| Surgery Section - Surgery for Morbid Obesity
| Topic: Surgery for Morbid Obesity |
Date of Origin: 01/1996 |
| Section: Surgery |
Policy No: 58 |
| Approved Date: 11/11/2008 |
Effective Date: 11/11/2008 |
| Next Review Date: 11/2009 |
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IMPORTANT REMINDER
This Medical Policy has been developed through consideration of medical necessity,
generally accepted standards of medical practice, and review of medical literature
and government approval status.
Benefit determinations should be based in all cases on
the applicable contract language. To the extent there are any conflicts
between these guidelines and the contract language, the contract language will
control.
The purpose of medical policy is to provide a guide to coverage. Medical Policy
is not intended to dictate to providers how to practice medicine. Providers
are expected to exercise their medical judgment in providing the most appropriate
care.
Description
Morbid obesity is defined as a body mass index (BMI) >40
kg/m2. (Note: BMI may be calculated by using
the BMI calculator.)
Individuals with morbid obesity are at high
risk for developing weight-related complications such
as diabetes, hypertension, obstructive sleep apnea,
and various types of cancers (for men: colon, rectum,
and prostate; for women: breast, uterus, and ovaries). In
addition, morbid obesity is associated with a shortened
life span.
The first treatment of morbid obesity involves dietary
and lifestyle changes. Although this strategy may be
effective in some patients, frequently the weight loss
is not durable, with only 5%-10% of patients able to
comply with lifestyle modifications on a long-term
basis. When conservative measures fail, some
patients may consider surgical approaches.
Surgery for morbid obesity, termed bariatric
surgery, falls into two general categories.
- Gastric restrictive procedures, which decrease
the size of the gastric pouch and limit food intake;
and,
- Malabsorptive procedures, which limits the absorption
of calories and nutrients by altering the way food
moves through the intestinal track. Some bariatric
procedures may include both a restrictive and a malabsorptive
component.
The following summarizes the different restrictive
and malabsorptive procedures:
Gastric Restrictive Procedures
- Vertical Banded Gastroplasty - (also known as vertically
banded gastric partition and gastric stapling) - CPT
code 43842
In this procedure the stomach is segmented along
its vertical axis. To create a durable reinforced
and rate-limiting stoma at the distal end of the
pouch, a plug of stomach is removed and a propylene
collar is placed through this hole and then stapled
to itself. Because the normal flow of food is preserved,
metabolic complications are rare. Complications
include esophageal reflux, staple line disruption,
and dilation or obstruction of the stoma, with the
latter three requiring reoperation. Dilation of
the stoma is a common reason for weight gain. Vertical
banded gastroplasty may be performed using an open
or laparoscopic approach. While this procedure was
once the most common kind of gastric restrictive
procedure performed in this country, it has fallen
out of favor due to a high reoperation rate.
- Adjustable Gastric Banding - CPT codes 43770-43774;
43886-43888
Adjustable gastric banding involves placing a
gastric band around the exterior of the stomach.
The band is attached to a reservoir that is implanted
subcutaneously in the rectus sheath. Injecting
the reservoir with saline alters the diameter of
the gastric band; therefore, the rate limiting
stoma in the stomach can be progressively narrowed
to induce greater weight loss, or expanded if complications
develop. Because the stomach is not entered, the
surgery and any revisions, if necessary, are relatively
simple. Complications include slippage of the external
band or band erosion through the gastric wall.
Currently, there are two devices approved by the
U.S. Food and Drug Administration (FDA) for marketing
in the United States, the Lap-Band® (BioEnterics,
Carpentiera, CA) and the REALIZE™ (Ethicon
Endo-Surgery, Inc.). The labeled indications for
the devices are similar.
According to the FDA labeling the Lap-Band® system
and REALIZE™ system are indicated for
use in weight reduction for severely obese patients
with a BMI of at least 40 or a BMI of at least 35
with one or more severe comorbid conditions. The
adjustable gastric bands are indicated for use only
in severely obese adult patients who have failed
more conservative weight-reduction alternatives,
such as supervised diet, exercise and behavior modification
programs.
- Gastric Bypass - CPT code 43846, 43644
Gastric bypass with Roux-en-Y anastomosis (RYGB),
involves both restrictive and malabsorptive components,
with horizontal or vertical partition of the stomach
in association with a Roux-en-Y procedure (i.e.,
a gastrojejunal anastomosis). Thus the flow of
food bypasses the duodenum and proximal small bowel.
The procedure may also be associated with an unpleasant "dumping
syndrome," in which a large osmotic load delivered
directly to the jejunum from the stomach produces
abdominal pain and/or vomiting. The dumping syndrome
may further reduce intake, particularly in "sweets
eaters." Operative complications include leakage
and marginal ulceration of the anastomotic site.
Because the normal flow of food is disrupted, there
are more metabolic complications compared to other
gastric restrictive procedures, including iron
deficiency anemia, vitamin B-12 deficiency, and
impaired calcium absorption, all of which can be
corrected by oral supplementation. Another concern
is the ability to evaluate the "blind" bypassed
portion of the stomach. Gastric bypass may be performed
with either an open or laparoscopic technique.
- Mini-Gastric Bypass (no specific CPT code)
The "mini-gastric bypass" is a variant
of the gastric bypass. Using a laparoscopic approach,
the stomach is segmented, similar to a traditional
gastric bypass, but instead of creating a Roux-en-Y
anastomosis, the jejunum is anastomosed directly
to the stomach, similar to a Billroth II procedure. The
unique aspect of this procedure is not based on
its laparoscopic approach, but rather the type
of anastomosis used. It should be noted that CPT
code 43846 does not accurately describe the mini-gastric
bypass, since the CPT code explicitly describes
a Roux-en-Y gastroenterostomy, which is not used
in the mini-gastric bypass.
