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JUNE 2009 • SUPPLEMENT
Proceedings Supplement from the
Second International Consensus Summit
on Sleeve Gastrectomy
Mechanisms of Action • Experience and Results • Sleeve and Type 2
Diabetes • Complications, Prevention, and Treatment • Conversions and
Revisions • New Concepts, Approaches, and Technologies
Supported by
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CONTENTS
LETTER
IS IT TIME TO BYPASS THE BYPASS? SHOULD
PYLORIC PRESERVATION BECOME AN IMPORTANT
PRINCIPLE IN BARIATRIC SURGERY?
by Mitchell S. Roslin, MD
PAGE 4
Dear Readers,
SLEEVE GASTRECTOMY AND THE SILS™
PROCEDURE: THE TEXAS ENDOSURGERY INSTITUTE
EXPERIENCE
by John J. Gonzalez, Jr., MD
PAGE 6
REDUCING RISK IN BARIATRIC SURGERY:
RATIONALE FOR SLEEVE GASTRECTOMY
by Eric J. DeMaria, MD
PAGE 8
LAPAROSCOPIC SLEEVE GASTRECTOMY:
MID-TERM WEIGHT LOSS RESULTS
by Gregg H. Jossart, MD, FACS, and Paul T.
Cirangle, MD, FACS
PAGE 10
SLEEVE GASTRECTOMY AND DIABETES: EARLY
CLINICAL AND HORMONAL CHANGES
by N. Basso, MD; F. Leonetti, MD; P. Mariani,
MD; M. Rizzello, MD; F. Abbatini, MD;
G. Alessandri, MD; G. Casella, MD; and
D. Capoccia, MD
PAGE 12
A SUMMARY ARTICLE REVIEWING SLEEVE
GASTRECTOMY AS A STAGING AND PRIMARY
BARIATRIC PROCEDURE
by Joseph A. Talarico, MD; Stacy A. Brethauer,
MD; and Philip R. Schauer, MD
PAGE 14
After a successful First International Consensus
Summit for Sleeve Gastrectomy in New York City in
October 2007, I believed that 18 months later
another summit was necessary. The necessity of
another summit was in part due to rapid emergence
of new knowledge about this operation, and also
because its adoption in every continent of the world
has caught like wildfire.
The Second International Consensus Summit for
Sleeve Gastrectomy was held March 19-21, 2009, at
the renovated and recently revived Fontainebleau
Hotel in Miami Beach, Florida. The meeting had
375 participants who traveled from more than 30
countries, and was partitioned into three segments
over three days—a live surgery session of nine
technically different cases, a full day of oral
presentations, and a half-day of debates. The oral
presentations sessions featured invited speakers and
presenters who submitted abstracts and, due to the
abundance of accepted material, was broken out into
several rooms simultaneously. These sessions focused
on discussions of mechanisms of action; cohorts
with five-year data; the effect of sleeve gastrectomy
on type 2 diabetes; special cohorts (low BMI,
adolescents, elderly patients, high-risk patients, and
quality of life); new emergent technology
surrounding sleeve gastrectomy; and complications
and revisions.
SLEEVE GASTRECTOMY, GLUCOSE TOLERANCE, AND
GLP-1
by Josep Vidal, MD, PhD
PAGE 16
Bariatric Times has assembled some highlights of this
meeting from experts who submitted summaries of
their presentations for purposes of this educational
supplement.
LAPAROSCOPIC REVISIONS OF SLEEVE
GASTRECTOMY
by Raul J. Rosenthal, MD, FACS
PAGE 18
Enjoy, and thank you for reading!
THE PROCESS OF REIMBURSEMENT FOR SLEEVE
GASTRECTOMY
by Grant Bagley, MD, JD
PAGE 20
DEBATES AND CONSENSUS: A SUMMARY
by Michel Gagner, MD, FRCSC, FACS
PAGE 22
3
Sincerely,
Michel Gagner, MD, FRCSC, FACS
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Is It Time to Bypass the Bypass?
Should Pyloric Preservation
Become an Important Principle in
Bariatric Surgery?
by MITCHELL S. ROSLIN, MD
AUTHOR AFFILIATIONS: Dr. Roslin is Chief of Bariatric Surgery, Lenox Hill Hospital, New York, New York.
ADDRESS CORRESPONDENCE TO: Mitchell S. Roslin, MD, Chief of Bariatric Surgery, Lenox Hill Hospital, 186 E. 76th St, New York, New York;
(212) 434-3285; E-mail: [email protected]
he vertical sleeve gastrectomy
has recently become an
increasingly popular surgical
option for the treatment of obesity.
However, many bariatric surgeons
have questioned its long-term
efficacy and have promoted Rouxen-Y gastric bypass (RYGB) as a gold
standard.
With an extensive experience
with RYGB and a practice with
thousands of post-RYGB patients, we
commonly encounter patients with
weight regain. It is our group’s
impression that weight regain
following RYGB is more common
than discussed. Supporting this
speculation are the results of two
recent trials that compared RYGB to
either banded bypass or duodenal
switch.1,2 Both demonstrated weight
regain of approximately 15 percent
in the bypass-only group between
the first and third postoperative
years. In a randomized trial
comparing banded bypass to
standard bypass, Dr. Bessler
T
concluded that banding the bypass
preserves weight loss after the first
year.1 In his study, the banded group
maintained a 70-percent excess
weight loss, whereas at the threeyear mark, the bypass only was
under 60-percent excess weight loss.
These results were statistically
significant. Similarly, three years
postoperative, duodenal switch
patients continued to lose weight,
whereas the bypass group in a trial
conducted at University of Chicago
regained 17 percent of their total
excess weight loss.2
Our participation in several
endoscopic trials, including the
RESTORe trial (Randomized
Evaluation of Endoscopic Suturing
Transorally for Anastomotic Outlet
Reduction) and the ROSE trial
(Revision Obesity Surgery,
Endoscopic), provided additional
insight. The goal of these trials was
to retighten the stoma or stoma and
pouch with endoscopic suturing
devices. During these trials, patients
reported similar experiences. They
still were eating a smaller quantity of
food during each meal. However,
they felt hungry shortly after eating.
As a result, we studied glucose
tolerance testing (GTT) on 36 postRYGB patients. The mean age of the
patients was 49 years old; average
BMI at time of surgery was 48. They
were a mean of 40 months postbypass, and average weight regain
was 17 pounds. We found that six
patients were diabetic based on GTT,
and 26 of 30 had reactive
hypoglycemia, two hours postglucose administration. Reactive
hypoglycemia was defined as glucose
less than 60 or a greater than
100mg/dL drop in one hour. Perhaps,
more importantly, 16 of 26 had
severe hypoglycemia where the ratio
of maximum to minimum glucose
was greater than 3 to 1.
We speculate that there is rapid
gastric emptying, and that when a
glycemic load is presented to the
small bowel, there is an abrupt rise
Success with sleeve gastrectomy has shown that severe malabsorption
does not need to be part of the duodenal switch.
4
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It is our contention that the best valve is the biologic valve that
is already present—the pylorus.
and fall in glucose level. The
combination of empty pouch and low
sugar causes hunger. We feel that
this cycle is contributory in the
weight regain and maladaptive eating
pattern that develops. Few patients
in our study had pathologic insulin
levels, suggesting neosidioblastosis is
not the primary etiology.
Since the comparative trials
between vertical banded gastroplasty
and RYGB that were performed in
the late 1980s and early 1990s, many
have suggested that gastric bypass is
the procedure of choice for sweet
eaters.3 As 60 percent of calories
consumed in the United States are
simple carbohydrates, this group in
all probability includes the majority
of bariatric patients. The primary
explanation given for the improved
early results with bypass was that
carbohydrate ingestion would cause
gastrointestinal symptoms of
dumping. This would act as negative
reinforcement. However, what
happens in patients who do not
experience gastrointestinal
symptoms associated with dumping.
With time, do they become
increasingly tolerant, and does the
bypass no longer challenge the
desire to eat simple carbohydrates?
Our data suggest that reactive
hypoglycemia is far more common
than previously reported.
Additionally, our histories seem to
indicate that this response,
combined with rapid emptying, is
somewhat responsible for weight
regain following bypass. In other
words, the dumping created by
performing the bypass may not be
helpful, as many have speculated.
Many readers will state how
successful bypass procedures have
been in their practices. It is
important to highlight that this is
one of many variables. Certain
patients may scar and maintain a
restrictive opening. There is
variation on the amount and type of
food eaten. Activity levels will be
different. However, it is clear that
the banded bypass patients have less
weight regain. Thus, we feel that
future versions of these procedures
will incorporate a valve that
regulates emptying. The valve can be
synthetic, like a silastic ring, marlex
mesh, or laparoscopic band; but this
can lead to different issues. It is our
contention that the best valve is the
biologic valve that is already
present—the pylorus. As opposed to
mechanical products, the pylorus,
the narrowest part of the
gastrointestinal tract, can relax,
open, and control the outflow of
solid food. We believe that this is far
more preferential than a synthetic
band.
Thus we believe that pyloric
preservation will become an
important principle in bariatric
surgery. Success with sleeve
gastrectomy has shown that severe
malabsorption does not need to be
part of the duodenal switch. An
increasingly popular option in our
practice is a laparoscopic duodenal
switch with a sleeve done over a 38
bougie with a 125 to 150cm common
channel. With this approach, we
have not had to lengthen any
common channel for protein
malnutrition, and patients report 1 to
3 bowel movements daily. None have
complained of spillage or poor
control. We believe that sleeve and
this type of duodenal switch or
pyloric preserving bypass will
become common. We also speculate
that this approach will improve longterm outcomes by increasing initial
weight loss and preventing
recidivism after the first
postoperative year.
REFERENCES
1.
Bessler M, Daud A, Kim T, DiGiorgi M. Prospective randomized trial of banded versus nonbanded gastric
bypass for the super obese: early results. Surg Obes
[JUNE
2.
3.
Relat Dis. 2007;3(4):480–484; discussion 484–485.
Epub 2007 Jun 4.
Prachand VN, Davee RT, Alverdy JC. Duodenal switch
provides superior weight loss in the super obese
(BMI>50kg/m2) compared with gastric bypass. Ann
Surg. 2006;244(4):611–619.
Sugerman HJ, Londrey GL, Kellum JM, et al. Weight
loss with vertical banded gastroplasty and Roux-Y gastric bypass for morbid obesity with selective versus
random assignment. Am J Surg. 1989;157(1):93–102.
KEY POINTS
• Weight regain is common
after gastric bypass.
