| Surgery Section - Bariatric Surgery
| Topic: Bariatric Surgery |
Date of Origin: 01/1996 |
| Section: Surgery |
Policy No: 58 |
| Approved Date: 04/13/2010 |
Effective Date: 05/01/2010 |
| Next Review Date: 05/2011 |
|
| |
IMPORTANT REMINDER
Regence Medical Policies are developed to provide guidance for members and providers regarding
coverage in accordance with contract terms. Benefit determinations are based in all cases on
the applicable contract language. To the extent there may be any conflict between the Medical
Policy and contract language, the contract language takes precedence.
PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that
are considered investigational or cosmetic. Providers may bill members for services or
procedures that are considered investigational or cosmetic. Providers are encouraged to inform
members before rendering such services that the members are likely to be financially responsible
for the cost of these services.
DESCRIPTION
Morbid obesity is defined as a body mass index (BMI) >40
kg/m2 (normal BMI range: 19-25 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 (colon, prostate, breast,
uterus, and ovaries). In addition, morbid obesity
is associated with a shortened life span. [1]
The first-line treatment of morbid obesity involves
dietary and lifestyle changes. Although this strategy
may be effective in some patients, a majority of morbidly
obese patients do not achieve significant weight loss
through lifestyle modifications. In addition, the weight
loss may not be durable, as only a small number of
patients are able to comply with the changes on a long-term
basis. When conservative measures fail, some patients
may consider surgery for morbid obesity (bariatric
surgery).
Several bariatric procedures have been developed,
but based on the underlying mechanism of weight loss,
all fall into one or both of the following categories:
Restrictive
procedures
- Decrease the size of the stomach and limit food
intake
Malabsorptive procedures
- Limit the absorption of calories and nutrients
by altering the way food moves through the intestinal
track
- Multiple variants exist, differing in the reconfiguration
of the small intestines and consequently the extent
of malabsorption.
The following table briefly summarizes
different bariatric procedures:
| Procedure |
CPT Code |
Description |
Gastric Bypass with Roux-en-Y Anastomosis
(RYGB)
AKA: Proximal or Short Limb Gastric Bypass |
43846
43644 |
- Currently considered “gold-standard” for
weight loss surgery
- Involves both restrictive and malabsorptive
components:
- A small gastric pouch is created from the
upper part of the stomach by segmentation or
resection to restrict the amount of food
that can be ingested
- The mid portion of the jejunum is divided
and the cut end of the distal limb (≤ 150
cm) is attached to the gastric pouch outlet
(Roux limb). The cut end of the proximal
limb (the limb consisting of the duodenum
and proximal jejunum) is attached to the
side of the Roux limb (the limb connected
to the pouch). This creates the Y configuration
of the small intestine, allowing food to
bypass the duodenum and proximal jejunum,
resulting in malabsorption.
|
| Distal
(Long Limb) Gastric Bypass |
43847 |
- The procedure involves both restrictive and
malabsorptive components and is a variant of
the standard gastric bypass with the longer (>150
cm) Roux limb. The longer the Roux limb, the
greater the bypass of the small intestine and
consequently the degree of malabsorption.
|
Biliopancreatic
Diversion (Bypass) Procedure
AKA Scopinaro procedure |
43847 |
- Involves both restrictive and malabsorptive
components:
- Subtotal (distal) gastrectomy
creates small gastric pouch at the top
of the stomach to limit food intake
- A long limb Roux-en-Y anastomosis (>150
cm) results in the biliopancreatic juices
being diverted into the distal ileum, significantly
increasing malabsorption
- Designed to preferentially inhibit the
absorption of fat
- Only partially reversible
|
| Biliopancreatic
Dieversion (Bypass) with Duodenal Switch (BPD-DS) |
43845 |
- This procedure is an adaptation of the standard
biliopancreatic bypass:
- The restrictive component involves subtotal gastrectomy
resulting in a tube or sleeve-like stomach
remnant that leaves the pyloric valve and
the initial segment of duodenum intact.
- The long limb Roux-en-Y anastomosis (>150
cm) provides malabsorption in this variant
as well, but the distal ileum is connected
to the duodenal segment leading from the
stomach sleeve, instead of the stomach pouch
itself.
|
| Mini-Gastric
Bypass |
no specific code |
- The procedure is a variant of the gastric bypass
and involves both restrictive and malabsorptive
components:
- The stomach is segmented to create a small
gastric pouch similar to traditional gastric
bypass
- Instead of creating a Roux-en-Y anastomosis,
the loop of jejunum is anastomosed directly
to the stomach pouch (similar to a Billroth
II procedure)
|
| Sleeve
Gastrectomy |
43775 |
- Greater curvature of the stomach is resected resulting
in a gastric remnant shaped like a tube or sleeve.