- Sleeve-Gastrectomy (no specific CPT code)
A sleeve gastrectomy is an alternative to gastrectomy
that can be performed on its own, or in combination
with malabsorptive procedures (most commonly biliopancreatic
diversion with duodenal switch). In this
procedure, the greater curvature of the stomach
is resected from the angle of His to the distal
antrum, resulting in a stomach remnant shaped like
a tube or sleeve. The pyloric sphincter is
preserved, resulting in a more physiologic transit
of food from the stomach to the duodenum, and avoiding
the dumping syndrome (overly rapid transport of
food through stomach into intestines) that is seen
with distal gastrectomy. This procedure is
relatively simple to perform, and can be done by
the open or laparoscopic technique. Some
surgeons have proposed this as the first stage
in a two-stage procedure for very high-risk patients
to improve a patient’s overall medical status,
and thus reduce the risk of a subsequent more extensive
malabsorptive procedure, such as biliopancreatic
diversion.
Malabsorptive Procedures
There are multiple variants of malabsorptive procedures,
which differ in the lengths of the alimentary limb,
the biliopancreatic limb, and the common limb, where
the alimentary and biliopancreatic limb are anastomosed.
These procedures also may include an element of a restrictive
surgery based on the size of the stomach pouch. The
degree of malabsorption is related to the length of
the alimentary and common limbs. For example, a shorter
alimentary limb (i.e. the greater the amount of intestine
that is excluded from the nutrient flow) will be associated
with malabsorption of a variety of nutrients, while
a short common limb (i.e. the biliopancreatic juices
are allowed to mix with nutrients for only a short segment)
will primarily limit the absorption of fat.
- Biliopancreatic Bypass Procedure (also known as
the Scopinaro procedure) - CPT code 43847
The biliopancreatic bypass (BPB) procedure, developed
and used extensively in Italy, was designed to address
some of the drawbacks of the original intestinal
bypass procedures that have been abandoned due to
unacceptable metabolic complications. Many of the
complications were thought to be related to bacterial
overgrowth and toxin production in the blind, bypassed
segment. In contrast, BPB consists of a subtotal
gastrectomy and diversion of the biliopancreatic
juices into the distal ileum by a long Roux-en-Y
procedure. The procedure consists of the following
components:
- A distal gastrectomy functions to induce a temporary
early satiety and/or the dumping syndrome in the
early postoperative period, both of which limit
food intake.
- A 200-cm long "alimentary tract" consists
of 200 cm of ileum connecting the stomach to a
common distal segment.
- A 300- to 400-cm "biliary tract,"
which connects the duodenum, jejunum, and remaining
ileum to the common distal segment.
- A 50- to 100-cm "common tract," where
food from the alimentary tract mixes with biliopancreatic
juices from the biliary tract. Food digestion
and absorption, particularly of fats and starches,
are therefore limited to this small segment of
bowel, creating a selective malabsorption. The
length of the common segment influences the degree
of malabsorption.
- Because of the high incidence of cholelithiasis
associated with the procedure, patients typically
undergo an associated cholecystectomy.
Many potential metabolic complications are related
to biliopancreatic bypass, including most prominently,
iron deficiency anemia, protein malnutrition, hypocalcemia,
and bone demineralization. Protein malnutrition
may require treatment with total parenteral nutrition.
In addition, there have been several case reports
of liver failure resulting in death or liver transplant.
- Biliopancreatic Bypass with Duodenal Switch - CPT
code 43845
The duodenal switch procedure is essentially a
variant of the biliopancreatic bypass described
above. However, instead of performing a distal gastrectomy,
a "sleeve" gastrectomy is performed along
the vertical axis of the stomach, preserving the
pylorus and initial segment of the duodenum, which
is then anastomosed to a segment of the ileum, similar
to the above procedure, to create the alimentary
limb. Preservation of the pyloric sphincter is intended
to ameliorate the dumping syndrome and decrease
the incidence of ulcers at the duodenoileal anastomosis
by providing a more physiologic transfer of stomach
contents to the duodenum. The sleeve gastrectomy
decreases the volume of the stomach and also decreases
the parietal cell mass. However, the basic principle
of the procedure is similar to that of the biliopancreatic
bypass; i.e., producing selective malabsorption
by limiting the food digestion and absorption to
a short common ileal segment.
- Distal (Long Limb) Gastric Bypass (Roux or alimentary
limb > 150 cm - CPT code 43847
Recently variations of gastric bypass procedures
have been described, consisting primarily of long
limb Roux-en-Y procedures, which vary in the length
of the alimentary and common limbs. For example,
the stomach may be divided with a long segment of
the jejunum (instead of ileum) anastomosed to the
proximal gastric stump, creating the alimentary
limb. The remaining pancreaticobiliary limb, consisting
of stomach remnant, duodenum, and length of proximal
jejunum is then anastomosed to the ileum, creating
a common limb of variable length in which the ingested
food mixes with the pancreaticobiliary juices. While
the long alimentary limb permits absorption of most
nutrients, the short common limb primarily limits
absorption of fats. The stomach may be bypassed
in a variety of ways, either by resection or stapling
along the horizontal or vertical axis. Unlike the
traditional gastric bypass, which is essentially
a gastric restrictive procedure, these very long
limb Roux-en-Y gastric bypasses combine gastric
restriction with some element of malabsorptive procedure,
depending on the location of the anastomoses. Note
that CPT code for gastric bypass (43846) explicitly
describes a short limb (<150 cm) Roux-en-Y gastroenterostomy,
and thus would not apply to long limb gastric bypass.