• Reactive hypoglycemia is
far more common than
expected after gastric
bypass.
• The combination of rapid
emptying of the pouch
and hypoglycemia causes
hunger between meals.
• For the best results, the
pouch needs a valve—
and the pylorus is the
ideal valve.
• Pyloric preservation will
become a principle in
bariatric surgery and the
new gold standard
procedure may be a
modified duodenal switch
with pouch similar to
sleeve and common
channel of 125 to 150cm.
2009,
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™
Sleeve Gastrectomy and the SILS
Procedure: The Texas Endosurgery
Institute Experience
by JOHN J. GONZALEZ, JR., MD
AUTHOR AFFILIATION: Dr. Gonzalez specializes in laparoendoscopic, bariatric, and pancreaticobiliary procedures at the Texas Endosurgery
Institute.
ADDRESS CORRESPONDENCE TO: Dr. John J. Gonzalez, Texas Endosurgery Institute, 4242 E. Southcross, Ste. 1, San Antonio, Texas 78222.
BACKGROUND
METHODS
Laparoscopic sleeve gastrectomy
(LSG) is one of the newest bariatric
procedures in our surgical
armamentarium. It likely works as a
result of gastric restriction, with
removal of 70 to 80 percent of the
stomach proximal to the antrum, as
well as an associated hormonal
component. There have been
excellent results in multiple centers
and the technique has been described
in detail elsewhere. There is little
variation in the described techniques
of LSG except with respect to the
appropriate size gastric pouch, ranging
anywhere from 32 to 50 Fr. Typically,
the procedure requires 5 to 6 skin
incisions for working trocars and a
liver retractor. The advent of the
Covidien SILS™ laparoscopic
procedure using a single incision has
now allowed for an even more
enhanced minimally invasive
experience and the ability to decrease
the number of skin incisions to one or
two. Single incision surgery has
exploded in the United States and has
been performed for such procedures
as appendectomy, cholecystectomy,
colectomy, nephrectomy,
hysterectomy, hiatal hernia repair,
gastric banding, and gastric bypass.
The LSG seems tailor-made for the
SILS™ procedure because of the
straightforward nature of the
procedure itself and the ability to
operate in a single quadrant of the
abdomen. The following is our
experience at the Texas Endosurgery
Institute.
Twenty-four consecutive patients
underwent attempted SILS™ sleeve
gastrectomy between June 2008 and
April 2009. All patients that were
eligible for the standard LSG were
considered for the SILS™ procedure.
Because this was a new technique for
the author, the body mass index (BMI)
was limited to 50 and below. Presence
of a known hiatal hernia was an
absolute contraindication for the single
access technique.
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OPERATIVE TECHNIQUE
The technique is similar to that
described by Saber et al1 with some
very minor modifications. The patient
is placed in the supine position on a
split leg table (Figure 1). The surgeon
stands between the legs, which
provides the most ergonomically
advantageous position for access to the
upper abdomen when working from
the umbilicus. The camera holder is on
the patient’s left side. A 2.5cm
curvilinear incision is then made at the
upper half of the umbilicus, taking care
to stay within the outer rim so as to
preserve cosmesis. The subcutaneous
tissues are separated down to the
anterior fascia. Small skin flaps are
often necessary to get as much room
as possible through this small incision.
A Veress needle is then introduced
into the peritoneal cavity and
pneumoperitoneum is achieved with a
pressure of 15mm/Hg. A 5mm, lowprofile Dexide™ (Autosuture™,
Covidien, Norwalk, Connecticut) trocar
is then inserted in the upper left
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portion of the incision, just to the right
of the linea alba. A long, 5mm, 30degree laparoscope is then inserted
and the abdominal cavity is carefully
inspected. A 15mm, bladeless trocar is
then inserted through the center of the
umbilical wound and a second 5mm
Dexide™ port is introduced through the
lower right portion of the incision, just
left of the linea alba (Figure 2). The
trocars are offset as much as possible
within the single incision and each
trocar has a separate fascial defect,
which is important to prevent leakage
and maintain pneumoperitoneum. The
patient is then placed into a steep
reverse Trendelenburg position. A
Nathanson liver retractor is then
inserted through a separate, 5mm stab
wound in the mid-epigastrium to
elevate the liver cephalad and expose
the esophageal hiatus and angle of His.
The remainder of the surgery is
essentially identical to a standard LSG.
Some critical differences are the length
of the instruments, which should
always be bariatric length, and the
ability of the graspers and dissectors to
roticulate, which is essential to avoid
“sword fighting” and maintain
triangulation. As with the standard
technique, the lesser sac is entered
with an AutoSonix™ (Autosuture™,
Covidien, Norwalk, Connecticut)
device and the greater curvature is
mobilized beginning approximately
6cm proximal to the pylorus. The
mobilization is continued all the way
up to the short gastric vessels around
the spleen and through the angle of
His. Once the fundus is completely
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3
1
4A
2
FIGURE 1. Patient in supine position on split leg table. FIGURE 2. Port
configuration for SILS™ sleeve gastrectomy. FIGURE 3. Roticulating,
bariatric-length instruments. FIGURES 4A & B. Single access ports.
4B
mobilized, the gastric resection is
begun 6cm proximal to the pylorus
with two firings of a laparoscopic
articulating 45mm Endo GIA™ stapler
with a green 4.8mm cartridge. The
stapler is angled away from the
incisura angularis to avoid narrowing
at this point. Once past the incisura,
a 34 Fr bougie dilator is passed along
the lesser curvature and into the
antrum by the anesthesiologist under
direct laparoscopic vision. The
remainder of the transection is then
accomplished by firing a series of
laparoscopic articulating Endo GIA™
staplers with blue 3.5mm cartridges.
This shorter staple height seems to
limit intraluminal bleeding without
any increase in sheering forces in
most stomachs in our experience.
Seamguard® Bioabsorbable Staple
Line Reinforcement (W. L. Gore &
Associates, Flagstaff, Arizona) is used
on the final firing around the angle of
His. Furthermore, the uppermost
firing of the stapler is angled off to
the left of the left crural pillar to
avoid encroachment on the
esophagus and to prevent a leak
here, which can be very difficult to
deal with in the postoperative period.
The relevant portion of the
procedure is then concluded with the
evaluation of the integrity of the
staple line and intraluminal
hemostasis by intraoperative
endoscopy.
All patients undergo gastrograffin
swallow evaluation on postoperative
day (POD) 1 and are begun
immediately on a clear liquid diet if
normal. Most patients are discharged
the afternoon of POD 1, though
occasionally patients will stay an
additional day primarily secondary
to nausea.
new laparoscopic surgical evolution
and appears to be a perfect fit for this
technique. It is important to note that
there is no compromise in surgical
technique when using the SILS™
procedure. It is clearly safe, technically
feasible, and not prohibitively
expensive for the community
laparoscopic bariatric surgeon. The
learning curve is not terribly steep but
does require the ability to use both
hands equally well and the ability to
operate in line with the optical port.
Technological advances in
instrumentation and optics will make
this operation easier and even more
accessible in the years to come.
RESULTS
During the 11-month study period,
24 sleeve gastrectomies were
attempted by SILS™ technique. There
were 17 females and 7 males with a
mean preoperative BMI of 44 (range
37–48). The procedure was
successfully performed in 19 patients,
with five conversions to a standard
five-port LSG because of the presence
of hiatal hernias not identified on
preoperative barium swallow. There
were no conversions to open
procedure. Mean operative time was 72
minutes (range 58–94 min.) and mean
blood loss was less than 30cc. Mean
hospital stay was 1.3 days (range 1–3
days). There were no intraoperative or
postoperative complications and no
mortality.
REFERENCES
1.
Saber AA, Elgamel MH, Itawi, EA, Rao AJ. Single incision laparoscopic sleeve gastrectomy (SILS): a novel
technique. Obes Surg. 2008;18(10):1338–1342.
DISCUSSION
The introduction of natural orifice
surgery (NOTES) has been an exciting
development in minimally invasive
surgery. However, it is reserved for a
handful of academic centers with
specialized equipment and research
protocols. The SILS™ procedure
provides a more enhanced minimally
invasive surgery experience to the
“average” advanced laparoscopic
surgeon with little to no additional
capital investment in new equipment.
New technology, including roticulating,
bariatric-length instruments (Figure 3),
single access ports (Figure 4A, 4B),
and improved, angulated optics, has
caused an explosion in the application
of single incision surgery. SILS™ sleeve
gastrectomy is a natural offshoot of this
[JUNE
KEY POINTS
• Sleeve gastrectomy is
tailor-made for the
SILS™ technique.
• There is no compromise
in surgical technique with
respect to a standard
laparoscopic sleeve
gastrectomy.
• SILS™ sleeve gastrectomy
is safe, feasible, and not
prohibitively expensive.
2009,
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Reducing Risk in Bariatric
Surgery: Rationale for
Sleeve Gastrectomy
by ERIC J. DEMARIA, MD
AUTHOR AFFILIATION: Dr. DeMaria is Professor and Vice Chair, Duke University Department of Surgery.
ADDRESS CORRESPONDENCE TO: E-mail: [email protected]
leeve gastrectomy is a
component part of the duodenal
switch procedure (DS) for
obesity treatment, which also
resembles the Morganstrasse-Mill
procedure (M&M) developed in
England, although the M&M
procedure does not involve a gastric
S
KEY POINTS
• Evolution of bariatric surgery
procedures over decades has
been characterized by
progressive adoption of risk
reduction strategies.
• Risk stratification systems
are key to identifying patients
who could benefit from risk
reduction strategies such as
medical optimization and preop weight loss.
• Sleeve gastrectomy
introduced the concept of
staged intervention into
bariatric surgery, an
approach demonstrated to
have value for risk reduction.
• A growing body of evidence
suggests sleeve gastrectomy
may be an appropriate
primary bariatric surgical
procedure primarily due to
low risk and ease of surgical
revision when required.
8
Bariatric Times
[JUNE
2009,
resection. Gagner first noted that the
DS procedure carried a high
prohibitive morbidity and mortality
risk when performed laparoscopically
in high-risk patients and suggested
dividing the complex laparoscopic DS
procedure into two component parts
performed laparoscopically—the
sleeve gastrectomy (LSG) followed by
the laparoscopic Roux-en-Y
ileoduodenostomy to create
malabsorption at a later time. Thus
was born the first generally accepted
proposal to stage bariatric surgery in
an effort to reduce the risks of the
surgical procedure in the field of
bariatric surgery. It is clear that the
evolution of sleeve gastrectomy to the
current time has been closely linked to
the concept of reducing surgical risk
in bariatric patients.