- The pyloric sphincter is preserved leaving
stomach function unaltered.
- Not reversible
- Can be performed as:
- A stand-alone procedure (restrictive)
- The first part of a two-stage surgical
procedure for the very high-risk patients
(BMI ≥50 kg/m2)
who need to lose some weight before they
can proceed with a malabsorptive procedure
(most commonly BPD-DS or RYGB)
|
| Adjustable
Gastric Banding |
43770-43774
43886-43888 |
- Restrictive procedure
- An adjustable, external, constrictive band
is wrapped around the upper portion of the
stomach to create a small stomach pouch
- The band can be adjusted through a subcutaneous
access port, foregoing the need to enter the
gastric cavity when adjusting the band
- The least invasive and least technically
complex bariatric procedure
- Lap-Band® (Allergan, Inc.) and the REALIZE™ (Ethicon
Endo-Surgery, Inc.) have received the approval
from the U.S. Food and Drug Administration
(FDA).
|
Vertical
Banded Gastroplasty
AKA Vertically banded gastric partition or Gastric
stapling |
43842 |
- Restrictive procedure
- Surgical stapling is used to create a small,
vertical gastric pouch at the top of the stomach
- The pouch outlet (stoma) is reinforced with
an external mesh collar
|
| Endoscopic
(Endolumial) Bariatric Procedures |
|
- The access to the stomach is gained through
the mouth, so no incisions are necessary.
- Endoluminal procedures being developed:
- Primary bariatric procedure
- Revision (e.g. for treatment of enlarged
gastric stoma and/or enlarged gastric pouches
that may be associated with weight gain after
bariatric surgery)
- Examples of the endoscopic revision bariatric
procedures include:
- gastroplasty using an endoscopically guided
stapler (reduces the size of the gastric
pouch)
- placement of gastric balloon (soft, silicone
balloon inserted into the stomach and filled
with sterile saline to induce feeling of
satiety)
- placement of duodenal-jejunal sleeve (sleeve
placed inside duodenum and upper jejunum
to prevent contact between food and the intestine).
- StomaphyX®, an endoscopically guided system
intended for tissue plication and ligation, has
received 510(k) FDA approval. The device is also
being investigated for endoscopic treatment of
gastroesophageal reflux.
|
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: |
| |
|
|
|
| |
A. |
At the
start of the medically supervised, nonsurgical
weight reduction program: |
| |
. |
BMI greater
than or equal to 40 kg/m2; or |
| |
|
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: |
| |
|
1) |
Hypertension |
| |
|
2) |
Dyslipidemia |
| |
|
3) |
Coronary heart disease |
| |
|
4) |
Sleep apnea |
| |
|
|
|
| |
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: |
| |
|
|
| |
|
1) |
Occur during
at least 6 consecutive months within the 24 months
prior to the request for surgery; and |
| |
|
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. |
| |
|
3) |
Be provided
by an MD, DO, NP, PA or a registered dietitian
under the supervision of an MD, DO, NP, or PA;
and |
| |
|
4) |
Include
assessment and counseling concerning weight, diet,
exercise, and behavior modification; and |
| |
|
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, psychiatrist, or LCSW
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 |
| |
|
|
| |
D. |
Clinical
documentation of willingness to comply with preoperative
and postoperative treatment plans; and |
| |
|
|
| |
E. |
Age greater
than or equal to 18 years. |
| |
|
|
|
|
|
| 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. |
| |
|
|
|
|
|
| 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: |
| |
|
|
| |
A. |
Mini-gastric
bypass (gastric bypass using a Bilroth II type
of anastomosis) |
| |
|
|
| |
B. |
Sleeve
gastrectomy, either as the sole procedure or as
one step in a staged procedure |
| |
|
|
| |
C. |
Distal
gastric bypass (long limb gastric bypass, i.e., >150
cm) |
| |
|
|
| |
D. |
Biliopancreatic
bypass (i.e., the Scopinaro procedure) |
| |
|
|
| |
E. |
Biliopancreatic
bypass with duodenal switch |
| |
|
| IV. |
The vertical
banded gastroplasty is no longer a standard of
care and is therefore considered not medically
necessary. |
| |
|
|
| V. |
Reoperation
to address complications of a bariatric procedure
may be considered medically necessary. These include,
but are not limited to, staple-line failure, obstruction,
