology STP/ARP/AFIP, Washington, DC, 1991.
Peraglie C. Laparoscopic minigastric bypass (LMGB) in the super- super
obese: outcomes in 16 patients. Obes Surg 2008;18:1126-9.
Chevallier J-M, Chakhtoura G, Zinzindohoue F. Laparoscopic mini-gastric
bypass. In: Deitel M, Gagner M, Dixon JB, Himpens J, eds. Handbook
of Obesity Surgery. 2010:pp78-84. www.HandbookofObesitySurgery.
com
Lee WJ, Ser KH, Lee YC et al. Laparoscopic Roux-en-Y vs. mini-gastric
bypass for the treatment of morbid obesity: a 10-year experience. Obes
Surg 2012;22:1827-34.
Musella M, Susa A, Greco F et al. The laparoscopic min-gastric bypass:
the Italian experience: outcome from 974 consecutive cases in a multicenter review. Surg Endosc 2013 Aug 28 [Epub ahead of print].
14 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013
An update from the MARS initiative
I
n 2007, Ethicon began the Metabolic Applied Research
Strategy (MARS) initiative, a multi-year, multi-million dollar
commitment to support fundamental research into obesity and
other metabolic disorders. Now in its sixth year, Bariatric
News talks to Dr Elliott Fegelman, Medical Director at Ethicon,
about the benefits the MARS programme is bringing to surgeons and
patients around the world…
“The MARS initiative was started because while we could see
excellent results bariatric and metabolic surgeons were obtaining but
as a community, we couldn’t really explain why,” began Fegelman.
“As a result, Ethicon established a partnership with surgeons to give
them the opportunities to provide some answers and to look for less
invasive methods of achieving the same results.”
As part of the initiative, the company started to support the work
of two research laboratories: the Metabolic Diseases Institute (MDI)
at the University of Cincinnati, and the Obesity, Metabolic & Nutrition Institute (OMNI) at the Massachusetts General Hospital (MGH).
These two institutions had the capbility to perform basic and translational research, and were committed to understanding the physiological changes that can occur after bariatric and metabolic surgery.
In essence, these two centres were charged with helping to
deconstruct, understand and reinvent bariatric procedures in ways
that improved outcomes, focusing on fundamental research around
obesity and metabolic disorders.
Research
The research undertaken at MGH is led by Dr. Lee Kaplan, Associate
Professor of Medicine at Harvard Medical School, Director of the
Obesity, Metabolism, and Nutrition Institute, and Director of the
Weight Center at MGH. Dr. Kaplan’s extensive research is focused
on the physiological and molecular mechanisms of gastrointestinal
regulation of energy balance and metabolic function. His group has
pioneered the development and use of rodent models for weight loss
surgery and gastrointestinal devices to explore these mechanisms.
Dr. Randy Seeley, Professor of Medicine at the University of
Cincinnati College of Medicine, Director of the Cincinnati Diabetes
and Obesity Center, and Director of the Obesity Research Center, is
leading the work on the actions of various peripheral hormones in the
central nervous system that serve to regulate food intake, body weight
and the levels of circulating fuels.
These two centres have performed the majority of the efforts
concentrating on the basic science level, which includes understanding surgical procedures’ mechanisms of action at the tissue, cellular,
molecular and genetic levels.
Understanding
“The MARS initiative has been responsible for some of the most
seminal work published on the mechanisms of action, microbiota and
metabolic signalling, and this work continues to be built upon,” said
Fegelman. “In a broader sense, what MARS has really allowed us
to understand is that the gastro-intestinal tract is a hugely complex
sensory organ with complex signalling mechanisms.”
“When we think about the GI tract in those terms, the techniques
and procedures become less important and the effects on the sensory
organ become paramount, and this is the focus of many current investigations,” he continued. “It has been known for years that the gut
and the brain communicated, what has changed recently is that we
have begun to understand what those signalling mechanisms look
like, what parts of the brain respond to these signals and how the GI
tract adapts.”
pany is also supporting other specialties. As part
of the MARS initiative, in 2010, the company donated U.S. $500,000
in funding to support up to three, three-year research grants through
the American Diabetes Association.
The research grants support the investigation of the specific
mechanistic effects of bariatric surgery on diabetes. They also support translational research to improve the clinical understanding of
various bariatric procedures as potential treatment options for people
with obesity and Type 2 diabetes mellitus.
This is a further example of how metabolic disease is not limited
to just one medical specialty or field and therefore requires a multidisciplinary approach to discover new ways to combat the disease.
“The MARS Scientific Advisory Board (SAB) changes every year
as they try to bring new people on board and identify new ways of
looking at the data and patient experience. The constantly evolving
Advisory Board is based on the questions we are asking or being
asked and the expertise we are looking for,” said Fegelman. “It is
primarily surgeons at this point, mostly because this is the group that
we have the most experience of working with and because they have
the greatest experience of bariatric and metabolic surgery.”
“However, as we move forward I am sure that the SAB will
continue to evolve and will include diabetologists and endocrinologists, nutritionists and bariatric physicians, as the gulf in dialogue
between the surgical and medical viewpoints regarding this patient
population narrows.”
Elliott Fegelman
Lee Kaplan
Randy Seeley
Such has been the rate of discovery that the MARS initiative has
achieved to date: it’s been responsible for more than 65 publications,
including 14 peer-reviewed articles, which have been published across
the whole spectrum of the medical field, underlining the multifaceted
aspects of metabolic disease.
Patient benefits
Not only has the MARS initiative brought new insights into our understanding of how bariatric and metabolic surgical procedures work,
but it has made a significant difference in the real world – to patients.
“Patients have benefitted by an increased knowledge of how effective a procedure will be for them. For example, we can now inform
patients about how a bypass will benefit them more than a band,”
Fegelman explained. “We can discuss the rationale of the procedure
and explain how GLP-1, insulin sensitivity etc., will impact the
outcome of surgery.
“From personal experience, I explain to patients how a procedure
changes their physiology; I can see that patients are much more confident in the procedure. Bariatric surgeons are no longer just performing
surgical procedures; through dedicated research, such as the MARS
Initiative, they are now in a position to inform as well as operate.”
Multi-disciplinary
Ethicon is not only working with bariatric and metabolic surgeons to
discover new and valuable insights into metabolic disease, the com-
The future
“I don’t think we are too far away from providing a solid economic
argument for bariatric and metabolic surgery. If we can identify the
optimum time to treat a patient so the disease-costs are significantly
reduced by surgical intervention, that is an investment I believe
society will pay.”
“I believe the ‘holy grail’ would be to find some insulin-like treatment that we could give to the patient subcutaneously that would
mimic hormonal signalling or a drug that functions as the serotonin
uptake inhibitors do to treat depression; that affects the signalling
mechanism at the hypothalamus. As a result, surgery would only be
considered in the most critical or an emergent case, similar to how
cardiac surgery is performed today.
“Let’s not forget, this is a super complex system with multiple
inputs and responses, and the body has evolved highly-developed
defences against manipulation. So whether we get there in a decade or
longer I really couldn’t say,” Fegelman concluded. “What I can say is
that working with Drs. Kaplan and Seeley on the MARS initiative has
provided incremental changes in our knowledge and understanding,
and that any future developments will come about by an evolutionary
rather than revolutionary process.”
For more information regarding the MARS Initiative, please visit:
http://www.ethicon.com/mars-education
To educate others on the critical findings of the principal researchers of the
MARS initiative, Ethicon has hosted 11 MARS Outreach Courses since late
2011. Due to the overwhelming interest in the information, 12 additional global
courses are planned for early 2014. Contact your local Ethicon representative
if you are interested in attending a MARS Outreach Course.
Increased risk of premature birth after surgery
No differences in still birth or
neonatal death rates between
sugical and non-surgical
patients
These pregnancies should be
considered risk pregnancies
and that prenatal care should
monitor them extra carefully
W
omen who have bariatric
surgery and then fall pregnant
are more likely to give birth
prematurely and to babies who are small
for their gestational age, according to a
large registry study carried out at Karolinska Institutet in Sweden and published
in the BMJ (Stephansson et al. Perinatal
outcomes after bariatric surgery: nationwide population based matched cohort
study. 2013). The researchers believe that
these pregnancies should be considered
risk pregnancies and that prenatal care
should monitor them extra carefully.
“Mothers with the same BMI gave
birth to babies of varying weights depending on whether or not they had undergone
bariatric surgery, so there is some kind
of association between the two,” said
Dr Olof Stephansson, obstetrician and
Associate Professor at the Clinical Epidemiology Unit at Karolinska Institutet.
“The mechanism behind how surgery
influences foetal growth we don’t yet
know, but we do know that people who
have bariatric surgery are at increased
risk of micronutrient deficiencies.”
However, the researchers noted that
bariatric surgery has numerous benefits
for mothers, such as lowering the risk of
diabetes, cardiovascular disease, cancer
and stroke, and untreated obesity is a
known risk factor for both mother and
baby during pregnancy and childbirth.
The study is the most extensive ever
performed in the field, was based on data
from the Swedish Medical Birth Register
and the Patient Register, and compared
2,562 babies born between 1992 and
2009 of women who had previously
undergone bariatric surgery with 12,500
babies born to mothers who had not.
The pregnancies were matched individually, so that the mothers’ BMI, age,
educational background, smoking habits,
and previous births were comparable in
both groups. The main outcome measures were preterm birth (<37 weeks),
small for gestational age birth, large
for gestational age birth, stillbirth (≥28
weeks), and neonatal death (0-27 days).
Results
Preterm birth was observed in 9.7%
(243/2511) of post-surgery births versus
6.1% (750/12 379) in matched controls
(risk difference 3.6%, 95% confidence
interval 2.4% to 4.9%; p<0.001). The
risks were increased for both medically indicated and spontaneous preterm
births. The risks of moderately and very
preterm birth were also higher in postsurgery births than in control births.
The risk of delivering a small for gestational age infant was higher in women
with a history of bariatric surgery than
in matched controls (5.2% (131/2507) v
3.0% (369/12 338); risk difference 2.2%,
95% confidence interval 1.3% to 3.2%;
p<0.001). Although, the opposite was the
case for large for gestational age births.
The researchers reported that the
procedure type or interval between
surgery and delivery did not impact
whether the baby was preterm or small
for gestational age birth.
There were no differences between
post-bariatric surgery and matched
control births were detected for stillbirth
(0.79% (20/2534) v 0.60% (75/12 468);
risk difference 0.19%, 95% confidence
interval −0.18% to 0.56%; p=0.32) or
neonatal death (0.28% (7/2514) v 0.26%
(32/12 393); risk difference 0.02%,
−0.20% to 0.24%; p=0.86).
The researchers said that women with
bariatric surgery history should be considered a risk group when pregnant and should
n Receive particularly close prenatal
attention
nHave extra ultrasound to check fetal
growth
n Given special dietary supplement
recommendations.
“This nationwide matched cohort study
found an increased risk of preterm and
small for gestational age births but lower
risk of large for gestational age births
in women with a registered history of
bariatric surgery compared with women
with similar characteristics but without a
history of bariatric surgery,” the authors
write. “This could not be attributed to
differences in maternal age, parity, early
pregnancy body mass index, smoking,
or educational level, which were used
as matching factors. Data suggested that
the increased risks of preterm and small
for gestational age births were confined
to the comparison of women with an
early pregnancy body mass index <35.”
“Our study did not investigate
whether the increased risk for small
for gestational age birth was caused by
micronutrient deficiencies, nor if it can
be reduced by more intensive micronutrient or foetal growth monitoring” they
conclude. “The mechanism behind the
observed effect modification by BMI
also needs further exploration, as no
excess risks were observed for preterm
or for small for gestational age birth in
women who were morbidly obese.”
bariatricnews.net 15
ISSUE 18 | DECEMBER 2013
Bariatrics+ app now free
App provides the information ‘at
their fingertips’
U
K bariatric specialists have developed the
Bariatrics+ app to help manage bariatric
patients in the emergency setting. The
unique app provides background information on
morbid obesity, surgery and other treatments and
how to manage early and late complications.
Managing a morbidly obese patient who presents as an emergency can be daunting for doctors
unfamiliar with bariatric surgery. Even when patients have lost weight, there are particular complications that need to be considered and the changes
in anatomy as a result of previous surgery can
be confusing. As a result, many bariatric patients
experience a delay in appropriate management, or
in some cases, are managed incorrectly.
Ms Sally Norton, consultant bariatric surgeon
and British Obesity and Metabolic Surgery Society
(BOMSS) council member, has developed a free iPhone app to help
address this problem and improve
patient safety.
“Trainees and consultants will
increasingly be faced with managing emergencies in this challenging
group of patients – this app provides all the information they need
at their fingertips,” she said.
Photos, illustrations and radiological images help the user
understand the operations and
implants that patients may have had
or complications that may have occurred. Links to medical or industry
websites provide extra information
as needed.
The app has the support of
BOMSS. In addition, generous industry support
from Medical Innovation Development (MID),
Covidien, Ethicon Endosurgery and Bariatric Solutions
has enabled the app to be
made available for free download via the iTunes store.
“I am very grateful to Covidien, Ethicon Endosurgery,
MID and Bariatric Solutions
for their generous sponsorship
which has enabled free downloads world-wide. I hope to find
additional sponsors to enable me
to build the same app for other
phone platforms and to translate
to other languages.”
The app, which was launched
at the recent AUGIS meeting,
is endorsed by BOMSS and
Sally Norton will be seeking
IFSO endorsement. She will
be publishing the results of the
surveys into the usefulness of
the app in due course
Key features of the app include:
n Morbid Obesity – background to the epidemic,
definition, associated problems and treatment
options.
n Bariatric Operations – understand about
common and not-so-common operations and
procedures to treat morbid obesity – as well as
the indications for revisional surgery.
n Emergencies – basic principles for treating
any morbidly obese patient, explanation of
symptoms and complications associated with
weight loss surgery, appropriate investigations
and urgent treatment options – including how
to deflate a gastric band.
n Images – gallery of photographs, X-rays and
operative images that may be invaluable in
managing bariatric emergencies, video link to
demonstration of gastric band deflation.
n More – useful links to educational and industry
websites where further information can be
found.
If you would like to provide suggestions for
improvement or would like to sponsor this patient
safety and medical education initiative to allow
translation into other languages and expansion to
other mobile platforms, please contact Ms Sally
Norton via BOMSS: [email protected]
BOMSS unveils new
Fellowship Curriculum
for UK surgeons
Updated Fellowship Curriculum
aimed at enhancing the delivery of
metabolic surgery
T
he British Obesity and Metabolic Surgery
Society (BOMSS) has issued an updated Fellowship Curriculum aimed at enhancing the
delivery of metabolic surgery.
Bariatric Fellows work at centres in North
Tyneside, Sunderland, Luton and Dunstable, Imperial, UCH and Taunton and are supported by an
unconditional grant from an industrial partner for
professional development of a metabolic surgery
service and intended to be applicable to other Royal
College of Surgeons (RCS) -approved Fellowships as
and when approved.
Richard Welbourn,
President of BOMSS
Six new Fellows will start work at the centres in
October and will use the new curriculum. The fellowships are RCSEng approved in high volume centres
providing specialist bariatric services.
“I’m delighted to announce that education and
Training experts at BOMSS have worked hard to
produce a comprehensive curriculum which offers
world-class Fellowships at UK centres,” said Mr
Richard Welbourn, President of BOMSS.
The Fellowship curriculum covers a wide range of
technical skills and professional attributes including:
n Managing patients who are morbidly obese and
understanding their surgical treatment, including
early and late complications
n Understanding different patterns of presentations
of complications
n Experience in Gastric Bypass and at least one
other bariatric procedure
nProducing work of scientific value in the field of
bariatric and metabolic surgery
n Teaching junior medical staff and allied healthcare professionals.
The updated curriculum can be viewed on the
BOMSS website: www.bomss.org.uk/trainees.htm
16 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013
Canadian study Bariatric surgery can be performed safely in secondary health care centres
Overall mortality and centrespecific mortality are well within
accepted values
L
aparoscopic bariatric surgery can be
performed safely in secondary health care
centres with a dedicated service corridor to
an affiliated tertiary health care centre, according to
a study published in the {{Laparoscopic bariatric
surgery can be performed safely in secondary health
care centres with a dedicated service corridor to
an affiliated tertiary health care centre.||Canadian
Journal of Surgery}}.
“With proper patient selection, a dedicated
health care team and a service corridor to an affiliated tertiary health care centre, laparoscopic
bariatric surgery, including gastric bypass can be
performed safely in secondary health care centres,”
wrote study author, Dr Nicolas Christou, Section
of Bariatric Surgery, Division of General Surgery,
McGill University, Montreal, Canada. “Further
study is needed to determine whether the model can
be applied across Canada.”
As in many countries around the world, access
to bariatric surgery is difficult and limited by a
number of factors including insurance coverage,
funding and hospital resources. In 2006, a unique
pilot project was started to determine whether laparoscopic bariatric surgery can be safely performed
in smaller hospitals, designated as secondary health
care centres, and linked via a dedicated service corridor to a full service tertiary health care centre.
The model was proposed by l’Agence d’évalu –
ation des technologies et des modes d’intervention
en santé (AETMIS) in a report to the Quebec Minister of Health and Social Services as a means of
increasing bariatric surgery capacity in the province.
The paper presents the outcomes from pilot project.
The 534-bed McGill University Health Centre
(MUHC), which has more than 40 years of bariatric
surgery experience, is fully equipped with an intensive care unit (ICU) and has dialysis capability,
Table 1: Patient stratification and complications recorded within the first 30 days after surgery at each site
Group; mean ± SD or no. (%)*
Factor
SHCC
THCC
p value
OS-MRS
1.6 ± 1.1
2.6 ±1.7
0.001
ASA class
2.8 ±0.8
3.2 ±0.8
0.001
Operating time in-out of room, min
89.0 ±12.0
145.0 ±23.0
0.002
Length of stay, d
1.9 ±0.1
2.8 ±0.4
0.003
Major complications
16 (2.3)
9 (5.8)
0.036
Minor complications
35 (5.2)
19 (12.3)
0.003
Readmission within 30 days of
surgery
16 (2.3)
3 (1.9)
0.003
Direct transfers to THCC
7 (1.2)
–
–
Deaths
0
2 (1.3)
NS
ASA = American Society of Anaesthesiologists; OS-MRS = obesity surgery mortality risk score; SHCC = secondary health care center; THCC = tertiary
health care center. •Unless otherwise indicated
was selected as the secondary health care centre.
The tertiary health care centre was the Centre
Métropolitain du chirurgie, a fully accredited 17bed private hospital with a “Specialized Medical
Centre” designation from the Ministry of Health
and Social Services.
The study included 830 patients: 676 treated at the
affiliated secondary health care centre and 154 at the
affiliated tertiary health care centre. Gastric bypass
was performed in 85.4% of patients, gastric band
in 11.1% of patients and gastric sleeve in 3.5% of
patients. BMI was significantly higher in the patients
treated at the tertiary health care centre, than at the
secondary health care centre (mean 54.4 vs. 47.5).
The same surgeon performed all procedures
with the same dedicated operating room team,
ward nurses and support staff over the duration of
the study. Patients with potentially life-threatening
complications were transferred to the tertiary
healthcare centre via a special ambulance using a
priori determined protocol (service corridor).
Outcomes
There were significantly more women treated
at secondary than tertiary health care centre, and
these patients were also younger (by about one
year). However, patients treated at a tertiary centre
were heavier and their BMI significantly higher
(p=0.001). Gastric bypass was the predominant
procedure because gastric banding was not publicly
funded in Quebec until recently.
There were two deaths at the tertiary centre and
no deaths at the secondary centre (overall mortality
was 0.2%). Logistic regression analysis failed to
identify any variables (age, sex, location of surgery,
starting BMI, ASA score, OS-MRS) contributing to
the risk of death owing to low incidence of death.
Complications recorded within the first 30 days
after the surgery were slightly higher at the tertiary
centre and obesity surgery mortality risk scores
and ASA score were also significantly higher at the
tertiary centre (Table 1).
The major complication rate was 2.3% (n=16) at
the secondary centre and 5.8% (n=9) at the tertiary
centre (p=0.036), and minor complications were
significantly more frequent in the tertiary centre
(p=0.003). Seven patients (1%) required direct
transfer to the tertiary centre and all were treated
successfully.
Weight loss in kilograms and the percentage
of total weight loss were equivalent between the
two centres. Although a comparison of the excess
weight loss between the centres regarding the
surgical procedure was not possible due to insufficient data, gastric bypass was associated with
significantly better weight loss results than the
gastric band and gastric sleeve procedures.
Whilst he acknowledges that the current study
represents the personal series of one experienced
bariatric surgeon, and a less experienced surgeon
may not be able to duplicate these results, Christou
believes that appropriate selection of a secondary
health care centre and adequate training of the preoperative, perioperative and postoperative teams,
remains imperative.
“We have now collected sufficient statistics
to suggest that, with proper patient selection, this
approach could be feasible,” claims Christou.
“Patient selection criteria allow for safe surgery to
be delivered at secondary health care centres with
acceptable mortality and short- and long-term complications. Overall mortality and centre-specific
mortality are well within accepted values.”
Publically-funded LAGB results in effective weight loss
Results demonstrate
achievable weight loss
through safe and least
complex obesity surgery
option
A
dapting bariatric surgery
in the Canadian public health
care system has the potential
to alleviate on-going health care
burden from obesity-related disease,
according to a study published in the
Canadian Journal of Surgery (Outcomes of the adjustable gastric band
in a publicly funded obesity program.
2013;56(4):233-6).
The data suggest that the weight loss
achieved with laparoscopic adjustable
gastric banding (LAGB) in a sustainable
public programme is substantial and
successful, the authors note, and that
the safety of the procedure was clearly
demonstrated.
Although they acknowledge that long
term data are still required to ‘ultimately
decide the true cost-effectiveness of
LAGB in our system’, the study of the
short-term results ‘represents a realistic
view of achievable weight loss through
this safe and least complex obesity
surgery option’.
The researchers undertook the study
as there is no uniform long-term data on
public bariatric surgery programmes or
consensus currently on patient selection
criteria for LAGB.
“These controversies are reflected
in that not all Canadian provinces fund
LAGB as a treatment for obesity,” they
note. “The publicly funded obesity
treatment program at our institution is
a referral-based, multidisciplinary clinic
providing tertiary medical, psychological and surgical interventions.”
The investigators performed a
retrospective study involving patients
who underwent LAGB during a six-year
period from 2005 to 2010 and the shortterm weight loss results at one-, two- and
three-year follow-up were analysed.
They calculated the weight loss
results as both percentage total body
weight loss (%TBWL) and percentage
excessive body weight loss (%EBWL)
based on an ideal body weight generated
using a normal BMI of 24.9.
The analysis of complications were
separated into two categories: short
(postoperative period before discharge
from hospital) and medium term (the
period from discharge up to three-year
follow-up).
In addition, they also reported the
operational costs for on-going LAGB
care, we assessed the duration of surgery, length of stay (LOS), frequency
of clinic visits and band fillings, and
methods of investigation used during
the follow-up period.
They included two generations
(Real 1 and 2) of the REALIZE adjustable gastric band (manufactured by
Ethicon Endo-Surgery) and reported
the differences in performance between
the two devices.
Outcomes
They identified 178 patients who underwent LAGB during the study period:
153 women (86%) and 25 men (14%).
The average age was 42.8 years, and
the average preoperative BMI was 44.2
(SD -/+7).
The trends of weight loss over the 3
years are illustrated in Figure 1. Three
patients’ weight data were not included
Figure1: Percentage total body weight loss and percentage excess body weight loss
among patients who underwent laparoscopic adjustable gastric band surgery.
in the weight loss analysis owing to early
removal of band (n=1) and complication
or pregnancy affecting weight (n=2)
before one-year follow-up. The preoperative conservative weight management
achieved a %TBWL average of 4.4%.
The most common short-term complications were postoperative nausea
(19%) and non–surgical site infections,
such as pneumonia and urinary tract
infections (1%). The reoperation rate
was 4.5%.
In an analysis of operational costs,
the average duration of surgery was
56 minutes, and the average LOS was
1.4 days. Clinic visits occurred most
frequently in the first year, with an average of seven visits, and dropped to four
visits in the next two years. The average
number of band fillings required was
three fills in year one, and one fill only
in the other two years.
They noted that 36% of our patients
required at least one investigation postoperatively. Fluoroscopy was the most
common method (86%), followed by
computed tomography (9%) and upper
endoscopy (4%).
REALIZE comparison
The comparison between Real 1 and
2 gastric bands is presented in Table
1. They found significant differences
in preoperative BMI, weight loss and
duration of surgery. The weight loss
analysis was based on one-year followup data because not enough patients
who received the newer Real 2 band had
complete two-year follow-up data.
The weight loss achieved through
LAGB in the short-term plateaued between the second and third year reaching
a %TBWL of 20% and %EBWL of 44%.
Regarding the comparison between
the first and second generations of the
REALIZE gastric band, the investigators claim the data suggest significant
differences in the duration of surgery
and weight loss at one-year follow-up.
The surgery was three minutes longer
in the newer Real 2 band group, which
likely represents a small learning curve
using the new product.
The %EBWL was higher in the Real
1 group; however, the preoperative BMI
between the 2 groups was also significantly different, with the Real 1 group
having a higher BMI.
“Since the 2 groups’ baseline characteristics were not identical, especially
with respect to preoperative weight,
it is difficult to determine whether the
observed difference in %EBWL is truly
significant,” the write. “More data collection with longer follow-up will be needed
to further investigate the difference in
weight loss observed between patients
who received the different bands.”
“Our patients may represent a distinct population that differs from that
in the private system,” the researchers
conclude. “Long-term data are necessary to determine the cost-effectiveness
of this important surgical option for
severe obesity.”
Table 1: Comparison between the first (Real 1) and second generation (Real 2) of the
REALIZE adjustable gastric band at one-year follow-up.