The evolution of LSG as a risk
reduction strategy should be no
surprise to those familiar with the
history of bariatric surgery, which can
be viewed as a steady march forward
in development of surgical procedures
to optimize the benefits while
minimizing the risks of surgical
intervention. The very earliest
bariatric procedures were intestinal
bypass operations (like the jejunoileal
bypass), which produced extreme
levels of gut malabsorption in order to
accomplish massive weight loss in
bariatric patients. Such procedures
progressively fell into disfavor due to
concerns about risk and were
ultimately replaced in the 1970s with
SUPPLEMENT]
gastric bypass due to its lower overall
risk profile. Subsequently, in the
1980s, Dr. Ed Mason advocated the
vertical banded gastroplasty
procedure as a risk reduction strategy,
and this procedure became widely
accepted and adopted. One can argue
that adjustable gastric banding,
increasing in popularity in the US in
recent years, provides a lower risk of
life-threatening complications, and
this is often cited by patients as the
primary reason for choosing the
adjustable band operation for their
obesity treatment.
It is interesting that this
progressive march toward safer
bariatric surgical interventions has
been undertaken without good tools
available to clinicians to assess
surgical risk in the bariatric
population. In fact, understanding the
risk of bariatric surgery has been a
neglected area of study for decades,
primarily because the overall risk of
mortality has been reported in large
case series to be small, mandating
tremendous numbers of patients to be
studied in order to draw any valid
conclusions. The available data
demonstrating low overall mortality
risk have also perpetuated the
inaccurate concept that the risk is
equally small for all patients
undergoing bariatric surgery—if it
were, it would be like no other
procedural intervention in medicine.
Identifying certain specific factors that
increase bariatric surgery risk is an
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important step in allowing us to
identify high-risk patients before
surgery is undertaken—patients who
could be treated with different
treatment algorithms in an effort to
reduce risk.
The Obesity Surgery Mortality Risk
Score (OS-MRS) provides such a risk
stratification system. It is the first
proposed system for risk assessment
in bariatric surgery to be validated by
study in a large series of patients from
outside institutions that were not
involved in the original defining cohort
of patients studied at the Medical
College of Virginia Hospital. The
scoring system divides patients into
low risk (Class A), intermediate risk
(Class B), and highest risk (Class C)
categories based upon factors easily
identified before surgery, often at the
first patient evaluation visit. The five
risk factors found to increase bariatric
surgery risk include male gender,
BMI>50kg/m2, age>45 years, and
comorbid medical conditions of
systemic hypertension or a bariatric
patient who presents with factors that
correlate with an increased risk of
venous thromboembolism (VTE). The
latter factors include a previous
episode of VTE, the presence of an
indwelling vena caval filter, the
presence of venous stasis disease on
examination, obesity–hypoventilation
syndrome, and/or pulmonary
hypertension.
One of the truly fascinating
phenomena found in the current LSG
literature is the apparent low risk for
morbidity and mortality in the
presence of a high-risk patient
population. Some pioneering surgeons
have clearly selected only high-risk
patients in the early development of
their sleeve gastrectomy procedure.
To date, very few surgical mortalities
have been reported in the cumulative
surgical literature on sleeve
gastrectomy despite the high-risk
group selection bias. Many of these
patients likely are in the OS-MRS
Class C category, although to date no
author has formally classified his or
her sleeve patients according to this
risk stratification system to confirm
the high-risk status.
TABLE 1. Mortality risk associated with Class A, B, and C patients undergoing open and
laparoscopic gastric bypass in the original defining cohort studied at Medical College of
Virginia (MCV) and in the validation study in four centers not associated with the original
study population.
Original MCV
Data
(N) %
Mortality
Validation
Cohort
(N) %
Mortality
Both Series
Combined
(N) %
Mortality
Class A
(957)
0.31
(2166)
0.2
(3123)
0.26
Class B
(999)
1.90
(2140)
1.2
(3141)
1.43
Class C
(119)
7.56
(125)
2.4
(244)
4.92
A number of questions remain
regarding LSG. Similar to other
commonly performed bariatric
procedures including RYGB, the
mechanism of effectiveness for sleeve
gastrectomy as a bariatric treatment is
not known. Restriction of oral intake,
neurohumoral changes in the
gastrointestinal tract as a result of the
gastric resection component of the
procedure, changes in gastric
emptying, or other unidentified
factors may explain the success of
sleeve gastrectomy as a weight loss
intervention. Another major
unanswered question is how often will
patients fail the sleeve procedure and
require revisional procedures?
Admittedly the available reports
suggest this to be a less frequent
phenomenon than many had
predicted. A potential advantage of
sleeve gastrectomy as a primary
bariatric procedure is the reported
ease of surgically revising a sleeve.
When it comes to sleeve revision,
some surgeons are re-sleeving
patients when the sleeve segment
dilates over time, while others
recommend conversion to another
form of bariatric surgery. Most
appealing for these latter cases is
conversion to DS since the sleeve
represents a component part of that
operation and therefore revision does
not usually require any revision of the
previously operated gastric portion of
the procedure, which likely reduces
risks such as leak. Another approach
[JUNE
has been to convert the sleeve to a
Roux-en-Y gastric bypass (RYGB) by
transecting the sleeve segment to
create an appropriately small gastric
pouch, followed by bringing up a Roux
limb using standard techniques. It is
premature to determine the risk
associated with conversion of sleeve
to RYGB since only small series have
been reported to date; however, those
who have performed this procedure
testify that it is technically easier than
many other revisions of previous
gastric surgery for obesity, such as
conversion of vertical banded
gastroplasty to gastric bypass.
LSG has become established as a
low-risk surgical option for high-risk
bariatric surgery patients. Should the
need for reoperation and
revision/conversion to another
bariatric procedure remain low over
time, it is likely that sleeve
gastrectomy will continue to increase
as a primary bariatric surgical
intervention around the world, similar
to its evident growth in popularity in
Europe.
REFERENCES
1.
2.
3.
4.
2009,
Ren CJ, Patterson E, Gagner M. Early results of laparoscopic biliopancreatic diversion with duodenal switch: a
case series of 40 consecutive patients. Obes Surg.
2000;10(6):514–524.
DeMaria EJ. Portenier D. Wolfe L. Obesity surgery mortality risk score: proposal for a clinically useful score to
predict mortality risk in patients undergoing gastric
bypass. SOARD. 2007;3:134–140.
DeMaria EJ, Murr M, Byrne TK, et al. Validation of the
obesity surgery mortality risk score in a multicenter
study proves it stratifies mortality risk in patients undergoing gastric bypass for morbid obesity. Ann Surg.
2007;246:578–582.
The ASMBS Clinical Issues Committee. Sleeve gastrectomy as a bariatric procedure. SOARD.
2007;3(6):573–576.
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THE 2009 INTERNATIONAL CONSENSUS SUMMIT ON SLEEVE GASTRECTOMY
Laparoscopic Sleeve
Gastrectomy:
Mid-term Weight Loss
Results
by GREGG H. JOSSART, MD, FACS, AND PAUL T. CIRANGLE, MD, FACS
AUTHOR AFFILIATIONS: Drs. Jossart and Cirangle are from the Laparoscopic Associates of San Francisco, California.
ADDRESS CORRESPONDENCE TO: Dr. Gregg Jossart, 2100 Webster Street, Suite 110, San Francisco, CA 94115; Phone: (415) 561-1310;
Fax (415) 561-1713; E-mail: [email protected]
BACKGROUND
The sleeve gastrectomy as a
solo procedure (independent of the
duodenal switch) has been
performed as early as 2000.1 The
operation was offered either as a
first stage for higher body mass
index (BMI) patients or as a single
stage to mainly lower BMI patients.
Due to the variations in risk,
starting BMI, and technique, weight
loss results beyond the first year
have been limited. Indeed, the
ASMBS position statement2
reviewed 35 publications
representing 2,410 patients, and
there were essentially no
significant results reported beyond
24 months. However, weight loss at
24 months was quite acceptable
and ranged from 50 to 90 percent.
DISCUSSION
The authors started performing
the procedure in 2002 as a first
10
Bariatric Times
[JUNE
2009,
stage for higher BMI patients.3 We
were very cautious in implementing
the procedure initially and only
performed 93 procedures from
2002 to 2005. During this time, we
saw a dramatic weight loss of 84
percent at 24 months
postoperative. We also began to
realize that some of these patients
would start to regain after the first
12 months. It was this weight
regain that prompted us to become
more aggressive with smaller pouch
volumes starting in 2005 (Figure
1). We started to staple close to
the 32 Fr bougie and resect the
fundus by starting within 2cm of
the pylorus.
Early problems with nausea and
dehydration increased, but our 30day emergency room (ER) visit
rate in 2006 for these problems was
only three percent, and now
decreased to 1.7 percent in 2008.
Our leak rate increased as well. It
SUPPLEMENT]
had been zero percent in the first
75 patients, then increased to two
percent until we changed to green
staple cartridges and started using
buttress materials or suture
inversion of the superior staple
line. Our current leak rate has now
stabilized at 0.3 percent. The leaks
that do occur in this narrow pouch
are very difficult to manage. We
also started to see some of our
early patients develop reflux and
hiatal hernias (Figure 2) beyond
one year and thus became more
aggressive about dissecting
posterior hernias and performing a
posterior hiatal hernia closure. In
2008, 30 percent of our patients
underwent simultaneous hernia
repairs. The early results have
shown resolution of reflux
symptoms.
We now have 93 patients that
are beyond four years
postoperative. The mean BMI for
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2
1
FIGURE 1. Technical changes in pouch
calibration with experience
FIGURE 2. Development of a hiatal hernia in a
patient 4 years postoperatively
FIGURE 3. Four-year weight loss separated
BMI less than 55 or greater than 55
4
3
FIGURE 4. Mid-term weight loss results
presented at the 2009 International
Consensus Conference on Sleeve
Gastrectomy.
this group was greater than 55. This
group also had larger pouches than
those patients operated on in 2005
and beyond. Figure 3 reveals fouryear weight loss of 68 percent for the
group, with a starting BMI less than
55 and 59 percent for those with a
starting BMI greater than 55.
By the end of 2010, we will have
501 patients who are more than four
years postoperative with a starting
mean BMI of 45. This group has
benefitted from the smaller pouch,
combined hiatal hernia repair, and
improved patient education, so we
hope to achieve even better, more
durable weight loss than our earlier
patients did.
