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ISSUE 13 | AUGUST 2012
ARIATRIC
NEWS
pages 18–19
THE NEWSPAPER DEDICATED TO THE TREATMENT OF OBESITY FOR THE HEALTHCARE PROFESSIONAL
IN THIS ISSUE...
Bypass may increase energy
At the Digestive
Disorders Federation
meeting in Liverpool,
UK, Marco Bueter
revealed how
RYGB may increase
energy expenditure
potentially
culminating in prolonged weight loss 4
ASMBS
Bariatric News reports the key
highlights from the 29th Annual
Meeting
10
Coffee time
Pradeep Chowbey,
Congress President
for IFSO 2012 talks
to Bariatric News
about his influences,
the Dalai Lama
and challenges for
surgery in India
14
News from the US
A study of hospitals has shown that
surgical quality varies widely in the US
while Allergan has reported a drop in
20
LAGB procedures
The future of suture?
Undergraduates from Johns Hopkins
University have developed FastStitch,
a disposable suturing tool to help
Patient selection improves
banding outcomes
Selecting patients according to predictive factors including their
initial weight and their willingness to stick to diet and exercise
regimes can result in greater weight loss and fewer reoperations
following gastric band surgery, according to a study presented at
the ASMBS’ 29th annual meeting in San Diego, California.
The study, ‘Better weight loss
and less reoperation rate following
laparoscopic banding in selected obese
patients’, validated five factors that
the authors had identified in a 2007
study (“Predictive factors of outcome
after gastric banding: a nationwide
survey on the role of center activity and
patients' behaviour”, Ann. Surg.. 2007
246(6):1034-9.) as positively affecting
the outcomes of surgery.
The patients had a significantly decreased rate of reoperation and reduction
in morbidity compared to the historical
series identified in their previous study.
The study’s lead author was Professor
Jean-Marc Chevallier, of Hopital Européen Georges Pompidou, Paris.
Results
9% of patients (35) in the study suffered from complications, including
12 slippages, three food intolerances,
and 14 port problems. This compares
with a complication rate of 19.2% in
their historical series, and rates between
33.1% and 50.4% in historical studies
published by Mittermair et al (Obes
Surg. 2009 19(12):1636-41), Suter et al
(Obes Surg. 2006 16(7):829-35) and Van
Nieuwenhove et al (Obes Surg. 2011
21(5):582-7).
Chevallier noted, however, that these
studies were based on long-term historical series involving unselected patients
who were not followed up, and who
received older gastric bands which are
no longer used.
5.1% of patients required abdominal
reoperations, compared to 17.2% in the
historical series, and 3% had their bands
removed, compared to 10.7% in the
historical data.
Methodology
429 patients were recruited for the study
between 2005 and 2011, and were followed for an average of 29.24 months.
Selection was based on five predictive
factors:
n BMI under 50 at time of surgery
(mean BMI was 41.60).
Jean-Marc Chevallier
n Advanced laparoscopic team.
n Likely to change eating behaviours.
n Likely to practice physical activity.
n Age under 40 (average age was
39.7 years).
40 patients dropped out during the study,
and the results were based on the remaining cohort of 389 selected patients.
Safety and efficacy was based on a
historical series of 1227 LAGB patients
identified in their 2007 study.
Chevallier also found in his 2007 study
that a surgical team performing two operations per week or more is likely to have
successful outcomes, with higher excess
weight loss and fewer complications.
Surgery and the redevelopment of eating disorders
surgeons by making the closure
process simpler and safer 25
Product and Industry news 29
Calendar of events
31
According to a recent
presentation at the Digestive
Disorders Federation meeting in
Liverpool, UK, bariatric surgery
procedures could lead to the redevelopment of eating disorders.
In her presentation “Eating
Disorders and gastric bypass:
slipping back?” Dr Denise
Thomas, Head of Nutrition and
Dietetic Services, Portsmouth
Hospitals NHS Trust, UK,
said eating disorders such as
anorexia nervosa (AN) and
bulimia nervosa (BN) have a
psychodynamic formulation.
Bariatric surgery and eating
disorders
Thomas discussed the link
between bariatric surgery and
eating disorders, and explained
how surgery influences predisposing (low self-esteem),
precipitating (extreme dieting
practice) and perpetuating (the
biology of semi-starvation)
factors, which could cause their
redevelopment.
Previous
research
has
reported both bulimic episodes
and vomiting for weight issues
occuring after surgery (de
Zwann et al, Surg Obes Relat
Dis. 6(1):79-85). Binge eating
behaviour is also triggered by
extreme dieting. However, the
self-induced vomiting seen in
BN is not seen post-surgery
as vomiting is generally not a
purging behaviour and 60% of
cases describe vomiting in response to an intolerable food or
one that has plugged (the result
of overeating particularly bread,
pasta and dry meats).
“Bariatric surgery leads to
Continued on page 3
Denise Thomas
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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
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
BARIATRIC NEWS 3
ISSUE 13 | AUGUST 2012
Surgery and the
redevelopment of
eating disorders
Continued from 1
significant changes in eating patterns. The main procedures are all
primarily restrictive in nature and as such could be suggested to
produce a precipitant to eating disorder pathology,” she added.
According to the literature, one paper has reported that gastric
surgery and restraint from food were the triggering factors of eating disorders in morbidly obese patients (Guisado et al. Int J Eat
Disord. 2002 31(1):97-100), however, there have been no recent
case reports of AN.
Thomas asked the audience to consider those patients who exceed their target weight loss and appear to be in a downward spiral
into normal BMI and beyond. “How many of these are now afraid
to eat and complain of gut symptoms? We investigate for many
gastro intestinal issues, but are these patients displaying anorectic
behaviours?”
Conditions such as anorexia can be triggered by severe dieting
restriction, so in a group of patients undergoing an enforced change
from overeating to an extreme restricted diet, this dramatic change
in eating habits could be a risk factor in this group of patients (as
described in the psycho-dynamic formulation).
Chicken or the egg?
The question then arises of whether the eating disorders are present
before surgery or a new population emerges post-surgery. A population that is adhering to a reduction in portion sizes, is chewing
thoroughly, eating slowly and feels the need to induce vomiting to
relieve sensations/pains, these are all permitted behaviours that resemble eating disorder pathology. These conditions therefore “find
a home” more readily in some patient’s psyches following surgery.
BED
Binge eating disorder (BED) is the most common eating disorder
reported in patients prior to bariatric surgery, ranging from 10%–50%
(Ashton et al urg Obes Relat Dis. 7(3):315-20) and 27% (Lilenfield et
al Compr Psychiatry. 49(3):247-54) of patients present with a lifetime
history of the disorder.
The Diagnostic and Statistical Manual of Mental Disorders (DSM)
defines BED as the consumption of a larger than normal amount of
food, taken over a discrete period of time, accompanied by a subjective loss of control. This is followed by an association of guilt, shame,
eating rapidly and having physical discomfort when eating.
According to Thomas, it was this definition that caused many
surgical teams to deny patients exhibiting BED surgery, as it was felt
the overeating would be incompatible with the restrictive nature of
the surgery.
However, one study has shown dramatic decreases in binge eating
due to the restrictive nature of the procedure, with a reduction from
48% to 0% of the cohort (Latner et al Obes. Res. 2004 12(6):956-61).
For patients with BED, one major issue is the return to eating larger
volumes of food often within six months of surgery as this triggers
feelings of guilt and shame, and of letting the surgical team down.
“It is easy to see how post-surgery patients may well exhibit
some of the traits more commonly seen within BED. Although these
patients appear to lose less weight than those who were previously
non-binge eaters, weight loss post-surgery results are significant.”
Disordered eating cycle
Understanding the vulnerability of patients is an important aspect of
their pre- and post-surgical care. In this respect, Thomas said it is vital
to recognise the disordered eating cycle, a continuing sequence of
stages patients undergo (Figure 1). Disordered eating cycles, whether
bulimic or binge eating, have a pattern based on restriction of eating.
Patients focus on the negative (rules too hard, denial of foods), leading the need to over-eat/crave, which triggers the feeling of failure, in
turn increasing the negative feelings and the cycle begins again.
“Obese individuals who have been susceptible to this pattern of
Negative
feelings/
low
self esteem
Restriction/
Control
of eating
Failure
Loss of
control/
‘overeating’/
craving
Rules
too hard
Figure 1: Disordered eating cycle
behaviour are therefore exposed to these issues post-surgery. There
is a vulnerability which must be recognised, understood and treated,”
explained Thomas.
Types of binge eating
According to Latner and Clyne (Int J Eat Disord. 2008 41(1):1-14)
there are two types of binge eating, objective and subjective. Objective binge eating is the consumption of a large amount of food with
a loss of control, whereas subjective binge eating is the consumption
of a moderate amount (perceived as larger than normal) with loss of
control. This suggests that it is the loss of control that is crucial.
“Subjective binge eating seems to possibly fit the pattern of the
bariatric patient post-surgery and it is the loss of control that is clinically significant, rather than the amount of food eaten,” she said.
“This resonates with the experience in my practice, where patients
compare the volume of food they eat. The patients who perceive
that they are eating too much feel guilt and shame, “I have let you
down” being a common phrase. They believed that they would
never eat this way again and feel distraught, although the binge is still
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2012 Copyright ©: 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,
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Board.
considerably less than it was before surgery. They feel out of control”.
Grazing
Thomas then asked whether bariatric surgery triggers a switch from
binge eating to a higher proportion of grazing behaviour in these
patients.
Grazing is defined by the consumption of a smaller amount of food
taken continuously over a longer period of time, eating more than
the subjects consider normal. One study in particular examined the
relationship between pre-operative and post-operative eating behaviour and weight loss outcome, and found that food volume decreased
but extended eating periods increased from 26% to 38% of patients
post-surgery(Colles et al, Obesity 2008 16(3):615-22).
It appears as though pre-operative binge eaters became grazers,
which was associated with poorer weight loss and higher psychological distress, tipping patient back into the negative cycle of
disordered eating again.
They concluded that uncontrolled eating (higher energy intake
with higher percentage fat, with less dietary restraint and more
hunger) and grazing were identified as two high-risk eating patterns post-surgery.
“Initially there is a great euphoria post RYGB because of the
dramatic weight loss and a feeling of being in control for once, but
that quickly changes with a return of “appetite” as they perceive
it,” said Thomas. “The ability to eat “more” is taken as “I must be
hungry, because I am eating and able to eat” independent of the
effect of gut hormones.”
Surgery means patients are placed back into the cycle of having to make decisions about volume and choices of foods. This
becomes part of the non-core elements of psychopathology of
the eating disorder. The pre-occupation with food and rituals that
the surgery itself causes, which prior to surgery had been due to
needing to exert control, now it has to be considered to ensure that
food can be eaten and tolerated.
“Gastric by-pass surgery therefore alters eating behaviour but
not the triggers to motivate the patient to binge eat,” she added.
Conflicting issues
The evidence points to patients having conflicting issues. Their
behaviour has a history of binge eating, but following surgery this
affects the patient’s eating habits with RYGB reducing circulating
ghrelin levels and increasing GLP-1 & PYY. However, for some
patients this does not appear to provide a feeling of satisfaction long
term and hence they switch into a pattern of grazing behaviour.
Previous binge eaters are more likely to continue with this eating
pathology or switch to grazing. The surgical effect on eating behaviour might also trigger a negative effect as it makes individuals who
were super sensitive to food choices, thinking about food continually,
all the more encouraged to do so.
Thomas said it is the likely interaction with the environment
(psychosocial issues, learned behaviour etc) that is the very powerful
influence on patients. Those who respond to such triggers may not
be aided as much by weight loss surgery, because these psychosocial
cues are not altered and remain constant in their lives.
Conclusions
Thomas said that cognitive behaviour therapy before surgery on disordered eating/binge eating appears beneficial and Ashton et al (Surg
Obes Relat Dis. undefined 7(3):315-20.) have shown that outcomes
post-surgery can improve (46% vs. 38% EBWL at six months; 59%
vs. 50% at one year).
4 BARIATRIC NEWS
ISSUE 13 | AUGUST 2012
What to do when the sleeve fails?
Safe, effective and durable
are words often associated with laparoscopic sleeve gastrectomy. However,
when the procedure does fail, what can a
surgeon do to rectify the situation?
According to Professor Andrés
Sánchez-Pernaute, Hospital Clínico
San Carlos, in Madrid, Spain, there are
several options available for both obese
and super-obese patients which result in
adequate excess weight loss.
The Hospital Clínico San Carlos, in
Madrid, Spain, currently performs approximately 150 bariatric procedures
annually. The most common procedure
is gastric bypass (around 60 cases per
year), followed by biliopancreatic
diversion with duodenal switch and
sleeve gastrectomy (around 45 cases
per year).
“Our indications for sleeve whether
to perform a two-stage or stand-alone
procedure are dependent on several
factors including BMI, co-morbidities,
age, weight loss, as well as considering
medical or surgical considerations,”
said Sánchez-Pernaute. “Approximately
50% of cases are stand-alone and 45%
the first step of a two stage procedure.
The remaining 5% cases are ‘run away’
cases, that is, cases in which intraoperative problems or findings indicate the
performance of a sleeve gastrectomy.”
Failure
In regard to patient outcomes, the
different results are explained by the
heterogeneous population receiving
treatment. For example, the re-operation
rates for stand-alone procedures are
5%, compared with 27% for two-stage
procedure.
“Operating on different patients and
getting different results because of different failures, means we need to be able
to offer different solutions,” SánchezPernaute.
In his own institution, SánchezPernaute explained that the key factors
influencing weight loss is whether a
patient’s BMI is over or under 50 and
whether they are older or younger
than 40.
Ten percent of sleeve patients fail
who are under 40 years of age and have
a BMI under 50. However, 40% of
sleeve patients fail if they are aged over
40 with a BMI over 50.
“The results show patients aged
over 40 with a BMI over 50 could not
be most appropriate population and
the sleeve could be an insufficient
operation. Therefore, we need to find
another solution.”
Solutions
Sánchez-Pernaute
said that as 36%
of gastric bypass
patients with a
BMI over 50 fail
to reach a 50%
excess weight loss
Andrés
beyond five years,
Sánchez-Pernaute
it is questionable
to convert a failed
sleeve into another procedure that is
going to offer the same rate of failures
as the sleeve. He questioned whether
converting a failed sleeve into a gastric
bypass is really an improvement over a
re-sleeve or a plication.
Therefore, after sleeve failure in a patient with a BMI over 50, the procedure
of choice is a malabsorptive procedure,
such as the single-anastomosis (one
loop) duodeno-ileal bypass with sleeve
gastrectomy (SADI-S).
The procedure has previously obtained good results (Sánchez-Pernaute
ey al, Obes Surg. 2010 20(12):1720-6);
however, would a one-loop DS (SADI)
work similarly as a second step after a
sleeve in a patient with an initial BMI
over 50?
To answer the question, SánchezPernaute and colleagues established a
prospective, randomised clinical trial
in which patients with BMI over 50
received initially a sleeve gastrectomy
as a first step. If the patient’s weight
stabilised or if they regained weight,
they were randomised to receive a
standard Roux-en-Y duodenal switch
or SADI. The patient characteristics are
shown in Table 1.
There were no intraoperative or postoperative complications in any of the
groups
With regards to excess weight loss
(%), no significant differences were
observed between both groups. Excess
weight loss (%) is shown in Table 3.
Time
DS
SADI
p
Table 1: Patient characteristics
3 months
54
52
0.8
Gender
8 male, 9 female
6 months
66
62
0.6
Age
40 ys (20 – 68)
9 months
74
67
0.4
Initial weight
165 kg (128 – 216)
12 months
82
74
0.3
Initial BMI
60.2 kg/m2 (53.4 – 76.1)
18 months
85
77
0.3
T2DM
4/17 (23.5%)
24 months
80
71
0.4
HTA
11/17 (65%)
% of WL
52
52.6
At a mean follow-up of 18 months, the
results of the sleeve showed a mean
weight of 122kg (94-183) and a mean
BMI of 44 (36-54). The outcomes following standard Roux-en-Y duodenal
switch or SADI are shown in Table 2.
Table 2: Patient characteristics at the
second step
DS
SADI
p
Initial BMI
57
63
0.04
Min. BMI Sleeve
41
48
0.01
% pts > 50% EWL 50%
28%
0.3
% pts BMI > 40
14%
62%
0.05
Mean op time
230m
138m
0.007
Table 3: Excess weight loss (%)
Conclusion
In conclusion, he said that biliopancreatic diversion is an adequate operation
in the super-morbid patient after a
failed sleeve gastrectomy, and a singleanastomosis duodeno-ileal bypass is at
least as effective as standard Roux-enY duodenal switch as a second step in
the super-morbid patient.
“When the sleeve fails in the
younger and less heavy patients, we
suggest to re-sleeve or plicate, but for
the heavier patient, divert the duodenum in one loop.”
Gastric bypass may increase energy expenditure
Rat studies suggest increased total
energy expenditure contributing to
weight loss after Roux-en-Y Gastric
Bypass (RYGB) surgery
ture, and other explanations such as malabsorption
and inflammation were excluded.
“This suggests that inflammation or infections
are unlikely to be causes of increased energy expenditure after RYGB”, Bueter said.
“These results are somewhat paradoxical, as
eating less and losing body weight usually leads
to a down-regulation of energy expenditure as a
physiological compensatory mechanism to oppose
weight loss.”
Bueter therefore proposed three physiological
mechanisms that could potentially explain the findings including alterations in diet-induced thermogenesis, increased gut hypertrophy and increased
activation of brown adipose tissue (BAT).
p=0.001
4.5
4.0
3.5
kcal/kg/hr
Potential mechanisms include gut
hypertrophy, activation of brown
adipose tissue and increased levels
of gut hormones
p=0.05
p=0.05
3.0
2.5
2.0
1.5
1.0
0.5
So far, the mechanisms underlying weight
loss maintenance following RYGB have not been
extensively studied. However, a recent presentation
at the Digestive Disorders Federation meeting in
Liverpool, UK, provided some unique insights into
potentially underlying physiological mechanisms
and concluded that RYGB may increase energy
expenditure potentially culminating in prolonged
weight loss.
In his talk, “Changes in energy expenditure after
gastric bypass,” Dr Marco Bueter, Department of
Surgery, University Hospital Zurich, Switzerland,
presented results of experimental and human studies aiming to investigate physiological mechanisms
behind the superiority of RYGB in inducing longterm body weight loss.
“Gastric bypass surgery in rats has been proven
to be a valid model of human metabolic surgery.”
Therefore, Bueter and his colleagues developed and
established a RYGB rat model to further examine
underlying mechanisms.
In his presentation, Bueter showed body weight
data of three experimental groups of rats: a RYGB
group, a sham-operated group with unlimited access to food (ad libitum fed) and a sham-operated
group that only received as much food as necessary
to maintain a similar body weight as the RYGB rats
(body weight-matched (BW)). While RYGB rats
lost approximately 15-20% of their body weight
within ten days after surgery and then maintained
their low body weight at a stable level, shamoperated rats initially lost some weight (potentially
due to the surgical trauma) and then gained weight
throughout the rest of the observation period.
In addition, Bueter and his colleagues observed
that the BW group of sham-operated rats required
only about 60% of food that was consumed
by the RYGB rats (Gastroenterology. 2010
May;138(5):1845-53).
“This finding indicates that the body weight loss
0
Sham
(n=7)
BW
matched
(n=7)
Gastric
bypass
(n=14)
Figure 1: 24 hour energy expenditure
after RYGB is not completely due to decreased
food intake alone and it raises the possibility of
enhanced energy expenditure following RYGB,”
said Bueter.
Therefore, the researchers measured 24-hour
energy expenditure using metabolic chambers
allowing to determine oxygen consumption and
CO2 production over a longer period of time. The
metabolic chambers further enabled Bueter to
investigate differences in physical activity between
the groups by measuring the number of interruptions of infrared sensors on both sides of the cage.