stricture, non-absorption resulting in hypoglycemia
or malnutrition, weight loss of 20% or more below
ideal body weight, band erosion, band migration. |
| |
|
|
| VI. |
Endoscopic
procedures: |
| |
|
|
| |
A. |
Endoscopic
procedures as the primary bariatric procedure are
considered investigational. |
| |
|
|
| |
B. |
Endoscopic
procedures are considered investigational to treat
complications of primary bariatric surgery, including
but not limited to weight gain due to a large gastric
stoma or large gastric pouch and dumping syndrome. |
| |
|
|
| |
C. |
Examples
of endoscopic devices/procedures include but are
not limited to: |
| |
|
|
| |
|
1) |
StomaphyX™ (EndoGastric
Solutions, Inc) |
| |
|
|
|
| |
|
2) |
ROSE procedure
(Restorative Obesity Surgery, Endoscopic ™) |
| |
|
|
|
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|
3) |
EndoCinch™ (Bard) |
| |
|
|
|
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|
4) |
EndoSurgical
Operating System™ (EOS) (USGI Medical, Inc) |
| |
|
|
|
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|
5) |
Sclerotherapy
of stoma |
POSITION STATEMENT
- Roux-en-Y Gastric Bypass (RYGBP)
The Roux-en-Y gastric bypass (RYGBP) is
currently considered the gold standard for weight
loss surgery and is the most commonly performed bariatric
procedure in the United States. It is considered
to have the most favorable benefit/risk ratio of
all bariatric procedures, and it consistently achieves
greater amounts of weight loss compared to alternative
procedures, without demonstrable increases in morbidity
or mortality. [2]
Consequently, in order to determine the safety and
efficacy of other bariatric surgical procedures,
they need to be compared to RYGB in well-designed,
well-executed randomized controlled trials (RCT).
- Laparoscopic Adjustable Gastric Banding (LAGB)
RCT data comparing the two procedures are
limited, however::
- LAGB is reversible and the least invasive of
all bariatric procedures.
- Weight loss following LAGB is less than what
is usually seen following RYGB.
- LAGB has low perioperative complications, however
inadequate weight loss or long term complications
of band erosion, slippage, or malfunction may require
additional surgery.
- Other Bariatric Surgical Procedures
The evidence is insufficient to determine the long
term safety and efficacy of bariatric surgery procedures
other than the RYGB or LAGB.
Non-randomized studies
Although the published, peer-reviewed literature
on non-RYGBP bariatric procedures is voluminous,
it consists mostly of case series and retrospective,
non-randomized comparisons. Evidence from these studies
is unreliable due to inherent design flaws, such
as non-random allocation of treatment, lack of appropriate
comparison groups, and short-term follow-up. In addition,
the inconsistent reporting of weight loss, resolution
of comorbidities, adverse events, morbidity, and
reoperation rates further limit meaningful comparisons
across these studies.
Randomized Controlled Trials
Very few randomized controlled trials compared other
bariatric procedures with RYBP. Overall, the trials
were of poor quality and the findings unreliable
due to at least one of the following design flaws:
- The trials had very small study populations,
limiting the ability to rule out the role of
chance as an explanation of findings.
- The randomization scheme was either inadequate
or not explained. Inadequate randomization of
study participants may result in unequal distribution
of potential confounders, such as clinical characteristics,
which in turn may affect the outcome.
- The studies have short follow-up times so there
is no long-term (5-10 years or longer) evidence
regarding:
- durability of weight loss
- complications (e.g. metabolic side effects,
nutritional deficiencies, anastomotic ulcers,
esophagitis, procedure-specific complications
such as band erosion)
- resolution of comorbidities (e.g. diabetes,
hypertension, obstructive sleep apnea,
increased cholesterol)
- need for reoperations
- Short-term complications, adverse events, morbidity,
resolution of comorbidities, and reoperation
rates are inconsistently reported, limiting conclusions
and comparisons across studies.
- There is limited understanding of appropriate
patient selection criteria for each of the non-RYGB
bariatric procedures (e.g. superobese patients
vs. morbidly obese patients).