Endoscopic Procedures for Patients who Gain Weight
after Bariatric Surgery
There are a number of reasons why patients who are
treated with accepted forms of bariatric surgery may
not lose weight or may regain weight that is initially
lost. These reasons include issues of adherence (compliance)
as well as technical (structural) issues. Some patients
who regain weight after bariatric surgery, e.g., after
Roux-en-Y gastric bypass (RYGB), are found to have
enlarged gastric stoma and/or enlarged gastric pouches.
Correction of these abnormalities has been reported
to again result in successful weight loss.
While these abnormalities can be revised using standard
operative approaches, novel endoscopic procedures are
being publicized as an option for these patients. Some
of these procedures use devices that are also being
evaluated for endoscopic treatment of gastroesophageal
reflux.
The StomaphyX™ device, which is one device used
in this approach, was cleared by the FDA through the
510(k) process. It was determined be equivalent to
the EndoCinch™ system which has 510(k) marketing
clearance for endoscopic suturing for gastrointestinal
surgery.
Policy/Criteria
| I. |
Gastric
bypass using a Roux-en-Y anastomosis with an alimentary
limb of 150 cm or less, or adjustable gastric banding,
consisting of an adjustable external band placed
around the stomach, may be considered medically
necessary in the treatment of morbid obesity when all of
the following criteria are met: |
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A. |
At
the start of the medically supervised, nonsurgical
weight reduction program: |
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BMI greater
than or equal to 40 kg/m2; or |
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BMI greater
than or equal to 35 kg/m2 either with a diagnosis
of type 2 diabetes mellitus or with at least two
of the following comorbid conditions which have
not responded to medical management and which are
generally expected to improve as a result of obesity
surgical treatment: |
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1) |
Hypertension |
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2) |
Dyslipidemia |
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3) |
Coronary heart disease |
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4) |
Sleep apnea |
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B. |
Documentation
of active participation for at least six months
in a structured, medically supervised nonsurgical
weight reduction program. A comprehensive commercial
weight loss program is an acceptable program
component, but it must be selected and monitored
under the supervision of the healthcare practitioner
providing medical oversight. Comprehensive
weight loss programs generally address diet,
exercise and behavior modification, e.g., Weight
Watchers.
Documentation from the clinical medical records must indicate that the structured
medical supervision meets all of the following criteria: |
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1) |
Occur during
at least 6 consecutive months within the 24 months
prior to the request for surgery; and |
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2) |
Include
at least three visits for medical supervision,
occurring at intervals of no longer than four months
apart, e.g., at the start, middle and end of the
6-month weight loss program. |
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3) |
Be provided
by an MD, DO, NP, PA or a registered dietitian
under the supervision of an MD, DO, NP, or PA;
and |
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4) |
Include
assessment and counseling concerning weight, diet,
exercise, and behavior modification; and |
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5) |
Demonstrate
active member participation and engagement resulting
in either weight loss or no further weight gain
by the end of the six month program. |
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C. |
Evaluation
by a licensed psychologist or psychiatrist documents
the absence of significant psychopathology that
can limit an individual's understanding of the
procedure or ability to comply with medical/surgical
recommendations (e.g., active substance abuse,
eating disorders, schizophrenia, borderline personality
disorder, uncontrolled depression); and |
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D. |
Documentation
of willingness to comply with preoperative and
postoperative treatment plans; and |
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E. |
Age greater
than or equal to 18 years. |
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| II. |
Adjustable
gastric banding and gastric bypass using a Roux-en-Y
anastomosis are considered investigational for
the treatment of any condition other than morbid
obesity, including but not limited to gastroesophageal
reflux disease. |
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| III. |
The following
surgical procedures are considered investigational
for the treatment of any condition, including but
not limited to morbid obesity and gastroesophageal
reflux disease: |
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A. |
Mini-gastric
bypass (gastric bypass using a Bilroth II type
of anastomosis) |
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B. |
Sleeve
gastrectomy, either as the sole procedure or as
one step in a staged procedure |
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C. |
Distal
gastric bypass (long limb gastric bypass, i.e., >150
cm) |
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D. |
Biliopancreatic
bypass (i.e., the Scopinaro procedure) |
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E. |
Biliopancreatic
bypass with duodenal switch |
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| IV. |
The vertical
banded gastroplasty is no longer a standard of
care and is therefore considered not medically
necessary. |
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| V. |
Endoscopic procedures
to treat weight gain due to a large gastric stoma
or large gastric pouch after bariatric surgery
are considered investigational, including but not
limited to: |
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A. |
StomaphyX™ (EndoGastric
Solutions, Inc) |
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B. |
ROSE procedure
(Restorative Obesity Surgery, Endoscopic ™) |
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C. |
EndoCinch
(Bard) |
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D. |
EndoSurgical
Operating System™ (EOS) (USGI Medical, Inc) |
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E. |
Sclerotherapy
of stoma |
Scientific Background
Outcomes of bariatric surgeries are difficult to evaluate
due in part to the constantly evolving nature of the
surgery. Small modifications are commonly made to decrease the incidence
of postoperative and long-term complications. In addition, with few exceptions
(discussed below) there have been no controlled studies that have directly
measured the weight loss and complications associated with the
different surgical approaches, particularly comparing
gastric restrictive procedures with malabsorptive procedures. Case series
from individual institutions or individual surgeons with varying lengths
of follow-up dominate the literature. The outcomes for specific surgeries
may widely differ among institutions or surgeons, perhaps due to small variations
in surgical technique, intensity of follow-up, or patient selection criteria.