As shown in figure 1, the researchers found
RYGB rats to have higher total energy expenditure
in comparison to ad libitum fed and body-weightmatched sham-operated control rats. Furthermore,
the increased energy expenditure did not correlate
with differences in activity and/or body temperaSham jejunum
Diet induced thermogenesis
“In a simplified way, diet-induced thermogenesis
can be considered as increase in the metabolism
after a meal ingestion”, said Bueter. He further
reported that “RYGB rats showed a greater cumulative increase in total energy expenditure after a
5-g test meal compared with the control groups.”
This suggests that differences in diet-induced thermogenesis may have a role in higher total energy
expenditure after RYGB surgery.
Gut hypertrophy
At necropsy, the researchers noted a difference in the
macroscopic appearance of the small gut between
sham-operated and RYGB rats, with the small
bowel of RYGB rats appearing thicker and stronger.
Histological analysis showed a significantly greater
mucosa height as well as a significantly thicker
muscle layer of the small bowel after RYGB compared to the small intestine of sham-operated rats
(Figure 2). Furthermore, there was a 72% increase
of total small bowel weight following RYGB.
RYGB alimentary limb
500µm
500µm
Figure 2: Histological image of alimentary limb mucosa of a RYGB rat in comparison with the corresponding segment
of the jejunum of a sham-operated rat.
Marco Bueter
“The small intestine is metabolically very active
and gut hypertrophy may hence explain a higher
energy requirement that contributes to body weight
loss”, Bueter concluded.
Brown adipose tissue
As brown adipose tissue (BAT) activity is
negatively correlated with the body mass index in
humans, it has been suggested that BAT may have
an important role in promoting weight loss. Bueter
and his colleagues therefore investigated whether
RYGB induces a higher activity of BAT in their
rodent model.
“We found that there was no difference in BAT
activity after RYGB compared to sham-operated
controls. Thus, RYGB surgery does not increase the
activity of brown adipose tissue in rats suggesting
that other mechanisms are involved to explain the
increased energy expenditure after RYGB surgery”,
Bueter said.
Conclusion
“The available experimental and clinical data
indicate that RYGB surgery functions by altering the physiology of body weight regulation, at
least partly by increasing energy expenditure and
diet-induced thermogenesis,” Bueter concluded.
“Potential mechanisms include an increased diet
induced thermogenesis, hypertrophy of the small
intestine, but most likely not an increased BAT
activity. Our study provides additional support for
further investigations of the underlying mechanisms of RYGB surgery to identify novel therapies
for obesity and related metabolic diseases.”
6 BARIATRIC NEWS
ISSUE 13 | AUGUST 2012
The Ring: to have, or not to have?
Study
The aim of the retrospective study was to evaluate whether BRYGB
procedures resulted in better postoperative weight loss and significantly improved long-term weight loss compared with RYGB.
Between 2007 and 2011, 236 patients in the banded group had a
conventional laparoscopic Roux-en-Y gastric bypass with additional
restrictive silastic ring (The GaBP Ring, Figure 1) and 349 in the nonbanded group had a conventional laparoscopic Roux-en-Y gastric
bypass alone.
All the patients were operated in three Bariatric Centres of Excellence in Sint Niklaas (Belgium) under Luc Lemmens’ ledership, in
Freiburg by Konrad Karcz and in Jeddah (Saudi Arabia) under Waleed
Bukhari’s leadership.
The primary outcome was post-operative reduction of BMI and
excess weight loss (EWL, %) at three-, six- and 12 months, two, three
and four years. Baseline patient demographics between the banded
and non-banded groups respectively were similar in terms of mean
weight (122kg vs. 115kg), mean BMI (42 vs. 41) and mean excess
weight (62kg vs. 57kg).
T2DM recurrence
mainly influenced by
diabetic history
A new study presented at The Endocrine Society’s 94th
Annual Meeting in Houston, TX, has claimed that T2DM
recurrence following bariatric surgery is mainly influenced by
a longstanding history of the condition prior to surgery. The
research was presented by the study’s lead author, Dr Yessica
Ramos, an internal medicine resident at Mayo Clinic Arizona
in Scottsdale.
Ramos and colleagues studied the medical records of 72
obese patients with Type 2 diabetes who underwent a Rouxen-Y gastric bypass operation between 2000 and 2007 and had
at least three years of follow-up visits. Of these, 66 patients
(92%) had a reversal of their diabetes at some point.
However, within three to five years after surgery, 14 (21%)
of the 66 patients experienced a recurrence of their type 2
diabetes (documented by bloodwork or restarting use of diabetes medications). The patients who did not have recurrence
of diabetes lost more weight initially and maintained a lower
mean weight throughout the five years of follow-up, although
both groups regained similar amounts of weight. There was
no significant association between higher recurrence rate and
body mass index before surgery, the authors found.
They did find that the longer the duration of type 2 diabetes
before surgery, the higher the probability of diabetes recurrence. Study patients with more than a five-year duration of
type 2 diabetes before they had bariatric surgery were 3.8
times more likely to have recurrence of type 2 diabetes compared to patients with less than a five-year history of diabetes.
“The recurrence rate was mainly influenced by a longstanding history of Type 2 diabetes before the surgery,” said
Ramos. “This suggests that early surgical intervention in
the obese, diabetic population will improve the durability
of remission of Type 2 diabetes. Providers and patients need
to be aware of this information, to have a better idea of the
expected outcome and be able to make an informed decision
about pursuing gastric bypass surgery.
100
*
75
% EWL (mean)
One of the current controversies in bariatric surgery is whether
to utilise a ring or ‘band’ during bypass surgery. At the recent IFSOEuropean Chapter meeting in Barcelona, a three-centre retrospective
study comparing banded bypass (BRYGB) to conventional non-banded bypass (RYGB) was presented with four year outcomes. The study
initiator PD Dr Konrad Karcz, University of Freiburg, Germany, was
inspirited by talks with MAL Fobi who encouraged him to perform
this study.
“Writing in the journal Obesity Surgery in 1994, the father of the
Roux-en-Y gastric Bypass, Dr Edward Mason, wrote ‘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’”, began
Karcz. “This loss of the restrictive component of the operation was
confirmed by increased caloric intake in some patients.”
The Silastic Ring Gastric Bypass (SRGBP) was introduced by
Mal Fobi in 1989, in an effort to enhance the restrictive mechanism
of the Roux-en-Y gastric bypass by controlling the stoma size and
reducing the reservoir capacity after the gastric bypass. Stretching of
the outlet combines the pouch and the dilated proximal jejunum into
a big reservoir.
Over the years, numerous materials and implants have been used
to ‘band’ the bypass including marlex mesh, porcine graft, bovine
graft, Ethibond suture the LapBand and mostly the GaBP Ring.
“However, opinion is divided as to whether BRYGB or RYGB produces the better long-term results,” he added. “Therefore, we decided
to retrospectively examine the results from three centres.”
*
50
Conv
Banded
* p<0.05
25
0
3
months
6
months
1
year
2
years
3
years
4
years
Figure 2: Post-operative data mean EWL (%)
Figure 1: Implanted GaBP Ring
The outcomes for BMI at four year show that patients in the
conventional group had a lower mean BMI than the banded patients
from the date of the operation to two years. However at three years,
the mean BMI was the same in both groups and at four years the mean
BMI was lower in the banded group (Table 1).
Table 1: Post-operative data mean BMI
Day1
3mo
6mo
1y
2y
3y
4y
BRYGB
43
34
31
28
27
26
25
RYGB
41
33
29
27
26
26
27
The authors reported a similar pattern when examining the postoperative mean EWL (%) with a benefit in conventional group out
to six months but with the benefit then shifting to the banded group
out to four years (Figure 2 and Table 2). Both these outcomes are
particularly important as the baseline mean weight (122kg vs. 115kg),
mean BMI (42 vs. 41) and mean excess weight (62kg vs. 57kg) were
higher in the banded group.
Table 2: Post-operative data mean EWL (%)
3mo
6mo
1y
2y
3y
4y
BRYGB
40%
58%
73%
77%
79%
85%
RYGB
40%
60%
72%
74%
72%
69%
Complications
The authors also examined ring-related complications and noted three
patients where the Ring was open two years after operation, leading to
wait gain. There were no erosions reported in this series.
However, Stubbs et al (Obes Surg. 2006 16(10):1298-303) and
Fobi et al (Obes Surg. 2001 11(6):699-707), have reported instances
of band erosion (rate of 1.63%, 48 of 2,949 patients) or migration into
the gastric lumen after banded gastric bypass, although the erosion
incidence was lower (0.92%) in primary operations.
Removal of the ring is combined with significant weight gain
occurring in 43.75% patients who underwent ring removal, with an
average of 14% EWL regained (Fobi et al. 2011 IFSO Congress and
Barroso et al. 2007 IFSO Congress).
Conclusion
The data suggests that banding the bypass leads to better weight loss
after four years and helps reduce the weight regain, which may be
due to prevention of pouch-outlet dilation, the authors concluded. In
addition, the GaBP-Ring is a standardized device which is easy to
remove in case of complications.
GABY study
The two years results of the multicentre, prospective, randomized
Banded versus conventional laparoscopic roux-en-y study, designed
to compare banded and non-band laparoscopic Roux-en-Y gastric
bypass, will be presented at the IFSO World Congress in New Delhi,
India, in September 2012.
“Banding the sleeve gastrectomy just makes sense”
Dr Mal Fobi, a world-renowned bariatric
surgeon and past president of the International
Federation for the Society of Obesity and
Metabolic Surgery (IFSO) in a presentation
at a surgeons’ workshop in Sint Nicklaas,
Belgium stated, “It just makes sense to band
the sleeve gastrectomy operation, just as the
gastroplasty operations were banded and as the
gastric bypass operation is banded to enhance
the restrictive mechanism of the operation”.
The sleeve gastrectomy is being used more
frequently as more and more surgeons are
switching from gastric banding.(Bariatric ENews July, 2011)
The currently understood mechanism responsible for the sleeve gastrectomy operation
are:
1.The ghrelin effect (resecting the parietal
mass that produce ghrelin resulting in anorexia),
2.The restrictive effect (creation of a small
tubular stomach pouch that decreases the
caloric intake) and
3.The rapid transit effect (rapid transit of food
from the small sleeve gastrectomy stomach
into the small bowel thus releasing incretins
from the small bowel that inhibit caloric
intake).
It has been reported that in the initial year after
the sleeve gastrectomy the weight loss is more
rapid than seen with the gastric bypass and the
total weight loss approaches that reported after
the gastric bypass operation.(Sleeve Gastrectomy Summit, OOBSJ, 2012)
“We do not have to reinvent the wheel”,
Dr Fobi continued. “30–50% of patients with
a sleeve gastrectomy will have progressive
weight regain because of the dilation of the
sleeve pouch thus minimising the restrictive
component of the operation and thus requiring
Mal Fobi
revision surgery which may be either re-sleeving or conversion of the sleeve gastrectomy to
either a gastric bypass or BPD with a switch.”
In an effort to address this loss in the restrictive mechanism of the sleeve gastrectomy,
as more and more surgeons use the sleeve
gastrectomy as a stand alone operation, there
has been the trend towards a very narrow
sleeve resulting in a significant leak rate (intractable leaks), strictures and reflux. Banding
the sleeve gastrectomy enhances the restrictive
mechanism just like banding the gastroplasty
operations and gastric bypass operation.
Surgeons banding the sleeve gastrectomy
with a GaBP ring have documented control of
the reservoir capacity of the sleeve and prolongation of the weight loss maintenance (Karcz,
SOARD 2010).
Bariatec Corporation, the maker of the
GaBP ring for banding the gastric bypass,
the sleeve gastrectomy and other gastroplasty
operations is carrying out a multi-centre international prospective clinical trial to
substantiate the benefit of banding the sleeve.
“Until prospective clinical trials with long
term results are performed and reported,” Dr
Fobi advised, “It just makes sense to band the
sleeve gastrectomy operation”.
8 BARIATRIC NEWS
ISSUE 13 | AUGUST 2012
Studies show new bariatric implant is “safe and effective”
A novel bariatric implant and its
delivery system have successfully completed both a proof-of-concept study
and a pivotal study, indicating that it can
feasibly be safely and effectively used in
adult patients.
The Prevail Implant System, designed
by California-based start-up Vibrynt, is
intended to fill the space that the stomach
normally expands into, thereby limiting
the patient’s food consumption. Both
studies were presented at the ASMBS’
29th Annual Meeting in San Diego.
The multi-centre, single-arm proofof-concept study was designed to evaluate feasibility and safety in the device,
and included six subjects aged 18-60
years with a BMI between 35 and 55.
Sixty-nine subjects were evaluated in
the pivotal study, which examined safety
through adverse events and effectiveness based on excess weight loss. The
mean excess weight loss among patients
installed with the device was 28.3% ±
14.45% at six months.
Feasibility was based on placement
success, and safety was based on severe
adverse events. In the pivotal study, the
device was successfully implanted on
the first attempt in 94.2% of patients.
Severe device-related adverse events
in more than one pivotal study subject
included abdominal and upper abdominal pain, and medical device removal.
The investigators concluded from
the studies that the use of the adjustable,
reversible implant in adult subjects appeared “safe and well-tolerated”.
Installation
Vibrynt, and its Prevail system, was
formed in California in 2006, in the
Exploramed medical device incubator.
The device is currently at an investigative stage, to establish whether the patient’s calorific intake can be restricted
by filling the space the stomach would
normally expand into, thereby inducing
early satiety.
After the ideal location for the device
is established using a template tool, the
Prevail implant is inserted laparoscopically through a single incision, within
the ribcage and next to the stomach. It is
then filled with sterile saline.
Once the device is inflated, the insertion tool can suture the device in place.
An adjustment port, similar to that seen
with an adjustable laparoscopic gastric
band, is placed at the incision, which can
be used to alter the amount of restriction
that the device places on the stomach.
The Prevail System does not require
any altering of the gastrointestinal
anatomy, and does not place any restrictions on the types of healthy foods the
patient can eat.
Future
The system is being evaluated in an
FDA-approved research study to support
a premarketing application to the FDA.
The purpose of the study is to determine the safety and effectiveness of the
system for the treatment of morbid obesity. It will compare the results attained
by patients using the Prevail system
to those attained using an adjustable
gastric band.
Study enrolment is currently scheduled to take place from August 2012 to
August 2013. Patients considered for the
study will have a BMI between 40 and
50, or between 35 and 40 with one or
more comorbidity; be aged 18–65; have
a five-year history of morbid obesity;
and will demonstrate a documented failure with non-surgical weight-reduction
options like diets, exercise and behaviour modification programmes.
‘Promising’ SAMSEN system performs endoscopic GI bypass
Using self-assembling magnets to
perform an endoscopic gastrointestinal bypass
is safe, can be performed in less than 30 minutes
and can be conducted using only local anaesthetic,
according to a study presented at the Digestive
Disease Week conference in San Diego.
“These findings suggest we may be close to
performing a surgical-quality gastrointestinal
tract bypass using an incisionless platform,
which is less invasive and potentially safer than
the surgical alternative,” said clinical study lead
Dr Marvin Ryou, from Brigham and Women's
Hospital in Boston, MA, who presented the threemonth outcomes.
The procedures were performed on five pigs.
An endoscope was advanced into the peritoneal
cavity of five pigs through the gastrotomy, and a
segment of the small bowel was grasped and pulled
closer to the stomach. An enterotomy was created,
and a custom overtube was advanced into the
small bowel for deployment the SAMSEN (SelfAssembling Magnets for Endoscopy) system.
A reciprocal magnetic assembly was then
deployed in the stomach and the two magnetic
systems were connected under fluoroscopic and
endoscopic guidance (See illustration).
After initial mating of the magnets, the compressed tissue between the two magnets would
die off over several days while tissue remodeling
would occur around the points of magnet compression. Eventually, a tunnel would form connecting
the stomach and the small intestine. The researchers assessed gastrojejunostomy leaks by contrast.
The pigs were scoped every three to six days until
creation of an anastomosis. The completely joined
Figure 1: Two magnetic systems are connected
magnets would be naturally expelled, leaving behind
a clean anastomosis without any foreign material.
“The anastomosis was created by magnetic
compression, a process that takes advantage of the
body’s natural healing process to remodel the GI
tract,” said Ryou.
Investigators performed necropsies on all pigs
after three months and found that the bypasses
remained large and completely open, which had
not been previously demonstrated by this technology. Weight trends plateaued in the bypass
pigs while age-matched, litter-matched controls
doubled their weight.
Furthermore, no adhesions were found, which
the researchers said represents a “significant
departure” from conventional surgery, and would
likely make any subsequent surgical procedures
less complicated. The absence of adhesions
could represent a significant step forward for
abdominal surgery.
Previous studies attempting this kind of procedure used small, solid magnets, which limited
the size of the bypass and naturally closed up
after a few weeks. Larger magnets could not
be delivered endoscopically due to anatomical
restrictions.
“That is why we developed the concept of these
smart magnets that can self-assemble into larger
structures within the GI tract, which in turn, create
larger and more durable bypasses,” added Ryou.
He claimed that the findings are also important
because they suggest other potential advantages
over surgical bypass. For example, an effective
endoscopic method of bypass creation is inherently
less invasive because it avoids abdominal incisions
of conventional surgery.
Ryou cautioned that these results, while promising, are from a small animal study, but he added
investigators are very close to commencing human
work in this area.
The researchers said that there are several
potential applications for this technology, including weight loss, treatment of type 2 diabetes and
palliation of an obstructing cancer.
This study was funded by the US Department of
Defense and Beacon Endoscopic, the developers of
the SAMSEN system.
Normal weight diabetics have higher mortality than overweight counterparts
Patients who are normal weight at the time of a diagnosis of diabetes experienced
higher rates of total and non-cardiovascular death, compared with those who
were overweight or obese at diabetes diagnosis, according to a study in the
Journal of the American Medical Association.
“Type 2 diabetes in normal-weight adults is an
understudied representation of the metabolically
obese normal-weight phenotype that has become
increasingly common over time,” the authors stated
in the paper. “It is not known whether the ‘obesity
paradox’ that has been observed in chronic diseases
such as heart failure, chronic kidney disease, and
hypertension extends to adults who are normal
weight at the time of incident diabetes.”
Dr Mercedes R Carnethon, Feinberg School
of Medicine, Northwestern University, Chicago,
and colleagues conducted a study to compare
mortality between participants who were normal
weight and overweight or obese at the time of new
adult-onset diabetes.
The study consisted of a pooled analysis of five
longitudinal studies with a total of 2,625 participants
with new diabetes. Included were men and women
(older than 40 years of age) who developed incident
diabetes based on fasting glucose 126mg/dL or
greater or newly initiated diabetes medication and
who had concurrent measurements of BMI.
Participants were classified as normal weight
(BMI 18.5 to 24.99) or overweight/obese
(BMI>25). Fifty percent of the participants were
women and 36% were non-white.
The proportion of adults who were normal
weight at the time of incident diabetes ranged from
9% to 21% (overall 12%). During follow-up, 449
participants died: 178 (6.8%) from cardiovascular
causes and 253 (10.4%) from non-cardiovascular
causes. Eighteen causes of death were unidentified.
In the pooled sample, total mortality and
cardiovascular and non-cardiovascular mortality
were higher in normal-weight participants,
compared with rates among overweight or obese
participants (284.8, 99.8, and 198.1 per 10,000
person-years, respectively, vs. 152.1, 67.8, and 87.9
per 10,000 person-years, respectively).
After
adjustment
for
demographic
characteristics and blood pressure, lipid levels,
waist circumference, and smoking status, hazard
ratios comparing normal-weight participants
with overweight/obese participants for total,
cardiovascular, and non-cardiovascular mortality
were 2.08 (95% CI, 1.52-2.85), 1.52 (95% CI, 0.892.58), and 2.32 (95% CI, 1.55-3.48), respectively.
“These findings are relevant to segments of the
US population, including older adults and nonwhite persons who are more likely to experience
normal-weight diabetes,” the authors noted.
The researchers write that mechanisms to explain
their findings are unknown, but could indicate a
genetic predisposition: “Previous research suggests
that normal-weight persons with diabetes have a
different genetic profile than overweight or obese
persons with diabetes. If those same genetic variants
that predispose to diabetes are associated with other
illnesses, these individuals may be ‘genetically
loaded’ toward experiencing higher mortality.”