- Bariatric Surgery in the Pediatric Population
Overall, there is very little evidence on the role
of bariatric surgery in treating morbidly obese pediatric
patients. Moreover, the evidence mostly comes from
small, non-randomized and therefore unreliable studies.
Specifically:
- There is limited evidence that bariatric surgery
leads to clinically significant, long-term sustained
weight loss and resolution of obesity-related comorbidities
in the pediatric population.
- The evidence does not permit conclusions regarding
morbidity associated with and safety of any bariatric
procedure in the pediatric population.
- There is no evidence regarding the long-term
potential impact of bariatric procedures on growth
and development in the pediatric population.
- Bariatric Surgery as a treatment for Gastroesophageal
reflux Disease (GERD)
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, well-executed
randomized controlled trials. However, 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 Bariatric Procedures
There is insufficient evidence to determine the safety
and efficacy of any endoluminal procedure as either
a primary bariatric procedure or a revision procedure. The
published evidence is very limited and consists of
only a few case series and one unreliable randomized
trial.
- Multidisciplinary approach to the clinical management
of bariatric surgery patients
The National Institutes of Health/National Heart,
Lung, and Blood Institute (NIH/NHLBI) clinical practice
guidelines state the importance of a multidisciplinary
approach to the clinical management of bariatric
surgery patients. Comprehensive programs should address
nursing, nutrition, exercise, behavior modification,
and psychological support, and they should provide
lifelong follow-up for treated patients. [1]
- Bariatric Surgery Centers of Excellence
The published evidence indicates that high volume
bariatric centers are more likely to be successful
in achieving optimal outcomes and lower complication
and mortality rates than low volume bariatric centers.
[3-5] These data have lead to national efforts
to establish bariatric surgery centers of excellence
by the American Society for Metabolic and Bariatric
Surgery, the American College of Surgeons, and the
BlueCross BlueShield Association.
Effectiveness
The following effectiveness review of bariatric surgical
procedures is based on randomized controlled trials
(RCT), Blue Cross Blue Shield Association (BCBSA) Technology
Evaluation Center (TEC) Assessments, Cochrane reviews, and
evidence-based guidelines. The non-randomized studies
(e.g. case reports, case series, retrospective reviews)
are not included in the review as they do not represent
the adequate level of evidence due to inherent study
design flaws, such as non-random allocation of treatment
and lack of appropriate comparison groups.
Distal (Long Limb) Gastric Bypass
TEC Assessment
The 2005 Blue Cross Blue
Shield Association (BCBSA) Technology Evaluation Center
(TEC) Assessment identified six comparative trials
of long limb gastric bypass with Roux-en-Y anastomosis
(LL-RYGB) vs. standard RYGB. [2] However, only two
were randomized controlled trials (RCT). The assessment
determined that there was not sufficient evidence to
reach conclusions on the efficacy and safety of LL-RYGB
compared to standard RYGB:
- In both RCTs, there was no significant difference
in weight loss between the two groups at 1 year.
- The evidence for the super obese (BMI ≥50
kg/m2) population was weak and did not allow conclusions
concerning whether LL-GBRY is superior in this
subgroup of patients
- The adverse events were poorly reported in all
comparative studies. Some of the reports contradicted
one another.
- There was no definite cut-off for “long” vs. “standard” limb,
making comparisons even more challenging.
Randomized Clinical Trials (RCT)
One RCT evaluated the effectiveness of the distal
gastric bypass for weight loss and control of comorbidities
[6]. The study included only super obese patients (BMI ≥50
kg/m2). There was no significant difference in the control
or improvement of hypertension, sleep apnea, or gastroesophageal
reflux disorder between the patients who underwent
long-limb (Roux limb = 250 cm) and short-limb gastric
bypass (Roux limb = 150 cm). In addition, there was
no difference in excess weight loss between the groups.
Although the study reports better control of lipid
disorders and diabetes in patients who underwent the
long-limb gastric bypass, several design flaws undermine
the reliability of the study findings:
- The small study population (n=105) limits the ability
to rule out the role of chance as an explanation
of findings.
- The randomization scheme was not explained. Inadequate
randomization of study participants may result in
unequal distribution of potential confounders, such
as clinical characteristics.
- The short-term follow-up limits conclusions regarding
the long-term complications and the effectiveness
of the distal gastric bypass in controlling weight
loss and comorbidities.
- The study included only super obese patients limiting
the generalizability of the study findings to other
patient populations (i.e. morbidly obese).
