Pending Policies - Surgery


Bariatric Surgery

Number:SUR716.003

Effective Date:02-01-2019

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

NOTE 1: Check member’s contract for benefit coverage and/or exclusions for bariatric surgery and complications related to bariatric surgery. Not all benefit contracts cover bariatric surgery or complications of non-covered surgery.

This medical policy does NOT address Gender Reassignment Services (Transgender Services). This medical policy IS NOT TO BE USED for Gender Reassignment Services. Refer to SUR717.001, Gender Assignment Surgery and Gender Reassignment Surgery and Related Services

PATIENT SELECTION CRITERIA FOR COVERAGE

For a member to be considered eligible for benefit coverage of bariatric surgery to treat morbid obesity, the member must meet the following two criteria:

1. Diagnosis of morbid obesity, defined as a:

Body mass index (BMI) equal to or greater than 40 kg/meter² (* see guidelines below for BMI calculation); OR

BMI equal to or greater than 35 kg/meters² with at least one (1) of the following clinically significant obesity-related diseases or complications that are not controlled by best practice medical management:

o Hypertension, OR

o Dyslipidemia, OR

o Diabetes mellitus, OR

o Coronary heart disease, OR

o Sleep apnea, OR

o Osteoarthritis in weight bearing joints; AND

2. Documentation from the requesting surgical program that:

Adult individuals who are ≥ 18 years of age or have reached full expected skeletal growth; OR

Adolescent individuals who have attained a Tanner 4 or 5 pubertal development or have a bone age ≥ 13 years in girls, or ≥ 15 years in boys; AND

Documentation from the surgeon attesting that the patient has been educated in and understands the post-operative regimen, which should include willingness to comply with ALL the following components:

o Nutrition program, which may include a very low calorie diet or a recognized

commercial diet-based weight loss program; AND

o Behavior modification or behavioral health interventions; AND

o Counseling and instruction on exercise and increased physical activity; AND

o Ongoing support for lifestyle changes to make and maintain appropriate choices that will reduce health risk factors and improve overall health; AND

Patient has completed an evaluation by a master’s level or higher behavioral healthcare provider acting within the scope of their licensure under applicable state law, within the 12 months preceding the request for surgery.

o Adult evaluation should document:

1. The absence of significant psychopathology that would hinder the ability of an individual to understand the procedure and comply with medical/surgical recommendations, AND

2. The absence of any psychological comorbidity that could contribute to weight mismanagement or a diagnosed eating disorder, AND

3. The patient’s willingness to comply with preoperative and postoperative treatment plans.

o Adolescent evaluation should document all requirements for the adult evaluation as well as documentation of consideration given to:

1. Psychosocial evaluation (e.g. supportive family unit), and

2. Adequate developmental maturity, and

3. Assent to the procedure.

Contraindications for surgical treatment of obesity include:

Patients with mental handicaps that render a patient unable to understand the rules of eating and exercise and therefore make them unable to participate effectively in the post-operative treatment program (e.g., a patient with malignant hyperphagia [Prader-Willi syndrome], which combines mental retardation/intellectual disability with an uncontrollable desire for food).

Patients with portal hypertension, an excessive hazard with laparoscopic gastric surgery.

Women who are pregnant or lactating.

Patients with serious medical illness in whom caloric restriction could exacerbate the illness.

Bariatric Surgery in Adolescents

Bariatric surgery in adolescent members may be considered eligible for benefit coverage according to the same weight based criteria used for adults.

NOTE 2: Forms of bariatric surgery performed without specific implantable devices (i.e., Roux-en-Y anastomosis or Sleeve gastrectomy) are surgical procedures and, as such, are not subject to regulation by the U.S. Food and Drug Administration (FDA). In addition, any devices used for bariatric surgery must be used in accordance with the FDA-approved indications.

Bariatric Surgery in Preadolescent Children

Bariatric surgery is considered experimental, investigational and/or unproven for the treatment of morbid obesity in preadolescent children.

Bariatric Surgery in Patients with a BMI less than 35 kg/m2

Bariatric surgery is considered experimental, investigational and/or unproven for patients with a BMI less than 35 kg/m2.