The researchers add that future research in
normal-weight persons with diabetes should test
these genetic hypotheses, along with other plausible
mechanisms to account for higher mortality,
including inflammation, the distribution and action
of adipose tissue, atherosclerosis burden and the
composition of fatty plaques, and pancreatic betacell function.
Editorial
In an accompanying editorial, Dr Hermes Florez,
University of Miami Miller School of Medicine,
and Miami Veterans Affairs Healthcare System,
noted that the study addresses an emerging challenge regarding diabetes and weight status.
“This could be a wake-up call for timely
prevention and management to reduce adverse
outcomes in all patients with type 2 diabetes,
particularly in those metabolically obese normalweight at diagnosis, who may have a false sense
of protection because they are not overweight or
obese,” the editorial stated. “Standards of diabetes
care recommend weight loss for all overweight
or obese individuals who have diabetes. Low
carbohydrate, low-fat, calorie-restricted, or
Mediterranean diets may be effective weight-loss
strategies in these individuals.”
Hermes adds that the additional benefits
of increased physical activity and behaviour
modification strategies may lead to the successful
implementation of weight management and healthy
living programs for all patients with diabetes.
“It is important to understand how diabetes
duration relates to the benefits of intentional weight
loss, as well as the clinical consequence associated
with sarcopenic obesity and bone loss in older
adults with or at high risk for diabetes.”
The research was funded by a National
Institute of Diabetes and Digestive and Kidney
Disease grant.
BARIATRIC NEWS 9
ISSUE 13 | AUGUST 2012
Do it right the first time: Banded bypass reduces long-term weight regain
I
t is clear by now that after five years the standard Roux en Y Bypass is faced with a considerable amount of re-operations due to weight
regain. This can mount up to 30 to even 50%
of the initial patients requiring revisional surgery.
Main reason for the weight regain is the dilatation
of the gastric pouch, eventually accompanied by
dilatation of the anastomosis and/or small bowel.
“Although patients lose weight and can be
no longer considered obese, some are still psychologically obese and after a year because
they can eat more they enter old eating habits,”
said Professor Volker Lange, director of adipostas surgery, Vivantes Hospital, Berlin-Spandau,
Germany. “The overeating can cause pouch dilatation and subsequent weight gain.”
This can be avoided by placing a gastric ring
on the gastric pouch 1-2cm proximally of the
anastomosis, therewith creating a neo pyloris
that induces an initial barrier to overeating. More
importantly, it protects the anastomosis from
overstretching. This helps the patients a lot in
changing their eating habits, as they experience
a stronger and longer-lasting feeling of satiety.
“We use the MiniMizer Ring from Bariatric
Solutions which has two major benefits in our
view: the ring is equipped with a blunt, silicone
covered introducer needle that helps us place
the ring without having to dissect posterior to
the gastric pouch,” said Lange. “We only need
to dissect a small opening in the serosa and the
introducer places the ring easily.
The ring also has four closing positions and
thereforev four different diameters, like a mini tie
wrap. Although the pouches can be calibrated with a 36French calibration tube, the thickness of the stomach wall can still vary and the
MiniMizer Ring offers the flexibility to close the
Volker Lange
ring at any desired diameter to match the size
of the pouch at hand. It also allows for re-opening if the ring is either too tight or too loose.
The material is soft, yet firm and the literature
has shown that rings of this size and elasticity
have only between 1-2% of erosion, which oftentimes passed via naturalis.
Lange added that the banded bypass is still
a very new procedure and although there are no
published data from any randomised clinical trials, Konrad Karcz will shortly published the outcomes from a trial comparing banded and nonband laparoscopic Roux-en-Y gastric bypass.
“A recent publication by Awad1, who compared banded vs. non-banded bypass over a
period of ten years, supports our choice for the
banded bypass. We feel the procedure is the
way to go and have made a standard part of the
therapeutic portfolio“
1 William Awad & Alvaro Garay & Cristián Martínez: Ten Years Experience of
Banded Gastric Bypass: Does It Make a Difference? Obes Surg (2012)
22:271–278
10 BARIATRIC NEWS
ISSUE 13 | AUGUST 2012
ASMBS 29th Annual Meeting –
News in Brief
29th Annual Meeting June 17–22 2012
Total vertical gastric plication:
positive experience
Dr Ariel Ortiz reported positive initial findings
from a series of 454
total vertical gastric
plication operations
performed between
July 2010 and October 2011.
Of the 454 patients, 429 were
having their initial
surgery and 25 were
receiving revisions from gastric band surgery. The mean surgery time was 42 minutes.
There were no fatalities, and a 4.3% total
complication rate.
Ortiz noted that while his initial experience
was positive, long-term data on the operation
was still not available.
Survey reveals malpractice suit
extent and cost
American bariatric surgeons receive on average 1.5 lawsuits during their career, according to a survey of ASMBS members.
Out of 329 surgeons who responded to the
survey, 464 lawsuits were reported from 156
responses. 48% of surgeons had never had
a bariatric-related lawsuit filed against them.
The average amount paid was $622,000.
Dr Ramsey Dallal et al found that the probability of a surgeon experiencing a lawsuit
was independently associated with the years
in practice and number of total cases the surgeon has performed.
Greater curvature plication appears
safe and effective
Laparoscopic greater curvature plication,
an emerging bariatric technique, appears to
be relatively safe and effective for morbidly
obese patients, according to a new study by
Dr Stacy Brethauer et al.
After one year, in 32 patients, the mean
overall percentage excess weight loss was
40% ± 24.2%. The most common post-operative complicatiosn were nausea (25), abdominal pain (17), and vomiting (7).
Brethauer noted the need for longer-term
outcome data to assess its potential as a primary bariatric procedure.
Increasing the biliopancreatic limb length
Dr José Salinas, Digestive Surgery, Catholic
University of Chile, Santiago, Región Metropolitano, Chile, reported that increasing the
biliopancreatic limb is a safe and successful
strategy for unsuccessful weight loss after
RYGB.
Nineteen patients underwent BPD revisional
with this surgical modification of primary gastric bypass. All cases were performed with a
laparotomy.
Revisional procedure was indicated for unsuccessful weight loss in all cases. Median
time from primary to revisional surgery was
3.9 (range 1.3 – 6.2) years.
Mean preoperative BMI was 45.4±6.9. Most
patients (78.9%) had obesity-related comorbidities. There were no major early complications. On follow-up
there were two (10.5%) patients with an internal hernia. Mean excess weight loss (EWL)
was 41.9% in patients followed for a median
of 1.5 years after revisional surgery. An accumulated EWL of 72.4% was observed since
the first surgery.
Ten-year trial: bypass beats band
A trial designed to assess outcomes for
patients receiving laparoscopic adjustable gastric
banding (LAGB) vs. laparoscopic Roux–en-Y
gastric bypass (LRYGB) has reported bypass has
better weight loss and reduced number of failures,
despite significantly longer operative time and
life-threatening complications.
Dr Luigi Angrisani and colleagues from the
General and Laparoscopic Surgery Unit, San
Giovanni Bosco Hospital, Napoli, Italy, said that
this prospective, randomised clinical trial was
established to provide much-needed data comparing the two most common bariatric procedures.
From January 2000 to November 2000, 51 patients aged 19 to 50 were randomly allocated into
two groups. Group A consisted of 27 patients who
received LAGB via pars-flaccida; the remaining
24 patients were allocated into group B and received standard LRYGB.
Baseline patient demographics revealed that
the vast majority of LAGB patients were female
(22 out of 27), had a mean age of 33.3 (range 2152), a mean weight: of 120kg (range: 92-150kg),
a mean BMI of 43.4 (range: 40.1-49.2); and a
83.8% excess weight (range 36.9-128.8).
Baseline patient demographics in the LRYGB
showed the majority were female (20 out of 24),
and had a mean age of 34.7 (range 20-50). Their
mean weight was 120kg (range 95-147kg), a
mean BMI 43.8 (range 40-48.9) and 83.3% excess
weight (range 34.6-126.53).
Results
The operative time, re-operation with hospital
stay, weight, BMI, and %EWL, were collected;
procedures in the study were considered to have
failed if BMI was over 35 at the endpoint. Data
were analysed by Student t-test (p>0.05 is considered significant).
Mean operative time was 60 minutes for group
A and 220 minutes for group B (p>0.001); no
deaths were reported. Five LAGB patients and
three LRYGBP patients were lost to follow-up.
The re-operation rate (p=ns) was 8/22 (36%)
compared with 3/21 (14%). Hospital stay ranged
from two to three days in group A and one week
to six months in group B.
After ten years, the mean weight was 101±22
and 83±18kg, BMI was 36±7 and 30±5, mean
%EWL was 46±27 and 69±29, with failure rate
7/14 (50%) and 4/21 (19%) in Group A and B respectively (p<0.001). Additionally, patients with
BMI<30 were 3/14 (21%) and 10/21 (48%) in the
same groups (p<0.001).
The researchers concluded that LRYGB produces better weight loss and fewer failures compared with LAGB, despite significantly longer
operative time and life threatening complications.
However, the investigators noted that long-term
nutritional sequalae of LRYGB are still unknown.
LSG has the lowest rates of procedure-related morbidity
According to the outcomes
of a new study presented at the Annual Meeting when compared with
other bariatric procedures laparoscopic sleeve gastrectomy (LSG)
appears to have the lowest procedure
related morbidity.
“The aim of the study was to
identify which of the bariatric
procedures performed today is
the safest in terms of procedure
related morbidity,” said Dr Raul J
Rosenthal from the Bariatric and
Metabolic Institute and the Section of Minimally Invasive and
Endoscopic Surgery, Cleveland
Clinic Florida. “So we carried out
a single institution retrospective
review of our centre’s six year experience since LSG was introduced
comparing the procedure with
Roux-en-Y gastric bypass (RYGB)
and laparoscopic adjustable gastric
band (LAGB).”
Rosenthal and colleagues retrospectively analysed a prospectively
collected database in morbidly obese
patients that underwent bariatric surgery between 2005 and 2011. They
identified and compared complications, hospital stay, readmissions
and re-operations in patients that
underwent all three procedures.
A total of 2,433 bariatric procedures were performed during
this period of time. There were no
significant differences between
the groups in terms of age, gender
or BMI. Rosenthal explained that
in his institution, banding is only
applied to patients with a BMI 3550, whereas LSG is applied to all
patients including the high risk and
RYGB is applied to all patients with
a BMI of >35.
Outcomes
Of those procedures 1,492 were
RYGB, 602 LSG and 339 LAGB.
The number of readmissions was
minimal in all three groups with
RYGB 1.7 times, LSG 1.3 times and
1.5 times for LAGB. The percentage
of procedures requiring reoperations
due to complications or failures was
7.7% in the RYGB group, 1.5% in
the LSG and 15.3% for the LAGB.
“LSG appears to have the lowest
rate of re-operations when compared
to banding and bypass, and surprisingly banding had the highest rate
of re-intervention,” said Rosenthal.
“The primary reason for removing
bands was slippage, followed by
failure and reflux.”
The outcomes also revealed that
average postoperative length of stay
was longer following RYGB (3.75
days) compared with LSG (3.4 days)
and banding (1.47 days). The leakage rate was 0.4% for the RYGB and
0.3% for the LSG (leakage rates are
not applicable for LAGB).
“One of the weaknesses of this
study, as with all retrospective
studies, is that patients were not
Raul Rosenthal
randomised,” he explained. “Therefore, it could be that there is a patient
population in one group or another
that could trigger a difference in the
outcomes.”
“However, I believe that this
study adds to the body of evidence,
which includes randomised studies
and meta-analyses, that LSG is an
outstanding treatment option for
morbid obesity,” concluded Rosenthal. “I think the message from this
relatively small study is that at this
point LSG is the safest procedure
when treating morbidly obese
patients.”
The co-authors of the study
were Drs Abraham Fridman, Karan
Bath, Andre Teixeira and Samuel
Szomstein.
High GDI best indicator of diabetes remission after bypass
Pancreatic function, and not initial
BMI, is the best indicator of diabetes remission
after Roux en Y gastric bypass, according to a
new study.
The study, ‘Predictors for Remissions of
Type 2 Diabetes Mellitus Following Roux En
Y Gastric Bypass’, found that 67% of gastric
bypass patients achieved diabetes remission one
year after surgery, but that number grew to more
than 96% if patients were not already on insulin
and did not have reduced pancreatic function
as measured by the glucose disposition index
(GDI).
If GDI was 30% of normal, patients were less
likely to achieve remission.
The study also found that neither patient’s
initial weight before surgery, nor weight loss both
after six weeks and one year, had no impact on
remission rates.
“The study shows beta cell function, the cells
in the pancreas that produce insulin, and insulin
dependence, not initial weight or subsequent
weight loss, are the greatest predictors of potential
diabetes remission after gastric bypass,” said
Richard A. Perugini, MD, a bariatric surgeon at
University of Massachusetts Medical Center in
Worcester and lead study author.
“The study further confirms type 2 diabetes becomes more difficult to manage as it progresses.”
The study included 139 gastric bypass patients aged 48 to 57, with BMIs ranging from 33
to 75. All required medication to manage their
type 2 diabetes.
36% of patients no longer needed diabetic
medication within two weeks of surgery, rising
to 46% at six weeks, 57% at six months and 67%
after one year.
However, over 96% of patients on diabetes
medications other than insulin and with a GDI
that had not fallen below 30 percent of normal
achieved remission.
All patients’ HbA1c levels fell from an average of 6.9% to 6.1% over the period of the study.
Patients achieved an average of 59% EWL and 15
BMI points after one year.
Co-authors for the study included John J.
Kelly, MD, Philip Cohen, MD, Donald R. Czerniach, MD and Karen A. Gallagher-Dorval, RN.
BARIATRIC NEWS 11
ISSUE 13 | AUGUST 2012
2 San Diego, CA
Are gender and race indicators of weight loss?
Two studies presented at the recent ASMBS
meeting in San Diego indicate that a patient’s race
is a factor affecting weight loss following bariatric
surgery.
In a the first study, researchers from the Einstein
Healthcare Network in Philadelphia reported that
African-Americans and males lost significant
weight after gastric bypass surgery, but not as much
as their white and female counterparts.
The study found African-Americans lost about
10% less of their excess weight than whites,
while men of all races lost 10% less than women.
Increasing age and higher initial weight were
also identified as significant factors in predicting
weight loss. The study examined 1,096 gastric
bypass patients with at least one-year follow-up.
Patients were on average 45 years old, and had an
average BMI of 47.6.
Excess weight loss was 63.2% in AfricanAmerican patients and 71.9% in white patients, and
63% in males compared to 71% in females. Resolution or improvement of obesity-related conditions,
including type 2 diabetes, hypertension and sleep
apnea, were similar across all groups.
“The improvements in health status are consistent among all groups, however, for some reason,
weight loss itself is variable,” said Dr Ramsey
M Dallal, chief of bariatric/minimally invasive
surgery at Einstein Healthcare Network.
“Further study is needed to determine what
makes some groups more resistant to weight loss
than others. It is likely there are many factors, from
genetics to environment.”
In the second study, by investigators from Duke
University, African-American women lost about
10% less of their excess weight after gastric bypass
Bariatric surgery turns
back kidney disease
Severely
obese
patients with chronic kidney
disease saw significant improvements in their condition within
one year of bariatric surgery, a
new study has revealed.
Patients in the study, called
‘Improved Renal Function
12 Months After Bariatric
Surgery’, went from having
moderate kidney disease to
mild kidney disease, or from
mild kidney disease to normal
function, within one year.
“With bariatric surgery we
are attacking the two main culprits of chronic kidney disease –
high blood sugar and high blood
pressure,” said study co-author
Wei-Jei Lee, from Min-Sheng
General Hospital and National
Taiwan University Hospital.
“However, this study suggests the earlier we treat chronic
kidney disease in the disease
process with bariatric surgery,
the more favourable the impact
on the kidney.”
The study included 233 patients who were on average 33
years old and had a BMI of 39.5.
Around 20% of the patients in
the study had mild to moderate
chronic kidney disease, and 25%
of patients had hyperfiltration, a
precursor to the disease.
More than 90% had type 2
diabetes and almost 50% had
hypertension – the two main
causes of chronic kidney disease, according to the National
Kidney Foundation.
Dr Lee and his coinvestigators found that the
patients’ glomerular filtration
rate (GFR), a test used to check
kidney function, improved
regardless of the initial state
of the patient’s kidneys. GFR
rose from 81.0 to 98.6ml/min
in the mild disease group, and
from 49.3 to 66.8ml/min in
the moderate disease group.
Ordinarily, GFR ranges from
90 – 120ml/min.
Patients in the study who
had hyperfiltration, a precursor
condition to kidney disease, saw
their GFR drop from an average
of 146.5 to 133ml/min.
Study co-authors from MinSheng General Hospital and
National Taiwan University
Hospital included Chun-Cheng
Hou, MD, Shu-Chu Chen, RN,
Professor Yi-Chih Lee, JungChien Chen, MD, and KongHan Ser, MD.
than their Caucasian counterparts, but if type 2
diabetes was present, weight loss and the rate of
diabetes remission was about the same.
The researchers said that while race may have
been a factor in weight loss, it did not play a role
in surgery’s effect on type 2 diabetes and in weight
loss among people with type 2 diabetes. Both
African-American and Caucasian women experienced similar diabetes remission rates (75% and
77%, respectively).
Larger differences occurred in excess weight
loss among women who did not have diabetes.
African-American women on average lost 56.7%
of their excess weight over three years, while
Caucasian women lost 64.7%. However, if diabetes was present, the weight loss gap narrowed.
African-American women with diabetes lost on
average 59.8% of their excess weight.
“For some reason, diabetes was the great
equaliser when it came to weight loss,” said Dr
Alfonso Torquati, Duke University, co-author of
the study. “African-American women with Type
2 diabetes lost a similar amount of excess weight
as Caucasian women. Racial differences in excess
weight loss only emerged between non-diabetic
women. Further study is needed to determine if
the reasons are genetic or because of differences in
body fat distribution or both.”
The 282-patient study compared the outcomes
of African-American women to Caucasian women
matched for initial BMI, age and health status.
On average, women were 40 years old and had a
BMI of 50. About 20% of the patients had type 2
diabetes. Nearly 70% of African-Americans had
hypertension, compared with 50% of Caucasians,
and about one third of both groups had sleep apnea.
Prophylatic IVC filter insertion: “more risks than benefits”
The risks of inserting prophylactic inferior
vena cava (IVC) filters in bariatric patients
exceed the benefits, and the practice should
be discouraged, according to a new study.
The study, “Peri-operative
complications
in
bariatric
surgery patients undergoing prophylactic inferior vena cava
filter insertion”, found that
patients who received a filter
had higher adjusted rates of venous thromboembolism, serious
complications, and death.
The new study follows advice
from the US Food and Drug
Administration that such filters
should be removed as soon
as protection from pulmonary
embolisms is no longer needed,
as extended insertions can lead
to complications like lower
limb deep vein thrombosis, filter
fracture, filter migration, filter
embolization and inferior vena
cava perforation.
The study, performed by
Birkmeyer et al, analysed data
from 29,326 patients included
in the prospective statewide
clinical registry of the Michigan
Bariatric Surgery Collaborative,
between 2006 and 2011.
Researchers used logistic re-
gression to assess relationships
between IVC filter insertion
and complications within 30
days of surgery, while controlling for patient risk factors,
bariatric procedure type, and
propensity score.
3.5% of the patients (1,018)
underwent filter placement
before their operation, 62% of
whom had no history of venous
thromboembolism.
0.43% of patients with IVC
filters had venous thromboembolism, compared to 0.21%
in the population of patients
without filters (p=0.019). 2.8%
of the IVC group had serious
complications; only 2.0% of
patients without IVC filters did
(p = 0.038).
The mortality rate in the
IVC and non-IVC groups was
0.2% and 0.05% respectively
(p=0.013). Of the patients with
IVC filters that died, four had
pulmonary embolism and two
had IVC thrombosis/occlusion.