- The need for nutritional supplementation after
the surgery was reported for the two treatment groups,
but there was a failure to include statistical testing
for this outcome.
Other comparative studies and case series
A number of non-randomized
studies (retrospective comparisons, case series) describe
the experiences of patients undergoing distal gastric
bypass. [2,7-9] As noted at the beginning
of the position statement, evidence from these studies
is unreliable.
Biliopancreatic Bypass and Biliopancreatic Bypass with Duodenal
Switch
TEC Assessment
The 2005 BCBSA TEC Assessment
identified only one comparative trial that compared
RYGB with biliopancreatic diversion with duodenal switch
(BPD-DS). [2] Although the trial included 237 RYGB
and 113 BPD-DS patients, it was not a randomized clinical
study (the choice of the surgery was determined by
surgeon and/or patient) and it followed participants
for only one year. The TEC Assessment did not find
this data sufficient to determine the risk/benefit
ratio for this procedure or that it results in greater
weight loss than RYGB:
- The % estimated weight loss (EWL) at one year was
the same for both the RYGB and BPD-DS groups.
- Data on short-term adverse events was limited,
except for the mortality and wound infection rates
which were equivalent in both groups.
- More anastomotic leaks were reported in BPD-DS
group.
- Long-term complications were not reported.
- Nutritional concerns were not adequately addressed.
This is of concern because BPD-DS further reduces
fat absorption, affecting the absorption of fat soluble
vitamins.
Randomized Controlled Trials (RCT)
Two prospective trials compared the experiences of obese patients undergoing
RYGB vs. BPD.
The first trial compared
weight loss, metabolic deficiencies, and resolution
of comorbidities in morbidly obese patients undergoing
RYGB vs. a variant of BPD (BPD with RYGB). [10] The study reports comparable nutritional deficiencies
between the two procedures. Although better weight
loss and resolution of diabetes and hypercholesterolemia
was reported in the BPD group, several design flaws
undermine the reliability of the study findings:
- The study employed an inadequate randomization
scheme: the report states that patients were chosen
to undergo RYGB or BPD, but fails to provide any
further explanation of how the treatment was assigned.
Inadequate randomization of study participants may
result in unequal distribution of potential confounders,
such as clinical characteristics.
- The RYGB group had a significantly higher level
of preexisting comorbidities (p = 0.01), suggesting
a difference between the treatment groups that may
have affected the outcome.
- The small study population (65 patients/surgery
group) limits the ability to rule out the role of
chance as an explanation of findings.
- The short-term follow-up (2 years) limits conclusions
regarding the long-term metabolic complications and
the long-term effectiveness of the BPD in controlling
weight loss and comorbidities.
Another small randomized trial (n=60) compared laparoscopic
RYGB and BPD-DS for superobese patients (BMI 50-60
kg/m2). [11] The study found comparable
30-day perioperative safety and greater weight loss
following BPD-DS in the first year. However, several
design flaws undermine the reliability of the study
findings:
- It is not certain from the data presented whether
the study was adequately powered to reliably observe
the treatment differences, especially in the stratified
sub-analyses.
- The short-term follow-up (one year) limits
comparisons regarding the long-term complication
rates and the long-term effectiveness of the two
procedures in controlling weight loss.
- The effectiveness of the procedures in controlling
comorbidites was not compared in this study.
Other comparative studies and case series
A number of non-randomized
studies (retrospective comparisons, case series) describe
the experiences of patients undergoing biliopancreatic
diversion with or without duodenal switch. [12-30] As noted at the beginning of the position statement,
evidence from these studies is unreliable.
Sleeve Gastrectomy
Cochrane Review
The 2009 Cochrane review of bariatric surgery identified
only one randomized controlled trial that compared
sleeve gastrectomy to gastric bypass with Roux-en-Y
anastomosis (RYGB). [31] This very small
(n=32) and short trial that followed participants for
only 1 year reported that:
- Weight loss and BMI were similar between the two
procedures, but % excess weight loss was greater
with sleeve gastrectomy.
- Two patients had diabetes at baseline, both in
RYGB group. The condition was resolved at 1 year
in both patients. The outcome of other
comorbidities reported at baseline was not reported
for RYGB or SG groups.
- Although the study reported no conversions to open
surgery and no intraoperative and postoperative complications,
the other complications and additional operative
procedures were not reported.
- The study did not assess a two-stage approach using
sleeve gastrectomy prior to another bariatric procedure
and consequently no conclusions about the two-stage
approach could be made.