Characteristic
Real 1
No. of patients
Gastric band; mean (SD)*
p value
Real 2
90
57
Age, yr
44.2 (10)
41.1 (9.8)
0.09
Preoperative BMI
45.7 (7.9)
41.2 (5.4)
< 0.001
Operative time, min
52.1 (14)
55.1 (10)
0.013
LOS, d
1.40 (1.4)
1.20 (0.045)
0.73
Excess body weight loss, %
22.7 (20)
12.1 (14)
0.002
5.5
0
0.15
Complication, %
BMI = body mass index; LOS = length of stay; SD = standard deviation. *Unless otherwise indicated.
bariatricnews.net 17
ISSUE 18 | DECEMBER 2013
Clinical comment
Access to surgery
Nicolas Christou Professor of Surgery,
McGill University, Montreal, Quebec, Canada
U
nder Canada’s publicly funded system,
if two 40-year-old mothers, each with
three children, require life-saving surgery, one a bariatric procedure for obesity and the
other a mastectomy for breast cancer, it is almost
always the latter who gets the surgery within a
reasonable time period. The reason is that society
views the obese mother as “a big fat slob who
should go on a diet”. Politicians think, “Obesity
is not a sexy political issue”. Policy-makers and
the public don’t understand that obesity is a highly
complex chronic disease, with causes rooted in a
patient’s biology, metabolism and mental health.
As a result, bariatric surgery is not well funded in
most of Canada.
Bariatric surgery is the only known treatment
that will reduce the risk of dying of cancer by 60%,
from a diabetes complication by 90%, or reduces
total mortality risk by 40% to 60%. There’s almost
nothing else we do in medicine that’s so effective
and has such a dramatic impact on one’s health.
Remarkably though, Canada only performs about
3,500 procedures per year in public hospitals.
Private-pay clinics (mostly adjustable gastric
banding) account for another 1,500 procedures
per year. The country is only touching the tip of
the iceberg in terms of dealing with the demand in
the population.
Ontario is the only province willing to make
a significant attempt at addressing the country’s
shortcomings in this area. In July 2008, it announced $741 million in new funding for a comprehensive, four-year diabetes strategy, of which
approximately 10% was targeted toward access to
bariatric services.
This $75-million initiative increased the province’s capacity for weight-loss surgery several fold
over the last five years to about 2,500 cases per
year or 250% increase in 2012-13.
The province of Quebec is unique within
Canada’s healthcare system because of the Chaoulli v. Quebec (Attorney General), 2005 SCC
35, [2005] 1 SCR 791 decision by the Supreme
Court of Canada which ruled that Section 15 of the
Health Insurance Act and section 11 of the Hos-
pital Insurance Act, which outlaw private medical
insurance, violate the right to personal inviolability
as guaranteed by the Quebec Charter of Human
Rights and Freedoms.
The decision proved to be highly contentious
by its political nature and its conflict with the
present government’s policy on health. There are
those who argue that this decision could potentially
lead to the dismantling of the Canadian Medicare
system, while others suggest that this could be a
much-needed wake-up call to repair the ailing
system.
Although in 2005 Quebec performed the
most obesity surgeries in Canada, the average
wait time for a procedure in the province was
~7 years. To address this, the Quebec Minister
of Health convened a panel of experts to come
up with a plan to increase capacity for bariatric
surgery in the province and thus reduce the wait.
The report tabled in 2006 recommended the
creation of 4 centers of excellence in bariatric
surgery that would anchor the 4 RUIS (Réseau
Universitaire Intégrée Sante) or integrated health
regions in the province. These centers would be
located in tertiary academic hospitals that would
be able to treat all bariatric surgery cases and all
bariatric surgical complications irrespective of
complexity.
The expert panel also recommended the creation of secondary bariatric surgery centers that
would perform bariatric surgery on uncomplicated
bariatric surgical patients (e.g. Body Mass Index
less than 50 kg/m2, minimal obesity associated
comorbidity and ASA class 1-3). These secondary
bariatric surgical centers would have a formal
association with one of the tertiary centers within
their respective RUIS for dealing with complications of bariatric surgery as well as academic and
research support.
In response to the Chaoulli decision, the Minister of Health also tabled a law, which created
a mechanism for guaranteeing surgery within a
timely fashion. If the public healthcare system
could not provide the required surgery (initially
for hip and knee replacements but eventually others such as bariatric surgery) within a predefined
timeframe (see figure), than patients would be
given the option to utilize the newly createdcmS
(Centre Médicale Spécialisée) clinics. Two types
ofcmS were proposed based on the funding model.
Privately delivered publically funded or privately
delivered privately funded.
As part of this initiative a pilot project was
started to determine whether acmS could carry
out bariatric surgery in a safe and timely manner.
The results of this pilot study show that the model
works in this particularcmS and should be tested
further with more secondary centers before wide
application.
MGB results encouraging, more evidence needed
Surgery resulted in a significant and consistent
reduction in BMI, glycaemia and HbA1c values
The prevalence of diabetes remission was evident
in both groups and increased overtime, regardless of
the type
D
espite “encouraging” results regarding the effectiveness of
mini-gastric bypass on diabetes remission, additional studies
are needed to provide definitive conclusions in selecting the
ideal procedure for diabetes remission before the procedure can be
seen as a valuable alternative to the Roux-en-y gastric bypass, according to a study published in the World Journal of Gastroenterology
(2013;19(39):6590-7).
The aim of the study was to investigate the weight loss and
glycaemic control status (blood glucose, haemoglobin A1c (HbA1c)
and hypoglycaemic treatment), following sleeve gastrectomy (SG) or
mini-gastric bypass.
Data from patients referred during a three-year period (from January 2009 to December 2011) to the University of Naples “Federico II”
diagnosed with obesity and diabetes were retrieved from a prospective
database.
A total of 53 subjects who underwent sleeve gastrectomy or minigastric bypass for obesity and diabetes were screened for the inclusion
in this study. Of these, four subjects were excluded because of surgical
complications, seven subjects were omitted because young surgeons
conducted the operations and 11 subjects were removed because of the
lack of follow-up.
Thus, a total of 31 obese patients (15 males and 16 females; mean
age: 38.32 ± 3.21 years; BMI: 44.78±4.25) were recruited for this study.
All patients were diagnosed with type 2 diabetes [15 (48.4%) on metformin and 16 (51.6%) on metformin + insulin], 18 subjects (58.1%)
reported hypertension and eight presented with hypercholesterolemia.
Figure 1: Prevalence of subjects achieving diabetes remission in the
sleeve gastrectomy group and mini bypass group.
The mean glycaemia value was 169.87±35.76, and the mean HbA1c
level was 8.5±1.0. A total of 15 subjects underwent SG (48.4%), and
16 patients underwent MGB (51.6%).
The authors report that following surgical intervention, “a significant and consistent reduction in BMI, glycaemia and HbA1c values
were observed relative to the baseline values”.
With regards to surgery type, sleeve gastrectomy and mini-gastric
were both associated with similar percent changes in BMI (-24.33 ±
4.48 vs. -24.19±4.42, p=0.931), glycaemia (-24.30 ± 11.40 vs. -28.42 ±
14.03, p=0.379) and HbA1c (-22.57±8.70 vs. -22.67±8.46, p=0.975).
However, significant correlations were not detected in the percent
change from baseline to 12-mo follow-up between BMI and glycaemia, as well as between BMI and HbA1c.
The results were confirmed based on the type of surgery and the
percent change in BMI did not correlate with changes in glycaemia
(r=-0.119, p=0.673 for sleeve and r=0.462, p= 0.071 for mini bypass)
or with changes in HbA1c (r=-0.349, p=0.202 for sleeve and r=-0.018,
p=0.946 for mini bypass).
The prevalence of diabetes remission was evident in both groups and
increased overtime, regardless of the type (Figure 3). At three months
post-surgical intervention, diabetes remission was reported by 18 subjects (53.3% sleeve vs. 62.5% mini bypass, p=0.722). The results were
confirmed at six-months (53.3% sleeve vs. 68.8% bypass p=0.473) and
12-months (66.7% sleeve vs. 87.5% mini bypass, p=0.220).
The percent change in BMI was similar between patients achieving
diabetes remission and patients who did not (-24.28 ± 4.33 vs. -24.15
± 4.53, respectively, p=0.97).
However, after adjusting for various clinical and demographic
characteristics in a multivariate logistic regression analysis, a high
HbA1c was considered a negative predictor of diabetes remission
at 12 months (OR=0.366, 95%CI: 0.152-0.884). Using the same
regression model, mini bypass showed a clear trend towards a
higher diabetes remission rate relative to SG (OR=3.780, 95%CI:
0.961-14.872).
“Although we observed a clear trend in our study, this did not
achieve statistical significance,” the authors note. “A multivariate
analysis was performed to adjust for major clinical and demographic
variables, but because of the relatively small sample size, our results
need to be validated in larger studies. Thus, the present work could
be considered a preliminary study, providing the rationale for a randomised prospective trial.”
The study authors noted that the exclusion of the duodenum could
suggest the potential superiority of mini-gastric bypass over sleeve
gastrectomy to obtain diabetes remission and that this mechanism
could suggest the potential superiority of mini-gastric bypass over
sleeve gastrectomy to obtain diabetes remission.
“Thus, although the gold standard for diabetes remission is still
the Roux-en-y gastric bypass, being similar mechanisms of diabetes
remission involved and being easier to be performed, the mini-gastric
bypass could become a valuable alternative,” they conclude.
18 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013
The role of a psychologically-led
Tier 3 multi-disciplinary intensive
weight management intervention as
part of a bariatric surgery pathway
Janet Biglari & Sevim Mustafa Joint Managing Directors The Bariatric Consultancy
Emeritus Professor Julia Buckroyd The University of Hertfordshire
Introduction
here has been extensive
debate as to the role and overall
benefits of Tier 3 non-surgical
specialist weight management services.
The new clinical commissioning policy
for Complex And Specialised Obesity
Surgery issued in April 2013 by the NHS
Commissioning Board brings this debate
into even sharper focus. Guidelines state
that all bariatric surgery candidates must
in the first instance access local Tier 3
multi-disciplinary specialist weight management services for a period of 12 to 24
months. For patients with a BMI over
50 the minimum acceptable period is six
months. This raises a question around
the role and responsibilities of these
services. Can they offer an alternative
non-surgical pathway or is their primary
function to provide multi-disciplinary
preparation for surgery?
As the field of obesity treatment matures, research suggests1,2 that not only is
it difficult for patients to achieve a weight
loss significant enough to improve
their health status, but also available
treatments are not supporting long-term
successful weight maintenance. Bariatric
surgery is largely considered to be the
only effective treatment for obesity it is
advocated by the National Institute of
Clinical Excellence (NICE). According
to Shedding The Pounds, (September
2010) compiled by the Office of Health
Economics, ‘between 11,000 and
140,000 people in England currently
qualify for bariatric surgery under NICE
guidelines, while the actual number of
surgeries that took place in England in
2009-10 was 3,607.’
It is clear that demand for bariatric
surgery in the United Kingdom exceeds
provision and there is a need for a more
sophisticated model to manage the demand for obesity services.
Bariatric surgery is often portrayed
by the popular media as a ‘magic cure’
that places little responsibility for a
good outcome on the recipient. However
T
success in bariatric surgery demands a
capacity to make significant lifestyle
changes and modify eating behaviour. It
provides a window of opportunity of 18
to 24 months for patients to implement
the changes neccessary. As with other
treatments surgery is unlikely to deliver
long-term weight maintenance if patients
do not make fundamental changes.
Whether a patient is treated in a specialist
weight management service or proceeds
onto a surgical pathway a growing body
of evidence suggests3 that programmes
combiing psychological behaviour
change, dietetics and a physical activity
component are the most effective model
for long term weight maintenance.
The Service Model
The Bariatric Consultancy has been developing and delivering specialist multidisciplinary Tier 3 weight management
programmes since 2008. We currently
deliver two services across the South of
England, offering treatment to around
600-700 patients a year.
The service model is psychologically
led. In March 2011 the National Obesity
Observatory (NOO), published its paper
Obesity and Mental Health, concluding
that there are strong bi-directional associations between obesity and mental
health. Research also suggests obesity
is associated with high levels of childhood maltreatment,4,5 which manifest
in adulthood as complex mental health
problems resulting out of a history of
trauma and poor attachment.6,7 These
early experiences often result in disordered eating and a reliance on food for
emotional regulation. It is our experience
that by addressing the roots of a patients
eating behaviour they are more able to
understand their triggers and develop an
alternative means of emotional regulation. Patients who have an intensive psychological intervention have shown high
retention rates in the service and engage
more extensively with the dietetic and
exercise components. Our research has
shown that patients who adhere to the
programme will lose between 5-10% of
their excess weight.
Since implementing these services we
have experienced a significant impact
on the numbers of patients requesting
surgery. In one locality over a 12 month
period the number of patients opting
for surgical weight loss was reduced by
70%. Tier 4 providers within the pathway
have reported that patients are better
informed and that only those who are
medically and psychologically prepared
are accessing surgical services.
Our specialist weight management
service fulfils the criteria set out by NICE
(2006), and also the new commissioning
policy (April 2013). Treatment is multidisciplinary delivered by specialist clinicians, including physicians, dietitians,
psychological therapists, and exercise
facilitators. The service model provides
a multi-disciplinary intervention including medical management, dietetics,
psychological therapy, and an exercise
component. A programme of this kind
identifies those who cannot commit to
lifestyle changes and are unlikely to
achieve a good outcome from surgery. It
also identifies those whose psychological
status is not sufficently robust for them to
undergo surgery, along with those whose
medical conditions, eating behaviour or
psychological disorders suggest the need
for prior treatment.
Our specialist services are offered
to patients with a BMI of 35≥ and are
delivered locally to the patient usually in
General Practices or Health Centres.
Patients are also able to access our
service post surgery for psychological
management if they are unable to make
sufficient change to support a good
outcome.
We have developed a four-phase
treatment intervention that offers:
1. Multi-disciplinary Assessment
2. Intensive Treatment Phase (12
weeks)
3. Maintenance Phase (nine months)
4. Tier 4 Assessment and Preparation
Our model is psychologically led with all
patients accessing an intensive psychological therapies intervention.
Clinics are spread geographically
across localities and work to address any
health inequalities present.
Intensive Treatment
Treatment is primarily delivered in a
group consisting of 10-15 participants.
The programme is carried out over 12
consecutive weeks and is based around
Cognitive Behavioural Therapy to facillitate behaviour change. There is also
an educational dietetic component, and
participants are prescribed activity goals
and encourgaed to engage in community
based activities and home exercise. All
patients receive follow up one to one
sessions with the psychological therapies
team and dietitians at six, nine and twelve
months. Patient’s emotional well-being
is monitored at the start and completion
of the Intensive phase using two outcome
questionnaires, Clinical Outcomes in
Routine Evaluation (CORE), and The
Rosenberg Self Esteem Scale.8,9
Patients that are considered not to be
psychologically robust enough for the
group programme, are offered a similar
treatment intervention but based on one
to one contacts with a psychological
therapist and dietitian but still encouraged
to join the group exercise programme.
Maintenance Treatment
Maintenance treatment takes place
over a nine month period. It is patient
led and incorporates regular contact
with the clinical team. Patients are also
invited to attend support group meetings
that are led by one of the therapy team.
Physiological and psychological markers
along with weight and BMI are collected
at six, nine and twelve months.
even if their weight loss has been poor.
Patients proceeding to surgery will
go through a preperation process. This
includes a specialist medical assessment with a Bariatric Physician and
attendance at a surgical seminar which
sets out to educate patients on every
aspect of surgery. This will include the
Tier 4 journey, and post surgical dietary
behaviour and lifestyle changes. Patients
are also educated on the problems associated with skin folds, and potential
medical and psychological complictions.
Patients are then provided with a list of
approved surgical centers that are available to their area, and asked to research
their preferred provider before making a
final choice.
Once a patient has been accepted
on to a surgical pathway, they are discharged from our service. Developing
close communication with surgical providers ensures that a patients progess is
monitored and each patient is contacted
by telephone six weeks post surgery by
the patient coordinator. If a patient is
found to be struggling with psychological change they can be re admitted to the
Tier 3 service for a further intervention.
The success of our services has been
an understanding of the complex needs
of this patient cohort and the requirement
to tailor services directly for them. We
have also been responsible for educating
and training other clinicians within the
obesity pathway on the management of
this complex patient group.
The debate around the part specialist
Tier 3 weight management services
have to play within a bariatric surgery
pathway will continue. As yet there is no
established standardised commissioning
model. The services already commissioned are in their infancy and there is
no long term data available to establish
their efficacy in weight reduction and
maintenance. However the responsibility they take for the in depth education
and preparation of surgical candidates
is measurable and should be evident in
patients who are referred on to bariatric
surgery pathways and are screened by the
surgical multi-disciplinary teams.
Tier 4 Assessments and
Preparation
Patients are not considered for onward
referral to a surgical service until they
have completed at least six months
treatment. Bariatric surgery will only be
considered for patients once the MDT
have agreed that all other avenues of non
surgical weight loss have been exhausted
and that the patient is both medically and
psychologically prepared. Patients must
Multi-disciplinary Assessment
also have demonstrated a commitment to
This takes place in two stages. Initially the Tier 3 programme and have shown
new referrals undergo a motivational the ability to address behaviour change
interview carried out by a patient coordinator usually by telephone. This will
4.Sansone, R. A., Schumacher, D.,
References
assess a patients readiness to change. PaWiderman, M.W., and Routsong1.Klem, M.L.,Wing, R.R., Lang, W.,
tients accepted onto the programme are
Weichers, L. (2008). The prevalence
McGuire, M.T., Hill, J.O. (2002) Does
of childhood trauma and parental
then assessed by the multi-disciplinary
Weight Loss Maintenance Become
caretaking quality among gastric surEasier Over Time? Obesity Reteam. Collection of baseline data such as
gery candidates. The Journal of Treatsearch,
8
(6):
438-444.
weight, BMI, and physiological markers,
ment & Prevention, 16, 117-127.
resting heart rate, blood pressure, and 2.Anderson, J.W., Grant, L., Gotthelf,
L., Stifler, L. (2007). Weight loss 5.Kivimaki, M., Batty, G., Singh-Manoux,
mobility assessment form part of this
A., Nabi, H., Sabia, S., Tabak, A.G, et
and long-term follow-up of severely
process. The results of the assessments
al. (2009). Association between comobese individuals treated with an
mon mental disorder and obesity over
determine an individual’s treatment plan.
intense behavioral programme. Inthe adult life course. British Journal of
ternational Journal of Obesity 31(3):
Patients are also screened for medical
Psychiatry, 195 (2): 149155.
488–493.
problems and unresolved complex
3.Cooper, Z., and Fairburn, C.G. 6.Wilde, J.E., Kalarchain, M.A.,
mental health issues. This may result in
Marcus, M.D., Levine, M.D., and
(2001). A new cognitive behavioural
a specialist referral to acute services or
Courcoulas, A.P. (2008). Childhood
approach to the treatment of obesiCommunity Mental Health Teams.
maltreatment and psychiatric morty. Behaviour Research and Therapy,
39, 499-511.
bidity in bariatric surgery candidates.
GLP-1 test could predict efficacy of bypass on T2DM remission
A
hormone test may be
able to predict the
extent of metabolic
improvement caused by the
gastric bypass, according to
the results of a rodent study by
researchers from the Institute
of Diabetes and Obesity (IDO),
Helmholtz Zentrum München,
Germany, and the University of
Cincinnati, Ohio.
They report that the sensitivity of the glucagon-like
peptide 1(GLP-1 hormone),
can predict the metabolic efficacy of a gastric bypass, and
therefore could be used as a
novel predictive biomarker for
personalised treatment of type 2
diabetes and obesity. The results
were published in the journal
{{GLP-1R responsiveness predicts individual gastric bypass
efficacy on glucose tolerance in
rats.||Diabetes}},
“If our results are confirmed
in clinical trials with patients,
the hormone response could
be tested before the planned
surgery and surgeons would
be able to predict how much
an individual patient’s glucose
metabolism would benefit,”
said Professor Matthias Tschöp,
Helmholtz Zentrum München.
“This will contribute to the
development of personalized
therapies for type 2 diabetes and
obesity. For surgical procedures
such as gastric bypass this is
particularly compelling because
such operations are complex
and cannot be easily reversed.”
One hundred ninety-seven
high-fat-diet-induced
obese
male Long-Evans rats were
monitored for body weight loss
during Exendin-4 (Ex4) administration. Stable populations of
responders and non-responders
were identified based on Ex4induced BW loss and GLP1-induced improvements in
glucose tolerance.
Sub-populations of Ex4
extreme responders and nonresponders received RYGB.
Following RYGB, responders
and non-responders showed
similar BW loss compared
to sham, but non-responders
retained impaired glucose tolerance.
“These findings present an
opportunity to optimize the use
of bariatric surgery based on
an improved understanding of
GLP-1 biology and suggest an
opportunity for a more personalised therapeutic approach to
the metabolic syndrome,” they
conclude. “This latest study
showed that GLP-1 responsiveness varied considerably with
regard to glucose metabolism,
and the more responsive the
animals were to GLP-1, the
greater the efficacy of the
gastric bypass turned out to be
regarding glucose metabolism
improvements. Thus, the responsiveness to GLP-1 could be
a key indicator for the success
of the gastric bypass.”
Matthias Tschöp
Obesity Surgery, Springer New York,
18, 306-313.
7.Biglari, J., Buckroyd, J,. Mustafa,
S,. Howlett, N. (submitted) Poor
Psychological Health and a History
of Abuse, in Bariatric Surgery Candidates: Levels of Pathology in the UK.
8.Rosenberg, M., (1965). Rosenberg
Self Esteem Scale.
9.Barkham, M., Margison, F., Leach,
C,.Lucock, M., Mellor-Clark, J.,
Evans, C.,Benson, L., Audin, K.&
McGrath, G. (2001). Service profiling
and outcomes benchmarking using
CORE-OM: Toward practice-based
evidence in the psychological therapies. Journal of Consulting and Clinical Psychology, 69 (2), 184-196.
bariatricnews.net 19
ISSUE 18 | DECEMBER 2013
ASBP develop algorithm to guide
physicians in obesity care
The algorithm emphasises
patients’ overall health and
reducing their risk of developing
obesity-linked conditions
T
he American Society of Bariatric Physicians (ASBP) has published an algorithm
to help physicians navigate medical
treatment for obesity care. Researchers have developed and written an obesity algorithm, which
aims to provide all physicians with training and
tools for prescribing and implementing an obesity treatment plan, tailored to each patient.
The algorithm emphasises patients’ overall
health and reducing their risk of developing
obesity-linked conditions. Following an examination of current lifestyle and family history, a
physical examination, and laboratory testing,
specific changes will be recommended. These
changes relate to diet and nutrition, physical
activity, counselling, and medication, as appropriate.
“Physicians are now confronted with the
need to understand what makes obesity a disease
and how patients affected by obesity are best
managed,” said Deborah Bade Horn, ASBP
president-elect and Algorithm Committee cochair. “They can benefit from the algorithm,
which compiles the experience of researchers
and clinicians who engage in obesity treatment
on a day-to-day basis.”
The society claims this is the first-ever
comprehensive algorithm that navigates the
physician’s role in medically treating and caring
for patients affected by obesity.
The ASBP Obesity aims to give all physicians
training and tools for prescribing and implementing obesity treatment plans for patients. Among
these plans, changes in nutrition, exercise and
behavior are included. Physicians may also
recommend weight-loss medications or discuss
surgical options for excess fat reduction.
“This will help give physicians a better opportunity to manage patients affected by obesity
in the most compassionate, scientifically sound
and cost-effective way possible,” said Dr
Jennifer Seger, ASBP Trustee and Algorithm Committee Co-chair.
The algorithm emphasizes patients’
overall health and reduction in risk of
developing associated conditions, such
as type 2 diabetes, hypertension, sleep
apnea, cardiovascular disease and depression. Changes will only be recommended
following an examination of the patient’s
current lifestyle, family history, physical
exam and laboratory testing. The algorithm
will aid physicians in determining whether
these results warrant a need for intervening
obesity treatment and what that care would
look like.
The algorithm also offers suggestions for
affordable treatment options. Physicians can
use the algorithm to create individualised
treatment plans for patients, providing them
with optimal obesity care at an affordable
cost.
The ASBP Obesity Algorithm, a summary
about how physicians can use the algorithm, the
Medical Obesity Treatment Options Fact Sheet,
and a patient-friendly infographic, is available as
a free download from the ASBP website: www.
asbp.org/obesityalgorithm
20 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013
DS results in greater weight loss and improved insulin sensitivity
RCTs are needed to determine
whether there is a significant longterm effect of these variations
C
ompared to gastric bypass, duodenal
switch results in greater weight loss and
improves insulin sensitivity and glucose
homeostasis without causing a hyperinsulinemic
response, according to a study published in Surgical Endoscopy (Mitchell et al. Response to glucose
tolerance testing and solid high carbohydrate
challenge: comparison between Roux-en-Y gastric
bypass, vertical sleeve gastrectomy, and duodenal
switch. 2013).
The study researchers, led by Dr Mitchell Roslin of Lenox Hill Hospital in New York, said that
hyperinsulinemic hypoglycemia is common after
Roux-en-Y gastric bypass (RYGB) and could be a
cause in weight regain. Therefore, they decided to
compare the effect of RYGB, vertical sleeve gastrectomy (VSG), and duodenal switch on insulin
and glucose response to carbohydrate challenge.
For this prospective nonrandomized study,
they gathered data from patients that met National
Institutes of Health criteria for bariatric surgery,
performed via a laparoscopic technique at a single
institution. Preoperatively and at six, nine and 12
months’ follow-up, patients underwent blood draw
to determine levels of fasting glucose, fasting insulin, glycated hemoglobin (HbA1c), C-peptide, and
two hour oral glucose challenge test.
The researchers then calculated the homoeostatic model assessment (HOMA)-IR, fasting to
one hour and one to two hour ratios of glucose and
insulin.
Outcomes
Data from a total of 38 patients (13 RYGB, 12
VSG, 13 duodenal switch) were available for
analysis. At baseline, all groups were similar; the
only statistically significant difference was that
duodenal switch patients had a higher preoperative
weight and BMI. All operations caused weight
loss (BMI 47.7 ± 10–30.7 ± 6.4 in RYGB; 45.7 ±
8.5–31.1 ± 5.5 in VSG; 55.9 ± 11.4–27.5 ± 5.6 in
duodenal switch), reduction of fasting glucose, and
improved insulin sensitivity.
The results also showed that RYGB patients
had a rapid rise in glucose with an accompanying
rise in one hour insulin to a level that exceeded
preoperative levels. This was followed by a
rapid decrease in glucose level. In comparison,
DS patients had a lower increase in glucose and
one hour insulin, and the lowest HbA1c. These
differences were statistically significant at various data points. The researchers added that for
VSG, the results were intermediary: “Because the
response to challenge after VSG is intermediary,
pyloric preservation alone cannot account for this
difference.”