Other serious IVC filter specific
complications included IVC
filter migration in two patients.
The study is the second that
the group has performed concerning IVC filters in bariatric
patients; the first, “Preoperative
placement of inferior vena cava
filters and outcomes after gastric
bypass surgery” (Ann. Surg..
2010 252(2):313-8.) found a
lack of benefit of filter insertion
for the prevention of pulmonary
embolism in bariatric patients,
but did not have the statistical
power to prove harms associated
with the practice.
Trio of studies underlines sleeve gastrectomy safety
Three new studies presented at the Annual Meeting
have shown that laparoscopic sleeve gastrectomy offers
comparable safety to gastric bypass and gastric banding.
In one study, Stanford University
researchers analysed safety data from
the BOLD database, including nearly
270,000 metabolic and bariatric surgeries performed between 2007 and 2010.
Almost 6% (nearly 16,000) of the surgeries were sleeve gastrectomies, which
had a 30-day serious complication rate
of 0.96%, compared to 1.25% for gastric
bypass and 0.25% for gastric banding.
The 30-day mortality rate for sleeve
gastrectomy was 0.08%, compared to
0.14% for gastric bypass and 0.03% for
gastric banding. The ASMBS pointed
out that this is lower than is typically
associated with gallbladder or hip replacement surgery.
Patients in the study saw their BMI
drop by an average of 30% after one year
(47.5 to 34.1) after sleeve gastrectomy,
compared to 40% for gastric bypass and
20% for gastric bands.
“In terms of risk and benefit, sleeve
gastrectomy sits nicely between gastric
bypass and adjustable gastric band,” said
lead study author John Morton, MD, as-
sociate professor of surgery and director adopted in America.
“Sleeve gastrectomy has proven
of bariatric surgery at Stanford Hospital
itself to be a safe and effective option
& Clinics at Stanford University.
in patients with morbid obesity and
Proof of safety
this procedure should be considered a
These data, along with several other large primary procedure for weight loss and
studies published within the last two years, obesity-related disease improvement and
were recently submitted to the Centers for resolution,” said Dr Robin Blackstone,
Medicare & Medicaid Services (CMS), president of the ASMBS.
as the agency considers a new national
In a further study, researchers from
coverage determination for laparoscopic Cleveland Clinic Florida reviewed safety
sleeve gastrectomy for its beneficiaries.
outcomes of more than 2,400 of their
The CMS recently proposed coverage patients who had sleeve gastrectomy,
for sleeve gastrectomy only as part of a gastric bypass or bariatric and metabolic
randomised control trial, ruling that cur- surgery between 2005 and 2011.
rently available evidence is insufficient
The study found sleeve gastrectomy
to support its widespread adoption.
had the lowest complication and reoperaThe ASMBS disagree, and are keen tion rates of the three procedures.
for sleeve gastrectomy to be more widely
1.5% of sleeve gastrectomies in the
study required reoperation due to complications. This is much lower than for
gastric band and gastric bypass, which
resulted in 15.3% and 7.7% requiring
reoperation respectively.
On average, patients had a BMI
between 44 and 48, were 46 years of age
and had at least two comorbidities.
A third study comparing sleeve gastrectomy with gastric bypass conducted
by the Naval Medical Center in San
Diego found while bypass patients lost
more of their excess weight after the first
year (72.3% versus 63.7%), there were no
statistically significant differences in excess weight loss after two and five years.
This study examined 486 patients.
Half had gastric bypass and half had
sleeve gastrectomy.
Lin
12 BARIATRIC NEWS
ISSUE 13 | AUGUST 2012
29th Annual Meeting June 17–22 2012 San Diego, CA
Bypass surgery reduces risk of heart attack
Gastric bypass surgery can lead to significantly reduced
cardiac risk factors even seven years after the operation, according
to new research presented at the ASMBS’ 29th annual meeting in
San Diego.
The study, ‘Long Term Improvement in Biochemical Cardiac
Risk Factors Following Gastric Bypass’, found that 11 risk factors
for heart attack, including total cholesterol, triglycerides and Creactive protein levels, remained greatly reduced in patients during
long-term follow-up.
“Patients significantly decreased their risk for having a heart attack within the first year of surgery and maintained that benefit over
the long-term,” said lead study author John Morton, MD, associate
professor of surgery and director of bariatric surgery at Stanford
Hospital & Clinics at Stanford University.
The study involved 182 patients who had surgery and follow-up
beyond three years at Stanford between 2003 and 2011. Patients
were 44 years old on average, and had an average BMI of 47.
In up to seven years of follow-up, patients maintained 56%
EWL on average. Almost 25% of patients were on statins before
surgery: these were discontinued shortly afterwards.
High sensitivity C-reactive protein fell by 80% (10.9 to 2.6mg/
dL), a result which Morton described as “astounding”.
“This is significantly better than what the best medical therapy
has been shown to achieve and underscores the inflammatory na-
ture of obesity, which can be reversed with surgical weight loss,”
said Morton.
Patients saw a 40% increase in high-density lipoproteins, a 66%
drop in fasting insulin levels, and a 55% drop in triglycerides.
Researchers also noted significant decreases in blood pressure
and diabetes markers like fasting insulin and hemoglobin A1c.
The US government estimated that in 2008, annual obesityrelated health spending reached $147 billion, double what it was
a decade ago.
Study co-authors include Nayna Lodhia, Leanne Almario, Adam
Eltorai, Jaffer Kattan, Matthew Kerolus, and Margaret Nkansah, all
from Stanford University.
Sleeve gastrectomy improves chances of organ transplant
Morbidly obese patients with end-stage organ failure may increase their
chances of successful organ transplantation by undergoing laparascopic
sleeve gastrectomy, according to a new study presented in San Diego.
The paper, ‘Laparoscopic Sleeve Gastrec-
tomy Is Safe And Efficacious For Pre-Transplant
Candidates’, examined 26 patients with an
average age of 57, who presented with end-stage
kidney disease (n=6) and severely compromised
liver function (n=20).
Within nine months of surgery, six patients
had liver transplants, one patient had a kidney
transplant, one had a combined liver and kidney
transplant, and one patient’s kidney function
improved to the point that he was taken off the
transplant list. 16 more patients are currently on
the transplant list and have lost enough weight to
qualify for transplantation.
The remaining patient in the study died four
years after surgery while waiting for a transplant.
There were six complications among the group.
Researchers say most US centres will not perform organ transplantation in patients with BMIs
of more than 35-40. The average starting BMI of
the patients in the study was 48.3.
“This study suggests sleeve gastrectomy
may be performed safely in carefully selected
morbidly obese patients with impending organ
failure and the significant weight loss they
achieve may make them more suitable candidates
for transplantation,” said lead study author Matthew Yi-Chih Lin, MD, a bariatric surgeon at the
UCSF School of Medicine.
While the study had a relatively low number
of participants, the study authors claim that it is
the largest study to examine the impact of gastric
sleeve surgery on pre-transplant patients.
The patients in the study lost 17% of their excess weight at one month, 26% at three months,
50% at 12 months and 66% at two years. As
well as the weight loss, seven of the 13 patients
with type 2 diabetes showed complete resolution
of the disease; one further patient was able to
significantly reduce insulin use.
According to the US government figures,
there were 16,898 kidney transplant procedures
in 2010, with 94,598 people on the waiting list.
Liver transplants numbered 6,291, with 16,954
people on the waiting list. About one-third of
people on organ transplantation waiting lists are
obese and as many as 15% are morbidly obese.
The surgeons in the study choose sleeve
gastrectomy over other methods because the procedure avoids implantation of foreign bodies like
gastric bands in immunosupporessed patients. It
also maintains endoscopic access to the biliary
system.
The ASMBS is currently in a disagreement
with Centers for Medicaid and Medicare Services
(CMS) after the latter proposed coverage for
sleeve gastrectomy only as part of a randomised
control trial, ruling that currently available
evidence is insufficient to support its widespread
adoption. The ASMBS, among other medical
groups, responded that the CMS did not consider
all relevant evidence when making their decision.
Co-authors for the study include Ankit Sarin,
MD, Mehdi Tavakol, MD, Shadee M. Amirkiai,
BS, Stanley J. Rogers, MD, Jonathan T. Carter,
MD, Andrew M. Posselt, MD, PhD.
Matthew Yi-Chih Lin
EndoBarrier helps diabetes factors in the overweight
The EndoBarrier duodenal-
jejunal bypass liner leads to “substantial”
metabolic improvement in overweight
and mildly obese type 2 diabetes patients, according to new data presented
at the annual meeting.
In the study, ‘Metabolic Improvements
in Type 2 Diabetes in Subjects Without
Severe Obesity With the Endoscopic
Duodenal-Jejunal Bypass Liner’, saw the
diabetic factors HbA1c, fasting plasma
glucose, and low-density lipoprotein,
drop after 12 months.
Three months after implant, 12
out of 19 patients (63.2%) exhibited
HbA1c levels under 7.0%, the level
at which diabetes is considered to be
controlled. Eight out of 13 patients
(61.5%) demonstrated HbA1c under
7% after 12 months.
The Endobarrier’s inventors, GI
Dynamics, are marketing the device as
a potential cure for diabetes as well as
for obesity.
“Our data point to a substantial
improvement in glycemic control
and other metabolic parameters even
among overweight – but not severely
obese – diabetic patients during
EndoBarrier Therapy,” remarked study
lead author Dr Ricardo V Cohen, from
the Center for the Surgical Treatment
of Morbid Obesity and Metabolic
Disorders, Hospital Alemão Oswaldo
Cruz, São Paulo, Brazil.
Ricardo Cohen
“These are promising data and
suggest that EndoBarrier may play a
valuable role for overweight patients
struggling to control their diabetes and
lose weight.”
Method and results
Twenty-three overweight and mildly
obese patients (BMI 23-36) were
enrolled for the study, all of whom had
type 2 diabetes were treated with oral
agents alone. 20 of the 23 subjects were
successfully endoscopically implanted
with the liner; three could not due to
unfavourable anatomy.
Over the 12 months of the study, there
were four early endoscopic removals:
twice because of device movement,
once because of abdominal pain, and
once after principal investigator request.
Follow-up
included
monthly
determinations of HbA1c, fasting
plasma glucose, lipids, and percentage
total body weight loss.
At the start of the study, patient
baseline HbA1c was 8.7±0.20%,
fasting plasma glucose was
at 197.5±16.8mg/dl, lowdensity lipoprotein was at
137.8±13.1mg/dl, triglycerides
were at 226.1±35.5mg/dl, and
average BMI was 30.2±0.83.
The device remained in place
for one year in 13 out of 17
patients (76.4%); three patients
kept their devices in place after
the endpoint of the study.
At one year, the patients’
HbA1c had decreased
by 1.3±0.37%, fasting
plasma glucose had
dropped by 44.1±20.7mg/
dl, low-density lipids had
decreased by 25.6±7.0mg/
dl, and triglycerides by
42.5±17.3mg/dl.
The patients’ total body
weight
loss
dropped
by
8.4±1.7%.
Patients in the study were men
and women between 18 and 55 years
who had type 2 diabetes for ten years
or less and were on oral diabetic
medications. Their initial HbA1c
levels were between 7.5 and 10%.
EndoBarrier
The EndoBarrier is an attempt to mimic
the effect of the intestinal bypass component of the Roux-en-Y gastric
bypass.
The device has already
been tested in a study by
Escalona et al (Ann. Surg..
2012 255(6):1080-5), which
examined the benefits of the
device in morbidly obese patients,
in terms of weight loss and metabolic
function.
The study found that patients
underwent significant weight loss and
improvements in cardiometabolic risk
factors after one year.
EndoBarrier
received
CE
Mark approval
for Europe in
2010 as well as
approval by the
Therapeutic Goods
Administration in
Australia in 2011 for
the treatment of type 2
diabetes and/or obesity.
EndoBarrier is currently
commercially available in
some European markets, as
well as Chile and Australia.
BARIATRIC NEWS 13
ISSUE 13 | AUGUST 2012
CMS allows LSG procedures in
some Medicare centres
The Centers for Medicare and Medicaid Services
(CMS) has announced its decision on coverage for
the laparoscopic sleeve gastrectomy (LSG). The final
decision will allow LSG to be covered by intermediary
Medicare administrators as a stand-alone procedure at
their discretion.
Reversal
The decision is a reversal of
their proposed coverage, as reported
in issue 12 of Bariatric News, to only
allow coverage of LSG as part of a randomised, controlled trial. However, the
announcement falls short of a national
coverage determination.
The CMS’ decision stated that
Medicare Administrative Contractors
acting within their respective
jurisdictions may determine coverage
of stand-alone LSG for the treatment
of co-morbid conditions related to
obesity in Medicare beneficiaries only
when all of the following conditions
1–3 are satisfied:
1.The beneficiary has a BMI ≥35kg/
m2,
2.The beneficiary has at least one comorbidity related to obesity, and
3.The beneficiary has been previously
unsuccessful with medical treatment
for obesity.
The decision statement also added
that the CMS believes that the available evidence “does not clearly and
broadly distinguish the patients who
will experience an improved outcome
from those who will derive harm such
as postoperative complications or
adverse effects from LSG.”
However, in its statement the CMS
does acknowledge the seriousness
of obesity and the possible benefits
of LSG in highly selected patients in
qualified centres, and has therefore
decided that local Medicare contractor
determination “on a case-by-case basis
balances these considerations in the
interests of our beneficiaries.”
The statement concluded that: “Our
local contractors are in a better position
to consider characteristics of individual
beneficiaries and the performance of
eligible bariatric centres within their
jurisdictions. Therefore, Medicare
Administrative Contractors acting
within their respective jurisdictions
will make an initial determination of
coverage under section 1862(a)(1)
(A) and we are not making a national
coverage determination under section
1869(F).”
ASMBS response
In a response posted on the their
website, the ASMBS commented:
“On behalf of our patients, ASMBS
is very pleased and gratified that
CMS has recognised the true value
and compelling need for coverage
of this procedure. ASMBS will immediately initiate the formal pathway
for coverage with each regional CMS
intermediary.”
The Society added that the
overwhelming response from patients,
surgeons and integrated health
members, along with the strong
evidence base for LSG, provided
CMS with a “persuasive argument
for LSG coverage”. In addition,
they acknowledged that the multidisciplinary support of the American
College of Surgeons, SAGES, The
Obesity Society and the American
Society of Bariatric Physicians
displayed an Obesity Care Coalition
in action working for patients’ best
welfare.
“We will now go forth to each
individual intermediary, and this
decision will open the door to
widespread coverage based on the
strong, available evidence. We are
confident coverage will be achieved,”
the statement concluded.
The CMS had previously approved
national coverage for Roux-en-Y
bypass, laparoscopic adjustable gastric
banding and biliopancreatic diversion
with duodenal switch.
Surgery results in positive
social and health changes
Bariatric patients reported
an overall improvement in quality of life
issues after surgery, according to a study
by Arizona State University researchers
presented at the 107th Annual Meeting of
the American Sociological Association.
The paper, “Social and Health
Changes Following Bariatric Surgery,”
assessed how bariatric patients felt
post-surgery. The researchers collected
data from 213 patients, aged from 26
to 73 years old (average age 50), via a
self-selected sample of participants in an
online support group.
Researchers asked a variety of
questions in the survey that was made
available through an online support
group for bariatric patients. Study
questions examined physical health,
self-esteem, social life, work life,
family life, mobility and satisfaction
with surgery results.
“We thought there would be more
negative reactions to the surgery, but the
response was very positive,” said study
co-author Jennie Jacobs Kronenfeld,
an ASU School of Social and Family
Dynamics professor. “Most people
had improvements in chronic health
problems.”
The study also recorded the patients
motivation to have the surgery. In order
of importance they were:
n to decrease the risk of health
problems;
n to improve overall health;
n to improve appearance; and
n to boost self esteem
Health issues that respondents reported
improvements in included diabetes,
heart disease, cholesterol level and sleep
apnoea. Study respondents also cited
increased mobility as one of the positive
aspects of having surgery to lose weight.
Weight loss among participants averaged
95lbs per person while the range of
weight experiences was wide (gaining
80lbs to losing 260 lbs).
People who elected to have the
surgery to reduce negative reactions to
their weight among friends and family,
reported better relationships after surgery.
Respondents also reported a decrease
in depression after the surgery.
“This
provides
evidence
that
overcoming the stigma of being
overweight, as reflected by negative
reactions of others, can lead to greater
satisfaction among relationships with
family and friends, and in social life in
general,” said Doris A Palmer, co-author
of the paper and a doctoral student in the
School of Social and Family Dynamics
sociology programme at ASU.
Satisfaction with how participants
felt about their appearance was lower
on average than satisfaction with other
aspects after the surgery.
“They were satisfied, but not as pleased
about the way they looked as with other
aspects of their lives,” said Kronenfeld.
“They may have hanging skin and those
kinds of issues to deal with. It's not clear
if most insurance companies will cover
treatment of those issues since it may be
considered cosmetic.”
ASMBS welcomes Medicare LSG decision
Following the June 27th decision by the CMS to allow local coverage of laparoscopic
sleeve gastrectomy (LSG), bariatricnews.net discussed the decision and its
implications, with Dr John Morton, chair of the ASMBS’ Access to Care Committee.
What was your initial reaction the
CMS’ decision?
My initial reaction was gratification that the CMS
realised that their proposed solution of creating a
randomised controlled trial was not the best step
forward for patients in need. The solution now is to
allow the regional administrators to decide if they
are going to cover LSG. The ASMBS is currently in
discussions with regional administrators to ensure
there will be LSG coverage for Medicare patients.
Given the proposed decision
announced in March 2012, were
you surprised by the U-turn?
We were hopeful that they would change their mind,
but there is never any sort of guarantee. We were
just very pleased that they were able to recognise
the additional evidence-based data we submitted.
In fairness to the CMS, when they carried
out the original review there was a considerable
amount of unpublished data that was not available
to them. Soon after the CMS’ proposed decision
in March, there were four randomised, controlled
clinical trial papers published in quick succession.
So the facts on the ground changed and I think
CMS was quite prudent in recognising the new data
and subsequently allowing LSG coverage.
So we are grateful that the CMS has
acknowledged the strength of the data and that LSG
does play an important role in what is our leading
public health problem. We need more tools at our
disposal and the LSG is a very powerful addition to
our arsenal in dealing with obesity.
The CMS stipulated that Medicare
beneficiaries must have a
BMI>35, at least one co-morbid
condition related to obesity (e.g.,
diabetes, heart disease), and have
previously been unsuccessful
with medical treatment for
obesity. Do you agree with these
requirements?
Yes, the requirements the CMS proposed are consistent with those that have been in place for many,
many years stemming from the 1991 National
Institutes of Health’s NIH Consensus Statement
on Bariatric Surgery. So these requirements do not
represent any significant change.
Regarding the patients with a BMI between
30–35, we are accruing more data and I think
it is becoming clear that patients, particularly
diabetic patients within this weight range would
benefit greatly from bariatric surgery. From a
cost standpoint, if you look at some of the newer
drugs to treat diabetes they are fairly expensive
particularly in the long-term. Therefore, I think
this will be a discussion that will take place sooner
rather than later.
What other aspects of the decision
were you pleased to see?
The CMS proposal from March was focused on the
elderly, which is a small percentage of the overall
Medicare population. The majority of the obese,
Medicare population who need assistance are the
disabled and the leading cause of disability in my
own home state of California is obesity.
The other group to mention are those patients
with end-stage renal disease, who are the only
group of patients in the US who are guaranteed
medical insurance coverage.
This group of patients really could benefit from
LSG as they are potential transplant candidates and
those of us in the bariatric community see LSG as
the ideal procedure for both pre- and post-transplant
patients. This is because there are reduced risk
around medical absorption, no risk of an in dwelling
foreign body on immune suppression, so in many
ways it the most suitable procedure.
It is important to remember that no field of
medicine treats a single disease with a single
medication or procedure, and bariatric and
metabolic surgery is the same. We need any many
options on the table as possible to try and treat what
is a very challenging disease.