* Guidelines on how to calculate BMI:

BMI can be calculated using pounds and inches with this equation:

BMI = [Weight (lbs) ÷ Height (in2)] x 703

BMI can also be calculated using kilograms and meters:

BMI = Weight (Kg) ÷ Height (m2)

To convert pounds to kilograms, multiply pounds by 0.45.

To convert inches to centimeters, multiply inches by 2.54.

To convert feet to meters multiple feet by 0.30.

COVERAGE STATEMENTS FOR SPECIFIC BARIATRIC SURGICAL PROCEDURES (Gastric Restrictive and Gastric Malabsorptive)

NOTE 3: For a member to be eligible for benefit coverage of any one of these procedures the member must meet the Patient Selection Criteria described above AND the member’s contract or certificate of coverage must allow coverage of bariatric surgery.

Gastric bypass using a Roux-en-Y anastomosis (up to and including 150 cm) may be considered medically necessary as an open or laparoscopic surgical treatment option for patients with morbid obesity who meet the eligibility criteria for surgery.

Adjustable gastric banding (open or laparoscopic), consisting of an external adjustable band placed high around the stomach creating a small pouch and a small stoma, may be considered medically necessary as a surgical treatment option for patients with morbid obesity who meet the eligibility criteria for surgery.

NOTE 4: If the original adjustable gastric banding procedure was a covered benefit, it is not necessary to request documentation for refill and maintenance procedures.

Sleeve gastrectomy (open or laparoscopic) may be considered medically necessary as a surgical treatment option for patients with morbid obesity who meet the eligibility criteria for surgery.

Biliopancreatic bypass (Scopinaro procedure) WITH duodenal switch (open or laparoscopic) may be considered medically necessary as a surgical treatment option for morbidly obese patients with BMI of 50 kg/m² or greater who meet the other eligibility criteria for surgery.

Gastric bypass, as a primary procedure, using a Roux-en-Y anastomosis, adjustable gastric banding, sleeve gastrectomy or biliopancreatic bypass (Scopinaro procedure) with duodenal switch are considered experimental, investigational and/or unproven for the treatment of any condition other than morbid obesity, including but not limited to metabolic syndrome, gastroesophageal reflux disease and sleep apnea. (See NOTE 5 below)

NOTE 5: See Miscellaneous Procedure Coverage Statements section under Complications for information on reoperation for intractable gastroesophageal reflux disease following sleeve gastrectomy.

The following procedures are considered not medically necessary as a treatment of morbid obesity:

Vertical banded gastroplasty is no longer standard of care.

Biliopancreatic bypass with duodenal switch as a treatment for patients with a BMI less than 50kg/m².

The following bariatric procedures are considered experimental, investigational and/or unproven as a treatment of morbid obesity, include, but are not limited to:

Gastric bypass using a Billroth II type of anastomosis (mini-gastric bypass),

Biliopancreatic bypass without duodenal switch,

Single anastomosis duodenoileal bypass with sleeve gastrectomy (SADI-S),

Long-limb gastric bypass procedure (i.e., >150 cm),

Two-stage bariatric surgery procedures (e.g., sleeve gastrectomy as initial procedure followed by biliopancreatic diversion at a later time) (see NOTE 6 below regarding staged procedures),

Laparoscopic gastric plication,

AspireAssist® device (aspiration therapy device),

Embolization of gastric arteries as a treatment of obesity,

Endoscopic bariatric procedures, either as a primary procedure or as a revision procedure (i.e., to treat weight gain after bariatric surgery to remedy large gastric stoma or large gastric pouches). This includes, but is not limited to:

o Insertion of the StomaphyX™ device,

o Natural Orifice Transluminal Endoscopic Surgery (NOTESTM),

o Transoral ROSE procedure (Restorative Obesity Surgery),

o Sclerotherapy of the stoma,

o Insertion of a gastric balloon,

o Endoscopic gastroplasty, or

o Use of an endoscopically placed duodenojejunal sleeve.

NOTE 6: A bariatric procedure that has to be aborted (i.e., no bariatric procedure is completed), but is then performed at a later date, is not considered a staged procedure. The patient must meet benefit coverage, contractual eligibility and coverage criteria at the time the bariatric procedure is completed.