The wide fluctuations in glucose levels seen
with gastric bypass could have an impact on hunger
and weight control in the long run, the researchers
concluded.
They stressed that randomised controlled
trials are needed in order to determine whether
there is a significant long-term effect of these
variations.
This paper was presented at the SAGES 2013
Annual Meeting, in April 2013, in Baltimore.
The study was sponsored by Covidien.
Study helps to explain mechanisms of duodenal switch
Results reveal that different postsurgical effects
of GB vs. DS in terms of food intake, eating rate,
energy expenditure and absorption
D
uodenal switch induces greater body weight loss by reducing food intake, increasing energy expenditure and causing malabsorption, compared to bypass that induces body
weight loss by increasing energy expenditure, according to a study
in rat models, Mechanistic Comparison between Gastric Bypass vs.
Duodenal Switch with Sleeve Gastrectomy in Rat Models, published
online in the journal Plos One.
The authors state that although both gastric bypass (GB) and duodenal switch have been widely used in bariatric surgeries, the latter
appears to be superior to GB in terms of weight loss. The procedures
have shown different efficacy in individual patients and the underlying mechanisms are not yet clear; whether this is due to biological or
behavioural factors.
The aim of the study was to better understand the mechanisms
leading to body weight loss by comparing these two procedures in
experimental models of rats.
Study
GB was performed without the Roux-en-Y reconstruction and the
postsurgical anatomy was similar to mini-GB on humans, and DS was
performed according to the rat anatomy.
Thirty-four rats, at 587.0±8.1g body weight, were randomly
divided into experimental (GB and DS) as well as control groups
(laparotomy, LAP): GB (14 rats), DS (7 rats), and LAP (13 rats). The
body weight was not different between the groups before surgery
(p=0.276). Because of markedly loss of body weight after DS, the
group of DS rats, together with age-matched group of laparotomized
rats (LAPDS, 7 rats), were followed up only for eight weeks, while
GB rats and the rest of laparotomized rats (LAPGB, 6 rats) were followed up for 14 weeks.
Outcomes
LAP alone did not reduce body weight during the study period
(maximum 14 weeks). GB caused approximately 20% weight loss
throughout the study period (14 weeks). DS induced approximately
50% weight loss within 8 weeks.
With regard to food intake (Figures 1 and 2), LAP and GB increased daytime (but not night-time) food intake (expressed as either
kcal/rat or kcal/100 g body weight) at three weeks, and had no effects afterwards (14 weeks postoperatively). In contrast, DS reduced
night-time (but not daytime) food intake (kcal/rat at both two and
eight weeks or kcal/100g body weight at two weeks). The food intake
(kcal/100 g) at eight weeks was not reduced because of markedly loss
of the body weight after DS.
GB increased night-time energy expenditure (kcal/hr/100g body
weight) at three weeks and daytime energy expenditure at 14 weeks
postoperatively (Fig 3A, C). DS increased daytime energy expenditure
both at two and eight weeks as well as night-time energy expenditure
at eight weeks postoperatively (Fig 3B, D).
Overall, the results show that the increased energy expenditure
took place only during night-time (relevant to active energy expenditure) shortly after GB (weeks) and switched to daytime (resting
energy expenditure) after months, whereas the energy expenditure
was increased during daytime shortly after DS and during both dayand night-time months after DS.
There was no change in the faecal energy density after GB. DS
had severe diarrhoea within 2 weeks postoperatively, so that it was
difficult to collect the faecal samples. At two months, the solid faeces
were collected and the energy density was increased (Figure 4).
The researchers acknowledge that there are several limitations of
the study:
n The rats used were not obese and therefore it is not known
whether postsurgical effects of these two procedures are different
between normal and obese rats
Figure 1: Total food intake (kcal/rat) (A, B) and relative food intake
(kcal/100 g body weight) (C,D) during day- and night-time. Short-term
after surgery: 3 weeks after gastric bypass (GB), 2 weeks after duodenal
switch (DS) or 2–3 weeks after lapatoromy (LAP). Long-term after
surgery: 14 weeks after GB, 8 weeks after DS or 8–14 weeks after LAP.
Data are expressed as means ± SEM. *: p<0.05, **: p<0.01, ns: not
significant between LAP (n=13) vs. GB (n=8) or DS (n=5).
Figure 2: Eating behaviour.Satiety ratio (min/g) (A,B) and rate of eating (g/
min) (C,D) during day- and night-time. Short-term after surgery: 3 weeks
after gastric bypass (GB), 2 weeks after duodenal switch (DS) or 2–3
weeks after lapatoromy (LAP). Long-term after surgery: 14 weeks after
GB, 8 weeks after DS or 8–14 weeks after LAP. Data are expressed as
means ± SEM. ***: p<0.001, ns: not significant between LAP (n=13) vs.
GB (n=8) or DS (n=5).
Figure 4: Faecal energy density. Three weeks after gastric bypass (GB)
or laparotomy (LAPGB) (A) and eight weeks after duodenal switch (DS)
or laparotomy (LAPDS) (B). Data are expressed as mean ± SEM. **:
p<0.01, ns: not significant between LAPGB (n = 7) vs. GB (n = 8) or
LAPDS (n = 6) vs. DS (n = 5).
Figure 3: Energy expenditure during day- and night-time. Short-term
after surgery: 3 weeks after gastric bypass (GB), 2 weeks after duodenal
switch (DS) or 2–3 weeks after laparotomy (LAP). Long-term after
surgery: 14 weeks after GB, 8 weeks after DS or 8–14 weeks after
LAP. Data are expressed as means ± SEM. *: p<0.05, **: p<0.01, ***:
p<0.001, ns: not significant between LAPGB (n=7) vs. GB (n=8) or
LAPDS (n=6) vs. DS (n=5).
n GB procedure used in rats was not exactly the same as it was
applied in humans.
n Although the size of gastric pouch after GB does not correlate
with weight loss outcome in patients it cannot be excluded
whether lack of the pouch in GB has impact on food intake,
satiety and eating behaviour.
n The differences between rats and humans are not only in terms
of the GI anatomy but also the responses to surgery. For instance,
sleeve gastrectomy only (without duodenal switch) works in
some patients but not in rats.
They added that it could be interesting to directly compare the effects
of sleeve only vs. sleeve with duodenal switch (one or two-staged) in
the future.
Conclusion
The study shows that the rat models provide results that are in accordance with results from clinical series in patients, i.e. greater weight
loss by DS than GB. Furthermore, the results reveal that different
postsurgical effects of GB vs. DS in terms of food intake, eating rate,
energy expenditure and absorption.
“Appropriately designed rat models provide significant insights
into the mechanisms of bariatric surgery which explain well the
clinical observations, e.g. that DS is superior to GB in body weight
loss,” the authors conclude. “The results of the present study may
suggest further that GB induces body weight loss by increasing
energy expenditure, whereas DS induces greater body weight loss
by reducing food intake, increasing energy expenditure and causing malabsorption.”
bariatricnews.net 21
ISSUE 18 | DECEMBER 2013
Study defines who needs bariatric surgery most
Diabetes, gender and smoking status better indicators
of risk of death among obese patients
M
ost patients who undergo bariatric
surgery are obese women, even
though their male counterparts are
more at risk, especially if those
men are smokers and have diabetes, according to a
study published in JAMA (Simple Prediction Rule
for All-Cause Mortality in a Cohort Eligible for
Bariatric Surgery, 2013).
Not only do the findings confirm that BMI is
not the best way to prioritise patients for bariatric
surgery, they outline who should have greater access to surgery.
“If you’re a female non-smoker without diabetes, which, incidentally, is who is being operated on
in general around the world, you have the lowest
risk,” said principal investigator of the study, Raj
Padwal from the Faculty of Medicine & Dentistry,
University of Alberta. “Bariatric surgery is most
often offered to younger, female non-smokers who
don’t have diabetes. “It’s simple math that will
predict a patient’s risk of death. For example, if
you’re a middle-aged, male smoker with diabetes,
your risk of dying in ten years is ten times higher
than a young, female, non-smoker who doesn’t
have diabetes, irrespective of BMI.”
The researchers created a simple mortality risk
calculator that physicians can use to determine
the risk of death in patients eligible for bariatric
surgery, by inputting age, gender, smoking status
and whether the patient has diabetes.
Study
Using current eligibility criteria for bariatric
surgery such as BMI thresholds has been criti-
Raj Padwal (left) and Arya Sharma
cised as arbitrary and lacking evidence. The study
was designed to verify the importance of BMI
as a mortality predictor, as well as identify other
important mortality predictors, and to construct a
mortality prediction rule in a population eligible
for bariatric surgery.
They studied individuals from the UK General
Practice Research Database, a population-representative primary care registry population-representative register who met contemporary eligibility
criteria for bariatric surgery (BMI, ≥35.0 alone or
30.0-34.9 with an obesity-related comorbidity)
from January 1988 to December 1998.
They included 15,394 patients and used binary logistic regression to construct a parsimonious
model and a clinical prediction rule for ten-year
all-cause mortality.
Outcomes
They found that the mean (SD) age was 46.9
(11.9) years, BMI was 36.2 (5.5), and 63.2% of
the patients were women. All-cause mortality was
2.1%, and mean follow-up duration was 9.9 years.
The final model, which included age (odds ratio,
1.09 per year [95% CI, 1.07-1.10]), type 2 diabetes
mellitus (2.25 [1.76-2.87]), current smoking (1.62
[1.28-2.06]), and male sex (1.50 [1.20-1.87]), had a
C statistic of 0.768.
Although BMI significantly predicted mortality (odds ratio, 1.03 per unit [95% CI, 1.011.05]), it did not improve model discrimination
or calibration.
They subsequently divided clinical prediction
rule scoring into four tiers. All-cause mortality
was 0.2% in tier 1, 0.9% in tier 2, 2.0% in tier 3,
and 5.2% in tier 4.
“If we have to decide who should get the
surgery first, it should be based on who has the
highest risk of mortality,” said Arya Sharma,
chair in obesity research and management,
scientific director of the Canadian Obesity Network. “We looked at thousands of patient files
and many different parameters, and surprisingly
enough it came down to three things, if you’re
male, you’re a smoker and you have diabetes,
you have the highest risk. These surgeries are
being done, but are the wrong people getting
them? The current BMI cut-off is missing the
boat on those who need it most. Having diabetes
is more important than BMI as a risk factor. Our
research showed BMI didn’t really matter, so
size alone isn’t a good way to decide who should
get the surgery.”
The research showed that diabetes was the
strongest predictor of death, noting that obese patients with diabetes were more than twice as likely
to die as obese patients without diabetes. Smoking
increased risk of death 1.6 times, and being male
increased risk 1.5 times.
“We think this will be a useful tool for physicians,” added Padwa. “It’s simple math that will
predict a patient’s risk of death. For example, if
you’re a middle-aged, male smoker with diabetes,
your risk of dying in 10 years is 10 times higher
than that of a young, female non-smoker who
doesn’t have diabetes – irrespective of BMI.”
The research was funded by the Canadian Institutes of Health Research.
22 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013
Side effects high for kidney
disease patients following surgery
Invitation to the 6th Congress of
IFSO EC 2014 in Brussels
Dear friends and colleagues,
K
idney disease patients
who undergo bariatric
surgery can successfully
lose weight, but many experience
significant side effects, according
to a study, “Safety and Efficacy
of Bariatric Surgery in Obese Patients with CKD: The London
Renal Obesity Network (LonRON) Experience”, at American
Society of Nephrology Kidney
Week 2013, in Atlanta, GA.
Although bariatric surgery
is currently the most effective
treatment for obesity, recent evidence suggests the complication
rate may be higher in those with
chronic kidney disease than in
those without. As a result, Helen
MacLaughlin and colleagues
from King’s College London, UK,
conducted a retrospective study of
all obese patients with kidney dis-
Kidney_x_ray_red
ease who underwent laparoscopic
bariatric surgery in three major
London teaching hospitals from
2007 to 2012.
Data from 74 patients’ medical
records revealed that across all
forms of surgery; 38% underwent
Roux-en-Y bypass (RYGB),
57% sleeve gastrectomy and 5%
adjustable gastric banding.
Eleven percent of patients were
classified as CKD stages 1-2, 59%
CKD stage 3, 12% CKD stage 4/
stage. Eighteen percent of patients
were on haemodialysis at the time
of surgery.
Excess weight was lost in 61%
of patients one year post-surgery.
There were 16 adverse events,
including two deaths (3%) related
to surgical complications. Acute
kidney injury was most frequent
(4%), followed by leak (3%),
acidosis and elevated blood potassium levels (3%), post-operative
chest infection (3%), vitamin B12/
iron deficiency (3%), fistula/graft
failure (3%), and heart attacks
(1%). An additional four deaths
occurred during the study period,
including two related to cancer.
“While bariatric surgery is
effective for weight loss in obese
patients with chronic kidney
disease, the adverse event and
mortality rates are high,” the
authors concluded. “Identification
of risk factors for adverse events
and investigation of non-surgical
alternatives remain priorities.”
The study authors called for
further research to identify risk
factors for harmful side effects
and death, and for nonsurgical
alternatives to help obese kidney
disease patients lose weight.
The BeSOMS (Belgian Section for Obesity and Metabolic Surgery) is proud to invite
you to the 6th IFSO EC congress in Brussels from Wednesday 30 April till Saturday 3
May 2014.
Belgium has a long history of Laparoscopic and Bariatric Surgery. From the earliest
bariatric procedures in Belgium dating already from 1970 and the first ‘laparoscopic
placement’ of a gastric band in 1992 towards now, Belgian general surgeons have
endorsed emphatically bariatric and metabolic surgery. On a population of 11 million
people, more than 100 surgeons are performing more than 8,000 bariatric procedures
per year. Several colleagues are world leaders in the bariatric field and are at the cutting
edge of new evolutions and developments. This will guarantee a high scientific level
of the meeting.
Even if some of you could think that everything has been said, as well for the
surgical techniques as for the metabolic approach, things are still evolving every day.
Standard and new surgical techniques and also metabolic surgery will be discussed
with a special focus on long term results.
We are also proud to organize the 3rd European Obesity Medico-Surgical Workshop
as a formal satellite of IFSO EC 2014 jointly organized by IFSO EC and EASO. It will
be a one-day workshop where surgeons and endocrinologist will have the opportunity
to discuss items of common interest.
Brussels, the Capital of Europe, will take care of the hosting and your comfort.
The meeting will take place in the brand new Congress Center, the Square, which is
situated in the center of Brussels in walking distance of the Grand Market Place, one
of Europe most beautiful historical settings. All the hotels are also in walking distance
of the Square.
Brussels is the center of Belgium. Beautiful cities such as Bruges, Ghent, Antwerp
and Liège can be reached in less than two hours drive.
Apart from the top restaurants, we have more than 600 different beers to taste.
Belgium is a nation of artistic giants such as our world famous painters Rubens,
Breughel, Ensor, Delvaux and Magritte.
We are convinced you will have an unforgettable stay in Brussels.
Luc Lemmens
Important Dates in 2014:
Deadline for Symposium Submission 15 January
Deadline for Abstract Submission 1 February
Early Bird registration
1 March
Regular Registration
1 April
Late registration
24 April
The pros of pre-bariatric
surgery psychological interview
Dr Edward Lurey is a licensed clinical psychologist and is
currently a member of the NC Psychological Association,
The American Psychological Association, American
Society for Metabolic and Bariatric Surgery, The Society for
Behavioral Medicine and The Academy for Eating Disorders.
E
very adult was once a child.
And every child has experienced
pain in the process of growing
up. None of us escape the criticism from
parents, other adults and especially other
children. One does not have to go back
very far in time to read about girls who
have chosen to commit suicide rather
than endure the taunts of other children
now utilizing social media to cast even
more stones of disparagement and
humiliation.
In my years of working with people
who are suffering from eating disorders.
I have concluded there are five hateful,
wounding words that leave very deep
and enduring scars.
Each of these words referring to their
character are used to label children (and
adults) leaving very deep and lasting
scars to their self-esteem and confidence.
One additional behavior that could be
added to the list of shame builders, and
that is dealing with one’s sexual behaviour. Most assumed character defects
are invisible to the naked eye with the
exception of the last two; fat and ugly.
Although we still maintain a sense of
decency in our society by not directly
saying to a person’s face that they are
ugly, telling someone they are fat or
questioning ‘you put on a few?’; is the
last of the socially condoned statements
that show no signs of abating in western
society. Very overweight children and
adults are seen in more negative ways
than their slimmer counter parts, and
the psychological remnants and mental
scars are very deep and difficult to
eliminate or eradicate from one’s own
self-assessment of who you are on the
inside. You know, the real you.....what
you really think about yourself seems to
be correct when you judge you.
In 1991 the NIH recommended
that two elective surgical procedures
were required to pass approval from a
psychologist prior to the surgery. The
two surgeries were gender reassignment
and bariatric surgery. At that time Rouxen-Y was the only bariatric surgery
available and was not considered to
be a reversible procedure nor was sex
change. Both of these radically different
surgeries have common elements. They
are both considered to be irreversible.
Once performed, neither can be easily
or completely returned to their original
physiological state. They also involve a
significant psychological changes in self
perception and self esteem, the foundations having been under construction
since early childhood and adolescence.
By the time a patient fulfills the
required psychological approval, most
of them are in the 30 to 60 year range.
They are seeking relief from many years
of emotional pain and suffering inflicted
by society, friends and family who have
treated them like ‘lepers’ among us due
to their excessive weight. Many see
themselves as morally and mentally
deficient because they have ‘allowed’
themselves to become morbidly obese.
And initially, bariatric surgery does
provide them with fulfilment,
increased self-esteem, and
self-confidence that accompanies a significant loss of
weight.
But eventually the body
and brain reach a new state of
homeostasis and the weight
loss slows down, stabilizes,
and in most cases people begin
to regain some of their lost
weight. Weight regain seems
to occur with all the bariatric
surgeries currently being
performed. The window of opportunity
to loose as much as possible appears to
have a time limit. What has been termed
‘the honeymoon’ in terms of time, when
a lack of any appetite comes to a end and
burning excess calories slows. Previously experienced food struggles return
and inertia to not exercise reappears
within the mind of the person. Where
do bariatric surgery patients facing these
problems seek help? The nutritionist
can tell you what to eat or not eat. The
exercise trainer can tell you to exercise
more often or more intensely.
The surgeon will suggest another fill,
(if you are a lap bander) or tell you to
seek help from another professional.
Re-enter the psychologist! A trained
professional who is capable of listening and understanding people who are
experiencing pain. Pain can be physical
or emotional but the only way to communicate that experience is to talk with
someone who understands. Not only
understands, but has the knowledge
and training in helping people who are
DON’T CALL ME…
1. Stupid, 2. Lazy,
3. Crazy, 4. Fat
or 5. Ugly
experiencing anxiety, depression and a
paralyzing fear of failure in the future.
Cognitive behavioural therapy is the
treatment modality of choice to assist
a struggling patient. Psychologists help
patients understand the chain of mental
events that are composed of Thoughts,
Feelings, and resulting behaviours.
An intervention of any of those factors
results in changes. The psychologist is
one member of the team, who surgical
candidates probably dreaded seeing
most in their initial pre surgical evalu-
On behalf of the Belgian Section for Obesity
and Metabolic Surgery (BeSOMS)
President of the 6th IFSO-EC Congress
Past-President of IFSO-EC 2008-2010
ations. Before seeing a psychologist for
their pre surgical evaluation, it is rare
they have professionally encountered
a psychologist. And most have never
talked with a psychologist (concern over
the labels, crazy, lazy, stupid and fat)
and many are extremely anxious when
they arrive for their initial appointment.
A portion of my interview session is
devoted to explaining the results of the
psychological tests they turned in prior
to their appointment. Another portion
of the session is devoted to asking and
assessing the patients knowledge and
commitment to what they are about to
undertake. A tenuous bond, is established
between the candidate and psychologist
as a part of the team approach that is
vital to the continued success of the patient who will undergo surgery. I take a
picture at the end of the appointment for ‘graduation’, as most
patients have a very difficult
time really ‘seeing’ themselves
when they return for the next requested scheduled appoint at six
months post-surgery and at one
year. Body image is a resistant
self-belief irrespective of what
others can say to the person.
Few of my anorexic patients can
really ‘see’ themselves except in
pictures and I believe the same
is true for bariatric patients that
have lost significant weight over the
last six to eighteen months. Typically,
they use one word to describe what
they see, “Wow”.
In summary, I believe the initial
psychological evaluation is important to
orient and familiarize the patient with a
treatment team member wishing to assist them in a difficult change in life. A
one-time meeting is the beginning of a
relationship that may be very helpful to
many patients who are not feeling total
success in their surgical results.
24 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013
Objective scale published to rate bariatric centres
Study compared with using individual
characteristics at surgical centres to measure
site quality
A
n objective measure that
includes procedure complications, patient and surgeon
volume, and other outcomes provided
a more suitable scale when rating
centres that perform bariatric surgery,
according to researchers from the
University of Michigan.
Published online in JAMA Surgery
(Dimick et al. Composite Measures
for Profiling Hospitals on Bariatric
Justin Dimick
Surgery Performance. 2013.), the
paper compares with using individual
characteristics at surgical centres to measure site quality, which did
not achieve significance, the composite scale was able to differentiate
risk of complications between low-scoring and high-scoring centres
(OR 1.99, 95% CI 1.14-3.47).
The researchers stated that the optimal approach for profiling
hospital performance with bariatric surgery is unclear, so they set out
to develop a novel composite measure for profiling hospital performance with bariatric surgery.
The objective rating scale for surgical centres was published shortly
after an announcement from the Centers for Medicare and Medicaid
Services saying they would eliminate certification requirements for
facilities that offer bariatric procedures, citing that certification was
not associated with improved outcomes at bariatric surgery centres.
The new measure was developed through data acquired from the
Michigan Bariatric Surgical Collaborative clinical registry on 2,942 patients who underwent bariatric surgery in Michigan from 2008 to 2010.
The registry includes 29 hospitals and 75 surgeons, and collects
information on patient characteristics, procedure type, processes of
care, and postoperative outcomes. The procedures included in the
study were open and laparoscopic gastric bypass, adjustable gastric
banding, sleeve gastrectomy, and biliopancreatic diversion with
duodenal switch.
The scale included scores for hospital volume, risk-adjusted
complication rates, risk- and reliability-adjusted complication rates.
Hospitals were scored on each of these categories individually and as
a composite scale.
Study
The authors, led by according to Dr Justin Dimick of the Center for
Healthcare Outcomes and Policy at the University of Michigan in Ann
Arbor, limited complications used in the scale to those considered
potentially life threatening, grade II, or worse. These included abdominal abscess, bowel obstruction, leak, bleeding, wound infection
or dehiscence, respiratory failure, venous thromboembolism, bandrelated problems that required reoperation, myocardial infarction,
cardiac arrest, renal failure requiring long-term dialysis, and death.
Adjustments were made based on patients’ BMI, mobility limitations, smoking status and comorbid conditions. These comorbidities
included pulmonary disease, cardiovascular disease, sleep apnoea,
psychological disorders, prior venous thromboembolism, diabetes,
chronic renal failure, urinary incontinence, gastro-oesophageal reflux
disease, peptic ulcer disease, cholelithiasis, previous ventral hernia
repair, and musculoskeletal disorders.
Risk and reliability measures were based on centre size-adjusted
complication rates, such as mortality, incidence of other complications, reoperation, readmission, and length of stay. Quality measures
were given weighted scores.
Patients were well matched across hospitals when scored through
the composite measure.
Centres were scored on a three-star rating scale; 3-star (top 20%),
2-star (middle 60%), and 1-star (bottom 20%). They assessed how
well these ratings predicted outcomes in the next year (2010) compared with other widely used measures.
Outcomes
The results showed that composite measures explained a larger
proportion of hospital-level variation in serious complication rates
with laparoscopic gastric bypass than other measures. For example,
the composite measure explained 89% of the variation compared with
only 28% for risk-adjusted complication rates alone.
Composite measures also appeared better at predicting future
performance compared with individual measures. When ranked on
the composite measure, 1-star hospitals had 2-fold higher serious
complication rates (4.6% vs 2.4%; odds ratio, 2.0; 95% CI, 1.1-3.5)
compared with 3-star hospitals.
Differences in serious complication rates between 1- and 3-star
hospitals were much smaller when hospitals were ranked using serious
complications (4.0% vs 2.7%; odds ratio, 1.6; 95% CI, 0.8-2.9) and
hospital volume (3.3% vs 3.2%; odds ratio, 0.85; 95% CI, 0.4-1.7).
“Composite measures are much better at explaining hospitallevel variation in serious complications and predicting future
performance than other approaches,” the authors conclude. “In this
preliminary study, it appears that such composite measures may be
better than existing alternatives for profiling hospital performance
with bariatric surgery.”
The study was supported by the Agency for Healthcare Research
and Quality and the National Institute of Diabetes and Digestive and
Kidney Diseases.
Video rating effective when assessing bariatric surgeons
Surgeons who received
low skill scores had
complication rates of 14.5%
vs. 5.2% among high skill
surgeons
R
ating a surgeons’ operating
skills by video technology
successfully predicted whether
patients would suffer complications
after they leave the operating room,
according to a University of Michigan
Health System study. The study, ‘Surgical skill and complication rates after
bariatric surgery published in the New
England Journal of Medicine, assessed
the relationship between the technical
skill of bariatric surgeons and postsurgery complications in 10,343 patients
undergoing common, but complex
laparoscopic gastric bypass surgery.
“Peer assessment of a surgeon’s
operative skill may be a more practical,
more direct, and ultimately more informative test for assessing the surgeon’s
proficiency than other measures,” said
lead study author Dr John D Birkmeyer,
professor of surgery and director of
the Center for Healthcare Outcomes &
Policy at the University of Michigan.
The researchers write that although
it has been assumed that the proficiency
of the operating surgeon is an important
factor underlying such variation, empirical data are lacking on the relationships
between technical skill and postoperative outcomes.
As a result they conducted a study
involving 20 bariatric surgeons in Michigan who participated in a statewide
collaborative improvement programme
with each surgeon submitting a single
representative videotape of himself
or herself performing a laparoscopic
gastric bypass.
Participation was voluntary and various skills such as a gentleness, time and
motion, instrument handling, flow of
operation, tissue exposure and overall
technical skill were rated anonymously.
Every videotape was rated in various
domains of technical skill on a scale of
one to five (with higher scores indicating more advanced skill) by at least ten
peer surgeons who were unaware of the
identity of the operating surgeon. The
relationships between these skill ratings
and risk-adjusted complication rates were
then assessed, using data from a prospective, externally audited, clinical-outcomes
registry involving 10,343 patients.