Currently, mid-term results are
only available from a few other
groups in Europe (Figure 4). These
data sets are currently not published,
but were presented at the 2009
International Consensus Summit on
Sleeve Gastrectomy in Miami. The
results are mixed due to certain
factors, such as starting BMI, pouch
caliber, fundus preservation, and
duration of followup. Percent excess
weight loss from 4 to 8 years can
range from 40 to 80 percent.
CONCLUSION
In summary, current four-year
results may not reflect refinements
in technique, patient selection, and
patient education. They do appear to
be similar to other stapling
procedures and probably superior to
adjustable gastric banding. This
operation has a high patient
satisfaction rate, is useful as a safer
option in certain risk groups, and is
completely modifiable. It must be
cautiously implemented due to the
long staple line and difficulty in
managing leaks. Experience is
needed to obtain the smallest
possible pouch without significant
complications or side effects, for the
one true challenge of this operation
is that optimal weight loss may
require the smallest possible pouch,
which may yield the highest
leak rate.
REFERENCES
1.
2.
3.
Deitel, M, Gagner, M. The First International Consensus
Summit for Sleeve Gastrectomy (SG). New York City,
October 25-27, 2007. Obes Surg. 2008;18(5):487–496.
Accessed at www.asmbs.org.
Lee C, Cirangle P, Jossart G. Vertical gastrectomy for
morbid obesity in 216 patients: report of two-year
results. Surg Endosc. 2007;21:1810–1816.
KEY POINTS
• Laparoscopic sleeve gastrectomy five-year results are limited and vary from 40 to
80 percent.
• The surgical technique and calibration of the pouch has improved to yield better
weight loss.
• Smallest pouch may be necessary to achieve durable weight loss but may also
yield a higher complication rate.
[JUNE
2009,
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THE 2009 INTERNATIONAL CONSENSUS SUMMIT ON SLEEVE GASTRECTOMY
Sleeve Gastrectomy and
Diabetes: Early Clinical and
Hormonal Changes
by NICOLA BASSO, MD; FRIDA LEONETTI, MD; PAOLA MARIANI, MD; MARIO RIZZELLO, MD;
FRANCESCA ABBATINI, MD; GIORGIO ALESSANDRI, MD; GIOVANNI CASELLA, MD; DANILA CAPOCCIA, MD;
AND ALDO FANTINI, MD
AUTHOR AFFILIATIONS: Drs. Basso, Mariani, Rizzello, Abbatini, Alessandri, Casella, and Fantini are with the Department of Surgery “Paride
Stefanini,” University of Rome “La Sapienza.” Drs. Leonetti and Capoccia are with the Department of Clinical Sciences, University of Rome “La
Sapienza.”
ADDRESS CORRESPONDENCE TO: Dr. Nicola Basso, Department of Surgery “Paride Stefanini,” Policlinico Umberto I, 00161 Rome, Italy;
Phone: 0039 0649970204; Fax: 0039 064940462; E-mail: [email protected]
leeve gastrectomy (SG) was
originally conceived as a first
stage of biliopancreatic
diversion-duodenal switch (BPD-DS)
for achieving weight loss and
reducing comorbidities in superobese
patients. Recently it has been
proposed that SG could also be
considered as a potential single
restrictive bariatric procedure.
Furthermore, Moon Han et al showed
that SG without the second-stage
operation was associated with an
excess weight loss of 71 percent and
100-percent resolution rate of type 2
diabetes mellitus (T2DM) at six
months after surgery. Lacy et al
reported that SG is associated with a
high resolution of T2DM at short
term (4 months after surgery), and
this resolution rate was comparable
to that in Roux-en-Y gastric bypass
(RYGB) (51.4% and 62%,
S
respectively, p=0.332). At 12
months, T2DM had resolved,
respectively, in 33 out of 39 (84.6%)
SG patients and in 44 out of 52
(84.6%) of the RYGB subjects
(p=0.618). Neither the weight loss
nor the degree of descent in the
waist circumference was associated
with T2DM resolution following SG
or RYGB. The aim of the study was
to elucidate the clinical and
hormonal effects of SG in T2DM
patients in the early postoperative
phase.
MATERIALS AND METHODS
Between October 2002 and
December 2008, 200 obese patients
underwent SG in our institution.
Fourty-eight patients (31:17 female
to male ratio; mean age 50.2 years;
mean BMI 50.8) had an altered
glucose homeostasis (32 T2DM and
16 impaired glucose tolerance [IGT]).
Evaluations were performed as
follows:
Group A (20 pts): BMI, fasting
glycemia (FPG), HbA1c, HOMA-IR
were evaluated preoperatively and at
3, 6, 12, 24, and 36 months
postoperative; euglycemic
hyperinsulinemic clamp at 12 months
postoperative.
Group B (22 pts): FPG and
basal insulinemia, HOMA-IR were
evaluated preoperatively and at 5,
15, 30, 60 days postoperative. In 10
of these patients, FPG and
insulinemia were evaluated on
postoperative Days 1, 2, 3, and 4.
Group C (6 pts): Insulin
sensitivity and secretion by
intravenous glucose tolerance test
(IVGTT), ghrelin, and GLP-1 values
were evaluated preoperatively and
60 hours postoperative. At one
KEY POINTS
• Sleeve gastrectomy is effective on T2DM independent of weight loss.
• An additional non-weight loss-related mechanism contributes to changes in insulin
resistance following SG.
• Modifications of ghrelin and GLP-1 after SG may play a role in T2DM resolution.
12
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1
3
2
FIGURES 1–3. Sixty hours postoperative in Group C, the insulin curve showed a restored normal
shape with marked improvement of insulin secretion and sensitivity (1), significant modification of
ghrelin was seen (2), and significant modification of GLP-1 values was seen (3).
month postoperative, we evaluate
ghrelin and GLP-1 values after meal.
The total number of SG procedures
and the effect on diabetic patients
were evaluated in the Italian registry.
RESULTS
In Group A, cure was obtained in 80
percent. The antidiabetic therapy was
discontinued 3.3 months
postoperatively (EWL 36.3±7.2%, FPG
125.5±15.5 mg/dL and HbA1c
59±0.4%). The BMI at the time of
discontinued therapy was not
significantly different from
preoperative value. Paradoxically, in
not cured patients we observed a
statistically significant reduction of
BMI at three months after procedure.
These data may be explained by the
longer duration of the diabetes in this
group. Twelve months after surgery, in
patients who had stopped antidiabetic
medications, hyperinsulinemic
euglycemic clamp was performed.
Insulin sensitivity was restored into
normal range in all patients.
In Group B, 66 percent of patients
did not resume postoperative
antidiabetic medications. In all
patients, a sharp (5 days) and
significant reduction of serum glucose
and insulin concentration and
HOMA-IR values was observed in
comparison with the preoperative
findings. Moreover, in seven patients,
serum glucose and insulin
concentrations and HOMA-IR values
were significantly lower than the
preoperative ones at the third
postoperative day. At the 15th
postoperative day, both serum glucose
and insulin concentration and HOMAIR remained significantly lower than
the preoperative values. By contrast, at
this time the BMI was not significantly
changed in comparison with the
preoperative values (EWL 14.7%). One
month postoperative, all patients on
preoperative diet therapy had normal
fasting glucose values (100.6mg/dL).
Eight of 12 (66.6%) patients on oral
hypoglycemic medication presented
normal fasting glucose values
(112mg/dL) without any medication,
two (16.6%) patients presented with
improvement of the disease and
needed less oral medications. At two
months, the insulin-treated patient
presented a better control of fasting
glucose values (107 vs. 256mg/dL) and
needed half the daily dose of insulin
(80 vs. 166IU). At 30 and 60
postoperative days serum glucose and
insulin concentration and HOMA-IR
values remained substantially
unchanged despite a greater weight
loss (EWL 23.6% and 32.3%,
respectively).
In Group C, postoperatively (60
hours), in IVGTT the insulin curve
showed a restored normal shape with
marked improvement of insulin
secretion and sensitivity (Figure 1).
Moreover, we observed a significant
modification of ghrelin (Figure 2) and
GLP-1 values (Figure 3).
In the Italian registry, the total
number of SG was 562 (448 in
2008; 14% T2DM patients). T2DM
was cured or ameliorated 3 to 6
months postoperative in 69.4
[JUNE
percent of patients.
CONCLUSION
These data confirm that sleeve
gastrectomy is effective on T2DM
independent of weight loss. We
observed a marked reduction in
HOMA-IR findings, thus indicating a
rapid (3–5 days) and remarkable
improvement of insulin action after SG
unrelated to weight loss. The results of
the present study strongly suggest that
an additional non-weight loss-related
mechanism contributes to changes in
insulin resistance following SG.
Modifications of ghrelin and GLP-1
after SG may play a role in T2DM
resolution. Further studies are needed
to confirm the role of ghrelin and
GLP-1 in T2DM resolution after sleeve
gastrectomy.
SUGGESTED READINGS
1.
2.
3.
4.
5.
6.
7.
8.
2009,
Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA.
2004;292(14):1724–1737.
Deitel M, Crosby RD, Gagner M. The First International
Consensus Summit for Sleeve Gastrectomy (SG), New
York, Oct. 25-27, 2007.Obes Surg. 2008;18(5):487–496.
Moon Han S, Kim WW, Oh JH. Results of laparoscopic
sleeve gastrectomy (LSG) at 1 year in morbidly obese
Korean patients. Obes Surg. 2005;15:1469–1475.
Karamanakos SN, Vagenas K, Kalfarentzos F,
Alexandrides TK. Weight loss, appetite suppression,
and changes in fasting and postprandial ghrelin and
peptide-YY levels after Roux-en-Y gastric bypass and
sleeve gastrectomy: a prospective, double blind study.
Ann Surg. 2008;247(3):401–407.
Lee CM, Cirangle PT, Jossart GH. Vertical gastrectomy
for morbid obesity in 216 patients: report of two-year
results. Surg Endosc. 2007;21(10):1810–1816.
Himpens J, Dapri G, Cadière GB. A prospective randomized study between laparoscopic gastric banding
and laparoscopic isolated sleeve gastrectomy: results
after 1 and 3 years. Obes Surg. 2006;16(11):1450–1456.
Vidal J, Ibarzabal A, Romero F, Delgado S, Momblán D,
Flores L, Lacy A.Type 2 diabetes mellitus and the metabolic syndrome following sleeve gastrectomy in severely
obese subjects. Obes Surg. 2008;18(9):1077–1082.
Yada T, Dezaki K, Sone H, et al. Ghrelin regulates
insulin release and glycemia: physiological role and
therapeutic potential. Curr Diabetes Rev.
2008;4(1):18–23.