However, during the 1970s and 1980s both vertical banded gastroplasty
(VBG) and gastric bypass became widely accepted types
of bariatric surgery, although VBG is now performed infrequently. These two
procedures were the focus of the 1991 NIH Consensus Development Conference
on gastrointestinal surgery for severe obesity, which also noted that limited
data were available regarding biliopancreatic bypass. (3) A 2003 BlueCross
BlueShield Association Technology Evaluation Center (TEC) Assessment (4)
summarized studies comparing open gastric bypass and vertical-banded gastroplasty.
These comparisons demonstrated that open gastric bypass resulted in a greater
amount of weight loss than vertical-banded gastroplasty, with no definite
differences in complication rates. Therefore, gastric bypass is considered
the gold standard for the purpose of this discussion, and the
results of this procedure will be compared to the newer
procedures not addressed by the 1991 conference; e.g., gastric banding and
biliopancreatic bypass with or without duodenal switch.
Given the chronic nature of morbid obesity, ideally,
long term outcomes (5 years or greater) are needed
to determine the safety, efficacy and durability of
results related to specific bariatric procedures.
- Weight Loss
The ultimate goal of bariatric surgery is to reduce
weight into a range that minimizes obesity-related
morbidity. An increasing degree of obesity will require
a greater amount of weight loss to achieve these
target goals. There are different definitions of
successful outcomes, but a successful procedure is
often considered one in which at least 50% of excess
body weight (EBW) is lost, or the patient returns
to a weight within 30% of ideal body weight. The
results may also be expressed as the percentage of
patients losing at least 50% of EBW. However,
it is noted by bariatric surgeons that significant
health improvements can occur in patients with weight
loss less than 50% EBW.
- Durability of weight loss
Weight change (gain or loss) at yearly intervals
is often reported. Weight loss at 1 year is considered
the minimum length of time for evaluating these procedures;
weight loss at 3–5 years is considered to be
an intermediate time period for evaluating weight
loss; and weight loss at 5–10 years or more
is considered to represent long-term weight loss
following bariatric surgery.
- Short-term complications
Operative and perioperative complications that occur
within 30 days are considered in this category. There
is an increased incidence of operative and perioperative
complications in obese patients in general, particularly
the incidence of thromboembolism and impaired wound
healing. Other perioperative complications include
anastomotic leaks, bleeding, bowel obstruction, and
cardiopulmonary complications such as pneumonia or
myocardial infarction.
- Reoperation Rate
Reoperation may be required to either "take
down"
or revise the original procedure. Reoperation may
be particularly common in vertical banded gastroplasty
due to pouch dilation or in adjustable gastric banding
due to band slippage or erosion.
- Long-term complications
Metabolic side effects and nutritional deficiencies
are included in this category. Metabolic side effects,
including iron deficiency anemia, vitamin B-12 deficiency
and hypocalcemia are of particular concern in malabsorptive
procedures. Other long-term complications include
anastomotic ulcers, esophagitis, and procedure-specific
complications such as band erosion or migration for
gastric banding operations.
- Improved health outcomes in terms of weight-related
comorbidities
Aside from psychosocial concerns, which may be considerable,
one of the motivations for bariatric surgery is to
decrease the incidence of complications of obesity,
such as diabetes, cardiovascular risk factors (e.g.,
increased cholesterol, hypertension), obstructive
sleep apnea, or arthritis. Except for type 2 diabetes
mellitus, these final health outcomes are not consistently
reported in the published literature.
There is strong evidence that bariatric surgery significantly
resolves or improves Type 2 diabetes for adult patients
with BMI ≥35. In a meta-analysis published
in 2004, Buchwald and colleagues found that after surgery
diabetes was completely ameliorated in 76.8% (95% CI
70.7%-82.9%) of patients. (44) In a study by Pories
and colleagues resolution or marked improvement in type
2 diabetes was noted to begin within days of surgery
even before weight loss. (45) The correction of
plasma insulin and glucose levels is due to changes in
gastrointestinal hormones after surgery. Sjostrom
and colleagues found that at a 2 year follow-up, patients
in the surgical groups had a 60% decrease in the plasma
glucose level. (46) The patients in the non-surgical
arm of this study at 2 years had a 3.7 times higher plasma
glucose level. Christou and colleagues found
that mortality risk from diabetes over a 10 year
follow-up after Roux-en-Y was less than in a non-surgical
group matched for age, weight, and BMI (1.0% vs.
4.5% for every year of follow-up). (47)
The following discussion provides a representative
summary of the literature on bariatric surgery, focusing
on improvements in the co-morbidities associated with
obesity.
Vertical Banded Gastroplasty (VBG)
While initial reported results for VBG were good in
terms of weight loss, complications and improvement
in comorbid conditions (6-9), the procedure has largely
been abandoned as results were noted to deteriorate
over time and longer term, less favorable outcomes
were reported in the literature. Staple-line
perforations requiring reoperation and poor sustained
weight loss were cited as reasons for long-term failure
of VBG. (5,12,13)
In addition, a smaller body of literature comparing
outcomes between vertical banded gastroplasty and open
gastric bypass consistently reported better weight
loss with gastric bypass. (10,11, 17,18) This
outcome was also confirmed in a 2003 BlueCross BlueShield
Association Technology Evaluation Center (TEC) Assessment
which evaluated eight nonrandomized comparative studies
and two randomized, controlled trials of open gastric
bypass versus VBG. (4)
Gastric Bypass with Short Limb (150 cm or less)
While vertical banded gastroplasty was perhaps the dominant
bariatric surgery in the 1980's, it has been surpassed
in this country by the gastric bypass procedure, based
on a variety of studies that report improved weight
loss with a gastric bypass procedure. This body of literature
has been instrumental in establishing that gastric bypass
should be the reference procedure to which other procedures
are compared. Practice patterns in the U.S. have adopted
this approach, with gastric bypass now comprising the
vast majority of all bariatric procedures performed.