MISCELLANEOUS PROCEDURE COVERAGE STATEMENTS

NOTE 7: Check member’s contract for benefit coverage and/or exclusions for bariatric surgery and complications related to bariatric surgery.

Complications

Reoperation related to previous bariatric surgery may be considered medically necessary for complications such as stricture, obstruction, or erosion except when the members benefit plan excludes coverage of such complications.

Removal of an adjustable gastric band may be considered medically necessary for complications not resolved by band deflation, including but not limited to obstruction, erosion, aspiration pneumonia, GERD, night cough, Barrett’s esophagus, persistent vomiting, or persistent pain except when the members benefit plan excludes coverage of such complications.

Reoperation for intractable gastroesophageal reflux disease using Roux-en-Y anastomosis following a sleeve gastrectomy may be considered medically necessary for patients who have objective historical documentation of diagnosed (e.g. upper endoscopy, 24-hour outpatient pH monitoring and Esophageal manometry) symptomatic gastroesophageal reflux disease that has either failed to respond to 6 months of medical therapy with proton pump inhibitors (PPIs) or the patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity.

Repeat/Revisions

Repeat/Revision of bariatric surgery: may be considered medically necessary only when specifically included as a benefit or covered service in the member’s benefit plan, summary plan description or contract AND when ALL of the following criteria are met:

o Technical surgical failure (e.g., dilatation of gastric pouch, gastrojejunal stoma, or gastrojejunostomy anastomosis; port leakage; or band slippage), has occurred that can only be addressed surgically, when the primary procedure was successful in inducing weight loss prior to the technical surgical failure (See NOTE 8 below), and the member has been compliant with a prescribed nutrition and exercise program; AND

o The patient is requesting reinstitution of an acceptable bariatric surgical modality.

NOTE 8: Successful weight-loss is defined as weight loss equal to or greater than 50 percent of excess body weight.

New bariatric surgery following a previous different bariatric procedure: A Roux-en-Y procedure following a previously approved vertical banded gastroplasty or laparoscopic adjustable banded gastroplasty is not eligible for coverage for patients who have been substantially noncompliant with a prescribed nutrition and exercise program following the original procedure or when the member’s benefit plan does not allow for coverage.

NOTE 9: When the initial bariatric surgical information is not available, medical information concerning the member’s weight from other healthcare providers may be considered.

Procedures Performed Simultaneously with Bariatric Surgery

Gallbladder removal during a bariatric surgery: may be considered medically necessary at the time of a covered gastric bypass surgical procedure, either for documented gallbladder disease or for prophylaxis.

Repair of a hiatal hernia at the time of bariatric surgery may be considered medically necessary for patients who have objective, historical documentation of a preoperatively-diagnosed (e.g. 24-hour outpatient pH monitoring and Esophageal manometry) symptomatic hiatal hernia that has either failed to respond to 6 months of medical therapy with proton pump inhibitors (PPIs) or the patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity.

Repair of a hiatal hernia at the time of bariatric surgery that is diagnosed at the time of bariatric surgery, or repair of a preoperatively diagnosed hiatal hernia in patients who do not have indications for surgical repair, is considered not medically necessary.

Liver biopsy at the time of bariatric surgery may be considered medically necessary for patients who have signs or symptoms of liver disease (e.g., history and physical, biochemical, and serological findings).

Description:

Bariatric surgery is performed for the treatment of morbid (clinically severe) obesity. Morbid obesity is defined as a body mass index (BMI) greater than 40 kg/m2 or a BMI greater than 35 kg/m2 with associated complications including, but not limited to, diabetes, hypertension, or obstructive sleep apnea. Morbid obesity results in a very high risk for weight-related complications, such as diabetes, hypertension, obstructive sleep apnea, and various types of cancers (for men: colon, rectum, prostate; for women: breast, uterus, ovaries), and a shortened life span. A morbidly obese man at age 20 can expect to live 13 fewer years than his counterpart with a normal BMI, which equates to a 22% reduction in life expectancy.