How much do you think the CMS
was influence by the actions and
additional submissions of the
ASMBS, SAGES, ASBP etc?
I think it played a significant role. Perhaps more
importantly, I think it demonstrated that we work
best when we work together and we showed that
our interests are not parochial around the surgical
field. We are well and truly in the obesity field and
looking to get all the possible tools at our disposal.
I think it also showed what it takes to rally the
surgical and patient community. The ASMBS,
working with the Obesity Action Coalition,
was able to get the word out and
mobilise patients and surgeons
alike.
For example, there were well
over 400 submissions received
during the comment period
and the vast majority spoke
in favour of LSG. This was
a huge increase from the 150
comments the CMS received
in the previous comment period.
I think it was really encouraging to
see this level of support.
For our readers
outside of
the USA,
could you
explain
the CMS’
decision
to allow
local Medicare contractors to
decide coverage and whether this
will mean a patient’s location will
determine if they are eligible?
This is something that is currently being discussed. In general, most of the regional administrators work in closely together, so this allows
the CMS to reach an appropriate conclusion and
gives them a degree of flexibility on a regional
level. We are hoping to reach out to all regional
administrators and convince them that LSG
coverage is the way forward.
What are the next steps the
ASMBS will take in regards to
gaining national coverage for LSG?
We will be publishing additional data from the
BOLD database, which showed that LSG was
positioned between the bypass and the band in
terms of safety and efficacy. We will also be reaching out to the regional administrators and to try
and ensure that everybody who means the
criteria has the opportunity to receive
the procedure.
The CMS’ decision is a positive
one for patients and the experience
has been a positive one for the
surgical community as we have
been able to put patient safety at the
centre of the argument, supported by
evidence-based medicine. Ultimately,
the decision is a positive one for the
country as we are going to be able to
treat many individuals who will
be able to lead a more
productive and
fulfilling role in
society.
John Morton
14 BARIATRIC NEWS
ISSUE 13 | AUGUST 2012
Coffee time with Pradeep Chowbey
Bariatric News speaks to Dr Pradeep Chowbey, Director – Max Institute of
Minimal Access, Metabolic & Bariatric Surgery, Max Healthcare, New Delhi
and Congress President of the XVII World Congress of the International
Federation for the Surgery for Obesity and Metabolic Disorders – IFSO 2012,
New Delhi, India.
Why did you decide to enter advanced laparoscopic procedures
and we believed that the technology
medicine?
I am from a small community and
the most important person in the
community was the doctor. The
doctor treated everyone including
other respected professionals such
as lawyers, judges and teachers. My
father was also a doctor (a surgeon).
I grew up with people of all stature
visiting my house. They were very
respectful towards my father, seeing
him as altruistic, generous and
helpful. Growing up, this was a very
strong motivation for me.
Why did you decide to
specialise in bariatric
surgery?
Bariatric surgery is very demanding
and each case presents different
challenges. But it is also very
rewarding enabling patients to
eradicate a very sinister disease,
which not only contributes to other
diseases such as diabetes, heart and
kidney disease, but in itself ruins the
patients’ quality of life. A bariatric
surgeon helps to eradicate not
only obesity but also its associated
diseases.
As I attended more conferences
and workshops around the world,
I could see an increasing focus
on laparoscopic procedures for
obesity. At the time, there were
very few patients presenting with
morbid obesity in India. However, we
knew that with the country’s rapid
economic growth this would increase
and in the late 1990s we began to
see an increase in the number of
morbidly obese patients.
We were already performing quite
could bring great benefits to this
group of patients. Many people,
including some doctors, were not
aware of the problems associated
with obesity, so we faced many
issues educating people about the
benefits of surgery.
However, there was also a need to
educate the wider population. I was
the Surgeon to the President of India,
so I was fortunate to be in a position
where I could interact with the high
officials and policy makers to make
them aware of the menace of obesity
hovering our country. As a result,
we were able to influence policy
and created an obesity awareness
campaign in schools and media.
Who have been your
greatest influences and
why?
My father has been the greatest
influence on my career, not only for
his surgical attributes but also for his
humanitarian attributes.
I was also greatly influence by
Professor O P Mishra, who was a
meticulous surgeon and dedicated
to his patients. He would remain with
the patients following surgery in case
there was an emergency. He was a
great inspiration to me!
What experience in your
training has taught you the
most valuable lesson?
When I started my surgical training
abscesses (collection of pus in the
body) used to be very common. We
were taught that the first course of
action was to make an incision and
drain the pus. This was seen as a
critical intervention and the earlier you
performed the intervention, the better
resident you were. This taught me the
important lesson to understand the
suffering of the patients and it was
deeply imbedded in my psyche. I still
uphold these principles today.
Tell us about one of your
most memorable career
experiences?
The most important moment in my
career was when I operated on
His Holiness the Dalai Lama. I had
previously operated on the president
of India, which was a great honour
and at that time I thought that it was
the pinnacle of my career.
In 2008, I had the honour of
operating on the Dalai Lama and I
realised that he may not be the chief
of a nation, but jewel of the world
and who ruled the hearts of people
all over the world. He is seen as the
incarnation of Buddha and is seen
all over the world as a great man. I
was deeply honoured to have been
chosen by him to be his surgeon.
It gave me a tremendous sense of
achievement. It was a great lesson of
peaceful existence in the world.
When I met him he told me he
knew about me, not by name, but
by my face. He knew four years
previously that he would require
surgery and decided on the features
of his surgeon – he is a man of great
intuition.
Can you tell us about
your obesity awareness
campaign in India over the
last decade?
The disease of obesity is probably the
most expensive to treat or manage
because it can lead to so many other
conditions. This is why it is important
to make people aware of its dangers
and educate our patients.
When we began the awareness
programmes in schools, I asked the
teachers to explain to parents about
the body mass index and the dangers
associated with an increasing BMI.
I also made presentations to the
president of India and the Ministry of
Health. Of course, the priority in our
country and the Indian sub-continent
are infectious diseases so there
are few resources available to help
prevent or treat lifestyle diseases.
How should we tackle the
obesity pandemic?
By awareness and education, A
country like India cannot afford an
obese population. We have to make
sure obesity awareness is taught
in schools and children grow up
knowing the dangers of the disease.
We know that 80% of obese children
will continue to be obese throughout
their lives. Everyone should know
their BMI, should know the effects
obesity has on the human body and
the long-term effects obesity could
have on their health.
What are the biggest
challenges facing bariatric
surgeons in India over the
next ten years?
The lifestyles of the population have
changed so dramatically over such
a short period of time that the vast
majority of people do not realise that
the ever increasing levels of obesity
are counter-productive.
In regards to surgery, one of the
biggest challenges is that in order
to have surgery patients must
pay cash, as insurance does not
cover bariatric surgery. In the near
future, I would like to see insurance
coverage of bariatric procedures.
Not only will this provide many more
people with the opportunity to have
life-saving surgery, but it will also
increase awareness about obesity.
It will be in the insurance company’s
Turning white adipose tissue
into brown adipose tissue
Researchers at the Columbia University
Medical Center (CUMC) claim to have identified
a mechanism that can give energy-storing
white adipose tissue (WAT) some of the
beneficial characteristics of energy-burning
brown adipose tissue.
The study could have implications for how new treatment
strategies for treating obesity and type 2 diabetes are developed. The
study was published in the journal Cell (2012 Aug 3;150(3):620-32).
“We have known for a long time that WAT stores excess energy
as triglycerides, whilst BAT burns energy as heat,” said study leader
Dr Domenico Accili, professor of medicine and the Russell Berrie Foundation Professor at CUMC. “Turning WAT into BAT is an
appealing therapeutic approach to staunching the obesity epidemic,
but it has been difficult to do so in a safe and effective way.”
Previous research has shown that by using thiazolidazines (TZDs)
it is possible to turn WAT into BAT (a process called “browning”), as
they activate a cell receptor called peroxisome proliferator-activated
receptor-gamma (ppar-gamma). However, the exact mechanism had
not been identified.
In addition, the use of TZDs has so far been limited due to their
adverse effects including liver toxicity, bone loss and weight gain.
The Columbia University study was undertaken to learn more
about the function of TZDs, with the ultimate goal of developing
better ways to promote the browning of WAT.
Accili and his colleagues studied a group of enzymes called
sirtuins, which are thought to affect various biological processes,
including metabolism.
The researchers had previously shown in mice that when sirtuin
activity increases, so does metabolic activity. In the present study,
they found that sirtuins boost metabolism by promoting the browning of WAT.
Sirtuins work by severing the chemical bonds between acetyl
interest to increase awareness about
the dangers of obesity. A second
challenge is to create more centres
of excellence of bariatric surgery in
and around our major cities. We need
to train and equip large numbers
of healthcare professions for the
inevitable rise in patients.
What are you current areas
of research?
We will soon be publishing the
five-year results from a clinical
study looking the outcomes for
200 patients with low BMI’s of 27
to 32.5. This study included the
study of procedures such as sleeve
gastrectomy and gastric bypass, and
I believe the five-year outcomes, in
terms of diabetes resolution, are quite
exciting. We expect to publish the
results in the next six months.
Away from surgery, how do
you relax?
My biggest relaxation is to be with
my family, my wife, my son and
daughter. All four of us are interested
in fine art and enjoy visiting galleries,
exhibitions and auctions. I particularly
enjoy speaking with artists and
learning about what inspires them
and discussing the emotions they
feel when creating their works of art.
When we are travelling on holiday, we
always visit places that have a rich
collection of museums and galleries.
What can delegates enjoy
away from the Congress?
Our country is such a wonderful
place to visit and our colleagues
from all over the world should come
and experience the warm hospitality
of India. India has something for
everyone and is a country with a rich
cultural history including one of the
Seven Wonders of the World. And
of course, the World Congress will
be blessed by his holiness the Dalai
Lama, and delegates will be able to
ask him questions about his latest
book, Beyond Religion: Ethics for the
whole world. This will be a unique
experience for all attendees.
groups and proteins, a process known as deacetylation.
“When we sought to identify how sirtuins promote browning, we
observed many similarities between the effect of sirtuins and that of
TZDs,” said lead author Dr Li Qiang, associate research scientist
in Medicine at CUMC. “So the next question was whether sirtuins
remove acetyl groups from ppar-gamma and, indeed, that was what
we found.”
To confirm that the deacetylation of ppar-gamma is crucial to the
browning of fat, the researchers created a mutant version of ppargamma, in effect mimicking the actions of sirtuins. The mutation
promoted the development of BAT-like qualities in WAT.
“Our findings have two important implications,” said Accili.
“First, they suggest that TZDs may not be so bad if you can find a
way to tweak their activity. Second, one way to tweak their activity is by using sirtuin agonists, that is, drugs that promote sirtuin
activity.”
“The truth is, making sirtuin agonists has proved to be a real bear,
more promise than fact,” he added. “But now, for the first time, we
have a biomarker for good sirtuin activity: the deacetylation of ppargamma. In other words, any substance that deacetylates ppar-gamma
should in turn promote the browning of white fat and have a beneficial
metabolic effect.”
The additional researchers were Ning Kon (CUMC), Wenhui
Zhao (CUMC), Sangkyu Lee (University of Chicago), Yiying Zhang
(CUMC), Michael Rosenbaum (CUMC), Yingming Zhao (University
of Chicago), Wei Gu (CUMC), and Stephen R Farmer (Boston University School of Medicine).
Our new website…
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18 BARIATRIC NEWS
ISSUE 13 | AUGUST 2012
ISSUE 13 | AUGUST 2012
BARIATRIC NEWS 19
20 BARIATRIC NEWS
ISSUE 13 | AUGUST 2012
Surgery quality
varies widely in US
Bariatric surgery is quicker, safer and cheaper in higher-quality
hospitals, but US care provision varies widely, according to a new report.
The report, “Choosing Bariatric Surgery to
Improve Overall Health”, examined the outcomes
of 201,821 bariatric operations between 2008 and
2010, and found that while bariatric surgery was
generally safe, there was a large amount of variation between levels of service offered by hospitals
around the country.
The paper also reported that bariatric procedures
in the 478 hospitals included in the study dropped by
6.39% over the three years, from 69,724 procedures
in 2008 to 63,868 procedures in 2010. It reported on
a total of 201,821 operations.
The report, published by health care provider
rating company HealthGrades, measured results
from 478 hospitals in 19 states, rating them as fivestar, three-star or one-star locations. They found that
patients in five-star programmes were 72.26% less
likely to experience an in-hospital complication than
patients at one-star programmes.
HealthGrades say that their hospital ratings are
independently created; no hospital can opt in or opt
out of being rated, and no hospital pays to be rated.
The in-hospital average complication rate for
one-star hospitals was 11.79%, compared to 3.03%
for five-star hospitals. HealthGrades calculate that
5,788 patients in their study could have avoided a
complication if the one-star centres had performed at
the same level as the five-star centres.
Patient volume also had a significant effect on
complication rate: 7.99% of procedures in hospitals
that performed under 75 operations in the three-year
period suffered from a complication, compared to
5.71% of patients in centres performing over 375
operations in three years.
Patients had an average stay of 1.88 days after their
operation in five-star programmes, half a day less than
the average 2.37-day stay in one-star programmes.
One-star hospitals charged on average $3,189
more than five-star programmes, a fact that the
report suggested may be due to the higher rate of
complications in the poorer-quality centres.
Geographical differences
Cost and provision of bariatric surgery differed dramatically across the 19 states that were studied. The
most inpatient procedures were performed in California, New York, and Texas, with 19.25%, 12.85%
and 11.86% of the total procedures respectively. Collectively, Iowa, Utah and Rhode Island performed
less than 3% of inpatient procedures.
Massachusetts and North Carolina showed
large increases in the number of inpatient bariatric
procedures, with an increase of 29.7% (3,771 to
4,891) and 24.65% (2,974 to 3,707) respectively;
meanwhile, Arizona, Rhode Island and Virginia
experienced declines in the number of inpatient
bariatric procedures, with drops of 31.61% (2,249 to
1,538), 30.87% (554 to 383) and 30.23% (3,166 to
2,209) respectively.
The most expensive state to receive a bariatric
operation in was found to be California, where the
average charge was $56,744 for a laparoscopic
procedure and $69,963 for an open procedure;
meanwhile, a laparoscopic procedure in Maryland cost
on average $15,631 and an open procedure $18,406.
The study found that the average cost for a
laparoscopic procedure was $41,594, and $45,137
for an open procedure.
Sharp drop in US gastric band operations
The number of laparoscopic gastric band
operations in the US dropped by around 20%
since 2011, indicating scepticism in the country’s
medical community over its efficacy and the
increasing popularity of new operative techniques.
In their second-quarter
earnings call, released August
1, Allergan, manufacturer of the
Lap-Band, reported that gastric
banding had a 33% share of the
bariatric market in May 2012,
down from “the low forties” in
2011.
David Pyott, CEO of Allergan, said that banding in the
US was losing to gains in laparoscopic sleeve gastrectomy,
which had garnered a 31% share
of US operations in May 2012.
Although Allergan’s secondquarter 2012 international net
product sales across their entire
product range were 8.7% up on
the previous year and secondquarter earnings were up yearon-year, their obesity intervention line declined 24.1%.
Allergan’s bariatric product
line consists of two products:
the Lap-Band, and the Orbera
gastric balloon, which sells
outside of the USA.
Pyott said that it was “encouraging” that the decline in
the overall US bariatric market
is flattening, saying that the
rate of decline in the last three
months to may was estimated at
2%, compared to 6% throughout 2011.
However, he admitted that
in a time of high unemployment, high patient co-pays
were a barrier for many, even in
patients with insurance coverage.
Following the publication
of the financial results, Allergan’s stock price jumped
10.5%, from $82.07 to $90.68.
Gastric bands
Allergan’s financial results
point to a diminishing role for
laparoscopic gastric bands in
US bariatric surgery. Their
Lap-Band makes up 90% of
the US gastric band market; the
only other FDA-approved band
is Ethicon’s Realize system.
While gastric bands generally result in fewer serious
complications than Roux-en-Y
gastric bypass, several studies
suggest that it is less clinically
effective over the long term.
Dr Luigi Angrisani recently
reported that in his 10-year
study, bypass patients were
likely to lose more weight and
keep it off for longer than band
patients. Another recently published six-year case-matched
study reported that Roux-en-Y
gastric bypass is associated
with better weight loss, resulting in a better correction of
some comorbidities than gastric
banding.
Sleeve gastrectomy is often seen as a useful midpoint
between gastric bypass and
gastric banding: more effective than banding, and with
fewer complications than bypass. In America, the Centers
for Medicare and Medicaid
Services recently announced
the operation could be supplied by some Medicaid
administrators.
Obesity drugs
While the FDA have recently
approved two anti-obesity
drugs in the USA – Belviq and
Qsymia – Pyott said he did not
see them as a further threat to
Allergan’s two obesity products.
“It’s a different type of
patient in terms of the number
of kilos they want to lose, and
I think that touches much more
diet change and exercise,” he
said.
Covidien
Meanwhile,
reported a third-quarter rise in
net sales of 3%, which included
sales of $2.06 billion in their
medical devices division,
fuelled in part by double-digit
gains for their line of staplers.
Johnson and Johnson, who
own Ethicon EndoSurgery,
reported second-quarter sales
of $16.5 billion, a year-on-year
decrease of 0.7%.
BARIATRIC NEWS 21
ISSUE 13 | AUGUST 2012
Bypass surgery alters gut
microbiota profile
Study urges Vitamin D
deficiency screening
Gastric bypass surgery
induces changes in the gut
microbiota and peptide release,
a study presented at the Annual
Meeting of the Society for the
Study of Ingestive Behavior has
found.
Previous animal research has
shown that ingestion of a highfat diet produces weight gain and
profoundly affects the gut microbiota composition, resulting
in a greater abundance of phyla
bacteria called Firmicutes, and
a decrease in Bifidobacteria spp
and Bacteroidetes (Cani et al, J.
Nutr. Biochem. 2011 22(8):71222, Cani et al Diabetes. 2007
56(7):1761-72 and Diabetologia. 2007 50(11):2374-83, de
Wulf J. Nutr. Biochem. 2011
22(8):712-2) . A similar pattern
has also been found in obese
humans.
Feeding of prebiotics, substances that enhance the growth of beneficial bacteria,
changes the composition and/or the activity of the
gastrointestinal microbiota, to promote the release of gut
peptides and to improve glucose and lipid metabolism in
diet-induced obese and type 2 diabetic mice.
“Our findings show that Roux-en-y gastric bypass
(RYGB) surgery leads to changes in gut microbiota that
resemble those seen after treatment with prebiotics,”
said lead author of the study, Dr Melania Osto, Institute
of Veterinary Physiology, Vetsuisse Faculty University
of Zurich, Switzerland. “The results of this study suggest that postsurgical gut microbiota modulations may
influence gut peptide release and significantly contribute
Adolescents should undergo
to the beneficial metabolic
effects of RYGB surgery.”
In her presentation,
Osto said that recent studies have reported substantial shifts in the composition of the gut microbiota
towards lower concentrations of Firmicutes and
increased Bacteroidetes in
obese subjects after RYGB
(Furent el at Diabetes.
2010
59(12):3049-57,
Zhang et al Proc. Natl.
Acad. Sci. U.S.A.. 2009
106(7):2365-70,
Bueter
et al, J Vis Exp. 2012
Jun 11;(64)). Most of the
human studies on gut microbiota have been carried
out using faecal samples,
which may not accurately
represent how RYGB
Melania Osto surgery affects the gut
microbiota profile along
different parts of the intestine.
This new measured the bacterial composition and
the amounts of different peptides that affect food intake
along different intestinal segments after RYGB in rats.
They reported that 14 weeks after surgery, Bifidobacteria spp, and Bacteroides-Prevotella spp content were
significantly increased, especially in the small intestine
of the RYGB rats compared with control animals.
Osto concluded that following RYGB, not only do
changes in gut microbe populations resemble those seen
after treatment with prebiotics, but microbiota changes
were also associated with altered production of gastrointestinal hormones known to control energy balance.
vitamin D deficiency screening before having bariatric surgery, according to research
presented at The Endocrine Society's 94th
Annual Meeting.