Many clinical series reporting results of open gastric
bypass have been published. Griffen summarized
the experience of over 10,000 gastric bypass operations
from a number of bariatric surgeons. (14) It
was estimated that 85% of patients reduced their weight
to at least 50% above the ideal weight. In approximately
5,000 patients who were followed for 10 years, 80%
were able to maintain this result. Pories and colleagues
reported on 608 patients who underwent a gastric bypass
procedure and were followed for 1-14 years. (15) One
of the unique features of this report is that only
3% of patients were lost to follow-up. The average
weight loss was 75% of excess weight at one year, declining
to 50% by the eighth year. The authors observed an
immediate drop in both blood glucose and exogenous
insulin requirements after surgery. Long-term observation
of 298 patients with preoperative diabetes or impaired
glucose tolerance revealed that 91% had normal values
for blood glucose and hemoglobin A1-C after surgery.
The incidence of hypertension declined from 58% before
surgery to 14% after gastric bypass. Flickinger and
colleagues reported on the incidence of diabetes and
hypertension in a case series of 397 patients. (16) Prior
to surgery, 22% had diabetes mellitus and 13% had impaired
glucose tolerance. After surgery, all but one of the
patients remained euglycemic. A total of 57% of patients
were hypertensive before surgery compared to only 18%
after surgery. Similarly, Pories and colleagues reported
that of 163 obese patients with diabetes or impaired
glucose tolerances, only 5% remained with inadequate
control after gastric bypass surgery and associated
weight loss. Other studies have reported that gastric
bypass surgery and weight loss are associated with
improvements in the lipid profile. (15)
As discussed previously, comparative trials summarized
in the 2003 TEC Assessment (4) consistently reported
favorable outcomes for open gastric bypass when compared
with vertical banded gastroplasty, including two randomized,
controlled trials. Some nonrandomized trials that compared
open gastric bypass with procedures other than vertical
banded gastroplasty were also summarized in the TEC
Assessment. While there were fewer trials for
these other procedures, comparisons of open gastric
bypass to gastric banding, horizontal gastroplasty,
and silastic ring gastroplasty all reported that weight
loss was superior with open gastric bypass.
Metabolic abnormalities were seen more frequently
in gastric bypass patients compared to those receiving
a vertical banded gastroplasty. Anemia, iron deficiency,
vitamin B-12 deficiency, and red blood cell folate
deficiency are commonly seen. Marginal ulcerations
are also seen in gastric bypasses, particularly in
those whose gastric pouches are too large and include
acid-secreting parietal cells.
Mini-gastric Bypass
The mini-gastric bypass has been primarily advocated
by one surgeon who published his experience with 1,274
patients. (19) The mean operating time was 36
minutes, and the mean hospital stay was 1.5 days. Mean
excess weight loss was 51% at 6 months, 68% at 12 months
and 77% at 2 years. The overall complication
rate reported was 5.2%. While this surgical approach
may result in decreased surgical time, the anastomosis
creates the risk of biliary reflux gastritis, one of
the reasons that this anastomosis has been abandoned,
in general, in favor of a Roux-en-Y anastomosis that
diverts the biliary juices away from the stomach. One
other large case series was published in 2005; however,
only short-term results were reported, so conclusions
concerning long-term effects on weight loss and adverse
effects cannot be reached. (20)
Adjustable Gastric Banding
A 2006 TEC Assessment (21) reviewed the evidence on
laparoscopic adjustable gastric banding (LAGB), and
compared outcomes to those of gastric bypass. This
Assessment concluded that for patients considering
bariatric surgery, there was sufficient evidence to
allow an informed choice to be made between gastric
bypass and LAGB. An informed patient may reasonably
choose either GBY or LAGB as the preferred procedure. Preoperative
counseling should include education on the comparative
risks and benefits (such as extent of weight loss and
frequency and timing of potential complications) of
the two procedures in order to allow the optimal choice
to be made based on preferences and shared decision
making.
Weight loss outcomes from the studies reviewed in
the Assessment confirm the conclusions of previous
TEC Assessments that weight loss at one year is less
for LAGB compared with GBY. The percent excess
weight loss (%EWL) at one year is in the range of approximately
40%, compared to 60% or higher for GBY. At time
points longer than one year, some of the comparative
studies report that the difference in weight loss between
LAGB and GBY lessens, but others do not. Weight
loss outcomes from the nine single-arm series with
the most complete follow-up do not support the hypothesis
that weight loss continues to increase after one to
two years of follow-up. It appears more likely
from the current data that attrition bias may account
for the diminution of the difference in weight loss
over time, particularly when patients who have their
band removed or deflated are excluded from analysis. These
studies also confirm that short-term (perioperative)
complications are very low with LAGB, and lower than
either open or laparoscopic GBY. Death is extremely
rare, and serious perioperative complications probably
occur at rates of less than 1%.