The first treatment of morbid obesity is dietary and lifestyle changes. Although this strategy may be effective in some patients, only a few morbidly obese individuals can reduce and control weight through diet and exercise. Most patients find it difficult to comply with these lifestyle modifications on a long-term basis.

When conservative measures fail, some patients may consider surgical approaches. A 1991 National Institutes of Health Consensus Conference defined surgical candidates as “those patients with a BMI of greater than 40 kg/m2, or greater than 35 kg/m2 in conjunction with severe comorbidities such as cardiopulmonary complications or severe diabetes.” (1)

Resolution (cure) or improvement of type 2 diabetes (T2D) after bariatric surgery and observations that glycemic control may improve immediately after surgery, before a significant amount of weight is lost, have promoted interest in a surgical approach to treatment of T2D. The various surgical procedures have different effects, and gastrointestinal rearrangement seems to confer additional antidiabetic benefits independent of weight loss and caloric restriction. The precise mechanisms are not clear, and multiple mechanisms may be involved. Gastrointestinal peptides, e.g., glucagon-like peptide-1 (1GLP-1), glucose-dependent insulinotropic peptide (GIP), and peptide YY (PYY), are secreted in response to contact with unabsorbed nutrients and by vagally mediated parasympathetic neural mechanisms. GLP-1 is secreted by the L cells of the distal ileum in response to ingested nutrients and acts on pancreatic islets to augment glucose-dependent insulin secretion. It also slows gastric emptying, which delays digestion, blunts postprandial glycemia, and acts on the central nervous system to induce satiety and decrease food intake. Other effects may improve insulin sensitivity. GIP acts on pancreatic beta cells to increase insulin secretion through the same mechanisms as GLP-1, although it is less potent. PYY is also secreted by the L cells of the distal intestine and increases satiety and delays gastric emptying.

Tanner Stages

The Tanner Staging or scale may be used to classify progression of puberty in children and adolescents. Stages of physical development/maturity are based on sex characteristics, for example – the development of genitalia in boys and the development of breasts in girls as well as pubic hair growth in both. Below the characteristic of each Tanner stage are described (136-137).

Tanner Stages

Pubic Hair for both Male and Female

Female

Male

1

Pre-adolescent; no pubic hair.

Pre-adolescent; elevation of the papilla only.

Pre-adolescent; Testes, scrotum and penis about the same size and proportion as in early childhood.

2

Sparse growth of long, slightly pigmented, downy hair appearing at the base of the penis or along the labia.

Breast bud stage; elevation of breast and papilla. Enlargement of the diameter of the areola.

The scrotum and testes have enlarged. The scrotal skin has some reddening and change in texture.

3

Considerably darker, coarser, and more curled. Hair spreads sparsely over the junction of the pubes.

Further enlargement of breast and areola. No separation of their contours.

Growth of the penis first mainly in length; further growth of testes and scrotum.

4

Hair is adult in type, area of coverage is smaller than most adults. No spread to the medial surface of the thighs.

Areola and papilla form a secondary mound above the level of the breast.

Further enlargement in length and breadth of the penis with development of glans. Further enlargement of testes and scrotum. Darkening of the scrotal skin.

5

Adult in quantity and type; distributed in an inverse triangle. Spread to the medial surface of the thighs.

Mature stage: projection of papilla only, recession of the areola to the general contour of the breast.

Genitalia adult in size and shape.

Types of Bariatric Surgery Procedures

The following summarizes the different types of bariatric surgery procedures.

Vertical-Banded Gastroplasty

Vertical-banded gastroplasty (VBG) was formerly one of the most common gastric restrictive procedures performed in the United States, but has now been replaced by other restrictive procedures due to high rates of revisions and reoperations. 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 uncommon. Complications include esophageal reflux, dilation, or obstruction of the stoma, with the latter 2 requiring reoperation. Dilation of the stoma is a common reason for weight regain. VGB may be performed using an open or laparoscopic approach.