The study, carried out researchers at
Columbia University Medical Center, New
York, found that the majority of adolescents
preparing for surgery were deficient in
vitamin D.
“This is particularly important prior to
bariatric surgery where weight loss and
decreased calcium and vitamin D absorption in some procedures may place these
patients at further risk particularly as they
have not reached their peak bone mass,”
said study lead author Dr Marisa Censani,
pediatric endocrinology fellow at Columbia.
“These results provide insight into
prevalence and risk factors for pre-existing
vitamin D deficiency in obese adolescents
prior to bariatric surgery.”
While previous studies have found an increased risk of vitamin D deficiency among
adults evaluated for weight-loss surgery,
whether this deficiency also occurred among
morbidly obese adolescents remained unclear. The investigators conducted the study
to determine the prevalence of vitamin D
deficiency in morbidly obese adolescents
evaluated for bariatric surgery
Study
Investigators analysed the medical records
of 236 adolescents who were being considered for bariatric surgery between March
2006 and June 2011. Of these patients, 219
provided medical records that included data
on vitamin D levels. 65% were female,
their average age was 16 years and a mean
BMI 48.2. 43% were Caucasian, 35% were
Hispanic and 15% were African American.
The study defined levels of serum
25OHD as:
n Adequate >30ng/mL
nInsufficient 20-29 ng/mL
nDeficient <20ng/mL
n Severely deficient <10ng/mL
Censani and her co-investigators found that
45% of adolescents undergoing evaluation
for weight-loss surgery were vitamin D
deficient and 9% had severe deficiencies
(totalling 54% of the patient group). 29%
and 17% had insufficient and adequate
vitamin D levels, respectively.
They also reported that patients with the
highest BMIs were the most likely to be vitamin deficient, with each kilogram increase
in BMI correlating with a 0.2ng decrease in
25OHD levels.
The investigators also identified several
racial differences and reported that African
Americans (82%) were the most likely to be
vitamin D deficient, followed by Hispanics
(59%), while Caucasians (37%) were the
least likely to have a deficiency.
“These results support screening all
morbidly obese adolescents for vitamin
D deficiency, and treating those who are
deficient, particularly prior to bariatric
procedures that could place these patients at
further risk,” Censani said.
The NIH National Institute of Diabetes
and Digestive and Kidney Diseases funded
the study.
22 BARIATRIC NEWS
ISSUE 13 | AUGUST 2012
IFSO news...IFSO news...IFSO news...
Invitation
Dear Esteemed Colleagues and Friends,
and Bariatric Surgery, we feel
On behalf of the Taiwan Society for Meta bolic
to participate in the 2013 IFSO-Asia
privileged to extent to you this cordial invitation
take place at the Crowne Plaza
Pacific Chapter Meeting, which is scheduled to
April 10 to April 13, 2013.
Hotel Kaohsiung E-Da World, Kaohsiung, Taiwan from
regarded as the paradise of
The Congress host country, Taiwan, has long been
triggers calories that are absorbed
gourmet cuisine in Asia. However, refined cuisine
syndromes take on an ascending
more easily, and as a result obesity and meta bolic
nt of bariatric and meta bolic surgery
trajectory. To solve this epidemic, the developme
rers.
in Taiwan has offered significant benefits to suffe
Chapter Meeting welcomes all
With this in mind, the 2013 IFSO-Asia Pacific
state-of-the-a rt diagnosis and
experts from all over the world to Taiwan to share
and meta bolism. In addition to the
treatment of all issues related to obesity, bariatric,
ress has arranged an IFSO Cross
Keynote Speech and the Parallel sessions, the Cong
ons in order to create a more
Strait Session, Live Surgery Demos, and Video Sessi
practical and multi-disciplinary discussion.
delegates and network in the
Moreover, this is a rare opportunity to gather all
ience the vibrant and buzzing energy
phenomenal city of Kaohsiung, where you can exper
are marked in your calendar! With
of Southern Taiwan. Make sure that the dates
meeting you in Kaohsiung, Taiwan, in
open arms and warm regards, we look forward to
April 2013.
Sincerely yours,
Prof. Pradeep Chowbey President of IFSO-Asia Pacific
Chapter
olic and Bariatric Surgery and IFSO APC President elect
Prof. Wei-Jei Lee President of Taiwan Society for Metab
Dr. Chih-Kun Huang President of 2013 IFSO-Asia Pacific
Chapter Meeting Congress
Alberic Fiennes named as
incoming IFSO-EC president
Alberic Fiennes has been named
as the next president of the European chapter of IFSO, the International Federation
for the Surgery of Obesity and Metabolic
Disorders.
Fiennes, who is currently president of
BOMSS, the British Obesity and Metabolic
Surgery Society, will lead IFSO-EC from
2014. He currently practices as in London
and at St Anthony’s Hospital in Surrey.
“I am honored to be following Professor Yuri Yashkov as the next President of
IFSO-EC,” said Fiennes of his appointment.
“Tackling obesity is complex and challenging. Patients who are severely overweight
have a disease that may spoil every aspect
of their lives.
“They need safe and correct professional
care plus understanding, kindness and
support – to be helped, not judged. IFSO
is playing a key role in improving that care
and I look forward to contributing to its
development.”
BOMSS Council member and consultant
bariatric surgeon Sally Norton said: “We are
very proud that our current president will
soon be leading the development and regulation of metabolic and weight loss surgery
across Europe.”
The International Federation for the Surgery of Obesity and Metabolic Disorders is a
federation of national societies for surgeons
and allied health professionals who treat
patients with severe and complex obesity.
Worldwide, the Federation is divided into
four Chapters, and is made up of 40 official
member associations as well as individual
members from countries currently without a
national society.
Fiennes was formerly director of
bariatric surgery at University College
London Hospital. Prior to this, he had been
associated with pioneers of British obesity
surgery in the 1980s at St George's Hospital
and Medical School in south-west London.
Later, as consultant surgeon and senior
lecturer, he went on to build up the current
multi-disciplinary service there.
BARIATRIC NEWS 23
ISSUE 13 | AUGUST 2012
Desk workers use as much energy as hunter-gatherers
The Hadza tribe's daily energy expenditure questions
our assumptions about exercise and weight.
Photos: hadzafund.org/Brian Wood, flickr.com/Phillie Casablanca
The cause of the obesity epidemic,
says conventional wisdom, isn’t complicated: we eat too much, of the wrong
things, and we don’t do enough exercise
afterwards. However, research by a
group of anthropologists on an African
hunter-gatherer tribe suggests that it
might be even simpler than that.
An
article,
“Hunter-Gatherer
Energetics and Human Obesity”,
published in PLOS One (PLoS ONE.
2012 7(7):e40503.), has challenged that
the common view that the widespread
adoption of machines, cars, and desks
has led to abnormally low calorie
expenditure in Westerners, and that this
has been a primary cause of obesity in
developed nations.
The study found that the Hadza
tribe, who live a similar lifestyle to our
Pleistocene ancestors, burn a similar
amount of energy per day to sedentary
Western workers, despite engaging in
significantly more physical activity.
The finding led the study’s lead
investigator, Dr Herman Pontzer, of
Hunter College, New York, to hypothesise
that energy expenditure may be a relatively
stable, constrained physiological trait,
influenced more by genetics than by an
individual’s environment and lifestyle.
“There’s certain set points that
humans have adapted to as a species,
and we think that energy expenditure is
one of those set points,” said Pontzer.
“Nobody would argue with the idea
that unhealthy weight gain happens
when energy intake exceeds energy
expenditure. That’s physics. The
question is, which side of this equation
is more important? Our data suggest it’s
food intake which is causing these big
differences in levels of obesity.”
The paper is the first to directly study
the energy expenditure of hunter-gatherer
tribes. It challenges assumptions made by
previous studies, which have attempted
to estimate their energy expenditure by
measuring their activity levels.
The findings came as a surprise
to Pontzer and his team. “We kind of
expected those estimates to be borne
out,” he said. “We had no reason to
think otherwise.”
Study
The investigators studied 13 men and 17
women aged 18-75 from the Tanzanian
Hadza tribe.
The men of the tribe hunt game and
gather honey, while women gather plant
foods, using tools similar to tribes from
the Pleistocene era. They live highly
active lifestyles, the women walking
on average 5.8km/day and the men 11.4
km/day. Around a third of their diet
consists of meat, with the rest made up
of honey, berries, tubers, and vegetables.
They eat no processed food.
Their energy expenditure was
measured through the doubly-labelled
water method, in which participants are
given water marked with uncommon
isotopes of hydrogen and oxygen.
The amount of the marked water
used in the creation of carbon dioxide
during respiration can be calculated
by measuring the concentration of the
isotopes in urine samples.
This rate of respiration was compared
with measurements taken from Western
workers, as well as figures from previous
studies investigating agricultural and
market economies across the world.
As expected, the Hadza group were
very lean, with body fat percentages
on the low end of the ordinary healthy
range among Western populations.
However, when they measured their
total energy expenditure, they found that
it was “statistically indistinguishable”
from Westerners.
Performing multivariate comparisons
of total energy expenditure controlling
for fat free mass and age, the researchers
found that Hadza women’s energy
expenditure was similar to that of
Western women and Hadza men’s
total energy expenditure was similar to
Western men; lifestyle had no effect on
total energy expenditure.
Exercise
Pontzer emphasised that his findings
did not diminish the importance of
exercise to a healthy lifestyle. “These
are snapshots of habitual energy use in
two populations living a normal daily
lifestyle,” he said. “After your body’s
adapted to a certain lifestyle, you can
throw a new exercise regime into that,
and that might end up changing your
energy expenditure at least for the short
term until your body adjusts again.”
The Hadza tribe had minimal levels
of heart disease, diabetes, and other
cardiovascular diseases, leading Pontzer
to hypothesise that physical activity
might be a part of keeping illness at
bay. “Activity is probably still really
important,” he said. “But not for obesity.”
The Hadza
The team lived with the Hadza tribe
for two months to perform their study,
although some in the group have been
working with the tribe for almost a decade.
“You can’t parachute in,” said
Pontzer. “If someone came into your
living room and said hey, would you
mind giving me a urine sample and
wear this GPS for the next couple of
weeks, you’d tell them to go jump in
a lake.”
In the future, Pontzer hopes to
be able to put their work on energy
expenditure and diet into a larger
context, including measuring the
Hadza’s health over their lifespan: the
study population, he said, was too small
to measure possible subtle effects of
age on energy expenditure.
As well as providing research data,
Pontzer also hopes that further study will
be beneficial to the Hadza. He has set up
a site, Hadza Fund, with his colleague
Brian Wood, to promote responsible
tourism in the Hadza homeland and
raise awareness of their culture.
24 BARIATRIC NEWS
ISSUE 13 | AUGUST 2012
Evaluating the benefits and risks of obesity drugs
The processes used to evaluate
pharmaceutical interventions to treat
obesity could be transformed, according to a new report published by The
George Washington University School
of Public Health and Health Services.
The Obesity Drug Outcome Measures
report outlines a series of new approaches
that should be considered by the FDA
when evaluating the benefits and risks
of obesity drugs. The Obesity Drugs
Outcome Measures Dialogue Group
was composed of a panel of experts and
diverse stakeholders who identified the
key issues surrounding the evaluation of
obesity drugs.
“At a time when so many Americans
suffer with obesity and are faced with
limited treatment options, there has been
a rising call to review the emerging science on obesity to update the framework
used when evaluating obesity drugs,”
said Dr Christine Ferguson, Professor in
the Department of Health Policy. “The
FDA, under a re-authorised Prescription
Drug User Fee Act, is likely to take a
wider, more comprehensive look at how
drugs developed to treat obesity affect
how individuals with obesity feel and
function. This report may help update the
risk-benefit framework.”
The report, which explored why the
development and approval of obesity
drugs have proven so difficult, makes
several recommendations including:
nObesity affects everyone differently – evaluating the benefits
and risks of interventions should
reflect the various considerations
within the different categories of
obesity based on feeling, functioning and health impairments.
nObesity drugs may provide an
additional option for helping
individuals who do not respond,
or inadequately respond, to other
interventions.
n Potential pharmaceutical
interventions should be reviewed
as obesity treatments rather than
weight loss agents and should be
limited to only those for whom
they are medically appropriate.
nThe benefit-risk evaluation of
treatment with obesity drugs
should extend beyond numerical
weight loss to improvement in
feeling and functioning.
In the last month, the FDA has approved
two obesity drugs (Belviq and Qsymia),
on Developing Products for
Weight Management does not
explicitly include consideration
of more symptomatic impairments in patient feeling and
functioning, so companies do
not tend to provide data on
how a proposed obesity drug
affects these types of health
conditions. Subsequently, the
FDA is unable to consider
drug-specific improvements
in these additional feeling and
functioning domains when
making approval decisions.
The report also states that
the FDA is not just concerned
with efficacy and tolerability
of drugs; the overall impact
on health status must be considered in judging the benefits
of an obesity medication, not
just the medication's impact
on weight alone.
Therefore, under a reauthorised Prescription Drug
User Fee Act, the FDA is
likely to take a wider, more
encompassing look at how
drugs developed to treat obesity affect how individuals
with obesity feel and function. Moreover, the agency
will include patient-centred
outcomes in its risk-benefit
framework for evaluating
these drugs.
the first such approvals in more than a
decade. However, this raises the question
of why the development and approval of
pharmacological interventions for treating obesity have proven so difficult.
According to the report, the approval
new obesity drugs has been limited due
to concerns over drug safety, medically
inappropriate use and the overall benefits
of obesity drugs – 5-10% weight loss
demonstrated on average in clinical
studies.
The FDA
According to the report, clinicians and
patients have repeatedly called for additional treatment options to be used in
conjunction with lifestyle interventions,
including pharmacotherapy.
When considering new weight loss
drugs, the FDA follows the draft 2007
Guidance for Industry on Developing
Products for Weight Management and
considers the recommendations of
experts that sit on its Endrocrinologic
and Metabolic Drugs Advisory Committee. Under the current Guidance for
Weight Management Products, the FDA
evaluates drugs intended for the clinical
treatment of obesity based primarily on
percentage of weight lost and changes
in cardiometabolic factors such as blood
pressure and lipid levels.
However, the Guidance for Industry
Findings
The report also made several recommendations with
regards to the approaches
obesity as a disease and post market
surveillance of pharmaceutical interventions:
nDrugs under investigation for
the clinical treatment of obesity
should be reviewed as obesity
treatments rather than weight loss
agents.
nCurrent clinical treatment options
for obesity are limited, and
obesity drugs may provide an
additional intervention for helping
individuals who do not respond,
or inadequately respond, to other
treatment interventions.
nThe benefit-risk evaluation of
treatment with obesity drugs
should extend beyond numerical
weight loss to improvement in
feeling and functioning. Drug
development and review should
more adequately capture and
consider how obesity drugs affect
how individuals feel and function
on a daily basis.
nObesity is not a homogenous
condition. The evaluation of the
benefits and risks of pharmacologic intervention should reflect
the different considerations within
different categories based on
feeling, functioning, and health
impairments of obesity.
n Use of obesity treatments should
be limited to those for whom they
are medically appropriate. Obesity
drugs, like all drugs, come with
side effects and risks. This requires
responsible use and promotion
and may require limiting access to
obesity drugs to those individuals
most likely to benefit due to
their significant weight-related
impairment in health, feeling, and
functioning.
Conclusions
The authors concluded that the current
FDA framework does not adequately
categorise which types of patients with
obesity could achieve benefits in feeling,
function, and health risk. In addition, it
stated that the agency does not adequately capture the many potential benefits of
weight loss (short-term symptomatic,
longer-term comorbidities or effects on
quality of life) that may be improved
through modest weight loss, aided by
pharmacologic treatment.
As a result, the report claims a more
comprehensive patient-centred approach
in making risk-benefit determinations
could help the FDA ensure that safe and
effective obesity drugs are available to
both adult and paediatric patient groups
for whom the benefits of improved
physical and mental health and quality of
life outweigh the risks associated with a
particular drug.
The report was supported by unrestricted gifts from Eisai, Novo Nordisk
Worldwide, Obesity Action Coalition,
Orexigen Therapeutics, Takeda Pharmaceuticals, the FDA and Vivus.
The report can be downloaded from:
http://sphhs.gwu.edu/releases/
obesitydrugmeasures.pdf
Study suggests bariatric fracture fears unfounded
given period) was comparable between the group of bariatric surgery
patients and the group of matched controls.
Up to three months post-operation, the rate of fractures for bariatric
surgery patients was 1.01%, compared to 0.76% for the control.
At 13-24 months, the rate had fallen to 0.80% compared to 0.79%;
between 25-60 months, the figures were at 0.59% and 0.83%.
The investigators stated that they did not observe an increase in
overall risk for any fracture (8.8 vs 8.2 per 1,000 person years; adjusted
relative risk 0.89, 95% confidence interval 0.60 to 1.33), osteoporotic
fractures (0.67, 0.34 to 1.32), or non-osteoporotic fractures (0.90, 0.56
to 1.45).
They noted that the patients in their study had a modestly increased
risk of fracture over the first three months, which reduced over the
next few years before trending towards an increased risk after three to
five years; however, there was no statistical significance to the trend
(figure 1, below).
The study found that bariatric surgery patients who had used
anti-anxiety agents in the previous six months, had a history of
cerebrovascular disease or a previous fracture had a raised risk of
fracture.
The researchers observed an increased risk of fracture with greater
reduction of excess BMI after surgery, but did not find a statistically
significant trend.
The study co-authors were Arief Lalmohamed, Frank de Vries,
Marloes T Bazelier, Alun Cooper, Tjeerd-Pieter van Staa, Cyrus Cooper,
and Nicholas C Harvey.
2.5
Adjusted relative risk for any fracture
Bariatric patients do not face an increased risk of bone
fracture in the first two years after their operation, according to a new
study published in the British Medical Journal.
The study, “Risk of fracture after bariatric surgery in the United
Kingdom: population based, retrospective cohort study”, examined
the outcomes of 2,079 UK bariatric operations, and did not find an
increased number of bone fractures compared to a cohort of 10,442
people who had not undergone bariatric surgery.
However, the study did not rule out the possibility of an increased
risk of fracture beyond the period investigated.
The finding comes despite the fact that bariatric surgery has been
shown to negatively affect bone remodelling, leading to a loss in bone
density.
Study co-author Nicholas Harvey, honorary consultant
rheumatologist at Southampton General Hospital, said “Overall,
for the first few post-operative years, these results are reassuring
for patients undergoing bariatric surgery, but do not exclude a more
protracted adverse influence on skeletal health.”
The authors say that the study is the first to investigate fracture risk
in patients who underwent bariatric surgery versus matched controls.
Study results
The study looked at records of 2,079 patients with a BMI of at least
30 from the United Kingdom General Practice Research Database,
and matched them to 10,442 control cases who did not have bariatric
surgery. The mean follow-up time was 2.2 years.
The investigators found that the rate of fractures (calculated as
the number of fractures divided by the number of person years in a
Bariatric surgery
95% CI
Relative risk 1.0
2.0
1.5
1.0
0.5
0
0
1
2
3
4
5
Years since bariatric surgery
Patients at risk:
Bariatric surgery
2,079
Matched controls 10,442
1,916
9,733
1,393
7,255
888
4,717
6
7
170
1,003
Figure 1: Spline regression plot of time since bariatric surgery and risk of any fracture in
bariatric surgery patients versus matched controls. Risk adjusted for confounders.
Source: “Risk of fracture after bariatric surgery in the United Kingdom: population based,
retrospective cohort study”
BARIATRIC NEWS 25
ISSUE 13 | AUGUST 2012
FastStitch tool will help surgeons by
making the closure process simpler
and safer
John Hopkins University
FastStitch: the future of suture?
Device could assist in reducing
complications and costs
Undergraduates from Johns Hop-
kins University, MD, have developed a disposable
suturing tool to guide the placement of stitches and
guard against the accidental puncture of internal
organs.