The reported rates of long-term adverse events vary
considerably. In the comparative trials, re-operations
are reported in approximately 25% of patients, while
in the single-arm studies the composite rate for re-operations
is approximately half of this value (11.9%). The
rates of other long term complications are also highly
variable, for example, the range of rates for band
slippage is 1 to 36% and the range for port access
problems is 2 to 20%. These data on long-term
complications remain suboptimal. The reporting
of long-term complications in these trials is not systematic
or consistent. It is not possible to determine
the precise rates of long-term complications from these
data; however, it is likely that complications are
under-reported in many studies due to incomplete follow-up
and a lack of systematic surveillance. The rates
of long-term complications reported in some studies
raise concern for the impact of these events on the
overall benefit/risk ratio for LAGB.
In comparing LAGB to GBY, there is a tradeoff in terms
of risks and benefits. LAGB offers a less-invasive
procedure that is associated with fewer procedural
complications, a decreased hospital stay and earlier
return to usual activities. However, the benefits,
as defined by the amount of weight loss, will also
be less for LAGB. The patterns of long-term complications
also differ between the two procedures. For LAGB,
longer-term adverse events related to the presence
of a foreign body in the abdomen may occur, and may
result in re-operations and removal of the band in
a minority of patients. Patients who have their
bands removed can later be offered an alternative bariatric
surgery procedure, such as gastric bypass.
Sleeve Gastrectomy
Sleeve gastrectomy may be performed as a stand-alone
procedure, or in combination with a malabsorptive procedure,
such as the biliopancreatic diversion with duodenal
switch. It has also been proposed as the first step
in a 2-stage procedure, with gastric bypass or biliopancreatic
diversion as the second stage.
As a stand-alone procedure, there are limited data
to evaluate outcomes and/or compare efficacy to other
procedures. A small number of clinical series have
been published that report on outcomes after sleeve
gastrectomy alone:
- In a series of 60 patients who had undergone sleeve
gastrectomy and who had at least 1-year follow-up,
83% EWL was reported at 12 months. (22) Diabetes
resolved in 100% of patients and hypertension resolved
in 93%.
- In a smaller series of 23 patients, 56% EWL was
reported at one year. (23)
There are also a small number of clinical series that
report on sleeve gastrectomy as the initial procedure
of a 2-stage operation. This approach has been generally
attempted in patients with “super” obesity
(BMI >50), in whom a more complex initial operation
may be associated with higher risk. Weight loss following
sleeve gastrectomy may reduce the risk of these patients
undergoing a more complex malabsorptive procedure in
the future. The available series to date report only
on very small numbers of patients. (24,25) The published
data on outcomes following completion of both stages
of a 2-stage operation are limited to case reports
and case series with very small numbers of patients.
Biliopancreatic Bypass (BPB)
There have been numerous clinical series of BPB published,
but as with other procedures, there is a lack of high-quality
trials that directly compare outcomes of this procedure
with gastric bypass. The bulk of experience with
BPB appears to be in Europe, particularly Italy. There
are no case series reported in this country. According
to Murr and colleagues, BPB has not been widely accepted
in this country due to unacceptable serious long-term
morbidities. (26) For example, BPB has largely
been abandoned at the Mayo clinic due to the occurrence
of steatorrhea, diarrhea, foul-smelling stools, severe
bone pain, and the need for a life-long commitment
to supplemental vitamins and minerals. In addition,
there have been scattered case reports of liver damage,
resulting either in death or liver transplant. (27,28) Murr
hypothesizes that the incidence of protein malnutrition
may be higher in this country compared to Scopinaro's
Italian series, since the North American diet has a
higher percentage of fat and lesser amounts of carbohydrates.
(26)
In a 2005 TEC Assessment, the outcomes of BPB, with
or without duodenal switch, were compared with those
of gastric bypass. (29) One comparative trial and seven
single arm series suggested that weight loss outcomes
at one year were in the same range as for gastric bypass. While
this data is not sufficient to distinguish small differences
in weight loss between the two procedures, it does
not support the hypothesis that BPB results in
greater weight loss than open gastric bypass.
Complication rates were poorly reported in these trials.
The data suggested that mortality was low (approximately
1%) and in the same range as for open gastric bypass.
However, rates of other complications, especially long-term
complications, could not be determined. Limited
data suggested that long-term nutritional and vitamin
deficiencies occur at a high rate following BPB.
For example:
- Slater and colleagues focused specifically on vitamin
and calcium deficiencies following BPB. (30) These
authors reported high rates of vitamin and calcium
abnormalities in their population over a 4-year period.
By year 4, approximately half (48%) of the patients
were found to have low calcium and 63% had low levels
of vitamin D. Other fat-soluble vitamins showed similar
patterns of abnormalities. Low vitamin A was found
in 69% of patients at 4 years; low vitamin K in 68%;
and low zinc in 50%.
- Dolan and colleagues reported similar data in a
study that compared several technical variations
ofBPB. (31) These authors reported low calcium
levels in 12–34% of patients; low vitamin D
in 22.2–70.6%; low vitamin A in 53–67%;
and low vitamin K in 44–59%. In addition,
this study reported high rates of iron deficiency
(11–47%) and anemia (11–40%).
The TEC Assessment did not find that the evidence
was sufficient to conclude that weight loss following
biliopancreatic bypass was greater than for gastric
bypass. In addition, the TEC Assessment found that
rates of nutritional and metabolic complications appear
to be very high following BPB.
Biliopancreatic Bypass with Duodenal Switch (DS)
There is a lack of high-quality trials that directly
compare outcomes of DS with gastric bypass.
- The largest case series reported on 465 patients
who underwent the duodenal switch procedure compared
to 252 patients who underwent the biliopancreatic
bypass. (32) It should be noted that in addition
to the preservation of the duodenum, the common segment
was elongated to 100 cm. The authors noted similar
weight loss in the two groups. In the DS group, a
lower incidence of metabolic abnormalities such as
protein malnutrition was noted, which prompted reversal
of the procedure in 1.7% of those undergoing BPB
vs. only 0.1% after the duodenal switch procedure.