Adjustable Gastric Banding

Adjustable gastric banding involves placing a gastric band around the exterior of the stomach. The band is attached to a reservoir implanted subcutaneously in the rectus sheath. Injecting the reservoir with saline will alter 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. Adjustable gastric banding has been widely used in Europe. Two banding devices are approved by the U. S. Food and Drug Administration (FDA) for marketing in the United States. The first to receive FDA approval was the LAP-BAND (original applicant, Allergan, BioEnterics, Carpinteria, CA; now Apollo Endosurgery, Austin, TX). The labeled indications for this device are as follows:

"The LAP-BAND® system is indicated for use in weight reduction for severely obese patients with a body mass index (BMI) of at least 40 or a BMI of at least 35 with one or more severe comorbid conditions, or those who are 100 lb or more over their estimated ideal weight according to the 1983 Metropolitan Life Insurance Tables (use the midpoint for medium frame). It is 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. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives."

In 2011, FDA-labelled indications for the LAP-BAND were expanded to include patients with a BMI from 30 to 34 kg/m2 with at least 1 obesity-related comorbid condition.

The second adjustable gastric banding device approved by FDA through the premarket approval process is the REALIZE® model (Ethicon Endo-Surgery, Cincinnati, OH). Labeled indications for this device are:

“This [REALIZE] device is indicated for weight reduction for morbidly obese patients and is indicated for individuals with a Body Mass Index of at least 40 kg/m2, or a BMI of at least 35 kg/m2 with one or more comorbid conditions. The Band is indicated for use only in morbidly obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise, and behavior modification programs.”

Open Gastric Bypass

The original gastric bypass surgeries were based on the observation that postgastrectomy patients tended to lose weight. The current procedure involves both a restrictive and a malabsorptive component, with horizontal or vertical partition of the stomach performed 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.” Surgical complications include leakage and operative margin ulceration at the anastomotic site. Because the normal flow of food is disrupted, there are more metabolic complications than with other gastric restrictive procedures, including iron deficiency anemia, vitamin B12 deficiency, and hypocalcemia, 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.

Laparoscopic Gastric Bypass

Introduced in 2005, laparoscopic gastric bypass is the laparoscopic version of the open gastric bypass described above.

Mini-Gastric Bypass

Recently, a variant of the gastric bypass, called the mini-gastric bypass, has been popularized. 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. This unique aspect of this procedure is not based on its laparoscopic approach but rather the type of anastomosis used.

Sleeve Gastrectomy

A sleeve gastrectomy is an alternative approach to gastrectomy that can be performed on its own or in combination with malabsorptive procedures (most commonly biliopancreatic diversion [BPD] 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) seen with distal gastrectomy. This procedure is relatively simple to perform and can be done as an open or laparoscopic procedure. Some surgeons have proposed the sleeve gastrectomy as the first in a 2-stage procedure for very high risk patients. Weight loss following sleeve gastrectomy may improve a patient’s overall medical status and, thus, reduce the risk of a subsequent more extensive malabsorptive procedure (e.g., biliopancreatic diversion).

Endoluminal Bariatric Procedures

With endoluminal bariatric (also called endosurgical, endoscopic, or natural orifice) procedures, access to the relevant anatomic structures is gained through the mouth without skin incisions. Primary and revision bariatric procedures are being developed to reduce risks associated with open and laparoscopic interventions. Examples of endoluminal bariatric procedures studies include gastroplasty using a transoral endoscopically guided stapler and placement of devices such as a duodenojejunal sleeve and gastric balloon.

Biliopancreatic Bypass Diversion Procedure

The biliopancreatic bypass diversion (BPD) procedure (also known as the Scopinaro procedure), developed and used extensively in Italy, was designed to address drawbacks of the original intestinal bypass procedures that have been abandoned due to unacceptable metabolic complications. Many complications were thought to be related to bacterial overgrowth and toxin production in the blind, bypassed segment. In contrast, BPD 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. A distal gastrectomy induces a temporary early satiety and/or the dumping syndrome in the early postoperative period, both of which limit food intake.

b. A 200-cm long “alimentary tract” consists of 200 cm of ileum connecting the stomach to a common distal segment.

c. A 300- to 400-cm “biliary tract” connects the duodenum, jejunum, and remaining ileum to the common distal segment.

d. A 50- to 100-cm “common tract” is 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, i.e., creating a selective malabsorption. The length of the common segment will influence the degree of malabsorption.

e. Because of the high incidence of cholelithiasis associated with the procedure, patients typically undergo an associated cholecystectomy.