Suture-related complications following abdominal surgery can results in infection, herniation
and evisceration, all of which require additional
treatment and in some cases, re-operation. In addition, the financial cost of treating herniation alone
is estimated to be some US$2.5 billion (follow-up
treatment and medical malpractice expenses).
This new device, called FastStitch, is described
as a cross between a pliers and a hole-puncher. The
device was created as part of a a biomedical engiFastStitch suturing device
neering course assignment for eight Johns Hopkins
students over the past school year. They were asked
to design and test a tool that that would improve the because it would feel familiar to surgeons and team. “Then, as you close the arms, the springway surgeons stitch together the fascia.
require less training.
loaded clamp is strong enough to punch the needle
“Doctors who have to suture the fascial layer
“The fascial layer is placed between the top through the fascial layer. When this happens, the
say it can be like pushing a needle
needle moves from one arm of the
through the leather of your shoe,”
tool to the other.”
said team member Luis Hererra, a
The device also features a
“This device allows the surgeon to bring the
sophomore biomedical engineering
visual guide to help ensure that
muscle layers back together evenly, safely and
major from Downey, DA. “If the
the stitches are placed evenly,
needle accidentally cuts into the
located the proper distance away
quickly, and this can lead to better outcomes and
bowel, it can lead to a sepsis infecfrom the incision and apart from
fewer complications.”
tion that can be very dangerous.”
one another. The students believe
To help prevent this, the students
this will also reduce postoperative
designed the FastStitch needle to
complications.
remain housed within the jaws of the stitching and bottom arms of the device,” said Sohail
The prototype was constructed mostly of ABS
tool. The hand-size pliers-like shape was chosen Zahid, of Morris Plains, NJ, leader of the student plastic, so that the instrument can be inexpensive
and discarded after one use.
“Just about every major operation in the
chest and abdomen requires a large cut to be
made through the muscle layers,” said Dr Hien
Nguyen, an assistant professor of surgery in the
Johns Hopkins School of Medicine, served as the
students' clinical advisor during the development
of FastStitch. “If these layers are not brought back
together evenly, complications can occur. This
device allows the surgeon to bring the muscle
layers back together evenly, safely and quickly,
and this can lead to better outcomes and fewer
complications.”
The students have formed a Baltimore-based
company, Archon Medical Technologies, to
conduct further research and development of FastStitch. The company is being supported by grant
funding and by most of the prize money won in
the student invention and business plan contests
earlier this year.
Animal testing of the device is under way, and
further testing with human cadavers is expected to
begin later in 2012.
Although the device is still in the prototype
stage, the FastStitch team has already received
recognition and raised more than US$80,000 this
year in grant and prize money to move their project forward. Among their wins were first-place
finishes in University of California, Irvine, and
University of Maryland business plan competitions and in the ASME International Innovation
Showcase.
In addition to Zahid and Herrera, the other students who have participated in the FastStitch project
are Andy Tu, Daniel Peng, Stephen Van Kootyen,
Leslie Myint, Anvesh Annadanam and Haley
Huang. Through the Johns Hopkins Technology
Transfer office, the team members have obtained
preliminary patent protection for their invention.
All eight students are listed as co-inventors, along
with Nguyen and Johns Hopkins graduate student
Adam Clark.
26 BARIATRIC NEWS
ISSUE 13 | AUGUST 2012
Controlled diet can aid CaOx supersaturation following bariatric surgery
Researchers report that urinary CaOx
supersaturation decreased significantly
According to a study by
researchers from the Mayo Clinic in
Rochester, MN, bariatric patients who
prescribe to a diet that is normal in
calcium, low in oxalate and moderate
in protein, can improve urinary calcium oxalate (CaOx) supersaturation,
but not urinary oxalate excretion,
in patients with a history of kidney
stones. The study is published in the
journal Urology (Lieske et al, , August
2012;80;2;250-254).
The aim of the study was to identify
the effect of a controlled metabolic diet
on reducing urinary CaOx supersaturation in subjects with hyperoxaluric
nephrolithiasis after potentially malabsorptive forms of bariatric surgery.
Using data from nine patients with
a history of CaOx kidney stones and
mild hyperoxaluria who underwent
bariatric surgery, Dr Ran Pang, and
colleagues investigated the effect of a
controlled metabolic diet on reducing
urinary CaOx supersaturation.
Baseline 24-hour urine samples
were collected while participants consumed a free choice diet. Before two
final 24-hour urine collections, participants were then instructed to consume
a controlled diet low in oxalate (70 to
80 mg/day), normal in calcium (1,000
mg/day), and moderate in protein before two final 24-hour urine collections
The researchers found that urinary
CaOx
supersaturation
decreased
significantly, from 1.97 ± 0.49 delta
Gibbs (DG) with the free choice diet
to 1.13 ± 0.75 DG with the controlled
diet. This decrease occurred without a
significant alteration in urinary oxalate
excretion (0.69 ± 0.29 mmol/day with
the free choice diet versus 0.66 ± 0.38
mmol/day with the controlled diet).
The change in CaOx supersaturation
was partially due to non-significant
increases (p>0.05) in urinary volume,
citrate and pH.
The researchers concluded that a
restriction of dietary oxalate alone
might not be enough to reduce urinary
oxalate excretion to normal levels in
this group of patients, with known
enteric hyperoxaluria. However, they
warmed that additional strategies could
be necessary, such as the use of oral
calcium supplements as oxalate binders and a lower fat diet.
“The results of the present study
suggest that a diet, normal in calcium
and moderate in protein, can improve
urinary CaOx supersaturation in
patients after bariatric surgery,” the
authors noted. “However, such a
balanced low-oxalate diet did not
normalise urinary oxalate excretion
by itself.”
Bariatric surgery patients have clinically significant sleep apnoea
The majority of bariatric surgery patients have clinically significant obstructive sleep
apnoea (OSA) but report fewer symptoms than other sleep disorders patients, according
to a study published in the August 2012 issue of the journal Sleep and Breathing.
“Patients with obstructive sleep apnoea
frequently complain of sleepiness during the daytime, loss of motivation and interest in activities,
as well as poor concentration and memory recall,”
said lead author, Dr Katherine M Sharkey, department of medicine, division of pulmonary, critical
care and sleep medicine at Rhode Island Hospital,
and University Medicine. “The aim of this study
was to evaluate associations between OSA severity
and self-reported sleepiness and daytime functioning in patients considering bariatric surgery.”
The study identified 269 patients (239 women)
who had who had overnight polysomnography and
completed the Epworth Sleepiness Scale (ESS) and
the Functional Outcomes of Sleep Questionnaire
(FOSQ) prior to bariatric surgery. The mean age of
the patients was 42.0 ± 9.5 years and the mean
BMI 50.2 ± 7.72. The patient’s OSA was classified
as none/mild (apnoea-hypopnea index (AHI) <15),
moderate (AHI 15-30) or severe (AHI≥30).
The researchers then calculated the proportion
of unique variance for the five FOSQ subscales.
Analysis of variance was used to determine if ESS
and FOSQ were associated with OSA severity and
unpaired t tests compared ESS and FOSQ scores in
the study sample with published data.
Results
The outcomes revealed that the average AHI was
29.5 ± 31.5 events per hour (range = 0–175.8), the
mean ESS score was 6.3 ± 4.8, and the mean global
FOSQ score was 100.3 ± 18.2. The proportion of
unique variances for FOSQ subscales showed
moderate-to-high unique contributions to FOSQ
variance, whilst ESS and global FOSQ score did
not differ by AHI group.
One hundred and twelve patients were classified
with none/mild AHI, 77 patients with moderate
AHI and 80 patients with severe AHI. Therefore,
58.3% of patients had moderate or severe OSA that
had not been diagnosed prior to the patients' evaluation in anticipation of bariatric surgery.
Although subjective sleepiness and functional
impairment were not associated significantly
with OSA severity, the researchers found that the
vast majority of patients considering bariatric
surgery for treatment of obesity have clinically
significant OSA.
Despite the high prevalence of sleep apnoea,
this sample of patients reported less sleepiness and daytime impairment than previously
reported studies.
“These patients also report fewer symptoms
and may be attributing daytime napping and
decreased functioning to something other than a
sleep disorder.”
Sharkey warned that patients with severe
obesity need evaluation for OSA as they underreport symptoms and self-report measures are not
an adequate substitute for objective assessment
and clinical judgment when evaluating bariatric
patients for OSA.
“The lack of symptoms of sleep apnoea in this
population means that we must be even more vigilant in identifying sleep apnoea prior to bariatric
surgery in order to reduce the risk of complications,” she added. “Further research is needed to
understand individual differences in sleepiness in
patients with OSA.”
The study was supported by internal funding.
Addition researchers involved in the study were Drs
Richard P Millman, G Dean Roye, David Harrington
and Christine Tosi, as well as Dr Henry J Orff, University of California at San Diego.
BARIATRIC NEWS 27
ISSUE 13 | AUGUST 2012
New drug sensitises leptin
leading to weight loss
A2bAR plays key role in obesity
A drug compound that increases
Researchers from Boston
sensitivity to the hormone leptin,
thereby suppressing appetite, could
have implications for the development of new treatments for obesity in
humans. The study was published in
the journal Cell Metabolism.
“By sensitising the body to
naturally occurring leptin, the new
drug could not only promote weight
loss, but also help maintain it,” said
senior study author George Kunos
of the National Institute on Alcohol
Abuse and Alcoholism. “This finding
bodes well for the development of
a new class of compounds for the
treatment of obesity and its metabolic
consequences.”
Although leptin is an appetite suppressant, leptin supplements alone
have not been effective at reducing
body weight in humans. It is believed
that the human body becomes desensitised to the hormone over time,
lessening its response.
Researchers do not know why desensitisation occurs; however, it has
been hypothesised that cannabinoid
receptors, which mediate the feelings
of hunger produced by cannabis and
naturally occurring cannabinoids in
the body, are involved in the process.
In this study, investigators tested
a new compound, JD5037, which
targets cannabinoid receptor type
1 (CB1R) without penetrating the
brain. They report that not only did
JD5037 suppress the appetite of
obese mice leading to weight loss, it
also improved metabolic health.
Appetite and weight reduction
caused by JD5037 are mediated by resensitising mice to endogenous leptin
through reversing the hyperleptinemia
by decreasing leptin expression and
secretion by adipocytes, and increasing leptin clearance via the kidney.
Importantly, the mice did not show
signs of anxiety or other behavioural
side effects.
Previously, researchers have concentrated on blocking these receptors
believing it could be more effective at
long-term weight loss and developed
anti-obesity drugs that target CB1R.
However, only one CB1R-binding
drug (rimonabant) was sold in Europe
beginning in 2006 and it was taken
off the market a few years later due
to serious psychiatric side effects,
including anxiety, depression and
thoughts of suicide.
In order to reduce these sideeffects, Kunos and his team developed a CB1R-targeting drug that
did not enter the brain as easily as
rimonabant. However, the drug was
not as effective at reducing weight
and improving metabolic health,
possibly because of its specific mode
of action.
“This study shows that inverse
agonism at peripheral CB1R not only
improves cardiometabolic risk in
obesity but has anti-obesity effects
by reversing leptin resistance,” said
Kunos. “Obesity is a growing public
health problem, and there is a strong
need for new types of medications to
treat obesity and its serous metabolic
complications, including diabetes
and fatty liver disease.”
University School of Medicine have
reported that the A2b-type adenosine
receptor (A2bAR) plays a significant
role in the regulation of high fat, high
cholesterol diet-induced symptoms of
type 2 diabetes. The study is published
online in PLoS ONE (2012 7(7):e40584).
“High fat diet and its induced changes
in glucose homeostasis, inflammation
and obesity continue to be an epidemic in
developed countries,” said study lead Dr
Katya Ravid, professor of medicine and
biochemistry and director of the Evans
Center for Interdisciplinary Biomedical
Research at BUSM.
“This study indicates that the
pharmacologic activation of A2bAR
demonstrated its newly identified role in
signalling down to regulate the levels of
IRS-2, which then improved the signs of
high fat diet-induced type 2 diabetes.”
Study
A2bAR is a naturally occurring protein
receptor found in the cell membrane and
is activated by adenosine. The role it plays
in regulating inflammation is also associated with type 2 diabetes and obesity.
To examine the association of A2bAR
activation with a diet high in fat and cholesterol, the researchers experimented
with mice that lacked A2bAR and compared the results with a control group.
The administration of high fat, high
cholesterol diet (HFD) for sixteen weeks
vastly upregulated the expression of the
A2bAR in control mice, while the mice
lacking A2bAR under this diet developed
greater obesity, compared with matching
control mice.
Katya Ravid
The signs also indicated the hallmarks
of type 2 diabetes demonstrated by elevated blood glucose levels and increased
insulin levels. When the control group was
given the same diet, however, the levels of
A2bAR increased, resulting in decreased
insulin and glucose levels and obesity.
A link also was identified between the
expression of A2bAR, insulin receptor
substrate 2 (IRS-2) and insulin signalling. The results showed that the level of
IRS-2, a protein that has previously been
shown to mediate the effect of insulin,
was impaired in tissues of the experimental model lacking A2bAR, causing higher
concentrations of blood glucose.
When A2bAR was activated in the
control group using a pharmacologic
agent with a diet high in fat and cholesterol, the level of IRS-2 was increased,
lowering blood glucose.
To correlate these results in humans,
the researchers then examined fat tissue
samples from obese individuals. The
results showed that A2bAR expression
is high in fat from obese individuals,
marked by inflammation, compared with
lean individuals, and is strongly correlated with IRS-2 expression.
“Our study suggests the important
role of A2bAR in maintaining the level of
IRS-2, a regulator of glucose and insulin
homeostasis,” concluded Ravid. “The
outcome could be potentially significant
in identifying therapies for obesity and
type 2 diabetes.”
The co-authors of the study included
Hillary Johnston-Cox, Dr Milka Koupenova-Zamor, Dr Noyan Gokce and Dr
Melissa Farb.
28 BARIATRIC NEWS
ISSUE 13 | AUGUST 2012
Obesity vaccine moves a step closer
The results of a new obesity
vaccine that promotes weight loss have
been reported by investigators from
Braasch Biotech.
The article, “Effects of novel vaccines on weight loss in diet-inducedobese (DIO) mice”, to be published
in the Journal of Animal Science and
Biotechnology, the researchers assessed
the effectiveness of two somatostatin
vaccinations, JH17 and JH18, in reducing weight gain and increasing weight
loss in mice.
Prior to the start of the study, male
C57BL/6J mice were fed a 60% Kcal
fat diet for eight weeks. They were then
vaccinated, via the intraperitoneal route,
with two formulations (JH17 & JH18)
of chimeric-somatostatin vaccines at
one and 22 days of the study. Control
mice were injected with phosphatebuffered saline (PBS). All mice were
fed 60% Kcal fat diet for the remainder
of the study.
The researchers measured the body
weights two times a week and food intake was measured weekly. At week six,
mice were euthanized, a terminal bleed
was made and antibody levels to somatostatin and levels of insulin-like growth
factor 1 (IGF-1) were determined.
Outcomes
The investigators reported that vaccination with both vaccine formulations
induced a statistically significant body
weight change over the study period, as
compared with PBS controls. Percentage of baseline body weight was also
significantly affected by vaccination
during the study period.
Vaccinates finished the study at
104% and 107% of baseline weight,
JH17 & JH18 respectively, while
untreated controls reached 115% of
baseline weight. Food intake per mouse
was similar in all mouse groups during
the entire study.
Control mice did not demonstrate any
antibody titers to somatostatin, while all
vaccinated mice had measurable antibody responses (>1:500,000 titer). IGF1 levels were not statistically significant
among the groups, but were elevated
in the JH18 vaccinates (mean 440.4ng/
mL), compared with PBS controls
(mean 365.6ng/mL). Vaccination with
either JH17 or JH18 chimeric -somatostatin vaccines produced a statistically
significant weight loss as compared with
PBS controls (p<0.0001), even though
the diet-induced-obese mice were continually fed a 60% Kcal fat diet.
“This study demonstrates the possibility of treating obesity with vaccination,” said Dr Keith Haffer, President
and CSO of Braasch Biotech. “Although
further studies are necessary to discover
the long term implications of these vaccines, treatment of human obesity with
vaccination would provide physicians
with a drug- and surgical- free option
against the weight epidemic.”
The company said the next stage
could see obese dogs and pigs tested
with the experimental vaccine.
UK hospital becomes IFSO centre of excellence
The South East Weight Loss Surgical Centre
in Orpington, Kent, has become the second hospital
in the UK to be recognised as an IFSO Centre of
Excellence in Bariatric and Metabolic Surgery.
The surgical centre, which is located at the
private BMI Chelsfield Park Hospital in the south
east of England, achieved the accreditation after
the centre and its surgical team, led by consultant
bariatric surgeon Shamsi El-Hasani, satisfied
the International Federation for the Surgery of
Obesity’s Centre of Excellence requirements.
“This accreditation highlights the expertise,
experience and dedication of my team to the care
of our patients.” Mr Shamsi El-Hasani, consultant
bariatric surgeon
These requirements include demonstration of
a surgeon’s experience and aptitude, a sufficient
caseload, appropriate follow-up, an available
multidisciplinary team, and suitable equipment
and resources.
“This accreditation highlights the expertise,
experience and dedication of my team to the care
of our patients,” said Mr Shamsi El-Hasani. “We
hope that this accreditation will lend support, both
to the South East Weight Loss Surgical Centre and
BMI Chelsfield Park Hospital, but also to the field
of bariatric surgery itself.”
“Deciding when and where to have surgery can
be a difficult choice but this recognition will place
BMI Chelsfield Park Hospital on the map as a centre of excellence in the UK and internationally.”
In order to achieve the accreditation, the
hospital had to make an investment in equipment
and furniture designed for bariatric patients. They
also had to demonstrate concern for the patients’
dignity while providing care and support to its
bariatric patients.
“Meeting the IFSO accreditation criteria
demonstrates our commitment to the highest
standards in bariatric patient care,” said hospital
executive director Ruth Hoadley. “At BMI
Chelsfield Park Hospital we believe that all our
patients deserve access to the highest standards
of care backed by the highest standards of medical expertise.”
“Many obese patients can feel isolated or
anxious but our team aim to support them at every
stage of their journey to ensure their decision to undergo surgery has a positive impact on their health,
confidence and outward appearance.”
European Centres of Excellence
There are currently 20 IFSO-accredited centres of
excellence across Europe. Before the South East
Weight Loss Surgical Centre’s accreditation, the
only other centre of excellence in the UK was the
Spire Manchester Hospital.
Spain and Greece lead the rest of Europe in
terms of centres of excellence, with five and four
centres holding the accreditation respectively.
The programme was created by IFSO in order
to create a gold standard for bariatric centres,
judged by the creation of guidelines that could define surgeon's credentials, as well as institutional
requirements for safe and efficient management
of morbidly obese and patients with metabolic
disorders.
Before a centre can be accepted into the programme, the surgeon must requirements including:
n appropriate certification,
n training and experience to perform general,
gastrointestinal and bariatric surgery,
n testimonials by mentors as to the surgeon’s
ability,
n a caseload of 25 procedures per year (or 50
cases where adjustable gastric banding is the
most common procedure),
n the ability to perform revisional surgery,
n and involvement in the training of other
surgeons.
Among other requirements, the institution must:
n ensure that surgeons performing bariatric
surgery have relevant training and experience,
n have consultants in cardiology, pulmonology,
psychiatry and recovery available,
n have a recovery room,
n have radiology department facilities,
n have a blood bank and blood testing facilities,
n have a complete line of necessary equipment,
n have a written informed consent process,
n have a digital database of all treatments and
outcomes
n and have a caseload of at least 50 surgical
cases per year including revisional cases
The full requirements can be found on the
European Accreditation Council for Bariatric
Surgery’s website. They were outlined in the May
2008 issue of Obesity Surgery (Obes Surg. 2008
18(5):497-500).