However, it is not known whether this outcome was
attributed to the lengthening of the common segment
versus retention of the pylorus.
- Hess reported on a case series of 440 patients
with variable lengths of the common channel. (33) The
percentage excess weight loss varied between 60%
and 90%, depending on the length of the common segment
and alimentary limb. There were 2 late deaths, 1
due to septic shock secondary to an infected panniculus
and 1 related to liver failure. A total of 10 patients
underwent revision to lengthen the common segment
secondary to low protein or excessive diarrhea. Seven
patients underwent shortening of the common segment
due to inadequate weight loss.
- In 2005, Hess and colleagues reported 10-year outcomes
for 167 of 1,404 patients (12%). (34) Of the
167 patients, 94% achieved 50% or greater excess
weight loss. Specific complication rates for
this cohort of patients were not reported; however,
the authors did report overall that 8 reversals
and 37 revisions were needed for excessive weight
loss, protein malnutrition, uncontrolled diarrhea,
or inadequate weight loss.
- Baltasar and colleagues reported on a case series
of 60 patients undergoing DS with a common segment
length of 75 cm. (35) One patient succumbed
to liver failure and another to malnutrition. The
authors questioned the safety of the procedure.
Gastric Bypass with Long Limb (greater than 150 cm)
As discussed in the Description section, the degree
of malabsorption associated with long limb gastric
bypass will vary with the length of the alimentary
and biliary limbs. These modifications have been developed
in an effort to decrease the metabolic side effects
associated with biliopancreatic bypass. However, there
is limited published evidence on outcomes of this procedure,
with a large amount of variability in the technical
aspects of the procedure reported.
A 2005 TEC Assessment reviewed studies that compared
outcomes of standard or “short” limb gastric
bypass with outcomes of “long” limb gastric
bypass. (29) There were six comparative studies
in which two or more different lengths of the Roux
limb were compared. However, although the categorization
of patients into “standard” versus “long-limb” is
based on the length of the Roux (alimentary) limb,
there is not a definite cutoff for “long” versus “standard” limbs.
In these studies, there was variability in the lengths
of the Roux limbs for both the “standard” gastric
bypass and for the “long-limb” groups.
The majority of comparisons of weight loss do not
reveal significant differences between “short” and “long” limb
gastric bypass. The strongest evidence in this category
is from two randomized, controlled trials (36,37) In
both of these trials, there were no significant differences
in weight loss between groups. Brolin and colleagues
compared three limb lengths, with the longest limb
(distal gastric bypass) group having a significantly
larger decrease in BMI at one year, while the other
two groups had similar decrease in BMI. (38) MacLean
and colleagues examined morbidly obese and superobese
patients separately, and reported a significant difference
in favor of the long-limb gastric bypass group. (39) However,
this analysis compared the final BMI of the two groups,
and did not report the actual change in BMI or the
initial BMI for each group.
Adverse events were poorly reported by these studies,
with only three of the studies reporting data on adverse
events. Mason and colleagues reported the percent of
patients with “major post-op complications,” which
was 2.3% for standard gastric bypass and 1.2% for long-limb
gastric bypass. (40) There was no further breakdown
of the types of major complications recorded, and no
statistical testing for this outcome. In the remaining
two studies, the rates of short-term adverse events
reported by Inabnet and colleagues (36) were
higher for standard gastric bypass, while the rates
reported by Brolin and colleagues (38) were higher
for the long-limb gastric bypass. Data on long-term
complications were scant, and did not reveal any apparent
differences between “short” and “long” limb
procedures.
Patient Selection Criteria
Clinical practice guidelines published by the National
Institutes of Health (NIH) and the National Heart,
Lung and Blood Institute (NHLBI) specifically define
surgical candidates as those patients with a BMI of >40
kg/m2 or >35 kg/m2 with comorbid conditions
when less invasive methods of weight loss have failed
and there is high risk for obesity-related morbidity
or mortality. (2)
In order to achieve optimal outcomes following bariatric
surgery, the guidelines further stress the importance
of careful patient selection as all bariatric surgeries
require a high degree of patient compliance. (2) For
gastric restrictive procedures, the weight loss is
primarily due to reduced caloric intake, and thus the
patient must be committed to eating small meals. For
example, gastric restrictive surgery will not be successful
in patients who consume high volumes of calorie rich
liquids. In patients undergoing procedures with a malabsorptive
component, reduced intake may not be as much of an
issue, but patients must adhere to a balanced diet
to avoid metabolic complications.
The guidelines specify that less invasive methods
of weight loss must have failed. Diet, exercise
and behavior modification are considered first-line
treatments for weight loss (and maintenance of weight
loss). The guidelines found strong evidence that
better results were achieved with dietary therapy when
the duration of the intervention was at least six months.
(2) In morbidly obese patients, while nonsurgical
treatment may not result in sustained, significant
weight loss, participation in a medically supervised
weight loss program for six months prior to surgery
is expected to achieve the following:
- Weight loss (or failure to gain further weight)
This provides an objective measure of the patient’s commitment and ability
to comply with diet and physical activity requirements that are necessary for
long-term success following bariatric surgery.
- Health benefits
Improvement or control of risk factors for cardiovascular disease and diabetes
are associated with even modest weight loss. Control of co-morbid conditions
prior to surgery may lower surgical risks.
Bariatric Surgery Centers of Excellence
The NIH/NHLBI clinical practice guidelines discuss
the importance of a multidisciplinary approach to the
clinical management of bariatric surgery patients.