Results
The outcomes showed that the mean
summary ratings of technical skill
ranged from 2.6 to 4.8 across the 20 sur-
geons. The bottom quartile of surgical
skill, as compared with the top quartile,
was associated with higher complication
rates (14.5% vs. 5.2%, p<0.001) and
higher mortality (0.26% vs. 0.05%,
p=0.01). The lowest quartile of
skill was also associated with
longer operations (137 minutes
vs. 98 minutes, p<0.001) and
higher rates of reoperation
(3.4% vs. 1.6%, p=0.01) and
readmission (6.3% vs. 2.7%)
(p<0.001).
“The technical skill of
practicing surgeons varied
widely,” said Birkmeyer.
“Summary ratings varied from
2.6 to 4.8 and greater skill was
associated with fewer postoperative complications and shorter
operations.”
In the study, surgeons who received
low skill scores had complication rates
of 14.5 percent compared to 5.2 percent
among high skill surgeon.
“Variation in surgical skill and
outcomes may never be eliminated,” he
added. “But coaching and constructive
feedback from peers may be an important strategy for upping everyone’s
game.”
The authors added that the findings
also suggest the formal evaluations of
technical skill may be useful in identify-
ing which medical students pursue careers as surgeons and in evaluating surgeons in training. For surgeons already
in practice, similar methods could be
invaluable for the board re-certification
process and hospital credentialing for
specific procedures.
“The technical skill of practicing
bariatric surgeons varied widely, and
greater skill was associated with fewer
postoperative complications and lower
rates of reoperation, readmission, and
visits to the emergency department,”
they concluded. “Although these findings are preliminary, they suggest that
peer rating of operative skill may be
an effective strategy for assessing a
surgeon’s proficiency.”
Improved body image and sex drive after bariatric surgery
The researchers also report that
two years after surgery, woman
also saw improvements in most
reproductive hormone levels
B
ariatric surgery not only results in years
of sustained weight loss but improves body
image and increased sexual satisfaction,
according to a study, ‘Changes in Sexual Functioning and Sex Hormone Levels in Women Following
Bariatric Surgery’, published in JAMA Surgery.
“For many people, sex is an important part of
quality of life. The massive weight losses typically
seen following bariatric surgery are associated with
significant improvements in quality of life,” said the
study’s lead author Dr David Sarwer, professor of
Psychology in Psychiatry and Surgery in the Perelman School of Medicine at the University of Pennsylvania. “This is one of the first studies to show that
women also experience improvements in their sexual
functioning and satisfaction, as well as significant
improvements in their reproductive hormones.”
Researchers from the University of Pennsylvania conducted a study to ascertain whether bariatric
surgery affects women’s sex drive and satisfaction.
They examined sexual functioning and sex hormone levels, as well as quality of life, body image
and depressive symptoms.
They report that during these years of sustained
weight loss, the women reported additional benefits, including improvements in body image and
increased sexual satisfaction.
The researchers also report that two years after
surgery, woman also saw improvements in most
reproductive hormone levels.
“These results suggest that improvements in
sexual health may be added to the list of benefits associated with large weight losses seen with
bariatric surgery,” the authors note. “Two years
following surgery, women reported significant
improvement in overall sexual functioning and
specific domains of sexual functioning: arousal,
lubrication, desires and satisfaction.”
The American Psychological Association states
that obesity and depression often go hand in hand,
obesity in women is associated with a 37% increase
in major depression.
The study included 106 women who underwent
bariatric surgery. The women lost an average of
32.7 percent of their initial body weight in the first
year and an average 33.5 percent at the second
postoperative year.
“Our study provides new information on changes
in sexual functioning, reproductive hormone levels,
and psychosocial functioning in women in the first 2
years after bariatric surgery,” the authors conclude.
“These results suggest that improvements in sexual
health may be added to the list of benefits associated
with large weight losses seen with bariatric surgery.
Future studies should investigate if these changes
endure over longer periods of time, and they should
investigate changes in sexual functioning in men
who undergo bariatric surgery.”
bariatricnews.net 25
ISSUE 18 | DECEMBER 2013
Variety of factors impact on effectiveness of surgery
Non-Hispanic black and
Hispanic patients were less
likely than non-Hispanic
white patients to experience
metabolic syndrome
remission
T
he impact of bariatric surgery
on risk factors for cardiovascular
disease depends on a variety of
factors, including the type of surgery, sex
of the patient, ethnic background, and
pre-surgery body mass index, according
to a Kaiser Permanente study published
in Annals of Surgery (Coleman et al
Metabolic Syndrome Is Less Likely to
Resolve in Hispanics and Non-Hispanic
Blacks After Bariatric Surgery. 2013).
Researchers examined the electronic
health records of more than 4,000 Kaiser Permanente patients in Southern
California who had bariatric surgery for
weight loss between 2009 and 2011 to
determine what factors led to remission
or reduction of metabolic syndrome
after surgery. Patients were studied
for up to two years after their bariatric
surgery to determine if their metabolic
syndrome improved.
The researchers report that nonHispanic black and Hispanic patients
were less likely than non-Hispanic
white patients to experience metabolic
syndrome remission. These differences
in remission were not a result of greater
weight loss during the follow-up period,
and these racial and ethnic differences
persisted even when researchers controlled for the rate of weight loss.
“In the majority of patients, bariatric
surgery may result in the remission of
many cardiovascular disease risk
factors, which could prevent those
patients from experiencing more
serious health conditions, such as
heart attack and stroke,” said study
lead author, Dr Karen J Coleman of
the Kaiser Permanente Department of
Research & Evaluation in Pasadena,
CA. “The benefits of bariatric surgery
are different for men and women and
different racial/ethnic groups. This
study highlights the importance of designing post-operative care models to
address the unique challenges different genders and ethnic/racial groups
face following bariatric surgery.”
The paper also reports that researchers also found women were more likely
than men to experience remission and
patients who were heavier at the time
of their surgery were less likely to
experience remission than those who
were lighter.
However, the effects of age, race/
ethnicity, and BMI at the time of
surgery remained after accounting for
weight loss.
Interestingly, patients who received the gastric sleeve were less
likely to experience metabolic syndrome remission than patients who
had a traditional gastric bypass.
Some individual markers of cardiovascular health were more likely
to improve than others following
bariatric surgery. For example, 44
percent lost enough weight following
surgery to no longer be considered
obese, and a significant 85 percent of
patients’ blood pressure returned to
healthy levels.
The study included patients who
had a laparoscopic Roux-en-Y gastric
Lyon (France)
April 25–26, 2014
IV
International
Symposium on
Non Invasive
Bariatric
Techniques
bypass or a laparoscopic vertical
sleeve gastrectomy between 2007
and 2009 (n=4088) without revision
during the study period of January
2007 and December 2011. Diagnosis
and resolution of metabolic syndrome
were determined using standard criteria with electronic medical records of
laboratory, diagnosis, and pharmacy
information.
Nearly half (49 percent) of the
Kaiser Permanente study’s sample
were either Hispanic or non-Hispanic
black, providing a unique opportunity
to study the effect of bariatric surgery
on metabolic syndrome in different
racial/ethnic groups.
Conclusion
“Although we do not know the
reasons for the racial and ethnic
differences we saw, one explanation
could be that the black and Hispanic
patients had surgery when they are
much heavier and sicker than the
non-Hispanic white patients,” said
Coleman “Our study highlights
that surgery may be an important
intervention tool for people earlier
in their weight gain trajectory. The
heavier they become, the less likely
that surgery will be successful at reducing these cardiovascular disease
risk factors.”
Based on the findings they conclude that bariatric surgery may be
most effective for patients who are
younger and early in the course of
their cardiometabolic disease. Future
research should investigate the factors
that lead to lower rates of disease
resolution after bariatric surgery for
Karen Coleman racial/ethnic minority groups.
26 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013
Surgical benefits demonstrated out to three years
S
everely obese patients who have a gastric bypass or laparoscopic adjustable gastric
band experience substantial weight loss three
years after surgery, with most of the change occurring in the first year, according to researchers from
the University of Pittsburgh’s School of Medicine
and Graduate School of Public Health.
The study findings, published online in the
Journal of the American Medical Association
(Courcoulas et al. Weight Change and Health Outcomes at three Years After Bariatric Surgery Among
Individuals With Severe Obesity), also found variability in both weight change and improvements in
obesity-related complications, including diabetes,
hypertension and high cholesterol.
“Bariatric surgery is not a ‘one size fits all’
approach to weight loss,” said lead researcher, Dr
Anita Courcoulas, a bariatric and general surgeon
at Magee-Womens Hospital of UPMC. “Our study
findings are the result of data collected from a multicentre patient population, and emphasise the heterogeneity in weight change and health outcomes for
both types of bariatric surgery that we report.”
Study
The researchers examined data from the Longitudinal Assessment of Bariatric Surgery (LABS)
Consortium, a multi-centre observational cohort
study, encompassing ten hospitals in six geographically diverse clinical centres and a data coordinating centre, that assesses the safety and efficacy of
bariatric surgical procedures performed in the US.
The researchers gathered highly standardised
assessments and measures on adult study participants undergoing bariatric surgery procedures and
followed them over the course of three years.
The research included 1,738 participants who
underwent bypass surgery and the 610 participants
who received a gastric band. The 110 participants
who underwent the less commonly performed
procedures in LABS-2 were not included.
In the three-year follow-up after bariatric surgery, the researchers observed substantial weight
loss for both procedures, with most of the change
occurring during the first year. Participants who
underwent gastric bypass surgery or laparoscopic
adjustable gastric banding experienced median
weight loss of nearly 32 percent and 16 percent,
respectively.
Additionally, of the gastric bypass surgical
participants who had specific obesity-related health
problems prior to surgery, 67 percent experienced
partial remission from diabetes and 38 percent
remission from hypertension. High cholesterol
resolved in 61 percent of the participants who
underwent bypass surgery.
For those who underwent laparoscopic adjustable gastric banding, 28 percent and 17 percent
experienced partial remission from diabetes and
remission from hypertension respectively, and
high cholesterol was resolved in 27 percent of
participants.
“LABS-2 data confirm in a heterogeneous population with a high degree of follow-up that RYGB
and LAGB were associated with significant weight
and health improvements at three years after sur-
Anita Courcoulas
gery,” the authors conclude. “Reduction in weight
and improvements in comorbid conditions with
LAGB were less than reported in previous studies
and not as large as those seen with RYGB. Longerterm follow-up of this cohort will determine the
durability of these improvements over time and
factors associated with variability in effect.”
Self-reported weights are valid post-bariatric surgery
S
mall differences between self-reported and measured
weights were found and may be due to differences in clothing,
inaccurate personal scales, time between measurements, or
intentional misrepresentation
Self-reported weights following bariatric surgery were close to
measured weights, suggesting that self-reported weights used in
studies are accurate enough to be used when measured weights are
not available, according to a Research Letter published online by
JAMA (Christian et al. Validity of Self-reported Weights Following
Bariatric Surgery).
Researchers from the University of Pittsburgh Graduate School of
Public Health investigated whether self-reported weights following
bariatric surgery differed from weights obtained by study personnel
using a standard scale. They used data collected between April 2010
and November 2012 at annual assessments from the Longitudinal
Assessment of Bariatric Surgery-2, an observational cohort study of
2,458 adults undergoing an initial Roux-en-Y gastric bypass (RYGB),
laparoscopic adjustable gastric band (LAGB), or other bariatric procedure at ten centres.
Participants were sent mailed questionnaires each year and asked
to report their: (1) weight from last medical office or weight-loss program visit (self-reported medical weight) and (2) last self-weighing
(self-reported personal weight).
The final analysis included 988 participants, including 164 with
a self-reported medical weight, 580 with a self-reported personal
weight, and 244 with both self-reported weights.
Across the two groups who self-reported weight, women and
men underreported their weight by an average 2.2lbs. or less and the
degree of underreporting was not different between women and men.
Self-reported medical weights were closer to measured weights than
were self-reported personal weights for both women and men.
“Small differences between self-reported and measured weights
were found and may be due to differences in clothing, inaccurate
personal scales, time between measurements, or intentional misrepresentation,” the authors write. “Self-reported weights after bariatric
surgery may be more accurate because participants who undergo
surgery to lose weight may be especially attentive to their weight.”
“In conclusion, self-reported weights following bariatric
surgery were close to measured weights. This suggests that selfreported weights may not unduly affect study results of surgically
induced weight change and can be used when measured weights
are not available.”
Bariatric surgery more effective than medical therapy
Paper calls for more
randomised controlled trials
to increase the evidence
base
A
retrospective literature review has
reported that bariatric procedures
were more likely to help obese
patients with type 2 diabetes to achieve
benefits, than medical therapy alone. The
study, which was published online in the
BioMed Research International journal
(Guo Xiaohu et al. The effects of bariatric
procedures versus medical therapy for
obese patients with type 2 diabetes:
meta-analysis of randomized controlled
trials. BioMed Research International,
2013), concluded that in order to provide
additional evidence further intensive
high-quality randomised controlled trials
at multiple centres with long-term followup should be performed.
The study researchers from the
Department of General Surgery and the
Hepatic-Biliary-Pancreatic
Institute,
Lanzhou University Second Hospital,
Lanzhou, China, wanted to assess the effects of bariatric surgery versus medical
therapy for type 2 diabetes mellitus.
Following a literature search, they
identified three randomised controlled
trials from 269 publications. These three
studies included 170 patients in the
bariatric surgery group and 100 patients
in the medical therapy group.
They reported that compared with
medical therapy, bariatric surgery
for type 2 diabetes can significantly
decrease the levels of HbA1c, FBG,
weight, triglycerides, and the dose
of hypoglycaemic, antihypertensive,
and lipid-lowering medicine, while
increasing the rate of diabetes remission
(RR=9.74, 95%CI, (1.36, 69.66)) and
the levels of high-density lipoprotein.
However, they noted are no statistical differences in serious adverse events
between the surgical and medical groups
(RR=1.23, 95%CI, (0.80, 1.87)).
Only two of the studies reported the
diabetes remission rates, with significant
heterogeneity between surgical and
medical groups (I2 = 53%, p=0.03).
Bariatric surgery was associated with significantly increasing the diabetes remission (RR=9.74, 95% CI, (1.36, 69.66)).
Schauer et al. reported that proportion of
patients with HbA1c ≤ 6% was 39.39%
in surgical group and 12% in medical
group, 12 months after surgery. Overall,
they noted that the results suggested
that bariatric surgery could effectively
improve patients’ glycaemic control after
two years after undergoing operations.
“This meta-analysis showed that
bariatric procedures could significantly
induce and maintain well-glycaemic
control, which was confirmed by the
results of several other studies,” they
write. “The gastric bypass, gastric banding, gastrectomy, and biliopancreatic
diversion decreased HbA1c by 0.79%,
1.13%, 0.89%, and 3.46%, respectively,
when compared with medical therapy;
the gastric bypass, gastric banding, and
biliopancreatic diversion decreased FBG
by 23.44%, 32.8mg/dL, and 27.14% at
baseline, respectively.”
The investigators also highlighted
significant differences in the change in
the number of patients without hypoglycaemia between all surgical groups and
medical groups. Patients in the gastric
bypass group, gastric banding group
and sleeve gastrectomy group all significantly increased the number of subjects
without hypoglycaemia compared with
medical group.
With regard to weight loss, bariatric
procedures significantly decreased the
patients’ weight, compared with medial
therapy alone.
“The results of our meta-analysis
showed that bariatric surgery could not
only significantly decrease the levels of
HbA1c, FBG, the amount of medicines
(including hypoglycaemic, antihypertensive, and lipid-lowering ones), weight,
and triglycerides,” the authors note, “but
also increase the rate of diabetes remission
and the levels of high-density lipoprotein.
Meanwhile, there were no statistical
differences in the serious adverse events
between surgical and medical groups.”
The researchers acknowledge that
their meta-analysis is limited by the
scarcity of research, the different operative methods and procedures performed
by different surgeons, and the small
follow-up period (12-24 months). To
overcome this shortfall of empirical
data, they call for the creation of additional randomised controlled trials to
confirm their findings.
bariatricnews.net 27
ISSUE 18 | DECEMBER 2013
Lap bands reduce cardiovascular disease risk
Study adds to the
evidence of the
cardiovascular benefits
of significant weight loss
P
atients
undergoing
laparoscopic
adjustable
gastric band (LAGB) have
significant weight loss and reductions in estimated ten to 30-year
cardiovascular risk within one
year post-LAGB, according to
a study published in the journal
Advances in Therapy (Reduction
in Framingham risk of cardiovascular disease in obese patients
undergoing laparoscopic adjustable gastric banding. 2013:2013
30(7):684-96), a Springer link
publication.
Data from a US healthcare
database revealed that ten- and
30-year estimated cardiovascular
risk decreased from 10.8 to 7.6%
(p\0.0001) and 44.34 to 32.30%
(p\0.0001), respectively, 12–15
months post-LAGB. Improvements were significantly greater
than in non-LAGB patients (n=
4,295) (p\0.0001).
The researchers set out to
examine whether weight loss in
obese patients treated with LAGB
is associated with meaningful
reductions in estimated 10- and
30- year Framingham CVD risk
12–15 months post-LAGB.
Obese adult patients (BMI30)
treated with LAGB were identified in a large US healthcare
database. Patients without CVD
at baseline and with measures
of BMI, systolic blood pressure,
diabetes, and smoking status
at baseline and follow-up were
eligible. Non- LAGB patients
were propensity score matched to
LAGB patients on baseline BMI,
age, and gender.
The estimated 10- and 30-year
Framingham CVD risks were
10.8 and 44.34% for LAGB patients and 10.56 and 41.79% for
comparison patients at baseline,
respectively.
Results
The outcomes showed that the
mean BMI in LAGB patients (n=
647, average age 45.66 years,
81.1% female) decreased from
42.7 to 33.4 (p\0.0001), with
35.4% no longer obese.
In the subset with lipid data
(n=74), improvements in total
(-20.6mg/dL; p\0.05) and highdensity lipoprotein (10.6 mg/dL,
p\0.0001) cholesterol one year
post-LAGB were also observed.
At 12–15 months’ follow-up,
mean BMI decreased significantly
in LAGB patients (-9.3kg/m2,
p\0.0001) and in comparison
patients (-0.6kg/m2, p\0.0001.
In addition, the researchers also
report that there were significant
reductions in SBP for both LAGB
(p\0.0001) and comparison patients
(p\0.05). At follow-up, the proportion of patients using anti-diabetic
medications decreased in LAGB
patients (p\0.0001) and increased
in comparison group (p\0.01).
Estimated 10- and 30-year
CVD risk scores decreased
SM-BOSS study
Continued from page 7
Figure 1: Change in estimated 10- and 30-year CVD risk at 12–15
months by gender and baseline BMI. BMI body mass index, CVD
cardiovascular disease, LAGB laparoscopic adjustable gastric banding.
*P\0.05 for changes from baseline between LAGB and non-LAGB
groups; BMI was presented as kg/m2.
ing LAGB to have significant
weight loss, and reduced CVD
risk factors and estimated CVD
risk, supporting the effectiveness
of the LAGB procedure as a potential approach for management
of obesity.
“These results add to the
evidence of the cardiovascular
benefits of significant weight
loss among obese individuals and
the potential long-term clinical
impact of the LAGB procedure
as a therapeutic intervention for
obesity,” the researchers write.
“Larger and long-term studies
are needed to further document
whether effects of LAGB on
weight loss and CVD risk factors translate into reduced CVD
incidence.”
Conclusion
The analysis and publication
The researchers concluded that charges were sponsored by Althe data showed patients receiv- lergan.
significantly in LAGB patients
(-3.2%, p\0.0001 and -12.04%,
p\0.0001, respectively), but
did not change significantly in
comparison patients ( 0.01%,
p= 0.91 and 0.13%, p= 0.42, respectively). Changes in CVD risk
factors and scores were evaluated
for subgroups stratified by gender
and baseline BMI (Figure 1).
Although the authors acknowledge that Framingham CVD risk
scores have not been validated
for measuring changes in CVD
risk over time or specifically in
obese populations, “in the present
analysis scores based on BMI
versus lipid data indicate similar
and consistent magnitude of risk
reduction,” they note.
ostomy and one stricture that
needed endoscopic dilatation.
Up to one year postoperatively,
no patient had to be re-operated
on for either insufficient weight
loss or internal hernia in both
groups.
Two patients of the LSG
group
experienced
severe
GERD symptoms, but until one
year after the operation, none of
them agreed to have undergone
conversion to LRYGB.
“Strictures or torsions of the
gastric sleeve are complications
that are difficult to treat and
often result in the resection of
the gastric sleeve at the end of
the treatment line,” the authors
warn. “Therefore, it is utmost
important that this procedure
is performed with the best
standardised technique by
experienced bariatric surgeons.”
The incidence of micronutrient deficiency was equal in both
groups (LSG: n=28 patients;
LRYGB: n= 27 patients), with
vitamin D deficiency being the
most frequent deficiency, followed by vitamin
B12 deficiency
(LSG:
n=7;
LRYGB: n=15;
p<0.12).
Conclusions
They
authors
state that LSG
is best suited for
patients with pre-existing
GERD are at a risk of dete-
rioration after LSG and should
rather undergo LRYGB, for
patients who expected major
adhesions, who need a staged
concept or suffer from Crohn
disease. The researchers believe that this tailored approach
allows the bariatric surgeon to
take into account the patients’
preoperative risk profile and
will optimise the long-term
results of bariatric surgery.
“We could show that LSG
and LRYGB are equally efficient regarding weight loss,
reduction in comorbidities, and
increase in quality of life at one
year,” the authors conclude.
“Therefore, we believe that
LSG is a valuable surgical
alternative for selected patients
with morbid obesity.”
Gastic sleeve
28 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013
Study also identified the
factors that result in a higher
rate of
long-term diabetes remission
O
verweight patients with type
2 diabetes continue to experience
the benefits of bariatric surgery
up to nine years after the procedure,
according to research published in the
Annals of Surgery (Brethauer et al. Can
diabetes be surgically cured? Long-term
metabolic effects of bariatric surgery in
obese patients with type 2 diabetes mellitus. 2013;258(4):628-36). According
to the researchers, the study shows that
obese patients with type 2 diabetes continue to improve or reverse their diabetes,
as well as reduce their cardiovascular risk
factors, nine years after the procedure.
“Uncontrolled diabetes can lead to
serious complications such as heart
and kidney disease. Only about half of
diabetics in the United States currently
have acceptable control of their blood
glucose level,” said lead investigator Dr
Stacy Brethauer of the Cleveland Clinic
Bariatric & Metabolic Institute. “Our
study, however, shows that 80 percent
of the diabetic patients still control their
blood glucose five years after their bariatric surgery. Additionally, nearly one-third
of gastric bypass patients had normal
blood glucose levels off medication for
over five years after surgery. This study
confirms that the procedure can offer
durable remission of diabetes in some
patients and should be considered as an
earlier treatment option for patients with
uncontrolled diabetes.”
The study also identified the factors
that result in a higher rate of long-term
diabetes remission. Long-term weight
loss, a shorter duration of diabetes
prior to surgery (less than five years),
and undergoing gastric bypass surgery
compared to adjustable gastric banding
are the biggest predictors of sustained
diabetes remission.
The retrospective study analysed data
on 217 patients with type 2 diabetes who
underwent bariatric surgery between
2004 and 2007 and had at least five years
follow-up. The patients were divided into
three groups: 162 patients underwent
gastric bypass surgery, 32 had the gastric
banding procedure done, and 23 underwent sleeve gastrectomy.
Researchers used strict criteria to
define glycaemic control, including an
HbA1c level of less than six percent,
which is a more aggressive target than the
American Diabetes Association (ADA)
guidelines. Of a HbA1c target of seven
percent.
At a median follow-up of six years,
data show that diabetes remission occurred in 50 percent of patients after
bariatric surgery. Specifically, 24 percent
of patients sustained complete remission
of their diabetes with a blood sugar level
of less than six percent without diabetes
medications, and another 26 percent
achieved partial remission; 34 percent
of all patients improved their long-term
diabetes control compared to presurgery
status. As expected, the patients who
received gastric bypass experienced the
highest rates of weight loss and diabetic
remission.
The study shows significant reductions
Picture courtest of Dr Stacy A Brethauer and ASMBS
Benefits from surgery
evident after nine years
Stacy Brethauer
in the number of diabetic medications
used in the long-term follow-up. There
was a 50 percent reduction in the number
of patients requiring insulin therapy in the
long term and a 10-fold increase in the
number of patients requiring no medications.
In addition, the data show patients
significantly reduced their cardiovascular
risk factors according to the Framingham
Risk Score. Diabetic nephropathy, characterized by high protein levels in the urine,
improved or stabilised as well.
Shorter duration of T2DM (p<0.001)
and higher long-term EWL (p=0.006) predicted long-term remission. Recurrence
of T2DM after initial remission occurred
in 19% and was associated with longer
duration of T2DM (p=0.03), less EWL
(p=0.02), and weight regain (p=0.015).
Long-term control rates of low highdensity lipoprotein, high low-density
lipoprotein, high triglyceridemia, and
hypertension were 73%, 72%, 80%, and
62%, respectively. Diabetic nephropathy
regressed (53%) or stabilised (47%).
“Bariatric surgery can induce a
significant and sustainable remission
and improvement of T2DM and other
metabolic risk factors in severely obese
patients,” the authors conclude. “Surgical
intervention within five years of diagnosis
is associated with a high rate of long-term
remission.”
Contouring can improve
weight control after bypass
Insurance should cover
body contouring
B
ody contouring surgery to
remove excess skin improves
long-term weight control in
patients after gastric bypass surgery,
claims a study in Plastic and Reconstructive Surgery, the journal of
the American Society of Plastic Surgeons. Since maintaining weight loss
to reduce long-term health problems
is the key goal of bariatric surgery, the
researchers believe that body contouring should be considered reconstructive rather than cosmetic surgery for
patients who have achieved massive
weight loss.
“We demonstrated that patients
with body contouring present better
long-term weight control after gastric
bypass,” said study author, Dr Ali
Modarressi and colleagues of University of Geneva, Switzerland.
The researchers compared longterm weight outcomes for two groups
of patients who underwent gastric
bypass surgery. In 98 patients, gastric
bypass was followed by body contouring procedures to remove excess
fat and skin. A matched group of 102
patients with similar characteristics
underwent gastric bypass alone, without body contouring.