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THE 2009 INTERNATIONAL CONSENSUS SUMMIT ON SLEEVE GASTRECTOMY
A Summary Article Reviewing Sleeve
Gastrectomy as a Staging and Primary
Bariatric Procedure
by JOSEPH A. TALARICO, MD; STACY A. BRETHAUER, MD; AND PHILIP R. SCHAUER, MD
AUTHOR AFFILIATIONS: All from the Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, Ohio.
ADDRESS CORRESPONDENCE TO: Philip R. Schauer MD, 9500 Euclid Ave. M61, Cleveland, Ohio 44195
leeve gastrectomy (SG) has
recently become popular both as
primary operation as well as
staged operation in the super morbidly
obese. It has similar outcomes to other
restrictive procedures and a risk
profile that is superior to other
bariatric operations for the super
morbidly obese. SG can be performed
quickly and safely and, like other
restrictive procedures, offers
immediate caloric restriction. There
are, however, several reasons to
practice caution in advocating SG—
irreversibility (unlike a band), major
complications (e.g. leak), and lack of
data beyond five years. Within this
short article, SG will be evaluated
based on the current evidence
regarding weight loss, complication
rates, postoperative mortality, and
comorbidity improvement. This article
S
KEY POINT
• SG outcomes, in terms
of weight loss and
comorbidity reduction,
exceed or are similar to
other restrictive
procedures based on the
complete examination of
case series, two
randomized trials, large
single institution studies,
and a systematic review
of the literature.
14
Bariatric Times
[JUNE
2009,
is meant to summarize a recent
systematic review submitted to
Surgery for Obesity and Related
Diseases.
Recently, the indications for SG
have begun to broaden, and there has
been a surge in interest evidenced by
numerous published reports, the
authors’ feedback, and presentations at
national and international conferences
(several of which are devoted to SG).
Our review was conducted in
accordance with published
recommendations and is under review
at this time.1 Several thousand
citations were reviewed with a
resultant 36 SG studies with 2,570
patients.2-36 Studies took place all over
the world, including one each from
Israel and Saudi Arabia. Although
there were only two randomized
controlled trials, three of the studies
were multicenter trials and the
remaining single institution studies had
large cohorts. After reviewing these
studies, several clearly state that SG
was being used as a staged procedure
or as a management strategy for a
high-risk patient population; however,
some studies reported results of the
SG used as a primary operation with
no intent of a second-stage procedure.
The mean preoperative BMI
among all 36 studies was 51kg/m2, 65
percent of patients were female, and
mean patient age was 42 years. When
the staged/high-risk subset was
examined, 55 percent were female and
the average age was 45 years. For
those articles that clearly point toward
a primary SG group, 70 percent of
patients were female and the average
age was just over 40 years. Ten studies
SUPPLEMENT]
showed 70 percent of patients
examined had improvement or
remission of type 2 diabetes within
follow-up periods ranging from 1 to 5
years. There were also significant
improvements in hypertension,
hyperlipidemia, sleep apnea, and joint
pain.
The mean excess weight loss
(EWL) after SG was reported in 24
studies and ranged from 33 to 85
percent, with an overall mean EWL of
55 percent. Mean postoperative BMI
was reported in 26 studies and
decreased from a baseline mean of
51kg/m2 to 37kg/m2 postoperatively.
The follow-up periods for weight loss
data ranged from 3 months to 60
months. Within subgroups, weight loss
data for the staged/high risk patients
was EWL 33 to 61% (mean 47%) at a
followup of five years and as a primary
procedure EWL 36 to 85% (mean
60%) with only a three-year followup.
One of the most important factors
to take into consideration when
offering this procedure to patients is
the risk profile. Significant
complications commonly include leaks
(2.2%), bleeding requiring reoperation
(1.2%), and postoperative strictures
requiring endoscopic or surgical
intervention (0.6%).27,36 All studies
reported mortality data with five
postoperative deaths (within 30 days
of surgery) for an overall mortality rate
of 0.19 percent.2-36
The trend toward SG as a primary
procedure has gained momentum
since 2006 when the first large series
started to appear.2,3,17,35 Initially, SG
studies included high-risk patients who
underwent LSG as a staged approach
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THE 2009 INTERNATIONAL CONSENSUS SUMMIT ON SLEEVE GASTRECTOMY
to bariatric surgery. Of the series
reviewed, large subsets were high risk
patients who were intended to
undergo SG as a planned staged
procedure prior to RYGB or BPD/DS.
Mostly male patients with high
preoperative BMIs, they were
significantly different than the series
utilizing SG as a primary procedure.
Generally, the high-risk patients return
to the operating room within two years
of SG to undergo second-stage RYGB
or DS after improvement in their
comorbidities and surgical risk. In
spite of the high surgical risk, reported
rates of postoperative leak, bleeding,
and stricture are acceptably low,
although low complication and
mortality rates reported in this highrisk group may be a reflection of the
bariatric surgeon’s experience and/or
may reflect some degree of
weight loss to the RYGB and DS
groups and a mean BMI of 28 at two
years. At the end of two years, the SG
patients had the greatest average total
weight loss (213 pounds) among all
surgical groups and approximately
four percent of SG patients had a
plateau in their weight loss at the time
of followup.
SG outcomes, in terms of weight
loss and comorbidity reduction,
exceed or are similar to other
restrictive procedures based on the
complete examination of case series,
two randomized trials, large single
institution studies, and a systematic
review of the literature. There is ample
data to make a case for SG as a
primary as well as a staged procedure.
The risk profile shows that rates of
significant postoperative complications
and mortality are acceptably low. And
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
2008;18(12):1567–1580.
Weiner RA, Weiner S, Pomhoff I, et al. Laparoscopic
sleeve gastrectomy--influence of sleeve size and resected
gastric volume. Obes Surg. 2007;17(10):1297–1305.
Melissas J, Koukouraki S, Askoxylakis J, et al. Sleeve gastrectomy: a restrictive procedure? Obes Surg.
2007;17(1):57–62.
Almogy G, Crookes PF, Anthone GJ. Longitudinal gastrectomy as a treatment for the high-risk super-obese patient.
Obes Surg. 2004;14(4):492–497.
Moon Han S, Kim WW, Oh JH. Results of laparoscopic
sleeve gastrectomy (LSG) at 1 year in morbidly obese
Korean patients. Obes Surg. 2005;15(10):1469–1475.
Baltasar A, Serra C, Perez N, et al. Laparoscopic sleeve
gastrectomy: a multi-purpose bariatric operation. Obes
Surg. 2005;15(8):1124–1128.
Milone L, Strong V, Gagner M. Laparoscopic sleeve gastrectomy is superior to endoscopic intragastric balloon as
a first stage procedure for super-obese patients
(BMI>50). Obes Surg. 2005;15(5):612–617.
Mognol P, Chosidow D, Marmuse JP. Laparoscopic sleeve
gastrectomy as an initial bariatric operation for high-risk
patients: initial results in 10 patients. Obes Surg.
2005;15(7):1030–1033.
Tucker ON, Szomstein S, Rosenthal RJ. Indications for
sleeve gastrectomy as a primary procedure for weight loss
in the morbidly obese. J Gastrointest Surg.
2008;12(4):662–667.
Braghetto I, Korn O, Valladares H, et al. Laparoscopic
sleeve gastrectomy: surgical technique, indications and
clinical results. Obes Surg. 2007;17(11):1442–1450.
Dapri G, Vaz C, Cadiere GB, et al. A prospective randomized study comparing two different techniques for laparoscopic sleeve gastrectomy. Obes Surg.
2007;17(11):1435–1441.
Gan SS, Talbot ML, Jorgensen JO. Efficacy of surgery in
the management of obesity-related type 2 diabetes mellitus. ANZ J Surg. 2007;77(11):958–962.
There is ample data to make a case for SG as a
primary as well as a staged procedure.
22.
publication bias.
SG as a primary procedure has
been generally offered to groups of
patients with a lower BMI than the
high-risk group; hence there is a
correspondingly greater percent EWL
and lower complication rate.
Complication rates reported in this
subset of patients are also lower than
in the high-risk group. Lalor et al
reported on complications of SG when
performed as a primary procedure.
Among 148 patients with an average
preoperative BMI of 44, the major
complication rate was about three
percent. In other publications, the
incidence of bleeding (1.0%) and
stricture (0.5%) in the low-risk groups
are approximately half that of the
high-risk group.36
The largest reported series of SG
as a primary procedure is by Lee et al.
It is a single-institution, retrospective
comparison describing two-year
outcomes of 216 patients.5 Lee reports
the average BMI for the SG cohort was
49 (higher than the nonrandomized
comparative groups undergoing
banding, RYGB, and DS). Surprisingly,
the SG group had a similar rate of
although long-term data is limited,
three-year (as a primary procedure)
and five-year (as in high risk/staged)
data demonstrate durability of SG as
comparable to other well established
restrictive procedures.
23.
24.
25.
26.
REFERENCES
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Stroup DF, Berlin JA, Morton SC, et al. Meta-analysis of
observational studies in epidemiology: a proposal for
reporting. Meta-analysis Of Observational Studies in
Epidemiology (MOOSE) group. JAMA.
2000;283(15):2008–2012.
Cottam D, Qureshi FG, Mattar SG, et al. Laparoscopic
sleeve gastrectomy as an initial weight-loss procedure for
high-risk patients with morbid obesity. Surg Endosc.
2006; 20(6):859–863.
Hamoui N, Anthone GJ, Kaufman HS, et al. Sleeve gastrectomy in the high-risk patient. Obes Surg.
2006;16(11):1445–1449.
Ou Yang O, Loi K, Liew V, et al. Staged laparoscopic
sleeve gastrectomy followed by Roux-en-Y gastric bypass
for morbidly obese patients: a risk reduction strategy.
Obes Surg. 2008; 18(12):1575-80.
Lee CM, Cirangle PT, Jossart GH. Vertical gastrectomy for
morbid obesity in 216 patients: report of two-year results.
Surg Endosc. 2007.
Karamanakos SN, Vagenas K, Kalfarentzos F, et al. Weight
loss, appetite suppression, and changes in fasting and
postprandial ghrelin and peptide-YY levels after Roux-enY gastric bypass and sleeve gastrectomy: a prospective,
double blind study. Ann Surg. 2008; 247(3):401–407.
Vidal J, Ibarzabal A, Romero F, et al. Type 2 diabetes mellitus and the metabolic syndrome following sleeve gastrectomy in severely obese subjects. Obes Surg. 2008;
18(9):1077–1082.
Felberbauer FX, Langer F, Shakeri-Manesch S, et al.