(2) Comprehensive programs should address nursing,
nutrition, exercise, behavior modification, and psychological
support, and they should provide lifelong follow-up
for treated patients.
The published data indicate that high volume bariatric
programs are likely to be more successful in achieving
optimal outcomes. Accumulating evidence supports a
correlation between increasing volume and positive
outcomes for bariatric surgery:
- Nguyen and colleagues compared outcomes of low-
and high-volume academic medical centers. (41) The
authors reported that higher volume hospitals (>100
cases/year) had lower rates of mortality (0.3% vs.
1.2%, p<0.01) and overall complications (10.2%
vs. 14.5%, p<0.01) when compared with lower volume
hospitals.
- Liu and colleagues examined complication rates
from bariatric surgery in California, classifying
programs as very low (<50 cases/year), low (50–99
cases/year), or high (>200 cases/year) volume.
(42) After adjusting for differences in case-mix,
patients at very low-volume hospitals were 2.72 times
more likely to experience perioperative complications,
and patients at low-volume hospitals were 2.7 times
more likely to experience complications, compared
with high-volume hospitals.
- Courcoulas and colleagues examined mortality and
complications in Pennsylvania bariatric surgery programs
by individual surgeon and hospital volume. (43) This
study reported that low-volume surgeons had higher
rates of adverse events (28% vs. 5%, p<0.05),
and a trend toward higher mortality (5% vs. 0.3%,
p= 0.06), when compared to high-volume surgeons.
This data has lead to national efforts to establish
bariatric surgery centers of excellence by the American
Society for Metabolic and Bariatric Surgery and the
American College of Surgeons.
Bariatric Surgical Procedures as a Treatment of
Gastroesophageal Reflux Disease
While there have been reports of improvement in GERD
symptoms after gastric bypass or laparoscopic adjustable
gastric banding, the suggestion that bariatric surgery
should be considered in obese patients to treat GERD
is based on the added health benefit of weight loss
and its effect on comorbid conditions. In order
to determine the safety and efficacy of bariatric surgical
procedures as treatments for GERD, they need to be
compared to standard medical or surgical treatments
of this condition in well-designed randomized trials. There
are no published studies of this nature. In addition,
there are no published evidence-based clinical practice
guidelines that recommend any bariatric surgical procedure
as a treatment of GERD.
Endoscopic Procedures for Patients who Gain Weight
after Bariatric Surgery
Enlarged gastric stoma and/or enlarged gastric pouches
may be associated with weight regain after bariatric
surgery. It is not known if endoscopic procedures
(e.g., insertion of the StomaphyX™ or other devices,
sclerotherapy, Restorative Obesity Surgery, Endoscopic ™)
are effective in the treatment of these abnormalities.
Results are reported for a number of different devices
and procedures (including sclerosing injections) as
treatments for regained weight following bariatric
surgery; however, the published data concerning use
of these devices is limited to small published case
series. (48,49) No comparative trials were identified. Comparative
trials are needed to reach conclusions about the effectiveness
of these treatments because of the known association
between an intervention and short-term weight loss.
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None
| Codes |
Number |
Description |
| CPT |
43644 |
Laparoscopy, surgical,
gastric restrictive procedure; with gastric bypass
and Roux-en-Y gastroenterostomy (roux limb 150 cm
or less) |
| |
43645 |
Laparoscopy, surgical,
gastric restrictive procedure; with gastric bypass
and small intestine reconstruction to limit absorption |
| |
43770 |
Laparoscopy, surgical, gastric restrictive procedure; placement of adjustable gastric restrictive device (gastric band and subcutaneous port components) |
| |
43771 |
Laparoscopy, surgical, gastric restrictive procedure; revision of adjustable gastric restrictive device component only |
| |
43772 |
Laparoscopy, surgical, gastric restrictive procedure; removal of adjustable gastric restrictive device component only |
| |
43773 |
Laparoscopy, surgical, gastric restrictive procedure; removal and replacement of adjustable gastric restrictive device component only |
| |
43774 |
Laparoscopy, surgical, gastric restrictive procedure; removal of adjustable gastric restrictive device and subcutaneous port components |
| |
43842 |
Gastric restrictive
procedure, without gastric bypass, for morbid obesity;
vertical banded gastroplasty |
| |
43843 |
Gastric restrictive
procedure, without gastric bypass, for morbid obesity;
other than vertical banded gastroplasty |
| |
43845 |
Gastric restrictive
procedure with partial gastrectomy, pylorus-preserving
duodenoileostomy and ileoileostomy (50 to 100 cm
common channel) to limit absorption (biliopancreatic
diversion with duodenal switch) |
| |
43846 |
Gastric restrictive
procedure, with gastric bypass for morbid obesity;
with short limb (less than 100 cm) Roux-en-Y gastroenterostomy |
| |
43847 |
Gastric restrictive
procedure, with gastric bypass for morbid obesity;
with small intestine reconstruction to limit absorption |
| |
43848 |
Revision, open, of gastric restrictive procedure for morbid obesity, other than adjustable gastric restrictive device (separate procedure) |
| |
43886 |
Gastric restrictive
procedure, open; revision of subcutaneous port component
only |
| |
43887 |
Gastric restrictive
procedure, open; removal of subcutaneous port component
only |
| |
43888 |
Gastric restrictive
procedure, open; removal and replacement of subcutaneous
port component only |
| |
S2083 |
Adjustment of gastric
band diameter via subcutaneous port by injection
or aspiration of saline |
Surgery Section Table of Contents 

|