Body contouring surgery usually
consisted of abdominoplasty (tummy
tuck), often with other procedures to
remove excess skin from the breasts,
legs and upper arms. Within two
years after gastric bypass, the patients
had lost an average of nearly 100lbs.
In subsequent years, patients who
underwent body contouring regained
less weight: an average of just over
one pound per year, compared to 4lbs
per year for patients who had gastric
bypass only.
Seven years after gastric bypass,
patients who underwent body contouring surgery achieved an average
weight of 17lbs, and those with
bariatric surgery alone, 220lbs. The
average weight before gastric bypass
was 275lbs in both groups.
Patients who underwent body
contouring had regained about four
percent of their initial body weight,
compared to 11 percent for those
who had gastric bypass only. After
accounting for the weight of excess
skin removed, average weight regain
was about 14lbs in patients who had
gastric bypass plus body contouring,
compared to nearly 50lbs with gastric
bypass only.
The researchers believe their
study adds to the argument that body
contouring should be considered an
essential part of successful bariatric
surgery and, because of its favourable
effects on patient health, should be
covered by insurance plans.
“Therefore, body contouring must
be considered as a reconstructive
operation in the treatment of morbid
obesity,” the researchers conclude,
“Since plastic surgery after massive
weight loss is mandatory for quality
of life improvement and weight loss
maintenance in many patients, body
contouring must be considered a
reconstructive surgery for those who
have achieved massive weight loss.
American societies publish obesity practice guidelines
New guideline urges
healthcare providers to
actively help their patients
achieve and maintain a
healthier body weight
Healthcare that includes
developing individualised plans
and focusing on behaviour
change is key to curbing
obesity
C
omprehensive treatment
recommendations
to
help
healthcare providers tailor
weight loss treatments to adult patients
affected by overweight or obesity have
been published by the American Heart
Association, American College of Cardiology and Obesity Society. The joint
guidelines is published simultaneously
Circulation: a journal of the American
Heart Association, Journal of the American College of Cardiology and Obesity:
Journal of The Obesity Society.
“Weight loss isn’t about will power.
It’s about behaviours around food and
physical activity, and getting the help
you need to change those behaviours,”
said Dr Donna Ryan, co-chair of the
writing committee and professor emeritus at Louisiana State University’s Pennington Biomedical Research Center in
Baton Rouge, LA.
The new guideline report is based
on a systematic evidence review that
summarises the current literature on
the risks of obesity and the benefits of
weight loss, as well as knowledge on
diets for weight loss, the efficacy and
effectiveness of comprehensive lifestyle
interventions on weight loss and weight
loss maintenance and the benefits and
risks of bariatric surgery.
The report recommends that healthcare providers calculate BMI at annual
visits or more frequently, and use the
BMI cut points to identify adults who
may be at a higher risk of heart disease
and stroke because of their weight. The
report also presents evidence showing
that the greater the BMI, the higher the
risk of coronary heart disease, stroke,
type 2 diabetes and all-cause mortality.
The new guideline recommends
healthcare providers develop individualised weight loss plans that include
three key components: a moderately
reduced calorie diet, a programme of
increased physical activity and the use
of behavioural strategies to help patients
achieve and maintain a healthy body
weight.
The best way to achieve these goals
is to work with a trained healthcare
professional, such as a registered
dietician, behavioural psychologist or
other trained weight loss counsellor, in
a primary care setting, according to the
recommendations.
Weight loss counselling should
focus on people who need to lose weight
because of obesity or overweight with
conditions that put them at higher risk
for cardiovascular diseases, such as
diabetes, high blood pressure, high
blood cholesterol, a waist circumference
of more than 35 inches for women and
more than 40 inches for men.
The most effective behaviour change
programs include two to three in-person
meetings a month for at least six
months. Web or phone-based
weight loss programs are also an
option for the weight loss phase,
although research shows they
are not as effective as face-toface programs, according to the
statement authors.
Currently, comprehensive
lifestyle programs that assist
participants in adhering to
a lower calorie diet and in
increasing physical activity
through the use of behavioural
strategies are not widely available.
“We hope that by laying
out the scientific evidence that
medically supervised weight
loss works and significantly reduces the
risk factors for cardiovascular disease, it
will be more fully embraced by patients
and doctors and effective programs will
eventually be reimbursed by all thirdparty payers,” she added.
Medicare began covering behavioural counselling for patients affected
by obesity in 2012, based on available
evidence at that time. Under the Affordable Care Act, most private insurance
companies are expected to cover behavioural counselling and other treatments
for obesity by 2014.
Other key recommendations include:
n Tailoring dietary patterns to a
patient’s food preferences and health
risks. For example, a patient with
high blood cholesterol would benefit
most from a low-calorie, lowersaturated fat diet including foods
that they find appealing.
n Focusing on achieving sustained
weight loss of 5 percent to 10
percent within the first six months.
This can reduce high blood pressure,
improve cholesterol and lessen the
need for medications to control
blood pressure and diabetes. Even as
little as 3 percent sustained weight
loss can reduce the risk for the
development of type 2 diabetes as
well as result in clinically meaningful reductions in triglycerides, blood
glucose and other risk factors for
cardiovascular disease.
n Advising adults with a BMI of 40
or higher and patients with a BMI
of 35 or higher who have two other
cardiovascular risk factors such as
diabetes or high blood pressure,
that bariatric surgery may provide
significant health benefits. The
guideline does not recommend
weight loss surgery for people with
a BMI <35 and does not recommend
one surgical procedure over
another.
“Healthcare providers should
do more than advise patients affected by obesity or overweight
to lose weight – they should be
actively involved and help their
patients reach a health body
weight,” said Ryan.
The obesity guideline is one
of four cardiovascular disease
prevention guidelines being released by the American Heart Association and American College
of Cardiology. Other guidelines
address lifestyle management,
cholesterol and cardiovascular
risk assessment.
The obesity treatment recommendations are based on the latest
scientific evidence from 133 research
studies.
The expert panel that wrote the
report was convened by the National
Heart, Lung, and Blood Institute of
the National Institutes of Health.
At the invitation of the NHLBI, the
American Heart Association, the
American College of Cardiology and
The Obesity Society officially assumed
the joint governance, management and
publication of the obesity guideline in
June. Committee members volunteered
their time and were required to disclose
all healthcare-related relationships, including those existing one year before
the initiation of the writing project.
The full report, “2013 ACC/AHA
Guideline for the Management of Overweight and Obesity in Adults” has been
published online on the websites of the
ACC and the AHA.
bariatricnews.net 29
ISSUE 18 | DECEMBER 2013
Bipolar patients should be
eligible for bariatric surgery
Bariatric patients increase use of
opioids post-surgery
All-cause mortality was lower in
bariatric patients than controls
Calls for proactive management of
chronic pain post-surgery
P
atients with bipolar disorder who
have been evaluated as stable can be
considered for bariatric surgery, according to a study published in the journal
Bipolar Disorders (Ahmed et al, The effect of
bariatric surgery on psychiatric course among
patients with bipolar disorder. 2013). The study
authors report that surgery did not increase the
risk for hospitalisation or the use of outpatient
psychiatric services among stable patients with
bipolar disorder.
The researchers included 144 severely obese
patients with bipolar disorder who underwent
bariatric surgery, and 1,440 control patients
with bipolar disorder, matched for gender,
medical centre, and contemporaneous health
plan membership. Controls met referral criteria
for bariatric surgery. Hazard ratio for psychiatric
hospitalization, and change in rate of outpatient
psychiatric utilization from baseline to years 1
and 2, were compared between groups.
Results
A total of 13 bariatric surgery patients (9.0%)
and 153 unexposed to surgery (10.6%) had
psychiatric hospitalisation during follow-up. In
multivariate Cox models adjusting for potential
confounding factors, the hazard ratio of psychiatric hospitalisation associated with bariatric
surgery was 1.03 [95% confidence interval (CI):
0.83–1.23]. This was not significantly different to
the 10.6% of 1,440 patients with bipolar disorder
who did not undergo such surgery.
After taking into consideration factors such
as age, ethnicity, psychiatric medication use,
baseline BMI, and comorbidities, the hazard ratio
for psychiatric hospitalization following bariatric
surgery was non-significant at 1.03, the team
reports in Bipolar Disorders.
There was also no significant increase in the
use of psychiatric outpatient services following
surgery, with only a 0.5 visit per year difference
in outpatient utilisation from baseline to year 2
when compared with controls.
All-cause mortality was lower in bariatric
patients than controls, at 2.88 versus 8.96 deaths
per 1,000 person–years of follow-up. This finding
is contrary to previous study that have reported
an increased risk for suicide following bariatric
surgery were not supported by the study.
The researchers point out that the study participants all had stable bipolar disorder, having
not been admitted to hospital in the year prior
to surgery and with no current substance abuse
or dependence. They therefore cannot surmise
how bariatric surgery affects disease course in
patients with unstable bipolar disorder.
“Given that patients with bipolar disorder
have a higher prevalence of obesity and obesityrelated comorbidities, this suggests that people
with stable bipolar disorder can be evaluated for
bariatric surgery using the same criteria as other
patients,” say the study authors, led by Ameena
Ahmed, The Permanente Medical Group, San
Francisco, California.
The authors concluded that bariatric surgery
did not affect psychiatric course among stable
patients with bipolar disorder and that the results
of the study suggest that patients with bipolar
disorder who have been evaluated as stable can
be considered for bariatric surgery.
The study was presented at the American
Psychiatric Association 165th Annual Meeting,
5–9 May 2012, Philadelphia.
P
atients who took chronic opioids for
non-cancer pain and who underwent bariatric
surgery, increased opioid use after surgery
compared with before, according to a study in JAMA
(Raebel et al. Chronic use of opioid medications before and after bariatric surgery. 2013;310(13):136976). Although it is not known if opioid use for chronic
pain in obese individuals undergoing bariatric
surgery is reduced, the authors called for proactive
management of chronic pain in these patients after
surgery.
Marsha A Raebel of Kaiser Permanente Colorado,
Denver, and colleagues conducted a study to examine opioid use following bariatric surgery in patients
using opioids chronically for pain control prior to
their surgery. The study included 11,719 individuals
21 years of age and older who had bariatric surgery
between 2005 and 2009, and who were assessed 1
year before and after surgery, with latest follow-up
by December 31, 2010.
In the year before bariatric surgery, 56 percent
of patients had no opioid use, 36 percent had some
opioid use, and 8 percent had chronic opioid use.
Among pre-surgery chronic users, 77 percent continued chronic opioid use after surgery. Relative to the
year before surgery, the amount of opioid use by patients who were chronic opioid users before surgery
increased by 13 percent the first year after surgery
and by 18 percent across 3 post-surgery years.
“There are limited options for pain management
available to bariatric surgery patients because nonsteroidal, anti-inflammatory medications increase
the risk of ulcers, particularly after bariatric surgery,” said Raebel. “Given the increasing chronic
usage rate reported in this study, it’s clear that the
medical community needs to develop better pain
management programs for patients who use opioids
long-term following bariatric surgery.”
For the group with chronic opiate use prior to
surgery, change in morphine equivalents before vs.
after surgery did not differ between individuals who
lost more than 50 percent of their excess body mass
index vs. those who lost 50 percent or less.
Neither preoperative depression nor chronic pain
diagnoses influenced changes in preoperative to
postoperative chronic opioid use.
“We anticipated [that] weight loss after bariatric
surgery would result in reduced pain and opioid use
among patients with chronic pain,” the authors write.
“However, patients with and without preoperative
chronic pain, depression diagnoses, or both had
similar increases in postoperative chronic opioid
use after surgery as those without chronic pain or
depression. One possible explanation is that some
patients likely had pain unresponsive to weight loss
but potentially responsive to opioids.”
“These findings suggest the need for better pain
management in these patients following surgery.”
In an accompanying editorial, Dr Daniel P
Alford, from Boston Medical Center, discusses the
importance of clinicians reducing or eliminating
opioid use among patients when warranted.
“The safe and appropriate prescribing of opioids
for chronic pain has become an important national
priority. Although core competencies for pain management are being developed, knowing when and
how to continue, change, or discontinue opioid
therapy must be included in all clinician education
efforts. Although Raebel et al are correct in reporting
that better pain management strategies are needed,
they also may have uncovered an equally important
problem—the need to know if, when, and how to
safely and effectively taper or discontinue opioid
therapy for patients with chronic pain.”
30 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013
Changing gut bacteria may lead to
obesity treatments
Insulin status linked to arterial
function following the weight loss
Research could lead to a new line of
therapeutics to treat obesity and diabetes
Study results indicate at least
10% weight loss is needed for
comprehensive vascular benefit
Gut bacteria
A
drug that appears to target specific intestinal
bacteria in the guts of mice may create a chain
reaction that could eventually lead to new treatments for obesity and diabetes in humans, according to a
team of researchers from Penn State University and the
Nation Cancer Institute.
The researchers found mice that were fed a high-fat diet
and provided tempol, an anti-oxidant drug that may help
protect people from the effects of radiation, were significantly less obese than those that did not receive the drug.
“The two interesting findings are that the mice that
received tempol didn’t gain as much weight and the
tempol somehow impacted the gut microbiome of these
mice,” said to Andrew Patterson, assistant professor of
molecular toxicology, Penn State. “Eventually, we hope
that this can lead to a new line of therapeutics to treat
obesity and diabetes.”
The researchers, who reported their findings in Nature
Communications (Li et al, Microbiome remodelling leads
to inhibition of intestinal farnesoid X receptor signalling
and decreased obesity. 2013), said that tempol reduces
some members of a bacteria, a genus of Lactobacillus, in
the guts of mice. When the Lactobacillus levels decreases,
a bile acid (tauro-beta-muricholic acid) increases. This
inhibits FXR (farnesoid X receptor), which regulates the
metabolism of bile acids, fats and glucose in the body.
“The study suggests that inhibiting FXR in the intestine might be a potential target for anti-obesity drugs,”
said Frank J Gonzalez, laboratory metabolism chief from
the National Cancer Institute.
The researchers said that tempol may help treat type 2
diabetes symptoms. In addition to lower weight gain, the
tempol-treated mice on a high-fat diet had lower blood
glucose and insulin levels.
“Previously, Dr Mitchell observed a significant difference in weight gain in mice on tempol-containing diet,”
said Patterson. “He approached us to help figure out what
was going on, and it had been an interesting journey wading through the complexities of the microbiome.”
Other studies hinted at the relationship between
tempol, the gut microbiome and obesity, but did not
O
focus on why the drug seemed to control weigh gain,
according to Patterson.
The researchers said these studies are demonstrating
how integrated the 100 trillion microbes that make up
the human microbiome are with metabolism and health
and how the microbiome may provide more pathways to
treating other disorders.
“There is a tremendous interest in how the microbiome
can be manipulated in a therapeutic way,” said Patterson.
“And we need to look at these microbiome management
techniques in a good, unbiased way.”
In the study, the researchers dissolved the tempol in
drinking water or delivered it directly to the mice. Within
three weeks, tempol reduced the weight gain for the mice
in that group. The mice showed significant reduction in
weight gain even after 16 weeks.
To further test the role of FXR in obesity, the researchers placed mice that were genetically modified so that they
lack FXR on the same high-fat diet. This group was resistant to the effects of tempol and taura-beta-muricholic
acid, which further strengthened the importance of FXR
in mediating the anti-obesity effect.
Gonzalez said that there are indications that FXR
plays a similar role in human obesity and diabetes.
The researchers must now test the treatments to ensure
it is effective in humans, as well as check for any potential
side effects, including cancer.
bese patients with high insulin
levels and had lost considerable
weight were the most likely to
experience better blood vessel function
following the weight loss, According to
researchers from Boston University School
of Medicine (BUSM) and Boston Medical
Center BMC.
The findings, which were published
online in the Journal of the American College of Cardiology (Bigornia et al. Insulin
status and vascular responses to weight loss
in obesity. 2013), also suggest that at least
10% weight loss is needed for comprehensive vascular benefit, which may in part
explain the negative findings of the recently
published Look Ahead study findings.
“Our study has shown that insulin
status is an important determinant of the
positive effect of weight reduction on
vascular function with hyperinsulinemic
patients deriving the greatest benefit,”
said study author Dr Noyan Gokce, associate professor of medicine at BUSM
and Director of Echocardiography at
BMC. “Reversal of insulin resistance and
endothelial dysfunction may represent key
therapeutic targets for cardiovascular risk
reduction in obesity.”
The researchers prospectively followed
208 overweight or obese patients receiving
medical/dietary (48 percent) or bariatric
surgical (52 percent) weight loss treatment
during a period of approximately one year.
They measured plasma metabolic parameters and vascular endothelial function using
ultrasound at baseline and following weight
loss intervention, and stratified analyses by
median plasma insulin levels.
They found that individuals with higher
Noyan Gokce
baseline plasma insulin levels (n=99, above
median >12uIU/ml), who had greater than
10 percent weight loss had significantly
improved brachial artery macro-vascular
flow-mediated vasodilation and microvascular reactive hyperemia (p<0.05).
In contrast, vascular function did not
change significantly in the lower insulin
group (n=109, <12uIU/mL) despite similar
degree of weight loss. In analyses using a
five percent weight loss cut-point, only
micro-vascular responses improved in the
higher insulin group (p=0.02).
“Insulin status is an important determinant of the positive effect of weight
reduction on vascular function with hyperinsulinemic patients deriving the greatest
benefit,” the researchers concluded. “Integrated improvement in both micro- and
macro-vascular function was associated
with ≥10% weight loss. Reversal of insulin
resistance and endothelial dysfunction may
represent key therapeutic targets for cardiovascular risk reduction in obesity.”
Insights into the role of the hypothalamus in obesity and T2DM
R
esearchers from the Joslin Diabetes
Center have gained new insights into how
obesity and type 2 diabetes can create
a stress response in the brain, especially in the
hypothalamus which regulates appetite and energy
production that may contribute to altering metabolism throughout the body.
“This is the first time a study has shown that
mitochondrial dysfunction can cause insulin
resistance in the hypothalamus and how this can
lead to altered metabolism throughout the body,”
said Dr Andre Kleinridders, study lead author and
an Investigator in the Joslin Section on Integrative
Physiology and Metabolism.
In the study, reported in the Journal of Clinical
Investigation (Kleinridders et al, Leptin regulation
of Hsp60 impacts hypothalamic insulin signalling. 2013), the researchers investigated the role
of the molecular chaperone heat shock protein 60
(Hsp60) in hypothalamic insulin resistance and
mitochondrial dysfunction in type 2 diabetes.
Hsp60 is a stress response protein that protects
the mitochondria, the power plants of the cell that
produce energy. They found that in type 2 diabetes
and obesity, the level of Hsp60 goes down, making
mitochondria less efficient and leading to insulin
resistance in the brain and altered metabolism
throughout the body.
“These findings link obesity and the fat cell
hormone leptin to the process of altered Hsp60
levels in the brain and this appears to start the ball
rolling toward altering metabolism in other tissues
of the body as well,” said Dr C Ronald Kahn, study
senior author and Joslin Chief Academic Officer
and Head of the Section on Integrative Physiology
and Metabolism, and Mary K Iacocca Professor of
Medicine at Harvard Medical School.
Although they used mice that were genetically
Leptin plays an important role in mitochondrial function and
insulin sensitivity in the hypothalamus by regulating HSP60
C Ronald Kahn
engineered not to produce Hsp60, it was discovered
that they also exhibited mitochondrial dysfunction
in the brain which led to insulin resistance in the
hypothalamus.
“It’s a vicious cycle: people become obese, obesity disturbs the way the hypothalamus responds
to stress, which makes people more likely to stay
obese and become diabetic,” added Kahn. “The
brain not only controls metabolism but the body’s
metabolism affects the brain and aspects of brain
function.”
The investigators also showed that leptin, the
hormone produced by fat cells that regulates appetite, is one of the key factors that regulate Hsp60
expression in the hypothalamus and that in obesity
this regulation is lost.
“Hsp60 deficiency is an acquired defect that can
be reversed by weight loss. Also, there is potential
to develop drugs that boost Hsp60 levels and
improve leptin sensitivity, which could help obese
people lose weight. There is definitely strong interest in this area,” explained Kahn.
Joslin researchers are also investigating how
mitrochondrial dysfunction and insulin resistance
affect the brain as it ages.
“Mitochondrial dysfunction and insulin resistance in the brain are associated with neurodegenerative diseases. If we could treat mitochondrial
dysfunction in the brain, it could increase cognitive
performance,” said Kleinridders.
“Importantly, type 2 diabetic patients exhibited decreased expression of HSP60 in the brain,
indicating that this mechanism is relevant to
human disease,” the authors conclude. “These
data indicate that leptin plays an important role
in mitochondrial function and insulin sensitivity
in the hypothalamus by regulating HSP60. Moreover, leptin/insulin crosstalk in the hypothalamus
impacts energy homeostasis in obesity and insulinresistant states.”
The study was funded by the National Institutes of Health.
bariatricnews.net 31
ISSUE 18 | DECEMBER 2013
Obesity damages vagal nerves
Study could explain why patients
struggle to keep off weight gain
T
he way the stomach detects and tells our
brains how full we are becomes damaged in
obese people and does not return to normal
once they lose weight, according to new research
from the University of Adelaide. Researchers believe
this could be a key reason why most people who lose
weight on a diet eventually put that weight back on.
The results, published in the International Journal of Obesity, (Kentish et al. Altered gastric vagal
mechanosensitivity in diet-induced obesity persists
on return to normal chow and is accompanied by
increased food intake. 2013), show that the nerves
in the stomach that signal fullness to the brain appear to be desensitized after long-term consumption
of a high-fat diet.
An in vitro gastro-oesophageal vagal afferent
preparation was used to determine the mechanosensitivity of gastric vagal afferents and the modulatory effect of leptin (0.1–10 nM) was examined.
Retrograde tracing and quantitative RT–PCR were
used to determine the expression of leptin receptor
(LepR) messenger RNA (mRNA) in whole no dose
and specific cell bodies traced from the stomach.
After 24 weeks, both the HFD and RFD mice had
increased body weight, gonadal fat mass, plasma
leptin, plasma insulin and daily energy consumption
compared with the SLD mice. The HFD and RFD
mice had reduced tension receptor mechanosensitivity and leptin further inhibited responses to tension
in HFD, RFD but not SLD mice.
Mucosal receptors from both the SLD and RFD
mice were potentiated by leptin, an effect not seen
in HFD mice. LepR expression was unchanged in
the whole no dose, but was reduced in the mucosal
“The stomach’s nerve response does not return
to normal upon return to a normal diet. This means
you would need to eat more food before you felt
the same degree of fullness as a healthy individual,”
says study leader Associate Professor Amanda Page
from University of Adelaide’s Nerve-Gut Research
Laboratory. “Leptin, known to regulate food intake,
can also change the sensitivity of the nerves in the
stomach that signal fullness. In normal conditions,
leptin acts to stop food intake. However, in the
stomach in high-fat diet induced obesity, leptin
further desensitizes the nerves that detect fullness.
These two mechanisms combined mean that obese
people need to eat more to feel full, which in turn
continues their cycle of obesity.”
In the study, eight-week-old female C57BL/6 mice
were either fed a SLD (n=20) or HFD (n=20) for 24
weeks. A third group was fed a HFD for 12 weeks and
then a SLD for a further 12 weeks (RFD, n=18).
afferents of the HFD and RFD mice.
“Disruption of gastric vagal afferent function by
HFD-induced obesity is only partially reversible by
dietary change,” they conclude. “Which provides
a potential mechanism preventing maintenance of
weight loss.”
“The results have very strong implications for
obese people, those trying to lose weight, and those
who are trying to maintain their weight loss,” said
Page. “Unfortunately, our results show that the
nerves in the stomach remain desensitised to fullness after weight loss has been achieved.”
“We know that only about 5% of people on diets
are able to maintain their weight loss, and that most
people who’ve been on a diet put all of that weight
back on within two years,” she added. “More research
is needed to determine how long the effect lasts, and
whether there is any way – chemical or otherwise – to
trick the stomach into resetting itself to normal.”
Vagus nerve stimulation increases energy expenditure
At least part of the effect of VNS intervention
on energy expenditure can be explained by BAT
activity
Short-term interruption of VNS therapy by turning off
the VNS for only several hours significantly decreased
energy expenditure
V
agus nerve stimulation
(VNS) is accompanied
by an increase in whole
body energy expenditure and
this thermogenesis is related to
changes in brown adipose tissue
(BAT) activity, according to a
study publishing online ‘Vagus
Nerve Stimulation Increases
Energy Expenditure: Relation to
Brown Adipose Tissue Activity’,
in the journal PLoS ONE.
It is known that human BAT
activity is inversely related to
obesity and positively related
to energy expenditure. BAT is
highly innervated and it is suggested the vagus nerve mediates
peripheral signals to the central
nervous system, there connecting to sympathetic nerves that
innervate BAT. VNS is used for
refractory epilepsy, but has been
reported to reported to generate
weight loss.
The study researchers from
Maastricht University Medical
Center, Maastricht, The Netherlands, sought to define the
relation between VNS energy
expenditure and BAT activation
in a patient cohort on chronic
stable VNS therapy for refractory
epilepsy, and hypothesised that
VNS increases energy expenditure by stimulating BAT activity.
Study
Between January 2011 and June
2012, 15 patients on stable VNS
therapy using the Vagus Nerve
Stimulation Therapy System
(VNS Therapy, Cyberonics) for
refractory epilepsy were recruited
for the study.
Energy expenditure was measured using indirect calorimetry
and BAT activity was assessed by
means of FDG-PET-CT during
actual VNS and when VNS was
inactivated. In addition, they
compared BAT activity during
VNS and during mild cold stimulation. The mild cold intervention
served as a control since it is
known to activate BAT.
Ten patients were measured
in thermoneutral (TN) conditions with active (VNS-On) and
inactive VNS (VNS-Off) respectively. In addition, five subjects
were measured with active VNS
in TN conditions (VNS-TN) and
during mild cold exposure (VNSCold) respectively.
Subjects were measured under
fasted conditions (no food intake
from 10pm the night before, only
water consumption was allowed)
from 9am to 2pm under supervision of a specialized research
nurse. VNS-On and VNS-Off
took place on separate occasions
within 14 days. During VNSOff the system was inactivated
(output current 0 mA, magnet
function 0 mA) at 9:30am prior
to the measurements. At the end
of the test day (2:00pm) the VNS
system was re-activated. During
VNS-Cold the settings of the
VNS system were not adjusted.