Laparoscopic sleeve gastrectomy as an isolated bariatric
procedure: intermediate-term results from a large series
in three Austrian centers. Obes Surg. 2008; 18(7):814–8.
Nocca D, Krawczykowsky D, Bomans B, et al. A prospective multicenter study of 163 sleeve gastrectomies: results
at 1 and 2 years. Obes Surg. 2008;18(5):560–565.
Rubin M, Yehoshua RT, Stein M, et al. Laparoscopic
sleeve gastrectomy with minimal morbidity early results in
120 morbidly obese patients. Obes Surg.
[JUNE
27.
28.
29.
30.
31.
32.
33.
34.
35.
36.
2009,
Parikh M, Gagner M, Heacock L, et al. Laparoscopic
sleeve gastrectomy: does bougie size affect mean %EWL?
Short-term outcomes. SOARD. 2008;4(4):528–533.
Skrekas G, Lapatsanis D, Stafyla V, et al. One year after
laparoscopic “tight” sleeve gastrectomy: technique and
outcome. Obes Surg. 2008;18(7):810–813.
Mui WL, Ng EK, Tsung BY, et al. Laparoscopic sleeve gastrectomy in ethnic obese Chinese. Obes Surg. 2008.
18(12):1571–1574.
Gagner M, Gumbs AA, Milone L, et al. Laparoscopic sleeve
gastrectomy for the super-super-obese (BMI>60). Surg
Today. 2008;38(5):399–403.
Kasalicky M, Michalsky D, Housova J, et al. Laparoscopic
sleeve gastrectomy without an oversewing of the staple
line. Obes Surg. 2008;18(10):1257–1262.
Frezza EE, Reddy S, Gee LL, et al. Complications after
sleeve gastrectomy for morbid obesity. Obes Surg.
2009;19(6):684–687.
Hakeam HA, O’Regan PJ, Salem AM, et al. Inhibition of Creactive protein in morbidly obese patients after laparoscopic sleeve gastrectomy. Obes Surg.
2009;19(4):456–460.
Quesada BM, Roff HE, Kohan G, et al. Laparoscopic
sleeve gastrectomy as an alternative to gastric bypass in
patients with multiple intraabdominal adhesions. Obes
Surg. 2008; 18(5):566–568.
Tagaya N, Kasama K, Kikkawa R, et al. Experience with
laparoscopic sleeve gastrectomy for morbid versus super
morbid obesity. Obes Surg. 2008 Dec 9. [Epub ahead of
print]
Takata MC, Campos GM, Ciovica R, et al. Laparoscopic
bariatric surgery improves candidacy in morbidly obese
patients awaiting transplantation. Surg Obes Relat Dis.
2008; 4(2):159–164; discussion 164–165.
Fuks D, Verhaeghe P. Results of laparoscopic sleeve gastrectomy: a prospective study in 135 patients with morbid
obesity. Surgery. 2009;145(1):106–113.
Stroh C, Birk D, Flade-Kuthe R, et al. Results of sleeve
gastrectomy-Data from a nationwide survey on bariatric
surgery in Germany. Obes Surg. 2009;19(5):632–640.
Uglioni B, Wolnerhanssen B, Peters T, et al. Midterm
results of primary vs. secondary laparoscopic sleeve gastrectomy (LSG) as an isolated operation. Obes Surg.
2009;19(4):401–406.
Himpens J, Dapri G, Cadiere GB. A prospective randomized study between laparoscopic gastric banding and
laparoscopic isolated sleeve gastrectomy: results after 1
and 3 years. Obes Surg. 2006;16(11):1450–1456.
Lalor PF, Tucker ON, Szomstein S, et al. Complications
after laparoscopic sleeve gastrectomy. Surg Obes Relat
Dis. 2008;4(1):33–38.
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Sleeve Gastrectomy, Glucose
Tolerance, and GLP-1
by JOSEP VIDAL, MD, PhD
AUTHOR AFFILIATION: Dr. Vidal is with the Obesity Unit, Endocrinology Department, Hospital Clinic, Barcelona, Spain.
ADDRESS CORRESPONDENCE TO: Dr. Josep Vidal, Villarroel 170; 08036 Barcelona; Phone: +34932279846; Fax: +34934616638;
E-mail: [email protected].
INTRODUCTION
Bariatric surgery is known to be a
highly effective and long-lasting
treatment for morbid obesity and
many related conditions, including
type 2 diabetes mellitus (T2DM) and
metabolic syndrome (MS).1,2 Data
suggest that the resolution of obesityassociated metabolic disturbances is
more common following the
predominantly malabsorptive and the
mixed malabsorptive-restrictive
procedures, compared to the purely
restrictive operations.1 However, data
on the resolution rates of T2DM and
MS following sleeve gastrectomy
suggest this bariatric technique is an
exception to this rule.
In a prospective study, we
demonstrated that at four months
after surgery, the resolution rate of
T2DM in subjects undergoing
laparoscopic sleeve gastrectomy
(LSG) was comparable to that in
subjects with T2DM undergoing
laparoscopic Roux-en-Y gastric bypass
(LRYGB) matched for DM duration,
type of DM treatment, and glycemic
control.3 Moreover, the clinical
features associated with the early
resolution of T2DM were similar
between the two surgical groups.
Likewise, in a subsequent study we
showed that at longer followup (12
months), LSG is as effective as
LRYGB in inducing remission not only
of T2DM, but also of MS.4 At one year
after surgery, T2DM had resolved in
approximately 85 percent of the
participants in both surgical groups.
The rate of resolution of MS was 62.2
percent and 67.3 percent (p=0.392)
following LSG and LRYGB,
respectively. The amelioration and
the resolution rate of the different MS
components at 12 months after
surgery was not significantly different
between the two study groups. A
younger age and a greater weight loss
relative to baseline were associated
with the resolution of MS following
the two surgical procedures.
Since changes in gastrointestinal
hormones have been implicated in
the resolution of T2DM following
bariatric surgery, we aimed to
compare the changes in glucose
tolerance and GLP-1 following LSG
and LRYGB.
METHODS AND RESULTS
Following a standardized test meal
(STM), the levels of GLP-1, insulin,
and glucose were determined before
and at six weeks after surgery in 12
normal-glucose tolerant obese
subjects (BMI=53.81kg/m2)
undergoing LSG (n=6) or LRYGB
(n=6). The two groups were matched
for gender distribution, age, and BMI.
Insulin secretion and insulin
sensitivity indices were derived from
the STM (Δ insulin0-30 / Δ glucose0-30,
AUC0-120 insulin/AUC0-120 glucose,
insulin sensitivity composite index),
and fasting samples (HOMA-S,
HOMAB). Four non-operated
morbidly obese subjects matched for
the BMI attained at six weeks after
surgery served as controls.
At six weeks after surgery, patients
in both surgical groups had lost
approximately 10 percent of their
initial body weight (LSG: median,
9.51%; LRYGBP: median, 10.2%;
p=0.690). The GLP-1 response to a
STM was larger than that prior to
surgery following LSG (p=0.043) and
LRYGB (p=0.028) (Figure 1). The
AUC0-120 of GLP-1 changed to a similar
KEY POINTS
• The resolution rates of T2DM following LSG and LRYGB are similar.
• The resolution rates of metabolic syndrome following LSG and LRYGB are similar.
• LSG and LRYGB are associated with comparable changes in the GLP-1 response to
meal intake.
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Our data suggest that although LSG is considered a
restrictive bariatric procedure, at least at short term, it is
associated with changes in the GLP-1 response to meal
intake, and glucose homeostasis comparable to those
observed following LRYGB.
extent following the two surgical
procedures (LSG: median, 493%,
LRYGB: median, 725%; p=0.343), and
was larger than that in the control
group (p<0.01). Likewise, changes in
fasting plasma glucose (LSG: median,
-2%; LRYGB: median, -8%; p=0.343)
and the AUC0-120 glucose in response
to the STM (p=0.268) did not differ
between the two surgical groups. As
shown in Figure 2, the time course of
the glucose response in the postsurgical examination was almost
superimposable between the two
groups. Changes in HOMA-S
(p=0.876), insulin sensitivity
composite index (p=0.530), and the
indices of β−cell function adjusted for
the prevailing insulin sensitivity
changed comparably following LSG
and LRYGB.
DISCUSSION
Our data suggest that although
LSG is considered a restrictive
bariatric procedure, at least at short
term, it is associated with changes in
the GLP-1 response to meal intake
and glucose homeostasis comparable
to those observed following LRYGB.
The data reported here is in
addition to that reported by
Karamanakos et al on the similarities
in the gut hormone response to food
intake between LSG and LRYGB.5 In
their study, a marked reduction in
fasting ghrelin levels and an increase
in fasting PYY were observed
following LSG (n=16). Fasting ghrelin
did not change, and fasting PYY
increased to a similar extent following
LRYGB (n=16). At three months after
surgery, meal intake induced a
reduction in plasma ghrelin levels
following LSG (n=6) but not following
LRYGB (n=6). Both surgical
procedures were associated with a
marked increase in the prandrial PYY
response relative to prior to surgery.
Korner et al have recently
reported a comparison of the ghrelin,
GLP-1, and PYY response to meal
intake following LRYGB and
laparoscopic adjustable gastric
banding (LAGB).6 In this prospective
study, the degree of suppression of
ghrelin levels post-meal did not differ
significantly pre-surgery to Week 52
in either the LRYGB or the LAGB
group. As previously reported, after
LRYGB, the post-prandial response of
GLP-1 and PYY was significantly
increased relative to baseline. In
contrast, in LAGB patients, the
postprandial rise of GLP-1 measured
at 30 minutes did not change after
surgery. The AUC for PYY in
response to the test meal increased
threefold at 26 weeks after surgery in
the LRYGB group. The AUC of PYY in
the LAGB subjects was also
increased, but to a lesser extent.
CONCLUSION
In summary, LSG does not appear
to fit in the category of purely
restrictive bariatric procedures. The
changes in the GLP-1 secretion
resemble those present following
LRYGB and are in contrast with those
reported in the literature following
LAGB. Although our data suggest
GLP-1 could play a role in the
changes in glucose homeostasis
following LSG, future studies are
required addressing this question
specifically in subjects with T2DM.
SUGGESTED READINGS
1.
2.
3.
4.
5.
6.
[JUNE
2009,
Buchwald H, Avidor Y, Brawnwald E, et al.
Bariatric surgery: a systematic review and metaanalysis. JAMA. 2004; 292:1724–1737.
Kral JG, Näslund E. Surgical treatment of obesity. Nat Clin Pract Endocrinol Metab.
2007;3:574–583.