BARIATRIC NEWS 29
ISSUE 13 | AUGUST 2012
Product and Industry news
FDA approves two
obesity drugs
The FDA has approved two obesity drugs
within the past two months, the first drugs to be
approved for the condition in over a decade.
Belviq (lorcaserin hydrochloride), marketed
in the US by Eisai and manufactured in Switzerland by Arena Pharmaceuticals, is believed to
decrease food consumption and promote satiety
by selectively activating serotonin 2C receptors
in the brain.
“Obesity threatens the overall well-being of
patients and is a major public health concern,” said
Dr Janet Woodcock, director of the FDA’s Center
for Drug Evaluation and Research. “The approval
of this drug, used responsibly in combination
with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are
overweight and have at least one weight-related
comorbid condition.”
Belviq is indicated to be used along with a
reduced-calorie diet and increased physical activity
for chronic weight management in adult patients
with an initial body mass index (BMI) of:
n BMI>30 or greater or
n BMI>27 or greater in the presence of at least
one weight related comorbid condition (e.g.,
hypertension, dyslipidemia, type 2 diabetes)
Clinical programme
The Belviq Phase 3 clinical trial programme
consisted of three double-blind, randomised,
placebo-controlled trials: BLOOM (Behavioral
modification and Lorcaserin for Overweight and
Obesity Management), BLOSSOM (Behavioral
modification and LOrcaserin Second Study for
Obesity Management) and BLOOM-DM (Behavioral modification and Lorcaserin for Overweight
and Obesity Management in Diabetes Mellitus).
All three trials included a standardized program
of diet, moderate exercise and behavioural counselling for both the placebo and Belviq groups.
BLOOM evaluated Belviq versus placebo over
a two-year treatment period in 3,182 non-diabetic,
obese adult patients (18 to 65 years old) with or
without comorbid conditions and non-diabetic,
overweight adult patients with at least one weight
related comorbid condition.
BLOSSOM evaluated Belviq versus placebo
over a one-year treatment period in 4,008 non-diabetic, obese adult patients (18 to 65 years old) with
or without comorbid conditions and non-diabetic,
overweight adult patients with at least one weight
related comorbid condition.
BLOOM-DM evaluated Belviq versus placebo
over a one-year treatment period in 604 obese and
overweight adult patients (18 to 65 years old) with
type 2 diabetes who were receiving oral antihyperglycemic agents.
The outcomes showed that Belviq along with
diet and exercise was more effective than diet and
exercise alone at helping patients lose 5% or more
of their body weight after one year and managing
the weight loss for up to two years.
The most common adverse reactions for patients without diabetes treated with Belviq were
treatment with placebo.
Approximately 62% and 69% of patients
lost at least 5% of their body weight with the
recommended dose and highest dose of Qsymia,
respectively, compared with about 20% of patients
treated with placebo.
Patients who did not lose at least 3% of their
body weight by week 12 of treatment with Qsymia
were unlikely to achieve and sustain weight loss
with continued treatment at this dose. Therefore,
response to therapy with the recommended daily
dose of Qsymia should be evaluated by 12 weeks
to determine, based on the amount of weight loss,
whether to discontinue Qsymia or increase to the
higher dose.
If after 12 weeks on the higher dose of Qsymia,
a patient does not lose at least 5% of body weight,
then Qsymia should be discontinued, as these paAbove: Qsymia is the first FDA-approved once-daily combination treatment for patients struggling with obesity tients are unlikely to achieve clinically meaningful
Below: Belviq is believed to decrease food consumption and promote satiety weight loss with continued treatment.
headache, dizziness, fatigue, nausea, dry mouth,
and constipation. In patients with diabetes, the
most common adverse reactions were hypoglycemia, headache, back pain, cough, and fatigue.
Post-marketing studies
As part of the approval procedure for Belviq, the
companies committed to conduct post-marketing
studies to assess the safety and efficacy of Belviq
for weight management in obese pediatric patients,
as well as to evaluate the effect of long-term treatment with Belviq on the incidence of major adverse
cardiovascular events in overweight and obese
subjects with cardiovascular disease or multiple
cardiovascular risk factors. The cardiovascular
outcomes trial will include echocardiographic assessments.
The FDA has recommended that Belviq be classified as a scheduled drug. The DEA will review
the FDA's recommendation and determine the
final scheduling designation. Once the DEA has
provided the final scheduling designation, Eisai
will announce when Belviq will be available to
patients and physicians in the United States.
Qsymia
The FDA also approved Qsymia (phentermine
and topiramate extended-release) as an addition
to a reduced-calorie diet and exercise for chronic
weight management.
“Qsymia is the first FDA-approved once-daily
combination treatment for patients struggling with
obesity,” said Peter Tam, president of Vivus. “The
degree and severity of obesity and the lack of
effective pharmacological interventions that we
face as a society were two primary reasons for the
development of Qsymia.”
The drug is approved for use in adults with a
BMI>30 or adults with a BMI>27 who have at least
one weight-related condition such as hypertension,
type 2 diabetes or dyslipidemia. Vivus expects to
launch the drug by the fourth quarter of 2012.
Qsymia is a combination of two FDA-approved
drugs, phentermine and topiramate, in an extended-release formulation. Phentermine is indicated
for short-term weight loss in overweight or obese
adults who are exercising and eating a reduced
calorie diet. Topiramate is indicated to treat certain
types of seizures in people who have epilepsy and
to prevent migraine headaches.
“Obesity threatens the overall well being of
patients and is a major public health concern,” said
Dr Janet Woodcock, director of the FDA’s Center
for Drug Evaluation and Research. “Qsymia, used
responsibly in combination with a healthy lifestyle
that includes a reduced-calorie diet and exercise,
provides another treatment option for chronic
weight management in Americans who are obese
or are overweight and have at least one weightrelated comorbid condition.”
The safety and efficacy of Qsymia were
evaluated in two randomised, placebo-controlled
trials that included approximately 3,700 obese and
overweight patients with and without significant
weight-related conditions treated for one year.
All patients received lifestyle modification that
consisted of a reduced calorie diet and regular
physical activity.
The recommended daily dose of Qsymia
contains 7.5mg of phentermine and 46mg of topiramate extended-release. Qsymia is also available
at a higher dose (15mg phentermine and 92mg of
topiramate extended-release) for select patients.
Results from the two trials show that after one
year of treatment with the recommended and highest daily dose of Qsymia, patients had an average
weight loss of 6.7% and 8.9%, respectively, over
Pathway Genomics signs agreement with DASA
Pathway Genomics, a San metabolism and exercise response, preDiego-based genetic testing laboratory,
has signed an agreement with Brazilian
company Diagnósticos da América
(DASA), the largest private medical
diagnostics company in Latin America.
The agreement will bring Pathway’s
reporting system to physicians in Brazil.
The Pathway system generates
genetic reports from saliva samples,
addressing a variety of medical issues
including an individual’s carrier status
for recessive genetic conditions, food
scription drug response, and propensity
to develop certain diseases such as heart
disease, type 2 diabetes and cancer.
“Pathway’s vision is to responsibly
reveal personalised and actionable
genetic information in order to globally
educate, inform and improve health and
well-being,” said Dr Michael Nova,
Pathway’s chief medical officer. “Our
alignment with DASA is a major part
of this vision, and we are excited to
help bring this scientifically-advanced
The FDA noted that Qsymia must not:
n be used in patients with glaucoma or
hyperthyroidism
n be used in patients with recent (within the last
six months) or unstable heart disease or stroke
n be used during pregnancy because it can
cause harm to a foetus (exposed to topiramate, in the first trimester of pregnancy has
an increased risk of oral clefts), females of
reproductive potential must not be pregnant
when starting Qsymia therapy or become
pregnant while taking Qsymia.
The Agency also recommended:
n females of reproductive potential should
have a negative pregnancy test before starting Qsymia and every month while using the
drug and should use effective contraception
consistently while taking Qsymia.
n regular monitoring of heart rate for all
patients taking Qsymia, especially when
starting Qsymia or increasing the dose.
The most common side effects of Qsymia are
paresthesia, dizziness, altered taste sensation,
insomnia, constipation and dry mouth.
The FDA approved Qsymia with a Risk
Evaluation and Mitigation Strategy (REMS) which
consists of a Medication Guide advising patients
about important safety information and elements
to assure safe use that include prescriber training
and pharmacy certification.
The purpose of the REMS is to educate
prescribers and their patients about the increased
risk of birth defects associated with first trimester
exposure to Qsymia, the need for pregnancy
prevention, and the need to discontinue therapy if
pregnancy occurs. Qsymia will only be dispensed
through specially certified pharmacies.
Vivus will be required to conduct ten postmarketing requirements, including a long-term
cardiovascular outcomes trial to assess the effect
of Qsymia on the risk for major adverse cardiac
events such as heart attack and stroke.
Laurie Traetow, executive director of the
American Society of Bariatric Physicians said,
“Obesity medicine specialists are excited about the
FDA adding another tool to the obesity treatment
toolbox, which for so many years had been virtually barren in the pharmacotherapy area.”
new cardiac panel was developed
with input from cardiology
centers. The genetic test claims
technology to the people of Brazil.”
to offer physicians insight into
Pathway’s multiple genetic tests,
how a patient’s genes may affect
includes:
heart-related conditions, includn Pathway Fit, which addresses a
ing various drug responses and
patient’s food metabolism and
genetic risk for developing certain
exercise response. The test has
cardiovascular diseases.
recently shown positive results
“The partnership between DASA and
with a clinical trial by California
Pathway represents a milestone in
Schools VEBA, in which, 179
Brazilian medicine, ensuring access
employees showed significant
to predictive genetic tests through an
weight loss success compared to
advanced and innovative technology,”
controls.
said Dr Octávio Fernandes, DASA’s
nCardiac Health Insight, Pathway’s chief operating officer. “With 50 years
of expertise, the company has one
of the largest medical teams in Latin
America, composed of nearly 2,000
world-renowned doctors, and offering
more than 3,000 types of laboratory
tests and imaging diagnostics provided
by more than 18,000 professionals.”
Pathway’s laboratory is accredited by the College of American
Pathologists (CAP) and accredited in
accordance with the US Health and
Human Services’ Clinical Laboratory
Improvement Amendments (CLIA) of
1988. Pathway is also a member of the
American Clinical Laboratory Association (ACLA).
30 BARIATRIC NEWS
ISSUE 13 | AUGUST 2012
Product News
Covidien launches world’s first knotless suture reload device
Covidien has released the V-Loc knotless to suture inside the body, according to a recent duced the occurrence of malformed staples in five
pre-clinical study (Omotosho et al J Laparoendosc
Adv Surg Tech A. 2011 21(10):893-7).
Compared with conventional suturing, the proprietary Endo Stitch suturing device can save 4570% of laparoscopic suturing time clinical studies
show (Nguyen et al, Surg. Res. 2000 93(1):133-6,
J Am Assoc Gynecol Laparosc. 1996 3(2):299303, Urology. 1995 46(2):242-5, Pattaras et al,
J Endourol. 2001 15(2):187-92).
“Covidien works closely with surgeons to
develop devices that not only improve patient
outcomes, but also make surgery easier, safer
and more efficient. We believe that our new
V-Loc knotless suturing reloads for
minimally invasive surgery will
help surgeons perform aspects
of their procedures with
greater efficiency,” said
Paul Hermes, Vice
President,
Chief
Technology OfEndo GIA Radial Reload with Tri-Staple Technology
ficer,
Covidien
Surgical
Solutions. “Covidien
is committed to
the advancement
of bariatric surgery
technology and offers a full portfolio of
products and services to
support bariatric surgeons,
University Medical Center. “As an early user of their practices and patients.”
the Endo Stitch device with the V-Loc reload, I’ve
been able to perform laparoscopic suturing with Endo GIA Black reload
greater ease and efficiency than I previously could Separately at the meeting, an investigahave using traditional devices that require knots.” tional team led by Dwight Bronson, Manager,
Research and Development, Covidien, presented
V-Loc device
a poster titled, “Comparison of EndoStapler
According to the company, combining proprietary Performance in Challenging Tissue Applications,”
automated needle-passing technology with a knot- (ASMBS Abstract No. P-178) co-authored by Coless suturing device, the V-Loc device for Endo vidien researchers Elizabeth Contini and Jennifer
Stitch and SILS Stitch devices offers distinctive Whiffen.
benefits over hand suturing and conventional
Their work demonstrated that the Covidien
automated suturing options.
Endo GIA Black reload with Tri-Staple technolThe V-Loc device for use with Endo Stitch has ogy, which deploys three rows of graduated height
a unique barb and loop design, enabling faster staples on either side of a transection, exhibited
suturing by eliminating the need to tie any knots significantly better “B”-shaped staple formation
and saving surgeons 35-42% of the time required (p<0.001) for all regions of the stomach and resuturing device, the world’s first knotless suture
reload for laparoscopic and single-incision procedures. The V-Loc is a reload that works with the
company’s proprietary Endo Stitch and SILS Stitch
suturing devices for multi-port and single-port
laparoscopic surgery. The new device can increase
operating room efficiency during bariatric surgery
and other procedures, the company claims.
“The ability to suture internal tissue laparoscopically without the need to tie knots can help
surgeons shorten one of the most labour-intensive
tasks performed during bariatric surgery,” Dr Dana
D Portenier, assistant professor of surgery, Duke
of the seven regions, compared with a competitive
thick tissue reload which deploys three rows of
single height staples (Staple formation comparison
between Covidien's EGIA60AXT and Ethicon's
ECR60G in an ex-vivo tissue model, Covidien Engineering Report No. PCG-006_rev1, January 24,
2012 (data on file)). The “B”-shaped staple, widely
considered the gold standard for staple formation,
ensures staple line security and allows blood flow
through the tissue, both of which are important
factors in promoting post-surgical healing.
Endo Stich barb and loop
Educational initiative
In addition, the company a new bariatric patient
education and practice management initiative,
‘Shaping a Better Future in Bariatric Surgery
program’. A key objective of this initiative is to
seamlessly support bariatric practices in their
efforts to build clinically effective relationships
with their patients, such as arming prospective
patients with useful information to guide treatment decisions when exploring bariatric surgery
as an option for weight loss.
Spider Surgical
System makes
Indian debut
TransEnterix
single-incision Spider Surgical System has been used
in the Asian-Pacific Region for the first time.
Dr Michel Gagner, who was attending
the symposium and surgical workshop at the
Max Institute of Minimal Access, Metabolic
& Bariatric Surgery at Max Super Specialty
Hospital in New Delhi, performed four sleeve
gastrectomies using the system.
He explained that the Spider platform
allows surgeons to exercise advanced minimally invasive techniques while preserving
the triangulation capacity they expect during
laparoscopic procedures.
The Spider System allows surgeons to
introduce a camera and multiple instruments
into the patient’s abdomen by way of a single
incision made in the naval. With a circumference of approximately 18 mm, the company
claims the system delivers the smallest singlesite incision in the market.
Using the system, a surgeon makes one
small incision and inserts the platform and
expands it like an umbrella. Expansion offers
true-left and true-right coordination between
the video camera monitor and the surgeon’s
hands, and allows the surgeon to approach the
operating site at the necessary angles.
Through the platform’s two rigid ports, the
surgeon inserts a camera and a wide variety
of off-the-shelf laparoscopic tools. Through
its two flexible ports, the surgeon inserts TransEnterix’s 360-degree flexible instruments.
“The flexible instruments allow a surgeon
to achieve angles and visualize critical
anatomy without requiring as many incisions
as traditional laparoscopy,” said the symposium’s director, Dr Pradeep Chowbey. “The
result may be fewer incisions and a fast recovery for the patient, while providing surgeons
with enhanced capabilities.”
The Indian procedures come a month after
the system was used for the first time in the
UK. The procedure was performed by Gagner
at Homerton University Hospital, in London.
New generation of Harmonic ACE+ shears approved for US sale
Ethicon Endo-Surgery's new Harmonic ACE+ shears
have received FDA 510(k) clearance, allowing the company to
market the device in the USA.
The new shears are a development of the existing Harmonic
group of ultrasonic surgical devices, intended for multiple surgical
jobs including dissection, sealing, transection, and otomy creation.
Ethicon claim that the device's “Adaptive Tissue Technology"
responds intelligently to varying tissue conditions by regulating
energy delivery and providing surgeons with enhanced audible
feedback, exhibiting 23% less thermal spread and delivering 21%
shorter transection times compared with the previous generation of
Harmonic Ace shears. The device's blade has also been redesigned
with multifunctionality, precise grasping and dissection in mind.
“I like how the Adaptive Tissue Technology senses and responds
with improved energy delivery and the generator tone changes,”
said Paul Kemmeter, bariatric surgeon at Grand Health Partners,
Michigan and consultant for Ethicon Endo-Surgery. “It makes me
feel very comfortable knowing that the optimal amount of energy
will be delivered consistently each time.
Ethicon say that since the introduction of the line in 1992,
Harmonic product have been used in more than 14 million surgical
procedures around the world.
“With the introduction of Adaptive Tissue Technology, the Harmonic Ace+ Shears elevate the precision of the Harmonic portfolio,"
said Tom O’Brien, Ethicon Endo-Surgery vice president, global
strategic marketing. “Based on surgeon feedback, Ethicon EndoSurgery will continue to advance the performance and precision of
Harmonic devices through better energy management and refined
design. We will also ensure our products make clinical and economic
sense to all of our customers."
Be Heard.
Send your press releases to Bariatric News
or add us to your press list [email protected]
BARIATRIC NEWS 31
ISSUE 13 | AUGUST 2012
Calendar of events 2012-13
September 11-15
October 22–23
XVII IFSO World Congress
New Delhi, India
www.ifsoindia2012.org
September 20-24
Obesity 2012
Charleston, United States
http://bariatricsummit.com/
Frankfurt, Germany
www.frankfurter-meeting.de
13th Minimally Invasive Surgery
Symposium 2013
October 24-28
October 1-5
European Association for the Study of
Diabetes
Frankfurt, Germany
www.frankfurter-meeting.de/
7th Frankfurter Meeting
Taunton, United Kingdom
www.aquaconferencemanagement.co.uk/
soba/soba-2012
Halifax, Nova Scotia, Canada
http://interprofessional.ubc.ca/obesity/
9th Annual Bariatric Summit 2012
7th Frankfurter Meeting
SOBA 2012
The 4th Conference on Recent Advances
in the prevention and Management of
Childhood and Adolescent Obesity
September 22–24
October 22–23
March 6–9
October 24-26
San Antonio, Texas
www.obesity.org
Berlin, Germany
www.easd.org
November 22-23
62nd Obesity & Associated Conditions
Symposium
Orlando, FL.
www.asbp.org
October 26–28
3rd Annual Fall Educational Event
Las Vegas, United States
http://fall.asmbs.org/
November 29–December 01
9th Congreso Internacional B.E.S.T 2012
Guadalajara, Mexico
www.bestcongress2012.com/
December 6-8
4th Annual Intnational Congress for
Sleeve Gastrectomy
New York City
www.icssg.com
2013
January 23-25
4th BOMSS Annual Meeting
Glasgow, UK
www.bomss.org.uk
Las Vegas, United States
www.miss-cme.org
April 10–13
2013 IFSO Asia-Pacific Chapter Meeting
Kaohsiung , Taiwan
www.ifso.com/Index.
aspx?id=ChapterMeetings
April 26-27
3rd International Symposium on
non-invasive bariatric techniques
Lyon, France
www.noninva-obesity.com
May 12-15
European Congress on Obesity
Liverpool, UK
www.eco2013.org
May 21–24
V IFSO Latin American Congress of
Bariatric and Metabolic Surgery
To list your meeting details here, please email: [email protected]
Cusco, Peru
www.ifsocusco2013.com/
The next issue of Bariatric News is out in December
Editorial deadline: 20 November 2012
Advertising deadline: 20 November 2012
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 press release, please email:
[email protected]
EDITORIAL BOARD
Henry Buchwald
BARIATRIC NEWS
Managing Editor
Owen Haskins
Simon Dexter
[email protected]
John Dixon
News editor
MAL Fobi
[email protected]
Ariel Ortiz Lagardere
Peter Myall
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
2012 Copyright ©: 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.
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