VNS-TN and VNS-Cold were
also performed within a 14-day
period. Body composition (body
fat%, fat mass (FM), fat free mass
(FFM)) was determined by dual
x-ray absorptiometry (DXA, type
Discovery A, Hologic, Bedford,
MA, USA).
Ten male and five female
patients with a mean age of
45±10 years and a mean BMI of
25.2±3.5 that were (successfully)
treated with VNS for refractory
Figure 2: FDG-PET-CT images of intervention group and cold exposed subjects.
Pre-VNS treatment body
weight and BMI were retraceable for 11 subjects and were
not significantly different from
weight and BMI during the
study (implant weight and BMI;
71.2±12.5, 24.7±3.4, current
weight and BMI; 72.9±11.6,
25.2±3.5, p=0.414). The subject
characteristics were not different
for the On/Off (n = 10) versus the
TN/Cold group (n = 5) (Table 1).
Figure 1. Basal metabolic rate
(BMR) during active and inactive
VNS in relation to BAT activity.
epilepsy were included (Table 1).
VNS implantation was on average 59±19 months (range; 22–89
months) ago and all subjects did
not have any recent adjustments in
their VNS settings or medication.
Outcomes
The researchers report that basal
metabolic rate (BMR) decreased
significantly when VNS was
Characteristics
Group
VNS-On/Off
VNS-TN/Cold
N
15
10
5
Se± (Male/Female)
10M/5F
4M/6F
1M/4F
P-value
Age (yrs)
45±10
42±10
49±8
0.203
Height (cms)
170±10.0
168.5±8.4
173±13
0.464
Mass (kg)
73±11.6
70.1±11.7
78.6±10.4
0.194
BMI (kg/m )
25.2±3.5
24.6±3.0
26.6±4.4
0.316
Fat-free mass (kg)
49.8±9.0
48.8±9.5
51.7±8.5
0.568
Fat mass (kg)
21.9±6.4
20.4±5.3
25.0±8.0
0.199
Body fat (%)
29.5±6.9
28.5±6.4
31.4±8.2
0.459
VNS output current (mA)
1.85±0.55
1.55±0.59
1.65±0.52
0.752
VNS input time (months)
59±19
64±15
50±24
0.185
VNS implant mass (kg)
71.2±12.5
69.8±13.9
72.8±12.0
0.717
VNS implant BMI (kg/m2)
24.7±3.4
24.9±3.1
24.5±4.1
0.861
2
turned off (68.6±7.9 J/s versus
67.2±8.1 J/s, p=0.038, mean
change; 2.2%, range; −3.1 to
7.8%, Figure 1).
Figure 2 shows representative
images of FDG-uptake on PETCT in the studied groups. The
mean SUV for BAT showed no
statistical difference during VNS
(BAT SUVMean; 0.55±0.25
versus 0.67±0.46, p=0.619). In
different muscles analysed, the
triceps muscle had a significantly
increased FDG-uptake when
VNS was turned off. However,
for all muscles together there was
no significant change in activity.
P-values shown for unpaired t-tests between VNS-On/Off and VNS-TN/Cold. *P<0.05.
doi:10.1371/journal.pone0077221.t002
Table 1. Subject characteristics for all subjects, the intervention group with Vagus Nerve Stimulator (VNS) On
and Off (n = 10) and for the group with VNS during thermoneutral (VNS-TN) conditions and cold exposure
(VNS-Cold) (n = 5).
Figure 3. FDG-PET-CT activity of
different tissue types upon VNS
intervention.
After cold exposure, all
subjects
showed
increased
BAT activity (BAT SUVMean;
0.65±0.29 versus 3.40±1.63,
p=0.012).
Energy expenditure during
VNS-On and VNS-Off measurements was not related to BAT
activity, activity of other tissue
(Muscle, WAT), skin perfusion,
core and skin temperatures or any
other study parameter in either
uni- or multivariate analyses.
However, the change in energy expenditure upon VNS intervention
(from VNS-On to VNS-Off) was
positively correlated to the change
in BAT activity (exponential curve
fitting, r = 0.935, p<0.001).
“This study shows that even
short-term interruption of VNS
therapy by turning off the VNS
for only several hours significantly decreased energy expenditure
in a cohort of treatment-stable
VNS patients,” the authors note.
“Despite the fact that mean BAT
activity did not increase upon
VNS, the change in BAT activity
explained a significant part of the
change in energy expenditure. To
our opinion, this suggests at least
part of the effect of VNS intervention on energy expenditure can be
explained by BAT activity.”
The study was registered in the
Clinical Trial Register under
the ClinicalTrials.gov Identifier
NCT01491282.
32 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013
US survey reveals views on dieting vs. surgery
56.5% of respondents have
no idea of their health
insurance coverage for
weight loss surgery
T
he results from a US survey
that asked participants to share
their thoughts on the safety
and effectiveness of bariatric surgery
compared to the success rate from commercial diet programmes has reported
that a majority perceive surgery as
either safe or very safe.
“Surgical weight loss procedures
such as the lap band or the gastric sleeve
have often been misconceived as dangerous, and nearly half of the responses
admitted to having this opinion,” said Dr
Shawn Garber, Founder and President of
the New York Bariatric Group, who carried out the survey in partnership with
SurveyMonkey. “These survey results
will help us educate the American
population on the
misconceptions of
commercial dieting
vs. weight loss
surgery procedures
and stress that
weight loss surgery
performed
by
experts in the field
Shawn Garber
of bariatric surgery
is very safe. In fact,
there are fewer risks involved with surgical weight loss procedures as there are
with staying obese and suffering from
multiple life threatening health issues.”
The survey entitled “Commercial Dieting vs. Surgery: Who wins the Weight
Loss battle?” asked over 2,000 men
and women across the US to share their
perspective towards commercial weight
loss programs vs. surgical weight loss
procedures. Key results of the survey
revealed:
n 61.2% of people who took the
survey were either overweight or
obese and would likely qualify for
weight loss surgery
n 58% of people said they have
considered some sort of weight loss,
yet, 46% of people don’t have an
opinion on weight-loss programs
n 6% of people said they did not
have an opinion on weight loss
programmes, 23.5% of people chose
Weight Watchers, while only 6.3%
would consider weight loss surgery
n When participants were asked
how much weight loss the average
person maintained two years after
completing a commercial weight
loss programme, more than half said
5-15lbs
n When they were asked how much
weight loss the average person
maintained two years after receiving
weight loss surgery, 57.6% said
between 30-80lbs
n 41.5% of people perceives weight-
loss surgery as the best solution for
those who have a serious weightrelated issue, while 35.5% of people
believe that people should be able to
diet and exercise long term, and not
resort to surgery
n 52.5% of respondents perceive
weight loss surgery as either safe or
very safe, while 47.5% still believe
it’s not very safe or extremely
dangerous
n 56.5% of respondents have no idea
of their health insurance coverage for
weight loss surgery and 25.7% would
assume that their health insurance
does not cover weight loss surgery
“One of the most interesting results we
found was that 56.5% of respondents
have no idea of their health insurance
coverage. As obesity is becoming a
serious, common health threat and is
now being formally recognized as a
disease, more insurance companies are
covering bariatric procedures because of
their effectiveness. That said, insurance
companies should be doing more to
make their members aware of the coverage available for bariatric surgery,” said
Garber. “I also find it interesting that
41.5% of people perceive weight-loss
surgery as the best solution for those
who have a serious weight-related issue,
while 35.5% of people believe that people should be able to diet and exercise
long-term, and not resort to surgery. This
proves that there is a common belief that
diets work long-term, when in fact, 95%
of the time, they do not work for those
who suffer from obesity.”
The New York Bariatric Group
will be executing a tailored and more
focused marketing initiative to address
some of the concerns and findings
reported in the survey.
Perceptions of access and waiting for surgery
T
hree important areas of perceived inequity related to waiting
for bariatric surgery: socioeconomic inequity, regional inequity, and inequity related to waitlist prioritisation
Patients’ perceptions of accessing and waiting for bariatric surgery
are shaped by perceived and experienced inequities within the healthcare system, according to a research paper titled ‘Patients’ perceptions
of waiting for bariatric surgery: a qualitative study’, published in the
International Journal for Equity in Health (Gregory et al. 2013;12:86).
The paper calls for a system to address these socioeconomic, regional and
waitlist inequities. Specifically, it states that ‘equitable access to treatment
should be a health system priority’ and that ‘supports and resources are
required to ensure the waiting experience is as positive as possible’.
Researchers from Memorial University, Newfoundland and Labrador, Canada, wanted to explore patients’ perceptions of waiting for
bariatric surgery, the meaning and experience of waiting, the psychosocial and behavioural impact of waiting for treatment and identify
healthcare provider and health system supportive measures that could
potentially improve the waiting experience.
The primary objective was to develop an understanding of the
pre-surgical experience of patients that choose to undergo a surgical
weight loss intervention for the management of morbid/clinical obesity after being placed on a waitlist for bariatric surgery. The meaning
of bariatric surgery and the psychosocial impact of waiting for this
form of treatment for individuals must be understood if multidisciplinary bariatric clinical team providers are to act as facilitators in
promoting satisfaction with care and quality care outcomes.
“In a publicly funded healthcare system that promotes universal care,
this research is highly relevant for policy makers who want to ensure that
patients have equal access to treatment based on need,” they write. “In
this paper we focus on patients’ experiences while waiting, particularly
the emotional consequences of waiting, and the insights that these experiences bring to a discussion of equity, including socioeconomic, regional,
and waitlist prioritization inequities. We include participants’ recommendations on how the waiting experience can be made more positive.”
Study
Twenty-one women and six men engaged in in-depth interviews
between June 2011 and April 2012. The data were subjected to reanalysis to identify perceived healthcare provider and health system
barriers to accessing bariatric surgery.
The age of participants ranged from 26 to 64 years, with an average
age of 45.3 years. Six participants (22%) had a high school education
or less, 15 (56%) had some post-secondary education and six (22%)
had a university degree. The majority of participants were Caucasian
(26, or 96%, while one identified as aboriginal), married or living
with a common-law partner (18, or 66%), had children (21, or 78%),
and were working full-time (16, or 59%). Approximately 85% of the
sample reported three or more co-morbid conditions.
BMI data were not collected during the interview since all participants met the Canadian consensus guidelines for eligibility for criteria
for bariatric surgery, were approved for bariatric surgery by the bariatric surgeon, and at the time of the initial interview, were waiting for
bariatric surgery. Participants’ self-identified waiting periods at the
time of the interview varied widely, with one third waiting for less
than six months, and half waiting for more than five years.
Outcomes
The researchers reported that the participants highlighted three
important areas of perceived inequity related to waiting for bariatric
surgery: socioeconomic inequity, regional inequity, and inequity
related to waitlist prioritisation.
Health system level factors including the lack of availability of
bariatric surgical services and individual level factors related to the
financial burden associated with accessibility of the existing service
were viewed as obstacles or barriers.
They also said that the longer the waiting period was for surgery,
the more difficult it was for participants to stay motivated and engaged
in maintaining their current health as they prepared for surgery
The researchers also comment on the regional and provincial
variations in capacity for bariatric surgery. It is estimated that
demand for bariatric surgery exceeds potential capacity by over
600-fold. In addition, they note that six of the thirteen provinces and
territories have no bariatric surgery programme, so patients from
these regions must travel to other provinces for bariatric surgery.
However, many of these provinces do not accept non-residents due
to the length of their wait lists.
Conclusion
“This study also brings attention to the need for a concerted effort
to address the growing dissatisfaction of patients accessing bariatric
surgery and the perceived unacceptable wait times that arise once the
patient is deemed eligible to undergo the surgery,” the authors conclude. “Recommendations on how to improve the waiting experience
included periodic updates from the surgeon’s office about their position on the wait list; a counsellor who specialises in helping people
going through this surgery, dietician support and further information
on what to expect after surgery, among others.”
Genetic mutations cause severe obesity
A
novel genetic cause of severe
obesity
which,
although
relatively rare, demonstrates
for the first time that genes can reduce
basal metabolic rate, researchers from
the University of Cambridge will report
in a paper. ‘KSR2 Mutations are Associated with Obesity, Insulin Resistance
and Impaired Cellular Fuel Oxidation’,
published in journal Cell.
Previous studies (performed by
David Powell and colleagues at Lexicon
Pharmaceuticals in Texas) demonstrated
that when the gene KSR2 (Kinase Suppressor of Ras 2) was deleted in mice,
the animals became severely obese.
Subsequently, Professor Sadaf Farooqi
from the University of Cambridge’s
Wellcome Trust-MRC Institute of
Metabolic Science decided to explore
whether KSR2 mutations might also
lead to obesity in humans.
“Up until now, the genes we have
identified that control body weight have
largely affected appetite,” said Professor
Farooqi. “However, KSR2 is different in
that it also plays a role in regulating how
energy is used in the body. In the future,
modulation of KSR2 may represent a
useful therapeutic strategy for obesity
and type 2 diabetes.”
In collaboration with Dr Ines Barroso’s team at the Wellcome Trust Sanger
Institute, the researchers sequenced the
DNA from over 2,000 severely obese
patients and identified multiple mutations in the KSR2 gene. KSR2 belongs
to a group of proteins called scaffolding
proteins which play a critical role in
ensuring that signals from hormones
such as insulin are correctly processed
by cells in the body to regulate how cells
grow, divide and use energy.
To investigate how KSR2 mutations might lead to obesity, Professor
Farooqi’s team performed a series of
experiments which showed that many
of the mutations disrupt these cellular
signals and, importantly, reduce the ability of cells to use glucose and fatty acids.
Patients who had the mutations in
KSR2 had an increased drive to eat in
childhood, but also a reduced metabolic rate, indicating that they have a
reduced ability to use up all the energy
that they consume. A slow metabolic
rate can be found in people with an
underactive thyroid gland, but in these
patients thyroid blood tests were in
the normal range – eliminating this as
a possible explanation for their low
metabolic rate.
The findings in this study provide
the first evidence that defects in a particular gene, KSR2, can affect a person’s
metabolic rate and how their bodies
processed calories.
Changes in diet and levels of physical
activity underlie the recent increase in
obesity in the UK and worldwide. However, there is a lot of variation in how
much weight people gain. This variation
between people is largely influenced by
genetic factors, and many of the genes
involved act in the brain. The discovery
of a new obesity gene, KSR2, adds another level of complexity to the body’s
mechanisms for regulating weight. The
Cambridge team is continuing to study
the genetic factors influencing obesity,
findings which they hope to translate
into beneficial therapies in the future.
“Our findings provide the first evidence that defects in a particular gene,
KSR2, may affect a person’s metabolic
rate and how their bodies process calories,” said Barroso.
This work was supported by the Wellcome Trust, Medical Research Council,
NIHR Cambridge Biomedical Research
Centre, and European Research Council.
bariatricnews.net 33
ISSUE 18 | DECEMBER 2013
Study survey: Choice and biology explain obesity
Over 90% of participants attributed
obesity to overeating and a majority
of participants (57%) agreed that
there is a medical cause to obesity
Psychotherapy or counselling was listed
by 44% of participants as the most
effective treatment for a food addiction,
followed by dietary changes (22%)
S
trong public acceptance of neurobiological explanations of overeating and obesity can
co-exist with the view that personal choice
is the predominant cause of obesity, according to
researcher Public Views on Food Addiction and
Obesity: Implications for Policy and Treatment.,
published online in the journal Plos One.
The study investigators, from the University of
Queensland, Brisbane, Australia, believes the study
shows that “as the concept of food addiction is developed, its advocates need to pay greater attention
to its effects on stigma, treatment and policy and to
assessing whether its net impact on public health is
likely to be harmful or beneficial”.
The authors undertook the study to examine the
public’s acceptance of the concept of food addiction as an explanation of overeating, and assess its
effects upon their attitudes toward obese persons
and the treatment of obesity.
It has been well documented that patterns of
eating in some individuals resemble the behaviour
of drug-addicted individuals and many compulsive
eaters and obese individuals demonstrate substance
dependence when these are applied to the consumption of specific foods.
Study
They conducted an online survey of 479 adults from
the US (n=215) and Australia (n=264), primarily
to identify any cross-cultural differences between
public attitudes in two developed Westernised
countries that have high rates of obesity.
They were asked three questions to assess their
understanding of the causes of obesity and its risk fac-
tors. The first question was a multiple-choice question
to assess what participants believed to be the main
cause of obesity. “Biological causes” and “genetics or
family history” were combined during analysis as the
two represent causes external to personal control.
Outcomes
A total of 610 individuals began the online survey,
with 79% completing the study without error (n=479),
yielding 215 US and 264 Australian participants.
One third of participants said personal choice
(32%) was the main cause of obesity, 27% ascribed
it either to biological and genetic causes, and 23%
chose the environment. A sizeable minority (18%)
chose “other”, with most of these participants indicating that obesity was caused by a combination
of factors.
Over 90% of participants attributed obesity to
overeating and a majority of participants (57%)
agreed that there is a medical cause to obesity,
although over a quarter were unsure. Views on the
causes of obesity did not differ significantly by
country of residence.
Almost three quarters (72%) of participants
believed that an addiction to certain foods caused
obesity, just over half (54%) agreed that obesity
should be treated as an addiction, and 64% were
prepared to classify obesity as an eating disorder.
Most (86%) participants thought that certain
foods are addictive (79% in the case of sugar) and
80% believed that some foods could be as addictive as alcohol, nicotine and cocaine. With regards
to region, there were no significant differences in
the participants belief that obesity was caused by
a food addiction (69% v. 74%) or who considered
obesity to be an eating disorder (60% v. 67%).
A significantly lower proportion of US (73%)
than Australian (86%) participants agreed that
obesity was harmful to society (OR = 0.49, 95% CI
0.29–0.84), and that obesity should be treated as an
addiction: 47% US vs. 59% Australia (OR = 0.59,
95% CI 0.38–0.92).
Two thirds (69%) of participants were aware of
research suggesting that foods could be addictive in
the sense of producing changes in the brain similar
to drugs of abuse. 81% of all participants supported
this view. Participants from the US and Australia
did not differ in their awareness and acceptance of
neuroscientific evidence for food addiction.
Treatment of obesity
Two-thirds believed that diet was the most common
treatment of obesity but only one quarter believed it
to be the most effective. Just over a quarter of participants (27%) thought that exercise was the most
effective treatment of obesity. Half of the participants thought that prescription drugs were the least
effective treatment of obesity, followed by surgery
(16%). Participants’ responses varied only slightly
by country of residence: 31% of US participants believed that exercise was most effective whereas 30%
of Australians thought that diet was most effective.
Psychotherapy or counselling was listed by
44% of participants as the most effective treatment for a food addiction, followed by dietary
changes (22%). Educational and support groups
were thought by 33% to be the most effective
policy to address food addiction. Restrictions on
advertising had the least support (5%). Over half
of the participants (57%) disagreed that imposing
a tax on certain foods would lower rates of obesity
and 49% did not think that such a tax would be
helpful to society. There were no significant differences between US and Australian participants
on the most effective treatment and policy changes
needed to reduce an addiction to certain foods.
While the participants were aware of and supported the concept of food addiction, this did not
change their attitudes toward obese individuals or
the most effective method of treating obesity in
75% and 53% of participants, respectively.
Obese participants were less than a third as
likely as their normal and overweight counterparts
to view obesity as harmful to society (OR = 0.30,
95% CI 0.16–0.54). Obese participants were also
less supportive of imposing a tax on foods than
normal and overweight participants (OR = 0.52,
95% CI 0.21–0.58).
Participants’ awareness of certain foods’ addictive
potential and their agreement with this did not significantly differ by BMI. Obese individuals were twice
as likely to report a change in their views about obese
individuals (p<0.05) and obesity treatment (p<0.001)
after hearing about neuroscientific explanations of
addiction than were normal weight participants.
Obese individuals believed that Sarah had less
control over her eating and weight (OR = 0.36, 95%
CI 0.21–0.58) and was less responsible for becoming
obese (OR = 0.34, 95% CI 0.21–0.55) and losing
weight (OR = 0.32, 95% CI 0.18–0.55) than normal
and overweight participants. Perceived personal responsibility for weight decreased as BMI increased.
“Our findings indicate that while participants
were willing to accept that some foods can be
addictive, this did not entail support for medical
treatments of obesity or change the strong emphasis placed on obese persons’ responsibility for their
weight,” they state. “It may also reflect the view
that medical treatments of obesity are of limited
effectiveness. Very few thought that medical interventions such as prescription drugs (1%), surgery
(8%) or psychotherapy (11%) would be effective.
Diet was seen as the most common treatment of
obesity by two-thirds of respondents but only a
quarter of respondents believed it to be effective.”
With regards to country, Australian participants
were more aware of the harmful effects of obesity
on society and a significantly larger proportion of
Australians thought that obesity should be treated
as an addiction.
“There was substantial support for the idea of
food addiction, particularly among obese participants,” they add. “Despite the strong support for
seeing obesity as a form of addiction, respondents
still saw obesity as primarily the result of personal
choices and emphasised the need for individuals to
take responsibility for their eating.”
Conclusion
“In our sample, obese participants were more likely
to support the view that obesity represents an addiction to certain foods,” the authors conclude. “The
apparent failure of neurobiological explanations of
overeating and obesity to alter public views toward
obese individuals and the treatment of obesity suggests that these explanations have not yet had the
beneficial impacts assumed by their advocates.”
New drug regimen reduces PONV
B
ariatric
surgery
patients avoided postoperative nausea and
vomiting (PONV) with the
addition of a second drug to
the standard treatment given
during surgery, according to a
study entitled ‘Aprepitant In
Combination With Ondansetron
Reduces Postoperative Vomiting
In Bariatric Surgery Patients’
presented at the Anesthesiology
2013 annual meeting.
“Nausea and vomiting are
some of the most common
post-op complications for all
patients who have general
anaesthesia,” said Dr Ashish C
Sinha, vice chair of anesthesiology and perioperative medicine
at Drexel University College of
Medicine, Philadelphia. “However after weight-loss surgery,
the consequences of vomiting
can be very serious. During this
kind of surgery, the stomach
is transformed to a small,
one-ounce sac. Vomiting risks
rupturing the fresh incision as
the contents of the stomach try
to violently exit the narrow,
freshly created stomach pouch.
Reducing this risk would mean
more comfortable patients as
well as safer surgery and anaesthesia.”
Morbidly obese patients
undergoing general anesthesia
for bariatric procedures can
often experience PONV for up
to 48 hours. Even with the use
of 5HT3 receptor antagonists for
antiemetic prophylaxis, 30-40%
of patients continue to experience PONV.
Aprepitant is a newer substance P antagonist that mediates
its effects by blocking the neurokinin-1 receptor, and is useful in
the prophylaxis of both acute and
delayed onset PONV.
A total of 124 patients were
enrolled in this randomised,
double blind, placebo controlled
trial from 2010 to 2012. On the
day of surgery, patients were randomised into one of two arms:
40mg oral aprepitant (n=64), or
a placebo (n=60). Aprepitant or
a placebo was given within one
hour of anticipated induction of
anaesthesia with a small sip of
water. All patients received 4 mg
intravenous (IV) ondansetron in
the operating room before induction.
Patients that experienced
intractable nausea that lasted at
least 15 minutes, or those who
requested antiemetic medication
were given rescue therapy. The
initial drug of choice was 4mg
IV ondansetron, followed by
additional antiemetic therapy at
the anesthesiologist’s discretion.
Nausea was assessed using a
ten-point scale at the following postoperative intervals: 30
minutes, one hour, two hours, six
hours, 24 hours, 48 hours, and 72
hours. The incidence of vomiting
was recorded.
Results
The results showed that the
occurrence of vomiting was
significantly lower in the treatment arm when compared to
the placebo (3% versus 15%,
p=0.02). However, the addition
of aprepitant was not effective in
reducing the rate of nausea when
compared to ondansetron alone
(36% versus 42%).
The researchers said that this
data supports the use of this combination therapy as an effective
prophylactic antiemetic regimen
in bariatric surgery patients.
“This multi-drug therapy can
benefit patients at higher risk for
PONV,” added Sinha. “There are
multiple receptors in the brain
stem that trigger vomiting; if
we use the combination therapy,
we can increase the number of
receptors blocked and lower the
incidence of vomiting.”
34 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013
Country news
British Columbia to increase number of bariatric procedures
B
ritish Columbia is looking to significantly boost the number of weight-loss surgeries performed in hospitals, according to a report in the Times Colonist.
British Columbia hospitals should be performing about 1,000 bariatric surgeries every year,
said Dr Mehran Anvar, president of the Canadian Association of Bariatric Physicians and
Surgeons. The province currently performs
about 260 each year in two centres: 120 at
Victoria’s Royal Jubilee Hospital and 140 at
Richmond General Hospital.
The province hopes to follow in the footsteps
of Ontario, which will fund 3,300 weight-loss surgeries in 2013-14.One Canadian study found
weight-loss surgery paid for itself within 3.5 years
and saved C$5,700 per patient after five years,
he said.
Increasing the number of surgeries in Ontario will save the province up to C$10,000 extra
per surgery it was paying for as many as 1,700
procedures to be done every year in the United
States. In contrast, British Columbia sent ten patients to Seattle in 2010.
“It is money well spent,” said Anvari, who
is also CEO of the Centre for Surgical Invention
and Innovation, affiliated with McMaster University. “Not only does the surgery restore patients’
health, it also restores the productivity lost by
their inability to work due to obesity.”
With one-time provincial funding, British Columbia has been able to reduce the number of
people on the waiting-list for surgery to 196 this
year from 462 in 2011.
“This is obviously a very under-serviced
group of patients across the country, not just in
British Columbia,” Anvari said. His goal as the
president of the national bariatric surgery association is to help all provinces provide programs
similar to Ontario’s.
Oversight of procedures
In addition, the British Columbia Ministry of
Health has requested more oversight of weightloss surgery provided to hundreds of morbidly
obese patients at private medical clinics. The request was made following a recent report from
health officials that “laparoscopic banding is not
as effective over the long-term as other forms of
bariatric surgery, according to international sci-
entific studies.”
Subsequently, the British Columbia College
of Physicians and Surgeons has been asked to
take steps to ensure the quality of surgeries after
laparoscopic banding.
Dr Mehran Anvari, president of the Canadian
Association of Bariatric Physicians and Surgeons,
said it’s up to each college to regulate private clinics in their provinces. “Banding is a recognised
technique, although there is increasing evidence
that patients that have banding do have higher reoperation rates and less effectiveness.”
Laparoscopic banding was approved by the
college in September 2009, since then some 318
procedures have taken place in private clinics.