- The short duration of the follow-up results in
underestimation of the impact of late complications
and the need for revisional surgery.
Randomized Clinical Trials (RCT)
One RCT compared the patients who underwent sleeve
gastrectomy (SLG) and standard RYGB surgery. The goal
of this study was to compare the effect of the RYGB
and SLG on glycemic control. [32] It was
noted that body weight and BMI decreased markedly and
comparably after either procedure. Although the study
found that both procedures markedly improved glucose
homeostasis (no significant difference was found in insulin
and GLP-1 secretion between the two procedures at three
months), two major design flaws undermine the reliability
of the study findings:
- The very small study population (n=27) limits the
ability to rule out the role of chance as an explanation
of findings.
- The very short duration of follow-up (3 months)
limits conclusions regarding the medium- and long-term
impact on glucose metabolism.
Other comparative studies and case series
A number of non-randomized
studies (retrospective comparisons, case series) describe
the experiences of patients undergoing sleeve gastrectomy.
[33-52] As noted at the beginning
of the position statement, evidence from these studies
is unreliable.
Adjustable Gastric Banding
BCBSA TEC Assessment
Although the 2007 Blue Cross
Blue Shield TEC Assessment identified eight comparative
trials of gastric bypass with Roux-en-Y anastomosis
(RYGB) vs. laparoscopic adjustable gastric banding
(LAGB), none of the trials was a randomized controlled
design that directly compared the two procedures. [53] Three trials matched patients on key clinical characteristics,
and the rest were comparisons of outcomes from separate
clinical series of patients who had RYGB or LAGB.
The assessment of the comparative trials found that
there was a tradeoff in terms of safety and efficacy
when comparing LAGB and RYGB:
- LAGB was less invasive, required a shorter hospital
stay, and was reversible.
- Short-term complications of LAGB were very low
and mortality exceedingly rare.
- Weight loss for LAGB at one year was substantial,
but inferior to RYGB. The data on the longer-term
weight loss was limited and the conclusions less
definitive.
- The data on the longer-term complications was inadequate,
but it suggested that a considerable minority of
the LAGB patients may require reoperations and/or
removal of the band.
Cochrane Review
The 2009 Cochrane review
of bariatric surgery identified only one randomized
controlled trial that compared laparoscopic adjustable
gastric banding (LAGB) to laparoscopic gastric bypass
with Roux-en-Y anastomosis (RYGB). [31] Both procedures were performed laparoscopically. This
very small trial (n=51) that followed participants
for five years reported that:
- RYGB was superior to LAGB on more than one measure
of weight loss (% excess weight loss, mean BMI)
- Early complications requiring reoperation were
more present in the RYGB patients, but numbers
were small and no tests of statistical significance
were reported.
- Comorbidities and late complications were comparable
but the numbers were very small and no tests of
statistical significance were reported.
Randomized Controlled Trials (RCT)
An updated literature search failed to identify any
additional randomized controlled trials that compare
LAGB with RYGB.
Other comparative studies and case series
A number of non-randomized
studies (retrospective comparisons, case series) describe
the experiences of patients undergoing LAGB. [50,53,54-59] As
noted at the beginning of the position statement, evidence
from these studies is unreliable.
Mini-Gastric Bypass
Randomized Controlled Trials (RCT)
One small RCT compared the
safety and effectiveness of laparoscopic RYGB and mini-gastric
bypass (MGBP). [60] The study found a
comparable rate of late complications (>30 days post-op), weight
loss, and comorbidity resolution. MGBP was associated
with fewer early complications (<30 days post-op). However, the following
design flaws undermine reliability of the study findings:
- The small study population (n=80) limits the ability
to rule out the role of chance as an explanation
of findings.
- Short-term follow-up (2 years) limits comparisons
regarding the longer-term complications rates and
the effectiveness of the two procedures in controlling
weight loss and comorbidities
Other comparative studies and case series
Several non-randomized studies (retrospective comparisons,
case series) describe experiences of patients undergoing
MGBP. [61-65] As noted at the beginning
of the position statement, evidence from these studies
is unreliable.