Many potential metabolic complications are related to BPD, including, most prominently, iron deficiency anemia, protein malnutrition, hypocalcemia, and bone demineralization. Protein malnutrition may require treatment with total parenteral nutrition. In addition, several case reports have noted liver failure resulting in death or liver transplant.

Biliopancreatic Bypass Diversion With Duodenal Switch

The duodenal switch procedure was introduced in 2005. The duodenal switch procedure is a variant of the BPD previously described. In this procedure, instead of performing a distal gastrectomy, a sleeve gastrectomy is performed along the vertical axis of the stomach. This approach preserves the pylorus and initial segment of the duodenum, which is then anastomosed to a segment of the ileum, similar to the BPD, 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 also decreases the volume of the stomach and decreases the parietal cell mass. However, the basic principle of the procedure is similar to that of the BPD, i.e., producing selective malabsorption by limiting the food digestion and absorption to a short common ileal segment. A new procedure, the single-anastomosis duodenoileal bypass with sleeve gastrectomy (SADI-S) is a simplified duodenal switch. (64)

Long-Limb Gastric Bypass (i.e., >150 cm)

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 (e.g., resection or stapling along the horizontal or vertical axis). Unlike the traditional gastric bypass, which is 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.

Laparoscopic Malabsorptive Procedure

This describes any of the malabsorptive/restrictive procedures done by laparoscopy.

Laparoscopic Gastric Plication

Laparoscopic gastric plication is a bariatric surgery procedure that involves laparoscopic placement of sutures over the greater curvature (laparoscopic greater curvature plication) or anterior gastric region (laparoscopic anterior curvature plication) to create a tube-like stomach. The procedure involves 2 main steps mobilization of the greater curvature of the stomach and suture plication of the stomach for achieving gastric restriction but technique specifics are not standardized.

Intragastric Balloon Devices

Intragastric balloon (IGB) devices are placed in the stomach using an endoscope or swallowing to act as space-occupying devices to induce satiety. As of 2015, 2 gastric balloon devices have FDA approval; both are designed to stay in the stomach for no more than 6 months. The ReShape Duo is a saline- inflated dual-balloon system and the OBERA Intragastric Balloon System (previously marketed outside of the United States as BioEnterics) is a saline-inflated silicone balloon.

Aspiration Therapy Device

Aspiration therapy involves an FDA-approved device (AspireAssist) that allows patients to drain a portion of the stomach contents after meals via an implanted tube connected to an external skin port.

Embolization of Gastric Arteries as a Treatment of Obesity

Bariatric arterial embolization (BAE), has been shown to modify body weight in animal models. The intent of BAE is to disrupt the arterial supply to the gastric fundus to reduce serum ghrelin levels; which stimulate appetite. Gastric artery embolization has recently been proposed as a minimally invasive intervention in the bariatric setting.

Regulatory Status

Forms of bariatric surgery performed without specific implantable devices are surgical procedures and, as such, are not subject to regulation by the FDA.

Table 1 includes examples of bariatric surgery with implantable devices approved by the FDA through the premarket approval process.

Table 1: FDA-Approved Bariatric Surgery Devices

Device

Manufacturer

PMA Date

Labeled Indications

AspireAssist

System®

Aspire Bariatrics

June 2016

For long-term use in conjunction with lifestyle therapy and continuous medical monitoring in obese adults >22 y, with a BMI of 35.0 to 55.0 kg/m2 and no contraindications to the procedure who have failed to achieve and maintain weight loss with nonsurgical weight loss therapy

ORBERA® intragastric balloon system

Apollo Endosurgery

Aug 2015

For use in obese adults (BMI, 30-40 kg/m2) who have failed weight reduction with diet and exercise, and have no contraindications. Maximum placement time is 6 mo. Balloon placed endoscopically and inflated with saline.