Vidal J, Ibarzabal A, Nicolau J, et al. Short-term
effects of sleeve gastrectomy on type 2 diabetes
mellitus in severely obese subjects. Obes Surg.
2007;17:1069–1074.
Vidal J, Ibarzabal A, Romero F, et al. Type 2 diabetes mellitus and the metabolic syndrome following sleeve gastrectomy in severely obese
subjects. Obes Surg. 2008;18:1077–1082.
Karamanakos SN, Vagenas K, Kalfarentzos F,
Alexandrides TK. Weight loss, appetite suppression, and changes in fasting and postprandial
ghrelin and peptide-YY levels after Roux-en-Y
gastric bypass and sleeve gastrectomy: a
prospective, double blind study. Ann Surg.
2008;247:401–407.
Korner J, Inabnet W, Febres G, et al.
Prospective study of gut hormone and metabolic changes after adjustable gastric banding and
Roux-en-Y gastric bypass. Int J Obes (Lond).
2009 May 5. [Epub ahead of print]
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Laparoscopic Revisions
of Sleeve Gastrectomy
by RAUL J. ROSENTHAL, MD, FACS
AUTHOR AFFILIATION: Dr. Rosenthal is Medical Director of the Bariatric Institute and Section Head of Minimally Invasive Surgery, Cleveland
Clinic Florida.
ADDRESS CORRESPONDENCE TO: Raul J. Rosenthal, MD, FACS, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd., Weston, Florida 33331;
Phone: (954) 659-5228; E-mail: [email protected]
BACKGROUND
The increasing implementation of
laparoscopic sleeve gastrectomy
(LSG) as a final or staged treatment
option for morbid obesity has
resulted in a new group of patients
with the potential for revisional
surgery.
Revisions of sleeve gastrectomy
can result from acute complications,
such as bleeding or leaks, and
chronic complications, such as
strictures or missed hiatal hernias,
resulting in severe gastroesophageal
reflux and pain. We must also
distinguish two groups of
complications, resulting when sleeve
gastrectomy is used as a primary
procedure or when sleeve
gastrectomy is used as a secondary
procedure or revisional approach to
replace another failed bariatric
surgery.
A different group of revisions of
sleeve gastrectomy is those that
result from failure of weight loss,
those that result from weight regain,
and those that are planned
conversions to malabsorptive
procedures, such as gastric bypass
(RYGB) or biliopancreatic diversion
with duodenal switch (BPD-DS).
To our knowledge, there are no
literature reports of revisional
surgery for failed sleeve gastrectomy
implemented as a final approach for
morbid obesity. There are several
publications, however, reporting the
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[JUNE
2009,
results of conversion of sleeve
gastrectomy to malabsorptive
procedures.
Reoperative bariatric surgery can
be the result of complications or
failures. The latter can be divided
into revisions and conversions. With
the introduction of staged
procedures, a new indication for
conversions of LSG was introduced.
Patients in this group of reoperaive
bariatric surgery will undergo an LSG
followed by a BPD-DS or RYGB
based on weight loss and resolution
of comorbidities. Reoperative options
for a failed LSG can be divided into
revisions such as trimming or
banding of the sleeve, or revisions
such as BPD-DS or RYGB.
While the results of conversional
surgery after LSG are well
documented by Schauer and Gagner,
there is minimal data of revisional or
conversional surgery of LSG when
performed as a final step.
At Cleveland Clinic Florida
Bariatric and Metabolic Institute,
LSG has been always performed as a
final step. In close to 370 cases, only
four patients underwent a conversion
to a RYGB (1.08%). The reasons for
failure were sleeve dilatation in all
cases. All cases were performed
laparoscopically, with no morbidity
or mortality.
As more surgeons adopt the LSG
as a primary procedure for weight
loss, more cases of surgical
SUPPLEMENT]
management of failure will be
reported, helping us understand the
reasons and options for revisional or
conversional surgery in this patient
population.
DISCUSSION
Complications of sleeve
gastrectomy are few, this being one
of the most appealing characteristics
of this procedure.
In a review of 149 sleeve
gastrectomies performed as a singlestage approach for the treatment of
morbid obesity, our group reported
an overall morbidity of 2.9 percent.
One patient had a staple-line
disruption resulting in an abscess
that required percutaneous drainage;
one patient had a bleeding episode
from a retractor liver injury requiring
laparoscopic drainage; one patient
had a bowel injury during access
requiring conversion to an open
procedure; and one patient
developed a stricture requiring
endoscopic dilatation. Long-term
complications of sleeve gastrectomy
in this report were related only to
the development of
choledocholithiasis. There was no
mortality in this series.
When used as a revisional
approach for failed gastric banding,
the incidence of complications of
sleeve gastrectomy is markedly
increased. In the same publication,
our group reported 14 patients that
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As more surgeons adopt the LSG as a primary procedure
for weight loss, more cases of surgical management of
failure will be reported, helping us understand the reasons
and options for revisional or onversional surgery in this
patient population.
Table 1. Reasons for revisional
underwent conversion of adjustable
gastric banding to sleeve
gastrectomy with an overall
morbidity of seven percent. One
patient developed staple-line
disruption followed by formation of
an abscess, requiring laparoscopic
revision and drainage. There was no
mortality in this series.
From a technical point of view,
the laparoscopic approach when
revising a complicated or failed
sleeve gastrectomy is similar to the
one utilized with other general
surgical procedures. We recommend
open access to the abdominal cavity
via Hasson canula and the use of
multiple trocars to allow wide
access to the surgical site. We also
mandate routine reinforcement of
staple lines with oversewing or
buttressing and drainage.
complications and low mortality. It
has been demonstrated to be a safe
and effective procedure in the short
term. The laparoscopic approach to
manage complications and revisions
is feasible.
Meticulous attention to
oversewing the staple line was the
main factor contributing to our
extended operative time, but we
feel this time is well spent to
achieve hemostasis and prevent a
leak that could result in significant
morbidity.
Prospective studies are required
after laparoscopic sleeve
gastrectomy to determine the longterm outcome and efficacy of
maintenance of weight loss and
resolution of comorbid conditions.
SUGGESTED READINGS
1.
CONCLUSION
Laparoscopic sleeve gastrectomy
can be performed with minor
2.
Roa PE, Kaidar-Person O, Rosenthal RJ, et al.
Laparoscopic sleeve gastrectomy as treatment for
morbid obesity. Obes Surg. 2006;16:1323–1326.
Lalor PF, Tucker O, Szomstein S, Rosenthal RJ.
Complications after laparoscopic sleeve gastrectomy.
SOARD. 2008;4(1):33-8.
surgery after sleeve gastrectomy
1. COMPLICATIONS
A. Acute
•
Bleeding
•
Leak
B. Chronic
•
Stricture
•
Hiatal hernia
•
Biliary tract disease
•
GERD
2. FAILURE OF WEIGHT LOSS OR
WEIGHT REGAIN
• Sleeve dilatation
3. STEP APPROACH
•
Conversion to RYGBP
•
Conversion to BPD DS
KEY POINTS
• Open access to the abdominal cavity via Hasson canula and the use of multiple trocars
to allow wide access to the surgical site is recommended.
• Routine reinforcement of staple lines with oversewing or buttressing and
drainage is mandated (in author’s practice).
• Laparoscopic sleeve gastrectomy has been demonstrated to be a safe and
effective procedure in the short term.
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The Process of
Reimbursement for
Sleeve Gastrectomy
by GRANT BAGLEY, MD, JD
AUTHOR AFFILIATION: Dr. Bagley is a Partner with HillCo Partners.
ADDRESS CORRESPONDENCE TO: Grant Bagley, MD, JD, HillCo Partners, 801 Pennsylvania Avenue NW, Suite 325, Washington, DC 20004;
Phone: 202-315-3811; E-mail: [email protected]
his summary focuses on the
Current Procedural
Terminology (CPT) code for
sleeve gastrectomy. This
presentation includes information
on the status of this particular
code, how a code is developed, and
what surgeons can do to assist in
the process of obtaining the code.
As a practicing surgeon, I was
having difficulty obtaining payment
for innovative surgical procedures.
Frustrated with the process, I
decided to begin working within
the government to assist in helping
surgeons with reimbursement. I
spent five years at the Centers for
Medicare and Medicaid Services
(CMS) working on physician fee
schedule and coverage issues, and
offer insight from that experience.
A consortium of surgeons from
the American Society for Metabolic
and Bariatric Surgery (ASMBS),
the Society for American
Gastrointestinal and Endoscopic
Surgeons (SAGES), and the
American College of Surgeons
(ACS) have worked together on the
T
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[JUNE
2009,
development and submission of a
code for the sleeve gastrectomy.
From a practical point of view,
there are three necessary steps in
getting paid: coding, coverage, and
reimbursement (rate setting).
Coverage. Coverage defines the
range and extent of services for
which an insurer will pay. Medicare
is a defined benefit program and
the benefit categories are specified
by law, such as medical surgical
services and inpatient or outpatient
hospitalization. Medicare and
private insurance further require
that the service be considered
“medically necessary,” or in terms
of the Medicare law, “reasonable
and necessary.”
Coding. Coding provides a
unique identifier for payers to link
procedures and payment. Surgical
procedures are reported using CPT
codes. Without a specific CPT
code, service must be reported
with a code for miscellaneous
procedures, which seldom gets
prompt or correct payment.
Reimbursement (Rate
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Setting). Reimbursement is the
process by which an insurer that
provides coverage for a service
represented by a code pays a
specific amount for the service.
Medicare determines the relative
value in terms of work and practice
expense for each service
represented by a CPT code. These
relative values determine the
Medicare payment. Private insurers
often pay based on some percentage
of the Medicare fee schedule or by
contracted amounts.
For the sleeve gastrectomy
procedure, the creation of a CPT
code and the determination of its
relative value were requested by
ASMBS, SAGES, and ACS. The CPT
Committee met in February, and the
CPT code for the sleeve
gastrectomy procedure was created.
Next, the process goes to the
Relative Value Scale Update
Committee (RUC). The American
Medical Association
(AMA)/Specialty Society Relative
Value Scale Update Committee was
established to ensure that physician
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Local and private payers...need to hear the
message about the efficacy of the sleeve
gastrectomy procedure.
services across all specialties are
well represented. The RUC makes
annual recommendations regarding
new and revised physician services
to the CMS and performs broad
reviews of the Resource-Based
Relative Value Scale (RBRVS) every
five years. The recommendations
from the RUC meeting are used by
Medicare for the physician fee
schedule and define the relative
cost. Following the ordinary
pathway, the CPT Code and the
Relative Value would be published
by CMS in November 2009 and
implemented in January 2010. (For
more information on the RUC,
please visit the AMA website at
www.ama-assn.org.)