Vertical Banded Gastroplasty (VBG)
VBG has largely been abandoned
in the United States due to insufficient weight loss
and high reoperation rates (approximately 30%). [31]
Endoscopic (Endoluminal) Bariatric Procedures
Randomized Controlled Trials (RCT)
A small randomized trial
compared the safety and efficacy of the transabdominal
circular stapler (CEEA®) and transoral circular
stapler (SurgASSIST®)
for performing the gastrojejunostomy in laparoscopic RYGB. [66] The study did not find a significant difference between the two
procedures on any of the measures except the rate of
port site wound infection, suggesting a benefit of
the transoral approach. However, several design flaws
undermine the reliability of the study findings:
- The very small study population (n=20) limits the
ability to rule out the role of chance as an explanation
of findings.
- Short-term follow-up (one year) limits comparisons
regarding the longer-term safety and effectiveness
of the two procedures in controlling the weight loss
and comorbidities.
- The randomization scheme was not explained. Inadequate
randomization of study participants may result in
unequal distribution of potential confounders, such
as clinical characteristics, which in turn may affect
the study outcome.
Other comparative studies and case series
A small number of non-randomized studies, primarily
case series, describe experiences of patients undergoing
different endoluminal procedures. [67-74].
As noted at the beginning of the position statement,
evidence from these studies is unreliable.
Pediatric Bariatric Surgery
Washington State Health Technology Assessment
The 2007 Washington State
Health Technology Assessment evaluated the published,
peer reviewed scientific literature describing bariatric
surgery in the pediatric population. [75] Data from 17 studies that enrolled a total of 553 pediatric
patients were included. Only one study was clearly
prospective. Eight studies reported outcomes after
LAGB, six after RYGB, two after VBG, and one after
banded bypass. The report concluded that:
- The evidence that LAGB for morbidly obese pediatric
patients leads to sustained and clinically significant
weight loss compared to non-operative approaches
was weak at the longest follow-up after surgery (1.7
to 3.3 years).
- The evidence that RYGB for morbidly obese pediatric
patients leads to sustained and clinically significant
weight loss compared to non-operative approaches
was weak at the longest follow-up after surgery (1
to 6.3 years).
- The evidence was insufficient to permit quantitative
estimates of the precise amount of weight loss after
any bariatric surgical procedure for pediatric patients.
- The evidence was insufficient to permit any conclusions
about weight loss after other bariatric surgical
procedures for pediatric patients.
- The evidence was insufficient to permit any conclusions
about weight loss in specific age subgroups (18-21,
13-17, 12 or less) within the pediatric population.
- The evidence that LAGB for morbidly obese pediatric
patients does resolve comorbid conditions linked
to obesity (diabetes, hypertension) compared to non-operative
approaches was weak.
- The evidence that RYGB for morbidly obese pediatric
patients does resolve comorbid conditions linked
to obesity (diabetes, hypertension) compared to non-operative
approaches was weak.
- The evidence was insufficient to permit quantitative
estimates of the likelihood of comorbidity resolution,
quality of life improvement, or survival after any
bariatric surgical procedure for pediatric patients.
- The evidence was insufficient to permit any conclusions
about comorbidity resolution in specific age subgroups
(18-21, 13-17, 12 or less) within the pediatric population.
- The LAGB studies reported no in-hospital or postoperative
death. However, the most commonly reported complication
was band slippage. Reoperations were performed on
7.9% of the LAGB patients to correct various complications
(band slippage, intragastric migration, port/tubing
problems).
- The RYGB studies reported one postoperative death.
The most frequently reported complication was related
to malnutrition and micronutrient deficiency. In
addition, potentially life threatening complications
(shock, pulmonary embolism, severe malnutrition,
bleeding, gastrointestinal obstructions) were reported.
- The evidence was insufficient to permit any conclusions
on potential impacts of bariatric surgery on growth
and development of pediatric patients.
- The evidence was insufficient to permit any conclusions
on potential harms in specific age groups (18-21,
13-17, 12 or less).
In summary, the assessment found that longer term,
prospective collection of data on physical growth,
quality of life, weight loss, persistence or resolution
of comorbid conditions, and long-term survival are
needed in order to fully understand the role of bariatric
surgical procedures in treating morbidly obese pediatric
patients.
RCT
No RCT evaluated the safety and effectiveness of either
RYGB or LAGB compared to non-surgical approaches in
the pediatric population. In addition, no RCT compared
the safety and effectiveness of RYGB compared to LAGB
in the pediatric population.
Other comparative studies and case series
Studies with short follow-up time
A small number of non-randomized
comparative studies reported significant weight loss
and resolution of some of the comorbidities in pediatric
patients undergoing bariatric surgery. [76-78] However, the studies were small and had a very short
follow up time.