“This is the first time a request [for oversight]
such as this has been made,” said Susan Prins,
spokeswoman for the British Columbia College
of Physicians and Surgeons.
Prins said the ministry sometimes requests
data from the regulatory body for British Columbia doctors, however in this case, the college has
been asked to review its accreditation of laparoscopic banding procedures in private clinics and
“ensure it monitors standards and outcomes for
laparoscopic banding.”
“The reality in British Columbia is that morbidly obese patients cannot access appropriate advanced surgery for obesity in the public facilities,
so their only option is gastric banding at the private facility’s cost,” said Prins.
The ministry’s one-time funding of C$2 million
has reduced the waiting list for bariatric surgery
from 462 in 2011 to 196. An additional two surgeons at Richmond General Hospital have begun
performing the surgery.
British Columbia’s Health Services Authority
is co-ordinating with the Vancouver Island Health
Authority and Vancouver Coastal Health, where
Richmond General Hospital now has two surgeons providing weight-loss surgery, to create a
standard for services, referrals and care.
“An implementation plan as well as plans for
the 2013-14 fiscal year is expected to be finalised
this fall,” the Health Ministry said in a statement to
the Times Colonist.
The number of procedures performed in the
province has increased considerably in the last
few years, in 2010 only 52 weight-loss surgeries
were performed in British Columbia.
CDC update: More than 78 million US adults are obese
T
he prevalence of obesity among adults
in the US is still more than one-third
(78 million adults) of the population,
according to the latest data published
by the Centers for Disease Control and Prevention (CDC). The data shows that 34.9%
of adults were obese in 2011–2012 (Figure 1)
and the obesity rate was higher among middle-aged adults (39.5%) than among younger
(30.3%) or older (35.4%) adults.
“It’s kind of a confirmation of what we saw
last time, that the prevalence of obesity in adults
may be levelling off,” said co-author Cynthia Ogden, a senior epidemiologist with the CDC’s National Center for Health Statistics. “From 2003-04
through 2011-12, there have been no statistical
changes in obesity in adults.”
Published by the National Center for Health
Statistics (NCHS Data Brief, No 131, October
2013), the update also reveals that the overall
prevalence of obesity did not differ between men
and women in 2011–2012.
However, among non-Hispanic black adults,
56.6% of women were obese compared with
37.1% of men (Figure 2). The prevalence of obesity was also higher among non-Hispanic black
(47.8%), Hispanic (42.5%), and non-Hispanic
white (32.6%) adults than among non-Hispanic
Asian adults (10.8%).
“The goal of the human species since we
evolved has been to have enough to eat, and
we’ve gotten there. Unfortunately, it’s so plentiful we can take in more than we need,” said Matt
Petersen, managing director of medical information and professional engagement for the American Diabetes Association. “The human body and
brain is wired to take in more than a sufficient
number of calories, and that’s a hard thing to
change. We’re talking about really powerful aspects of our metabolism.”
The US economy loses an estimated US$270
billion a year due to healthcare costs and loss of
productivity associated with obesity and overweight, according to a 2011 report produced by
the Society of Actuaries.
“It just shows that we still have a lot of work to
do,” said Rachel Johnson, a professor of nutrition
at the University of Vermont and a spokeswoman for the American Heart Association. “We’re
making a little bit of progress in childhood obesity, some very small declines, but it at least feels
like we’re making some headway there. There
are some small pockets in a few cities or states
where we’ve seen a modest decline in childhood
Figure 1: Age-adjusted prevalence of obesity, by
sex, among adults aged 20 and over: United States,
2009–2010 and 2011–2012.
effectiveness or lifestyle modifications like diets
and physical activity plans and finding out how
well kids will stick to them.
Nationally, childhood obesity rates seem to
be levelling or falling slightly. In August 2013, researchers from the Centers for Disease Control
and Prevention (CDC) reported drops in obesity
rates among pres-choolers living in 18 states and
the US Virgin Islands.
Figure 2. Age-adjusted prevalence of obesity, by sex
However, Kelly warned that while the nationand race and Hispanic origin, among adults aged 20 al problem may be levelling, severe obesity rates
and over: United States, 2011–2012
among children are on the rise.
1. Significant difference from non-Hispanic Asian.
2. Significant difference from non-Hispanic white.
3. Significant difference from women.
4 Significant difference from Hispanic.
NOTE: Estimates are age-adjusted by the direct method to the 2000 US census population using the age groups 20–39, 40–59, and 60 and over.
SOURCE: CDC/NCHS, National Health and Nutrition Examination Survey, 2009–2010 and 2011–2012.
obesity, due to very aggressive interventions.”
“My view is that we have to start making
some pretty major environmental changes so
we make the healthy choice the easy choice,”
she said. “We’ve got to move beyond the idea
that it’s all about personal choice and education,
and we need to start making these environmental changes.”
“The beginning of this century has got to be
about behavior change,” Johnson added. “How
do we help people make healthy choices, and
how do we create an environment that’s conducive to good health?”
Childhood obesity
Meanwhile, researchers reviewing data on
US children have determined that five percent have severe obesity, according to a scientific statement published in the AHA’s journal Circulation (Researchers reviewing data
on US children have determined that five percent have severe obesity, according to a scientific statement published in the AHA’s journal Circulation (Severe obesity in children and
adolescents: identification, associated health
risks, and treatment approaches: a scientific statement from the american heart association.2013:128(15):1689-712).
The policy statement, which defines severe
childhood obesity for other doctors, states that
children are often assessed based on how their
body mass compares to that of their age group.
They are considered overweight if their BMI falls
into the 85th to less than 95th percentile of others of their age and gender. Obesity is diagnosed
if a child has a BMI equal or greater to 95 percent
of their peers. Overall, one-third of US children
are considered obese or overweight.
“Severe obesity in young people has grave
health consequences,” said study author Dr Aaron Kelly, a researcher at the University of Minnesota Medical School in Minneapolis. “It’s a much
more serious childhood disease than obesity.”
The AHA’s scientific statement reveals a new
definition for those who are severely obese: having a BMI at least 20 percent higher than the 95th
percentile for their age and gender, or a BMI of 35
or higher. That means a seven-year-old girl of average height that weighs 75lbs or a 13-year-old
boy who weighs 160 points would be considered
severely obese.
Statement
The statement calls for innovative approaches to
fill the gap between early interventions lifestyle
changes and medication, and the final intervention – weight loss surgery.
“Bariatric surgery has generally been effective
in reducing body mass index and improving cardiovascular and metabolic risk factors; however, reports of long-term outcomes are few, many
youth with severe obesity do not qualify for surgery, and access is limited by lack of insurance
coverage,” the authors write.
He also noted that severely obese children
face a significant risk of developing type 2 diabetes, high blood pressure, high cholesterol levels,
and cardiovascular issues.
“Even highly intensive lifestyle interventions
generally have left subjects still markedly obese,
albeit with modestly improved cardiovascular
and metabolic profiles,” they note.
Specific suggestions from the statement’s
authors include conducting new studies on the
Recommendations
The American Heart Association recommends
the following tips to healthcare professionals to
address the obesity problem:
n
More research into the effects and safety of
bariatric surgery.
n
Attention into the effectiveness of lifestyle modification interventions such as adhering to a
diet and physical fitness.
n
Research into other useful weight loss tools including drugs and medical devices.
n
The recognition of severe obesity as a chronic
disease that requires care and management.
Cardiologist, Dr Valentin Fuster, director of Mount
Sinai Heart at The Mount Sinai Medical Center in
New York City, said weight management is difficult for children because due to hormones they
tend to want to eat more, while some have such
low self-esteem from their lifelong struggles with
weight, they simply give up trying.
He explained that it was too simple to argue
kids are eating too much and that early interventions should target anxiety, family or genetic-related issues that may be contributing to obesity
at such a young age.
“This is why it’s so important to know the reasons for why you’re obese,” he added. “All society
should be aware that this is a huge problem, leading to an epidemic of cardiovascular diseases.”
“Alternative approaches are needed for
youth who medically qualify for bariatric surgery
but are not interested in this option, for youth
who lack the family support or emotional maturity for the surgery and resulting change in food
intake, and for children too young for surgery but
with severe obesity and severe comorbidities,”
they concluded. “The task ahead will be arduous and complicated, but the high prevalence
and serious consequences of severe obesity require us to commit time, intellectual capital, and
financial resources to address it.”
bariatricnews.net 35
ISSUE 18 | DECEMBER 2013
Country news
Australian coalition to provide more funding for bariatric surgery?
Calls for more funding to go into
prevention not treatment
The newly-elected coalition government in Australia could provide more public funding for
weight loss surgery to tackle Australia’s growing
obesity problems, according to comments made
by the coalition’s health spokesman, Peter Dutton, during an election health debate before the
Coalition was elected at the weekend.
During the debate with the previous Health
Minister, Tanya Plibersek, Dutton said that he
plans to cut health bureaucracies like the Australian National Preventative Health agency.
More than half the adult population is now
overweight or obese and Dutton said that he is
keen to use bariatric surgery to help tackle the
problem.
“And in terms of bariatric surgery, yes, we’re
open to some discussions with the states predominately about investment in that space. I’d be
happy to look at that,” he said.
More than 17,000 Australians a year undergo bariatric surgery and the National Health and
Medical Research Council now recommends
if for those with a BMI over 30 and poorly controlled diabetes.
However, just six per cent of the surgery
is funded in public hospitals and it costs up to
AUS$15,000 in a private hospital.
The coalition has also stated that it may cut
the budgets of the Australian National Preventive
Health Agency to help fund its election commitments.
“We want to look at ways in which we can
streamline some of that which may well result in
some of the agencies folding into those with a
similar task, there will be no changes to the programmes they are offering,” said Dutton.
Dr Paul Burton, a senior research fellow at the
Monash University Centre for Obesity Research
and Education, said that Australia needs more
public funding because bariatric surgery works
better than other weight loss techniques.
“At present, people may miss out due to the
costs of the surgery,” he said. “It saves money
by remitting disease, reducing hospital admissions and improving people’s capacity for employment.”
He added that the initial public expense
would be counter-balanced with the reduction in
on-going health costs.
“But it’s only beneficial if done well, in combination with high quality patient follow up. If either
of these are deficient, outcomes are not optimal.”
However, Dr Debra Hector, a senior research
fellow in prevention research collaboration at
Sydney University, said she would prefer to see
money invested in a more holistic approach.
“Government should be funding surgery as
we have a lot of very obese people who need the
surgery, however focusing only on that one solution is ridiculous,” she said. “Surgery is a treatment –– it’s not preventing people getting to that
place in the first place.”
Hector said the government needs to make
healthy living more accessible if we want to deal
with the cause of obesity, not just the symptoms.
“We need to make it easier for people to be
more healthy and live more actively,” she said.
“Things like more open spaces, more green
spaces and more active travel to enable people to walk and bike to work. We need to make
fruit and vegetables more affordable and available, and put a tax on soft drinks and confectionary. Soft drink is just not needed, especially
when you get two litre bottles for AUS$1, milk is
even more expensive.”
10.8 million Australians are
overweight or obese
The propsed increase in funding comes as new
data showed that more than six out of ten Australian adults are too fat to be healthy, according
to data that shows 10.8 million are overweight
or obese. The new report. National Health Performance Authority 2013, Healthy Communities:
Overweight and obesity rates across Australia,
2011–12 (In Focus), also shows that obesity in
the country has increased from 11% in 1989 to
28 per cent in 2011-12.
It is thought that this is the first report to show
that the percentage of adults who were obese
varied threefold across local areas, from 14%
in Sydney North Shore and Beaches to 41% in
Loddon-Mallee-Murray. The percentage of adults
who were overweight or obese increased with
geographic remoteness and lower socioeconomic status.
However, 54% of adults in the wealthiest urban areas were overweight or obese, and almost
two in ten (19%) were obese.
The area of greatest concern is western New South Wales, where 79% of people are overweight or obese. The second is
Queensland’s Townsville-Mackay, followed by
country South Australia, Victoria’s Gippsland
and Western Australia’s Goldfields-Midwest,
with approximately three quarters of the population overweight.
Eastern Sydney is the slimmest area, with
49% of people overweight or obese, while Sydney’s north shore and northern beaches and inner north-west Melbourne follow at 50%.
“Using our local-level analysis, clinicians and
health managers can now better target and drive
health system improvements specific to their local community’s needs,” said Performance Authority CEO Dr Diane Watson. “Rates of adult
obesity have been rising very rapidly over time,
while smoking rates have been falling nationally.
The health and economic impact of obesity and
smoking can be extremely serious.”
Drink tax could reduce UK adult obesity by 180,000
Tax could cut drinks purchases by
15% and lead to a reduced energy
intake of 28 calories per person per
week
A
20% tax on sugar-sweetened drinks
would reduce the number of UK adults
who are obese by 180,000 (1.3%)
and who are overweight by 285,000
(0.9%), according to a study (Briggs et al.
Overall and income specific effect on prevalence of overweight and obesity of 20% sugar-sweetened drink tax in UK: econometric
and comparative risk assessment modelling),
published in BMJ.
A typical sugary drink contains six to 15 teaspoons of sugar, a teaspoon is equivalent to 4g
of sugar or 16 calories. The researchers estimated that such a tax could cut drinks purchases by
15% and lead to a reduced energy intake of 28
calories per person per week.
“Sugar-sweetened drinks are known to be
bad for health and our research indicates that a
20% tax could result in a meaningful reduction in
the number of obese adults in the UK,” said Dr
Adam Briggs, lead study author from the Nuffield
Department of Population Health at Oxford University. “Such a tax is not going to solve obesity
by itself, but we have shown it could be an effective public health measure and should be considered alongside other measures to tackle obesity in the UK.”
Researchers at the universities of Oxford and
Reading set out to estimate the effect of a 20%
tax on sugar-sweetened drinks on obesity in the
UK, and to understand the health effect on different income groups.
Using a series of statistical models based on
available data the researchers estimated that a
20% tax (which would raise the cost of a 70p
can to 84p) would decrease sugary drink consumption by about 15%. This, they estimate,
would lead to a 180,000 (1.3%) reduction in
the number of obese adults in the UK, and a
285,000 (0.9%) reduction in the number of overweight and obese adults.
The health gains would be similar across all
income groups, but would decline with age. Although the study’s authors claim that this is a relatively modest effect, people aged 16-29 years
as the major consumers of sugar sweetened
drinks, would be impacted the most.
“There’s ample evidence to suggest that taxing soft drinks won’t curb obesity, not least because its causes are far more complex than this
simplistic approach implies,” said Gavin Partington, director general of the British Soft Drinks Association. “Indeed, the latest official guidance
from the National Institute for Health and Care
Excellence points to the need to look at overall
diet and lifestyle. Trying to blame one set of products is misguided, particularly when they comprise a mere 2% of calories in the average diet.”
The tax would be expected to raise £276m
(€326m; $442m) annually (around 8p per person per week) and would reduce consumption of
sugar sweetened drinks by around 15%.
This revenue, say the authors, “could be used
to increase NHS funding during a period of budget restrictions or to subsidise foods with health
benefits, such as fruit and vegetables.”
They conclude that taxation of sugar sweetened drinks “is a promising population measure
to target population obesity, particularly among
younger adults.” But they stress that it “should
not be seen as a panacea” and say further work
is needed to clarify the level (and patterns) of
sugar sweetened drink consumption in the UK.
“Most nutritionists agree it would be better to
drink water than sugar-sweetened beverages,”
said Tom Sanders, professor of nutrition and dietetics at King’s College London, UK. “However, many consumers like sweet drinks and if they
could not afford to buy sugary fizzy drinks they
can always revert to drinking tea with added sugar as in the past. The cost of sugar-sweetened
beverages is currently so low that any price increase would be so marginal that it would be unlikely to affect intake.”
It is believed that obesity-related complaints
cost the NHS £5 billion a year.
American Heart Association
The American Heart Association has issued the
following statemnet, supporting the outcomes of
the study:
“The American Heart Association supports
a multi-pronged approach to address obesity across our nation. We must make it easier for
Americans to choose affordable nutritious foods
and beverages by making them more accessible. This includes creating and implementing new
policies that provide healthier options as well as
efforts to educate all Americans on nutrition.
The American Heart Association advocates
that communities should increase the availability
of healthy drinks and decrease the availability of
unhealthy drinks. The economic model used for
this study from the British Medical Journal, and
the existing evidence, provides policymakers a
compelling case to enact targeted sugar-sweetened beverage taxes of at least one penny per
ounce. This will help further evaluate the impact of
price on the consumption of sugary drinks. Many
published economic models have demonstrated
the potential benefit of a penny-per-ounce tax on
sugary drinks. Once states and cities enact such
policies, we need thorough evaluation to see the
real world impact on consumer purchasing, consumption of sugary drinks, industry response and
health outcomes. Mexico’s effort provides an excellent starting point, but we need U.S. states and
communities to enact the tax as well. We agree
with the new study’s conclusion that calls for more
substantial beverage taxes so that real world evidence can demonstrate their effectiveness at
curbing sugary drink consumption and improving
the health of Americans of all ages.
It is well-established that sugar-sweetened
beverages are the number one source of added
sugars in the American diet. A 12-ounce can of
regular soda contains about 130 calories and 8
teaspoons of sugar. Consumption of sugary drinks
has increased 500 percent in the past 50 years and
now is the single largest category of caloric intake
in children, surpassing milk a decade ago. Children
take in 10 to 15 percent of their total daily calories from sugary drinks. We recommend low- and
no calorie beverages such as water, unsweetened
tea, diet soft drinks, and fat-free or low-fat milk as
better choices than full-calorie soft drinks. In addition, Americans should try to limit the amount of
added sugars in all the foods they eat.
We further advocate that state and local governments that generate revenue from beverage
tax initiatives direct these funds toward public
health and obesity education and prevention efforts with strong evaluation components.”
36 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013
Country news
Mexico: Taxes are a war on obesity
The proposed tax could help prevent
515,000 new cases of diabetes
by 2030 and lead to $14 billion in
savings for the health system
Obesity cost the Mexican health system
42 billion pesos (US$3.2 billion) in 2008
M
exico’s lawmakers have declared
a war on obesity after they passed
a law imposing significant new taxes on junk food and sugary drinks.
The taxes will increase the price of junk foods
(those high in saturated fat, sugar and salt) by
8%. It will also put one peso on a litre of sugary
drinks, which the average Mexican consumed
at a rate of 43 gallons per person per year.
The money raised is intended to go towards
health programmes and increased access to
drinking water in schools. Among other measures, the government will introduce a nutritional stamp of approval for healthier foods on sale in
supermarkets.
“Never before has any civilization faced an
epidemic that didn’t involve an infectious disease,” said Enrique Ruelas, president of Mexico’s
National Institute of Medicine. “Today, this situation is not only unprecedented, but a threat to the
nation’s future.”
According to the UN Food and Agricultural Organisation report 32.8% of Mexican adults
are obese. The healthcare burden of diabetes
and heart disease in Mexico is already impacting lives. Some 9.2% of children in Mexico now
have diabetes.
Diabetes cost the lives of about 81,000 Mexicans in 2011, almost three times the number of
homicides in a nation wracked by violence as
drug cartels battle one another and the government for territory.
Obesity cost the Mexican health system 42
billion pesos (US$3.2 billion) in 2008, an amount
equivalent to 13 percent of spending on health,
according to the National Academy of Medicine.
Should current trends hold, that cost would rise
to 101 billion pesos in 2017.
The proposed tax could help prevent 515,000
new cases of diabetes by 2030 and lead to $14
billion in savings for the health system.
Mexico has fronted the food and drink industry, and resisted lobbying and warnings that raising prices would do nothing to help the country’s economy.
The government believes that any potential
economic harm from reduced junk food and soft
drink sales, will be insignificant compared with the
damage (both social and economic) in years to
come if the country’s obesity rates continue to rise.
The vote by congress is a triumph for the anti-obesity crusade of President Enrique Peña Nieto, who will now sign the measures into law.
As the legislation was passed, he called for a
“change of culture” in his country, including the
incorporation of at least an hour of exercise for all
Mexicans every day.
The plan will also award products that meet
standards for having lower calories or higher fibre
content a ‘seal of nutritional quality’, which he said
would give industry an incentive to re-formulate
products. He also announced plans for educational, health-monitoring and sports programmes.
“We can’t keep our arms crossed in front of a
real overweight and obesity epidemic,” the President said. “The lives of millions of Mexicans are
literally at risk.”
Wales: Two thirds of middle-aged men are overweight
Four in 10 men who were
overweight said they were making
an effort to lose weight
N
early two thirds of people in Wales
in their early 40s are overweight or
obese, according to research. A University of London study found 37% of
adults were overweight by the age of 42, and
men are more likely than women to have a
weight problem but are less likely to realise it.
A further one in four men (26%) and women
(27%) were obese.
Researchers studied the BMI of almost
10,000 men and women in Wales, Scotland and
England. They found that men in Wales were significantly more likely to be overweight than women in middle age, the research finds. Nearly half
of men (46%) were overweight at 42, compared
to almost a third of women (30%).
In Scotland, the proportion of men and women who were overweight at age 42 was identical
to Wales, while obesity rates were slightly lower.
The proportion of middle-aged adults in England who were overweight was also similar but
the obesity level was again lower, 23% for men
and 19% for women.
The study authors said that British men were
significantly less likely than women to realise they
are carrying excess weight. The research was
carried out by Dr Alice Sullivan and Matt Brown
of the university’s institute of education centre for
longitudinal studies.
“People who are overweight or obese face
a higher risk of many health problems, including cardiovascular disease, diabetes and cer-
tain cancers,” said Sullivan. “But carrying excess weight is far more socially acceptable for
men than for women and men will not respond
to health messages about weight and obesity if
they do not recognise that they are overweight.
This is a particular concern given that cardiovascular disease is the leading cause of death for
men aged 35 and over.”
The researchers also found that men and
women born in 1970 were considerably more
likely to be obese at 42 than those born in 1958
at the same age.
“People born in 1970 grew up at a time when
lifestyles were becoming increasingly inactive
and high-calorie convenience foods were widely available for the first time,” she added. “We
know that both exercise and diet are important
for maintaining a healthy weight. But our findings show that ready meals, frozen foods, and
takeaways are popular with this generation, while
nearly a third (32%) of women and a quarter
(24%) of men do no vigorous exercise in a typical week.”
The researchers also report that only four in
10 men (41%) who were overweight said they
were making an effort to lose weight, compared
to two thirds (66%) of women. Obese women
were also more likely to be trying to lose weight
(77%) compared to 62% of obese men.
Dr Sullivan presented the findings at a seminar, as part of the Economic and Social Research
Council’s Festival of Social Science.
She will underline the importance of making men more aware of their BMI status and the
health risks associated with excess weight.
Nearly half (47%) of men and women born in
1970 said they ate convenience foods, such as
frozen fishfingers, burgers, oven chips or readymade pizzas, at least once or twice a week, and
28% ate ready meals once a week or more.
Nearly a third (32%) of those who were obese ate
takeaways at least once a week, compared to
21% of those who were normal weight.
Obesity specialist, Dr Nadim Haboubi, chair
of the National Obesity Forum for Wales said
poor diets and sedentary lifestyles meant the nation was banking up problems for the future. He
said there has been a lack of interest in the disease and the health profession, up until now, has
been ineffective in dealing with it.
“We have this epidemic, which is rising all
over the world, but primarily in the UK – the prevalence of obesity has been halted in the US,
but not here and what this report shows is that
Wales is worse off than England and Scotland,”
said Haboubi, who runs the country’s only NHSfunded obesity clinic at Ysbyty Aneurin Bevan in
Ebbw Vale. “Various reports, some of which were
commissioned by the Government and National Audit Office have estimated that by 2025 60%
of the population may be overweight or obese.
“And if the current rise of 3% per year is allowed to continue then it is quite possible that by
2050 85% of the population could be overweight
or obese. These are devastating figures and this
is a crisis waiting to happen. I don’t think Wales
is taking obesity seriously enough. This trend has
being going on for so long and is known to those
in public health and to politicians and very little
has been done.
Haboubi said while the problem was now presenting itself among today’s 40-somethings, the
problem was equally worrying among children.
“The Welsh Government’s Pathway for Obe-
Product, Industry and Trial news
Apollo Endosurgery buys
Allergan’s obesity unit
Continued from page 1
2012. Some sources on Wall Street suggested that
the unit would be snapped up by a private equity
firm, others claimed a more well established medical device firm, whilst it has also been suggested a
pharmaceutical company (with obesity drugs in the
pipeline) may take the plunge.
Apollo certainly faces a tough challenge turning
round the units fortunes, which has seen its share of
the bariatric surgery market dropped from a high of
around 40% to as little as 30%, according to some
estimates. Industry analysts expect that the unit’s
share of the market will continue to fail given the
rise in the number of sleeve gastrectomy procedures.
Nevertheless, it is certainly an interesting acquisition by Apollo Endosurgery and one which the
whole bariatric community will watch very closely
over the coming years.
Allergan acquired the Lap-Band business in 2006
as part of a US$3.1bn merger with medical aesthetics company Inamed, along with a line of breast
implants.
sity, which was a great report, has done very little to change things since it was launched. There
are no services available to tackle obesity and
prevent those who are overweight from becoming obese and there are no services to ensure
those who are obese do not get the associated
co-morbidity conditions like diabetes, high blood
pressure and stroke.”
“The figures are the same among children,
25% are either overweight or obese in Wales.
A 10-year-old Welsh child is about 10kg heavier than a child of the same age 30 years ago.
There is no doubt that inactivity and poor diets
are to blame.”
Professor Rhys Williams, a retired professor
of clinical epidemiology at Swansea University
said obesity is an “horrendous societal problem”
that we need to take it even more seriously than
we are now.
“We are taking the prevention of obesity seriously in Wales – probably as seriously as anywhere else in the UK. We are very aware of the
problems but in the UK, as in many other places, its a case of trying to reverse trends in society
that are so engrained that they need a super-human effort to shift.”
A Welsh Government spokesman said: “We
are aware that over half of adults in Wales are
overweight or obese – this is something we are
addressing. Obesity is a complex issue and our
multi-layered approach to tackling it reflects
that. We are not simply focused on telling people to lose weight. We have to enable people to
make healthy choices, by improving access to a
healthy balanced diet, to increase opportunities
for physical activity, and to ingrain these habits
from childhood.”
bariatricnews.net 37
ISSUE 18 | DECEMBER 2013
Product, Industry and Trial news
SafeStitch Medical and
TransEnterix complete merger
Ethicon’s Harmonic ACE+ 7
shears gain FDA approval
E
30 million financing raised
from existing Transenterix and
Safestitch Medical stockholders
Combined company to be renamed
Transenterix
S
afeStitch Medical and TransEnterix have closed SafeStitch’s previously
announced acquisition of TransEnterix. The combined company is expected to be
renamed TransEnterix, subject to stockholder
approval, and headquartered in the Research
Triangle, NC. The company will continue to
trade under the name SafeStitch Medical on
the OTCBB under the symbol SFES, until
the anticipated name change is approved by
stockholders, which is expected to occur in
the fourth quarter of 2013.