The AMA, by way of the RUC,
has taken over the development of
the cost for the code. Part of this
process involves the participating
medical societies surveying
members in an effort to compile
information about the work involved
in performing the procedure. This
includes not only the operative
procedure, but also the preoperative
and postoperative effort. These
surveys are critical to the process,
and participation is encouraged.
Carefully completed surveys are
necessary for the involved specialty
societies to present and defend
values at the RUC meeting.
We must also convince third
party payers that this procedure is
medically necessary. As a surgeon,
what else can you do to assist in the
process? If you have not done so
already, begin speaking with local
and private payers. They need to
hear the message about the efficacy
of the sleeve gastrectomy
procedure. Surgeons need to bring
information to the carriers, and
eventually Medicare will cover it as
well. As a community, the message
needs to be about evidence-based
decisionmaking, which supports this
procedure. While the concept of
evidence-based medicine was not
envisioned as a way for insurers to
create policy, it has become the
standard for adding coverage for
new procedures, and has evolved
beyond the physician-patient
discussion; therefore, we must use
it in convincing third-party payers
to cover new procedures. Often the
level of evidence needed is directly
proportional to the cost of the new
technology. In presenting the case
to medical directors for insurers, be
knowledgeable about the studies—
both the good and the bad. Thirdparty payers are particularly
interested in how to formulate a
policy with clear selection criteria
from which patients are likely to
benefit.
Both private payers and Medicare
will worry about the cost of
payment and the utilization of
sleeve gastrectomy. A policy that is
based on evidence and is clear in
terms of proper patient selection
criteria will result in more rapid
coverage. Success depends on how
well we convey the message of the
benefits of sleeve gastrectomy and
whether we can make it clear that
utilization can be restricted to those
patients most likely to benefit.
The new national coverage
determination (NCD) of bariatric
surgery for diabetes has been
helpful. Groups need to work
together to advocate for coverage
change. More clinical studies have
been conducted and long-term
results have improved. Now, as a
group, we need to convey the
message to get coverage adequately
defined.
KEY POINTS
• Surveys from the participating medical societies about the work involved in performing
SG are critical to the process, and participation is encouraged.
• Local and private payers need to hear the message about the efficacy of the sleeve
gastrectomy procedure.
• We must use evidence-based medicine in convincing third-party payers to cover new
procedures.
[JUNE
2009,
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Debates and Consensus:
A Summary
by MICHEL GAGNER, MD, FRCSC, FACS
AUTHOR AFFILIATION: Dr. Gagner is Clinical Professor of Surgery, Florida International University, Department of Surgery, Mount Sinai Medical
Center, Miami Beach, Florida.
ADDRESS CORRESPONDENCE TO: Dr. Michel Gagner, FRCSC, FACS, Clinical Professor of Surgery, Florida International University, Department
of Surgery, Mount Sinai Medical Center, 4302 Alton Road, Miami Beach, Florida 33140; E-mail: [email protected]
INTRODUCTION
The last day of the conference was
dedicated to six debates coordinated
with the participation of Dr. Scott
Shikora, current president of the
American Society for Metabolic and
Bariatric Surgery (ASMBS). The six
major topics debated are listed in
Tables 1 and 2. For each debate, a
panel of six experts was requested
with a moderator that had prepared
multiple choice questions, and
included audience participation using
a Meridia system. Each question was
well deliberated for 30 minutes.
Question 1: What is the
mechanism of action of the sleeve
gastrectomy?
From the audience participation,
nearly 80 percent judged that
restriction was the main mechanism,
and 20 percent answered primarily
that sleeve gastrectomy had a
hormonal action. Unfortunately,
answer choices were not formulated
with an association of both, which
might have been the right answer
ultimately. Concerning the effect of
sleeve gastrectomy on gastric
emptying, two-thirds of participants
registered an answer which supposed
that results are now contradictory and
more studies are needed. Still, one
quarter supported the idea that a
faster gastric emptying resulted.
Concerning hormonal studies and
what was presented, a majority of the
audience (90%) believed that sleeve
gastrectomy had the most profound
reduction of serum ghrelin (more
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[JUNE
2009,
than gastric bypass!). There is
therefore a consensus on this—that
sleeve gastrectomy appears to be a
restrictive procedure primarily, with a
secondary hormonal action causing
intense reduction of serum ghrelin.
Question 2: What is the best
procedure for weight regain after
sleeve gastrectomy?
The audience was divided on this
issue. Where 50 percent would opt for
a gastric bypass, 42 percent would
favor a duodenal switch (DS).
Perhaps this was because most
participants were familiar with gastric
bypass as opposed to DS. Nobody
chose gastric banding, and some
wanted to re-sleeve (6%). Weight
regain after sleeve gastrectomy,
similar to gastric bypass, appears after
two years, and most authors do not
have enough experience yet to
engage in the matter.
Question 3: What is the best
option for a patient with a BMI of
35 to 50kg/m2 with poorly
controlled type 2 diabetes?
After debating different operations
for these conditions, it appears that
the literature is favoring gastric
bypass, but this is primarily because
sleeve gastrectomy is a recent option,
with few published cohorts, while
gastric banding and gastric bypass
have had plenty of evidence, including
randomized trials. Nevertheless,
sleeve gastrectomy came as a better
selection than gastric banding for
type 2 diabetes, as the voters were 50
SUPPLEMENT]
percent for gastric bypass, 34 percent
for sleeve gastrectomy, six percent for
DS, and only five percent for gastric
banding. When the question was
articulated for BMI group of 35 to
40kg/m2, then sleeve gastrectomy and
gastric bypass were equal at 46
percent of the yes vote each.
Consequently, this is almost tempting
to conclude that for type 2 diabetes,
sleeve gastrectomy can play a role,
especially in smaller BMI patients.
Question 4: What will be the
best future access to perform
sleeve gastrectomy?
This session was debated by
experts who perform sleeve
gastrectomy using a single incision, or
put all ports in the periumbilical area
(NOTUS), or have a transvaginal
approach (NOTES). The audience was
not convinced that this approach is
superior; most participants assumed
that the future was still with
conventional laparoscopy at more than
70 percent of the vote and only 31
percent pushing for single incision/port
technology, and NOTES only garnered
seven percent. When the question was
asked about the patient perspective on
this, most participants thought that
patients would favor a NOTES
approach to sleeve gastrectomy (49%
of the vote). In terms of technique
adoption, the shortest learning curve
was seen with SILS™/NOTUS
techniques, and the audience agreed
with this statement overwhelmingly by
86 percent. Most participants thought
that weight loss data would show a
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THE 2009 INTERNATIONAL CONSENSUS SUMMIT ON SLEEVE GASTRECTOMY
One can conclude that sleeve gastrectomy can be considered
a primary operation for adolescents (which gives similar
weight loss results to that of young adults), patients with a
high BMI, and patients with inflammatory bowel disease,
especially Crohn’s disease.
failure or success from these
approaches at two years (39%), and
most agreed that these new
approaches needed to demonstrate a
50-percent excess weight loss (EWL).
Question 5: Yes or No—Should
the sleeve gastrectomy be
considered a primary operative
procedure for the conditions
listed in Table 2?
Concerning these different
questions, which were avidly debated,
the voting results expressed resulted
in a no vote by nearly 70 percent for
portal hypertension, a yes vote by 60
percent for adolescents, a yes vote by
85 percent for high BMI groups, a no
vote by nearly 90 percent for severe
gastroesophageal reflux disease, a too
close call (yes 54%) for diabetic
gastroparesis, a no vote at nearly 60
percent for severe psychiatric illness,
and a yes vote at 82 percent for
Crohn’s disease. Therefore, one can
conclude that sleeve gastrectomy can
be considered a primary operation for
adolescents (which gives similar
weight loss results to that of young
adults), patients with a high BMI, and
patients with inflammatory bowel
disease, especially Crohn’s disease.
Question 6: In your opinion, is
there currently enough published
data to support the sleeve
gastrectomy as a primary
procedure to treat morbid
obesity on par with adjustable
gastric banding and Roux-en-Y
gastric bypass?
Several groups presented cohorts
of patients with follow-up periods of 4
to 8 years the day before. Jossart
and colleagues in San Francisco
presented eight years’ experience,
including 1,200 cases, whereas at
more than four years, weight loss
resulted in a similar curve to gastric
bypass. At higher BMI (>55kg/m2) a
plateau of nearly 40kg/m2 demanded
a second stage, but below a BMI of
55, the operation was terrific.
Schauer and colleagues assessed the
literature from 35 reports, studied
more than 3,000 published sleeve
gastrectomy cases, and found an
extremely low mortality rate (near
0.12%). Results have shown
excellent weight loss and
comorbidity reduction that is
comparable to or exceeds other
bariatric operations, and that the
sleeve gastrectomy is safe and
efficacious. Himpens of Belgium
analyzed his patients from 2001
through 2002 to attain six-year
followup. Sixty-five percent of 46
patients were considered a “success”
(%EWL>50) at two years. At six
years, the success rate was
maintained at 59 percent. Weiner
from Frankfurt and MacMahon of
Leeds, who started in 2000, also had
similar results.
Certainly, the audience thought
there was enough evidence
published to support the sleeve
gastrectomy as a primary procedure
to treat morbid obesity on par with
adjustable gastric banding and
Roux-en-Y gastric bypass with a yes
vote at 77 percent. This is perhaps
the strongest contribution to this
second consensus conference.
[JUNE
TABLE 1. Consensus debate
questions
1. What is the mechanism of action
of the sleeve gastrectomy?
2. What is the best procedure for
weight regain after sleeve
gastrectomy?
3. What is the best option for a
patient with a BMI of 35 to 50
with poorly controlled type 2
diabetes?
4. What will be the best future
access to perform sleeve
gastrectomy?
5. Should the sleeve gastrectomy
be considered a primary
operative procedure for the
conditions listed in Table 2?
6. In your opinion, is there
currently enough published data
to support sleeve gastrectomy
as a primary procedure to treat
morbid obesity on par with
adjustable gastric banding and
Roux-en-Y gastric bypass?
TABLE 2. Conditions where sleeve
gastrectomy could be considered as
a primary operative procedure
•
•
•
•
•
•
•
2009,
Portal hypertension with varices
Adolescents 12–17 years of age
Men BMI>70kg/m2
Severe gastroesophageal reflux
Diabetic gastroparesis
Severe psychiatric disease
Crohn’s disease
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