ReShape® Integrated Dual Balloon System

ReShape Medical

Jul 2015

For use in obese adults (BMI, 30-40 kg/m2) and ≥1 comorbid conditions who have failed weight reduction with diet and exercise, and have no contraindications. Maximum placement time is 6 mo. Balloon delivered transorally and inflated with saline.

REALIZE® Adjustable Gastric Band

Ethicon Endosurgery

Nov 2007

For use in weight reduction for morbidly obese patients and for individuals with BMI of at least 40 kg/m2, or a BMI of at least 35 kg/m2 with ≥1 comorbid conditions, or those who are ≥45.4 kg over their

estimated ideal weight. Indicated for use only in morbidly obese adults who have failed more conservative weight-reduction alternatives (e.g., supervised diet, exercise, behavior modification programs).

LAP-BAND® Adjustable Gastric Banding System

Apollo Endosurgery (original applicant: Allergan)

Apr 2010

For use in weight reduction for severely obese adults with BMI of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with ≥1 severe comorbid conditions who have failed more conservative weight-reduction alternatives (e.g., supervised diet, exercise, behavior modification programs).

BMI: body mass index: FDA: Food and Drug Administration; PMA: premarket approval.

In February 2017, the FDA issued a letter to health care providers discussing the potential risks with liquid-filled intragastric balloons in response to reports of 2 types of adverse events related to the balloons. Several dozen reports concerned spontaneous overinflation of the balloons, which caused pain, swelling, and vomiting. The second set of adverse event reports indicated that acute pancreatitis developed in several patients due to compression of gastrointestinal structures. These reports involved both ReShape and ORBERA brands. The adverse events may require premature removal of the balloons.

In August 2017, the FDA issued a second letter to health care providers informing them of 5 unanticipated deaths occurring from 2016 through the time of the letter, due to intragastric balloons. The FDA recommended close monitoring of patients receiving these devices.

Rationale:

Patient Selection Criteria for Coverage

A requirement that a candidate for bariatric surgery complete a formal, medically supervised weight loss programs of specified duration has been a fixture of Health Care Service Corporation (HCSC) bariatric surgery medical policy for some time. The rationale for this requirement was founded on review and interpretation of available evidence in the scientific medical literature, primarily national consensus guidelines. However, HCSC has decided to modify this requirement based on a current review of the bariatric surgery scientific literature related to required pre-surgery weight loss programs, and including consideration of input from bariatric surgeons and their professional societies. The HCSC policy will no longer require documentation that a morbidly obese member must have completed a pre-surgery weight loss program of specified duration as one of the criteria for benefit coverage of bariatric surgery. This change does not mean, however, that HCSC no longer believes that successful bariatric surgery requires multi-disciplinary support from the member's bariatric surgery program and a life-long commitment to life-style changes.

Considerations for Bariatric Surgery in Adolescents

Guidelines for bariatric surgery in adolescents are not uniform, with variability in weight-based criteria, ranging from a BMI of 35 kg/m2 with comorbidities to a BMI of 50 kg/m2. Most guidelines use weight-based criteria that parallel those for adults.

In addition to the weight-based criteria, there is greater emphasis on issues of developmental maturity, psychosocial status, and informed consent for adolescent patients. All guidelines mention these issues, but recommendations are not uniform for addressing them.

The choice of procedure in adolescents may also differ from adults, but there is a lack consensus in guidelines or expert opinion as to the preferred procedure(s) for adolescents. The following factors should be considered in the choice of bariatric surgery in adolescents (130):

As in adults, laparoscopic gastric bypass is the most common procedure in adolescents.

Devices used for laparoscopic adjustable gastric banding do not have FDA-approval in the United States for individuals younger than age 18 years.

Some guidelines for bariatric surgery in adolescents do not recommend biliopancreatic diversions because of the greater frequency of nutritional deficiencies on long-term follow-up, but other guidelines do not specify that biliopancreatic diversion not be done in adolescents.

Weight Loss Outcomes

There is no uniform standard for reporting results of weight loss or for describing a successful procedure. Common methods of reporting the amount of body weight loss are percent of ideal body weight achieved or percent of excess body weight (EBW) loss, with the latter most commonly reported. These 2 methods are generally preferred over the absolute amount of weight loss, because they reflect the ultimate goal of surgery: to reduce weight into a range that minimizes obesity-related morbidity. Obviously, 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 EBW is lost, or when the patient returns to within 30% of ideal body weight. The results may also be expressed as the percentage of patients losing at least 50% of EBW. Table 2 summarizes the variation in reporting weight loss outcomes.