Under the terms of the merger agreement
with TransEnterix, SafeStitch Medical issued approximately 105.5 million shares of
its common stock to stockholders of TransEnterix, has reserved approximately 17.0
million shares for exercise of TransEnterix
options and warrants, and paid an aggregate
of approximately US$350,000 in cash to
TransEnterix’s former stockholders whose
TransEnterix shares did not convert to SafeStitch shares.
Concurrent with the closing of the merger,
SafeStitch raised $30.2 million, before offering expenses, in a private placement of
its equity securities. Existing TransEnterix
investors contributed $19.7 million and Dr
Phillip Frost and Dr Jane Hsiao, either personally or through affiliated entities, along
with other existing SafeStitch investors,
contributed an additional US$10.5 million in
the financing.
Todd M Pope, the Chief Executive Officer
of TransEnterix, will serve as the Chief Executive Officer and a Director of the combined
company. Paul LaViolette, a Partner at SV
Life Sciences and Chairman of TransEnterix,
will serve as the Chairman of the combined
company’s Board of Directors. Dr Jane Hsiao,
the former Chairperson of SafeStitch Medical
will continue to serve as a Director of the combined company, and Dr Phillip Frost, Chief
Executive Officer and Chairman of OPKO
Health and Chairman of Teva Pharmaceutical
Industries has joined as a Director.
“We believe the business combination
with SafeStitch will enhance our ability to
bring flexible minimally invasive surgical
technologies to market,” said Mr Pope. “This
accompanying fundraising provides the
company with the resources to advance the
development of SurgiBot, a novel patient side
minimally invasive surgical robotic system.”
The remaining Directors are Dr Aftab R.
Kherani, Principal of Aisling Capital; David
B Milne, Managing Partner at SV Life Sciences; Dennis J Dougherty, Managing General Partner of Intersouth Partners; Richard
C Pfenniger, former Chief Executive Officer
of Continucare Corporation and a member
of the SafeStitch Board pre-merger; and
William N Starling, Managing Director of
Synergy Life Science Partners, LP.
SafeStitch Medical is a development
stage medical device company focused on
the development of medical devices that
manipulate tissues for the treatment of obesity, gastroesophageal reflux disease, hernia
formation, and other conditions through
endoscopic and minimally invasive surgery.
TransEnterix is a development stage
medical device company that is pioneering
the use of flexible instruments and robotics
to improve how minimally invasive surgery
is performed. TransEnterix is focused on
the development and commercialisation of
SurgiBot, a novel patient side minimally
invasive surgical robotic system.
thicon
Endo-Surgery
has announced that its
Harmonic ACE+ 7 shears
with advanced hemostasis has
received 510(k) clearance from
the FDA. The company claims that
the Harmonic ACE+ 7 shears with
advanced hemostasis is the first ultrasonic surgical device indicated
to seal vessels up to and including
7mm, while also delivering on the
Harmonic promise of precision
and multi-functionality.
The Harmonic ACE+ 7
represents the latest evolution
in the Harmonic legacy of innovation. The device leverages
the proprietary Adaptive Tissue
Technology, which enables the
system to actively sense and adapt
to changing tissue conditions and
intelligently deliver energy resulting in improved performance with
superior precision.
“I use Harmonic because it
offers me the ability to perform
precise dissection that you simply
don’t get with an advanced bipolar
energy device. However, the
advanced bipolar energy devices
have always been able to seal larger
vessels,” said Dr Bartley Pickron, Colon and Rectal Surgeon,
Colorectal Surgical Associates,
Houston, Texas. “The addition of
the 7mm vessel sealing capability
to the Harmonic ACE+ 7 makes
it an optimal tool for laparoscopic
colon surgery. Previously, I would
have to use a Harmonic ACE for
tissue dissection and then another
device, such as stapler, clips, or
endoloops, for control of the larger
vascular pedicle. The development of the Harmonic ACE+ 7
has the potential for improved
operative efficiency by eliminating
instrument exchanges during a
procedure. Furthermore, the avoidance of using multiple instruments
should result in a cost savings for
the overall procedure.”
Harmonic ACE+ 7 shears with
advanced hemostasis designed
for use in numerous procedures
and specialties including general,
colorectal, bariatric, gynaecology,
thoracic and urology, enhancing
surgeons’ ability to handle multiple jobs with superior precision.
The company believes the new
Harmonic ACE+7 is best suited
for cases which require dissection,
mobilization and large vessel sealing.
“We continue to set the standard
for performance in both ultrasonic
and advanced bipolar energy,”
says Tom O’Brien, Ethicon Vice
President, Energy Global Strategic
Marketing. “The recent introduction of our Enseal G2 Articulating
(advanced bipolar) tissue sealer
and now the 510(k) clearance of
the new Harmonic ACE+7 both
demonstrate our commitment to
developing meaningful innovations that can help improve outcomes in critical procedures, while
giving surgeons the best choices
to meet the needs of their unique
patients and procedures.”
Enseal G2
The company has launched its Enseal G2 Articulating Tissue Sealer
in the US. The company claims
that the device is the first and
only, articulating advanced energy
device designed to allow surgeons
to take a perpendicular approach to
cut and seal vessels up to 7mm in
diameter and lymphatics through a
5mm port.
The Enseal G2 Articulating is
unique because it can bend, making
it easier for surgeons to access difficult to reach parts of the anatomy
and provides better access to tissue
in deep or tight spaces for greater
control of the angle of approach to
vessels, according to the company1.
It allows surgeons to take a
perpendicular approach to vessel
sealing, which contributes to stronger seals when compared to Enseal
non-articulating devices. It also
increases their ability to take the
full vessel in a single bite, reducing
the likelihood of internal bleeding
and post-surgery complications for
patients.
The “Perpendicular Blood Vessel Sealing in Surgical Practice”
White Paper, a cross-specialty
collaboration between Drs Andrew
I Brill and Michael J Stamos,
concludes that in certain procedures, “technical accuracy and the
security of vessel sealing are best
accomplished using a perpendicular approach for the clarification of
key anatomy and the optimal use of
advanced bipolar electrosurgery.”2
Vessels sealed with a perpendicular approach using Enseal G2
Articulating are more than 28%
stronger than vessels sealed at a 45
degree angle.3
“The Enseal G2 Articulating
allowed me to perform the entire
para-aortic dissection from the
same port,” said Dr Steven A Elg,
GYN-Oncologist, Iowa Methodist.
“Prior to Enseal articulation this
was not possible.”
Enseal G2 Articulating builds
on the company’s existing portfolio of advanced bipolar tissue. The
Enseal advanced bipolar devices
incorporate an I-Blade that delivers
high uniform compression along
the entire length of the jaw. The
Enseal G2 Tissue Sealer portfolio
also includes the Enseal G2 Super
Jaw device, launched in 2011, and
the Enseal G2 Curved and Straight
Tissue Sealers, launched in 2012.
References
1.Compared to a non-articulating device. Based on
a benchtop burst pressure study. PRC051608
2.“Perpendicular Blood Vessel Sealing in Surgical
Practice” – Dr Andrew I Brill, MD and Dr Michael
J Stamos, MD. Case ummary, pg 6.
3.Enseal devices tested in a benchtop study on
5-7mm porcine carotid arteries. With NSLG2C35A
sealed at a 90° angle compared to vessels sealed
at a 45° angle (p=0.001).
ovidien has launched two advanced
energy devices, the LigaSure Impact
curved large jaw open sealer/divider
LF4318 and LigaSure blunt tip laparoscopic
sealer/divider LF1637. According to the
company, the two products offer improvements in handling, control and performance,
as compared to their predecessor devices.
LigaSure products used with the ForceTriad energy platform utilise TissueFect
sensing technology, a proprietary Covidien
control system designed to precisely manage
energy delivery, creating a range of options
for desired tissue effect.
The company claims that the LigaSure Impact device, featuring a curved, large jaw open
sealer/divider, offers improved visibility in the
surgical field, more intuitive jaw positioning
and enhanced ergonomics for a better surgical
experience. In addition, it is also claimed that
the LigaSure blunt tip laparoscopic sealer/
divider has contoured tips for improved dissection, better handling and a more compact,
E
pressures
burst pressures were 28% higher for vessels
Company hopes for
FDA approval in first
half of 2014
C
burst
(p=0.0007). With NSLG2S35A devices, mean
Covidien introduces LigaSure
product enhancements
decision in the first half of 2014.”
EnteroMedics’
proprietary
technology, VBLOC vagal blocking therapy, delivered by a
pacemaker-like device called the
Maestro Rechargeable System,
is designed to intermittently
block the vagus nerves
using
high-frequency,
low-energy,
electrical
impulses.
VBLOC
allows
people
with
obesity to take a positive
path towards weight loss,
addressing the lifelong
challenge of obesity and
its comorbidities without sacrificing wellbeing or comfort.
EnteroMedics’ Maestro Rechargeable System has received
CE Mark and is listed on the Australian Register of Therapeutic
Goods.
median
angle compared to vessels sealed at a 45° angle
EnteroMedics nears Maestro
Rechargeable System approval
the coming weeks.
“We are very encouraged by
the responsiveness of the FDA
and are confident in our ability to
address their questions in a timely
nteroMedics has re- manner,” said Dr Mark B Knudceived a formal response, son, EnteroMedics’ President and
a standard component of the PMA process,
from the FDA with regard
to its Premarket Approval
Application (PMA) for
approval of the Maestro
Rechargeable System as
a treatment for obesity.
The response contains
follow-up questions related to the Chief Executive Officer. “We will
application pertaining primarily continue to work closely with
to device testing and clinical data, the FDA throughout this process.
including training programs for We believe that the Company
users and a post approval study. continues on track for a panel in
The company anticipates respond- late fourth quarter of of the first
ing to the FDA’s questions within quarter of 2014 with approval
devices,
were 51% higher for vessels sealed at a 90°
ergonomic handle for greater comfort and
control for various hand sizes.
“Around the world, Covidien’s LigaSure
devices are a trusted and valued product portfolio in the operating room. LigaSure vessel
sealing instruments already are used in millions of surgical procedures and we continue
to innovate to enhance our products,” said
Chris Barry, President of Advanced Surgical
Technologies, Covidien. “Since introduction
in 1998, our LigaSure devices, combined with
TissueFect sensing technology, have set the
standard in vessel sealing.”
Both the LigaSure Impact and blunt tip devices
received FDA 510(k) clearance earlier in 2013.
LigaSure tissue fusion in the ForceTriad
energy platform, has faster fusion cycles, more
flexible fusion zones and less desiccation than
the original LigaSure generator. TissueFect
sensing technology monitors changes in tissue 3,333 times a second and adjusts energy
output accordingly to deliver the appropriate
amount of energy for the desired tissue effect.
38 BARIATRIC NEWS ISSUE 18 | DECEMBER 2013
Calendar of events 2013/14
December 12–14
First Gulf Obesity Surgery Society
Meeting
Kuwait City, Kuwait
www.gulfobesity.com/
March 12–16
April 30–May 3
2014 Spring Obesity Conference
January 13
Philadelphia, United States
www.asbp.org/physiciansclinicians/resources/
events.html?start=5
6th Congress of the International
Federation for the Surgery of Obesity and
Metabolic Disorders, European Chapter
Obesity Update 2014
London, United Kingdom
www.asbp.org/cmecertification/livecme/
internationalobesityupdate.html
December 13
5th Emergencies in
Bariatric Surgery Course
January 22–24
London, United Kingdom
[email protected]
5th British Obesity and Metabolic
Surgical Society (BOMSS) Annual
Meeting
December 14
4th Annual Meeting of the European
Society for Perioperative Care of the
Obese Patient
Bruges, Belgium
www.espcop.org
2014
Kenilworth, United Kingdom
www.bomss.org.uk/2014conference/
March 9–11
Brussels, Belgium
www.ifsobrussels.com/
March 17–20
June 25–28
12th International Congress on Obesity
Kuala Lumpur, Malaysia
www.iaso.org/events/ico/ico-2014/
14th World Congress
of Endoscopic Surgery
Paris, France
www.eaes.eu/eaes-meetings/
14th-world-congress-paris.aspx
March 24-27
Society for Endocrinology
Liverpool, UK
www.endocrinology.org/meetings/sfebes/
index.aspxcom/
August 26–30
IXX IFSO World Congress
Montreal, Canada
www.ifso2014.org
12th International Expert Meeting for the
Surgery Obesity and Metabolic Disorders
Salzburg, Austria
www.obesity-online.com/expertmeeting/
To list your meeting details here, please email:
[email protected]
BNEWS
ARIATRIC
The next issue of Bariatric News is out in March
Editorial deadline: 10 February 2014
Advertising deadline: 10 February 2014
If you are interested in submitting an article for the newspaper, please contact:
[email protected]
If you are interested in advertising in Bariatric News, please contact:
[email protected]
If you would like to submit a press release, please email:
THE NEWSPAP
ER DEDICATE
IN THIS ISS
UE…
Bariatric
surgery in
Kuwait
In an exclusive
interview with
Dr
Salman Al Sabah
we report on the
current status
of
bariatric surger
y in Kuwait
Coffee Time
Professor Mervy
n
Deitel talks to
Bariatric News
about his career
and the evoluti
on
of bariatric
surgery
8
Mini-Gastric
Bypass
Conference
An special
report from the
2nd Internation
Consensus
Conference
13
Variety of facto
rs
The impact of
bariatric surger
y
on risk factors
for
cardiovascular
disease depen
ds
on a variety
of factors,
including the
type of surgery,
sex, ethnic
background, and
pre-surgery BMI
D TO THE TREA
TMENT OF OBES
ITY FOR THE HEAL
THCARE PROF
ESSIONAL
ISSUE 18 | Clinical comm
ent
Canada: Acce
to surgery ss
Nicolas Chris
tou discusses
access to baria
surgery in Canatric
the publically da under
-funded
healthcare syste
m
DECEMBER
2013
More time
n
the costs eeded to recupera
of bariatric
te
surgery
Page 17
Based on proje
ction
would take more s, it
than ten
years to reco
ver the costs
of the LRYGB
procedure.
between Januar
y 2003 and
September
31 2009. LAGB
and LRYGB
claimants
were propen
HE time taken
sity score match
to recuperate
ed to two
the
control sampl
costs from bariatr
es: one restric
ic surgery are
ted to those
with a MO
more likely
diagnosis code
to be double
5.25 years
the
and one
without this
previously estima
restriction. The
laparoscopic
ted for
sample of
random
adjustable gastric
120,00
0
individuals
(LAGB), accord
band
provided directl
was
ing
y from
sessed ‘The Busin to a study that asPropensity score Medstat.
ess Case for
matching was
Bariatric
Surgery Revisi
to ensure that
used
ted: A Non-R
the
andomized
Case-Control
similar as possib four groups were as
Study busine
le. LRYGB
ss case for
bariatric surger
were
patien
matched to LAGB
ts
y’, published
online in
the journal
patients based
on patient and
PlosOne (Octob
health
er 2013).
plan characterThe authors
istics, and on
conclude that
diagnoses and
the time to
recuperate the
the year prior
costs in
costs
to the quarte
Roux-en-Y gastric from laparoscopic
r before the
bariatric proced
bypass (LRYG
ure.
greater given
B) would
Using the four
the procedure
matched sampl
results in increa be even recuperate the
stay and proced
an
analysis datase
costs using an
sed hospital
es,
ure time.
t was create
does not rely
alternative sampl
The study author
included
d that
on the MO diagno
e that inpatie
s state that previo
sis code.
nt (both facilit quarterly payments of total,
“Regardless
have examined
us studies that
of the time
y and physic
the
(including payme
to breakeven,
pointing out
ian), non-inpatien
on a comparison cost of bariatric surgery
it is worth
nts for hospit
that the expec
have relied
t
sample of those
al outpatient,
office visits,
tation for any
intervention
(MO) diagno
with a morbi
physician’s
and emergency
to show a return
surgical tion
sis code, despit
d obesity and
department),
on investment
drug claims.
e the fact that
group might
few effective
and prescripis unusual
this high cost
not be a true
relative to (pseud Each quarter represented
the authors state. interventions reach this
reflection of
eventually have
the
o) band placem
threshold,”
time
patients who
“LAGB, howev
LAGB or LRYG
ent.
exceptions.”
er, may be one
result, this study
B procedures.
of the Resu
re-estimated
As a
lts
The analysis
the net costs
is
and time to
A total of 9,631
ketScan Comm based on claims data from
patients (after
the Mar- ing
ercial Claims
matching), were
and Encounters
in each surgic
includal group. The
database
groups of patien
ts are
6
T
Apollo Endo
surgery buys
Allergan’s ob
esity unit
A
Continued on
Medicare Co
E policy could
limit
minority access
to surgery
Evidence
Continued on
POLLO
Endosurgery
has talent to
completed the
our
acquisition of
the be a cataly team, this acquisition will
obesity interv
ention divisio
st for growth
Allergan, which
as we continue
n of advan
manufactures
ce technologies
to
weight loss
and sells iatric
in the fields of
solutio
and minimally
barLap-Band adjust ns comprised of the
invasive surger
Apollo, who
y.”
able gastric
announced the
system and the
banding tion
acquisiOrbera intra-g
in October
astric balloon system.
2013, will
25
the unit for up
purchase
to US$110 millio
“With world
total includes
n. This
wide obesity
Country news
an
upfron
reaching epidem
numbers US$75
t cash payme
ic
nt of
million, a minor
36
of the Lap-Band levels, the acquisition in
ity equity interes
Apollo by Allerg
and
t
gies places Apollo the Orbera technolo- and
Industry and produ
an of US$15
millio
up
Endosurgery
ct news 39
ership positio
in a lead- contin to US$20 million in additio n,
n to provide
gent consideration
nal
surgeons and
patients with
to be paid upon
achievement
innovative and
Calendar of even
of certain regula
less invasive
solutions in the
ts
sales milestones.
tory and
fight against obesit
42
Dennis McWi
y,” said
lliams
The
of Apollo Endos , President and CEO lation, deal comes after a year
of specuurgery. “By
since the Allerg
expanding
both our produ
an announced
were planning
ct portfolio
they
to sell the unit
and adding
in October
page 38
page 3
supporting or
discontinuing
baria
is ‘inconclusive’ tric CoE
vs. non-Medicar
e patients before
after implem
and
entation of
a Medic
coverage policy
, reported a declin are
the number
e in
of minority
patients with
HE policy of
Medicare receiv
treating Medic
ing bariatr
are after the
bariatric surger
policy was implem ic surgery
y patients
at
high-volume
ented.
“The
Medicare center
hospitals designated as Cente
s of excellence policy
rs of Excellence
was associated
be blocking
could percen
with a 4.7
obese minor
tage point (17
ities’ access
to care, accord
percent) declin
in the proportion
ing to ‘Baria
e
of Medicare
tric
gery in Minor
patients
ity Patients Before Sur- receiving bariatr
ic surgery who
After Implementa
and non-w
were
hite,” said Dr
tion of a Cente
Excellence Progra
Lauren Hersc
rs of Nicho
las,
h
m’, published
in JAMA (JAMA
online an assista lead author of the letter
and
. 2013 310(1
nt
profes
sor
3):139
400.).
with the Depar
9- ment of
tHealth Policy
The study, which
and Management
at Johns Hopki
compared rates
bariatric surger
ns
of School
y for minority
of Public Health Bloomberg
Medicare
. “It appears
T
Continued on
page 3
[email protected]
EDITORIAL BOARD
Henry Buchwald
Simon Dexter
John Dixon
MAL Fobi
Ariel Ortiz Lagardere
BARIATRIC NEWS
Managing Editor
Owen Haskins
[email protected]
Industry Liaison Manager
Martin Twycross
[email protected]
Designer
Peter Williams
[email protected]
Publisher
Dendrite Clinical Systems
10 Floor, CI Tower
St George’s Square, High Street
New Malden, Surrey KT3 4TE – UK
Tel: +44 (0) 20 8494 8999
Managing Director
Peter Walton
[email protected]
Printed by CPL Associates
© 2013 Dendrite Clinical Systems Ltd. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, transmitted in any form
or by any other means, electronic, mechanical, photocopying, recording or otherwise without prior permission in writing of the Managing Editor. The views,
comments and opinions expressed within are not necessarily those of Dendrite Clinical Systems or the Editorial Board.
Our website…
Bariatricnews.net
Stay informed.
Get involved.
Be heard.
Register your interest and be kept
informed with regular updates: email
[email protected]
If you’ve got an idea for an article, suggestions
for topics to cover, or would like to take part in
a debate, we’d love to hear from you. Email
[email protected]
Send press releases to
[email protected]
For advertising options, email
[email protected]
Our newspaper…
Bariatric News
BNEWS
ARIATRIC
FREE subscription.
For your free subscription email your full
postal address to:
[email protected]
THE NEWSPAPER DEDICATED
IN THIS ISSUE…
Bariatric
surgery in
Kuwait
In an exclusive
interview with Dr
Salman Al Sabah
we report on the
current status of
bariatric surgery in Kuwait
6
Professor Mervyn
Deitel talks to
Bariatric News
about his career
and the evolution
of bariatric
surgery
8
Mini-Gastric
Bypass
Conference
Like us on Facebook:
facebook.com/bariatricnews
ITY FOR THE HEALTHCARE PRO
An special
report from the
2nd Internation
Consensus
Conference
13
Variety of factors
Based on projections, it
would take more than ten
years to recover the costs
of the LRYGB procedure.
25
Country news
36
A
Industry and product news 39
Clinical comment
Canada: Access
to surgery
Nicolas Christou discusses
access to bariatric
surgery in Canada under
the publically-funded
healthcare system
Page 17
between January 2003 and
September
31 2009. LAGB and LRYG
B claimants
were propensity score match
ed to two
control samples: one restric
ted to those
with a MO diagnosis code
and one
without this restriction.
The random
sample of 120,000 indivi
duals was
provided directly from Meds
tat.
Propensity score matching
was used
to ensure that the four group
s were as
similar as possible. LRYG
B patients
were matched to LAGB patien
ts based
on patient and health plan
characteristics, and on diagnoses
and costs in
the year prior to the quarte
r before the
bariatric procedure.
Using the four matched
samples,
an analysis dataset was
created that
included quarterly payments
of total,
inpatient (both facility and
physician), non-inpatient
(including payments for hospit
al outpatient, physician’s
office visits, and emergency
department), and prescription drug claims. Each quarte
r represented the time
relative to (pseudo) band placem
ent.
T
recuperate the costs using
an alternative sample that
does not rely on the MO diagn
osis code.
“Regardless of the time to
breakeven, it is worth
pointing out that the expec
tation for any surgical
intervention to show a return
on investment is unusual
and few effective intervention
s reach this threshold,”
the authors state. “LAGB,
however, may be one of the
Results
exceptions.”
A total of 9,631 patients (after
The analysis is based on claim
matching), were includs data from the Mar- ing
in each surgical group. The
ketScan Commercial Claim
groups of patients are
s and Encounters database
Apollo Endosurgery buys
Allergan’s obesity unit
The impact of
bariatric surgery
on risk factors for
cardiovascular
disease depends
on a variety
of factors,
including the
type of surgery,
sex, ethnic
background, and
pre-surgery BMI
FESSIONAL
2013
More time needed to
re
the costs of bariatric cuperate
surgery
HE time taken to recuperate
the
costs from bariatric surger
y are
more likely to be doubl
e the
5.25 years previously estima
ted for
laparoscopic adjustable gastri
c band
(LAGB), according to a study
that assessed ‘The Business Case
for Bariatric
Surgery Revisited: A Non-R
andomized
Case-Control Study busine
ss case for
bariatric surgery’, published
online in
the journal PlosOne (Octo
ber 2013).
The authors conclude that
the time to
recuperate the costs from
laparoscopic
Roux-en-Y gastric bypass
(LRYGB) would be even
greater given the procedure
results in increased hospital
stay and procedure time.
The study authors state that
previous studies that
have examined the cost of
bariatric surgery have relied
on a comparison sample of
those with a morbid obesit
y
(MO) diagnosis code, despit
e the fact that this high cost
group might not be a true
reflection of patients who
eventually have LAGB or
LRYGB procedures. As a
result, this study re-estimate
d the net costs and time to
Coffee Time
Follow us on Twitter:
@bariatricnews
TO THE TREATMENT OF OBES
ISSUE 18 | DECEMBER
POLLO
Endosurgery
has talent to our team,
this acquisition will
completed the acquisition
of the be a catalyst for growt
h as we continue to
obesity intervention divisi
on of advance technologies
Allergan, which manufactur
in the fields of bares and sells iatric and minim
ally invasive surgery.”
weight loss solutions comp
rised of the
Apollo, who announced the
Lap-Band adjustable gastri
acquisic banding tion in Octob
er 2013, will purchase
system and the Orbera intra-g
astric bal- the unit for up
to US$110 million. This
loon system.
total includes an upfront cash
“With worldwide obesity
payment of
numbers US$75 million,
a minority equity interest
reaching epidemic levels, the
acquisition in Apollo by
Allergan of US$15 million,
of the Lap-Band and the Orber
a technolo- and up to US$2
0 million in additional
gies places Apollo Endosurgery
in a lead- contingent consid
eration to be paid upon
ership position to provide
surgeons and achievement
of certain regu
patients
Continued on page 3
Medicare CoE policy could
limit
minority access to surgery
Evidence supporting or
discontinuing bariatric CoE
is ‘inconclusive’
vs. non-Medicare patients
before and
after implementation of
a Medicare
coverage policy, reported
a decline in
the number of minority patien
ts with
Medicare receiving bariat
ric surgery
HE policy of treating Medic
are after the policy was
implemented.
bariatric surgery patients
at
“The Medicare centers of
high-volume hospitals desigexcellence policy was associated
nated as Centers of Excel
with a 4.7
lence could percentage
point (17 percent) decline
be blocking obese minorities’
access in the proportion
of Medicare patients
to care, according to ‘Baria
tric Sur- receiving bariat
ric surgery who were
gery in Minority Patients
Before and non-w
T