Studies with mid-term follow-up time
Two observational studies
with mid-term follow-up times (≤10 and ≤8 years)
reported experiences of pediatric patients undergoing LAGB (sample size 41and
107 respectively). [79,80] The first study found that weight
loss was initially successful and resulted in resolution of
some comorbidities, but it slowly increased over the
time and ultimately was unsatisfactory in many patients.
The second study reported 65.5% excess weight loss
at eight years. Both studies reported high complication
and reoperation rates (Lanthaler: 46% patients had
complications that required reoperation; Mittermaier:
46% patients had complications and 29% required reoperation).
However, as noted at the beginning of the position
statement, evidence from these studies is unreliable.
Evidence-based Guidelines for Pediatric Bariatric Surgery
The 2005 American College
of Physicians evidence-based guideline on use of bariatric
surgery in adolescents and children states that the
current evidence on surgical treatment of pediatric
population is limited to a few case series which do
not permit quantitative analysis. Further, the guideline
states that it is unclear whether extrapolation of
adult data for bariatric surgery to the pediatric population
is appropriate and that RCTs are needed (and feasible)
to establish the role of bariatric surgery in this
population. [81]
GERD
RCT
No randomized controlled trials compared standard medical or surgical treatments
of GERD with bariatric surgical procedures as a treatment of GERD.
Other comparative studies and case series
One retrospective study
compared the in-hospital outcomes of morbidly obese
patients who underwent laparoscopic fundoplication
for the treatment of GERD versus laparoscopic gastric
bypass for the treatment of morbid obesity and related
conditions, including GERD. [82] As noted
at the beginning of the position statement, evidence
from these studies is unreliable.
Safety
General Surgical Risks
Bariatric procedures are associated with all the potential
risks of any major abdominal surgical procedure including
but not limited to:
- Bleeding
- Death
- Infection
- Injury to internal organs or gastrointestinal tract
- Thromboembolic complications
Procedure-specific Surgical Risks
The following table summarizes the most common procedure-specific
risks. However, other adverse events are also possible.
RYGB [2] |
- Cholecystitis
- Depression
- Dilated stomach pouch
- Dumping syndrome†
- Gastritis
- Leaks or obstructions at the anastomotic site
- Marginal ulcer
- Reoperations†††
- Staple line failure
- Vitamin/mineral deficiencies (iron, folate,
B12)
|
| LL-RYGB[2] |
- All RYGB risks
- Additional unknown risks associated with the
greater bypass of the small intestine and consequent
increase in malabsorption††
|
| BPD/BPD-DS[2, 31] |
- Dilated stomach pouch
- Gastric obstruction
- GERD
- Leaks or stenoses at anastomotic sites
- Malnutrition and/or vitamin deficiencies
- Nausea/vomiting
- Wound dehiscence
|
| SG[31,38,83-85] |
- Abscesses
- Frequent vomiting
- Gastric fistulas
- GERD
- Leaking from the stomach pouch
- Reoperations†††
|
| LAGB[53] |
- Band slippage
- Dilated stomach pouch
- Erosion of the device through gastric wall
- GERD
- Malnutrition and vitamin deficiencies
- Nausea and vomiting
|
| MGB [60] |
- Bile reflux
- Gastrojejunostomy leak
- Marginal ulcer
- Reoperations†††
- Vitamin/mineral deficiency
|
| Endoluminal Procedures |
The safety concerns are specific to the endoluminal
procedure performed:
Transoral circular stapler (SurgASSIST®):
[66]
- Bowel obstruction
- Intra-abdominal adhesions
Dduodenal-jejunal bypass sleeve (DJBS): [70]
- Abdominal pain
- Implant site inflammation
- Nausea and vomiting
TOGa system endoscopic stapling: [71]
- Nausea
- Vomiting
- Pain
- Transient dysphagia
|
† Abdominal pain, diarrhea,
and/or vomiting shortly after eating due to reduced
transit time in the intestine;
††The evidence, especially from the studies with long-term follow-up,
is limited and not much is known about the long-term complications of LL-RYGB;
†††Due to insufficient weight
loss or technical issues; |
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Regence Consumer Tx: Weight loss (Bariatric) Surgery
| 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 |
| |
43775 |
Laparoscopy, surgical,
gastric restrictive procedure; longitudinal gastrectomy
(ie, sleeve gastrectomy) |
| |
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 |
| HCPCS |
None |
|
Surgery Section Table of Contents 

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