Table 2. Weight Loss Outcomes

Outcome Measure

Definition

Clinical Significance

Decrease in weight

Absolute difference in weight pre- and post-treatment

Unclear relationship to outcomes, especially in morbidly obese

Decrease in body mass index (BMI)

Absolute difference in BMI pre- and post-treatment

May be clinically significant if change in BMI clearly leads to change in risk category

Percent of excess weight loss

Amount of weight loss divided by excess body weight

Has anchor to help frame clinical significance; unclear threshold for clinical significance

Percent patients losing >50% of EBW

No. pts. losing >50% EBW divided by total patients

Additional advantage of framing on per patient basis. Threshold for significance (>50%) arbitrary

Percent ideal body weight

Final weight divided by ideal body weight

Has anchor to help frame clinical significance; unclear threshold for clinical significance

BMI: body mass index; EBW: excess body weight

Durability of Weight Loss

Weight change (i.e., 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 to 5 years is considered an intermediate time period for evaluating weight loss; and weight loss at 5 to 10 years or more is considered to represent long-term weight loss following bariatric surgery.

Short-Term Complications (Operative and Perioperative Complications <30 Days)

In general, the incidence of operative and perioperative complications is increased in obese patients, particularly in thromboembolism and wound healing. Other perioperative complications include anastomotic leaks, bleeding, bowel obstruction, and cardiopulmonary complications (e.g., pneumonia, 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 (VBG) due to pouch dilation.

Long-Term Complications (Metabolic Adverse Effects, Nutritional Deficiencies)

Metabolic adverse effects 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 surgeries.

Improved Health Outcomes in Terms of Weight-Related Comorbidities

Aside from psychosocial concerns, which may be considerable, one motivation for bariatric surgery is to decrease the incidence of complications of obesity, such as diabetes, cardiovascular risk factors (i.e., increased cholesterol, hypertension), obstructive sleep apnea, or arthritis. Unfortunately, these final health outcomes are not consistently reported.

Overview: Bariatric Surgery in Adults with Morbid Obesity

There is a vast literature on bariatric surgery for adults with morbid obesity. This literature is characterized by a preponderance of single-arm clinical series from individual institutions. These types of studies can be used to determine the amount of weight loss expected from surgery, the durability of the weight loss, and the rate of adverse events. However, these studies are not adequate for determining the comparative efficacy of bariatric surgery versus conservative treatment, or the comparative efficacy of different bariatric surgery techniques. Some comparative trials, including randomized and nonrandomized designs, compare bariatric surgery with conservative therapy and/or compare outcomes of different bariatric surgery procedures. The emphasis for this medical policy will be on comparative trials of bariatric surgery and nonsurgical therapy or of different types of bariatric surgery procedures.

Randomized controlled trials (RCTs) of bariatric surgery have been performed but are limited and insufficient to draw conclusions about comparisons of bariatric surgery and conservative treatments for weight loss. (2) RCTs are difficult in bariatric surgery because many experts consider it inappropriate or unethical to randomize patients to bariatric surgery. Also, most patients and clinicians have strong feelings about their preferences for treatment, which result in a select population that might agree to randomization and, therefore, limited generalizability. As a result, the literature that is most important in determining the efficacy of bariatric surgery is from nonrandomized studies.

Swedish Obese Subjects Trial

The Swedish Obese Subjects (SOS) trial is the most influential study of bariatric surgery versus conservative treatment. The SOS trial started in 1987 with a registry containing a detailed questionnaire and clinical data on obese patients with a body mass index (BMI) greater than 34 kg/m2 at 480 primary health care centers in Sweden. From this registry, patients who met eligibility criteria were recruited and offered bariatric surgery. Thus, SOS patients self-selected into treatment, and there were baseline differences between groups, primarily reflecting more excess weight and a higher incidence of comorbidities in the surgery group. A total of 2010 people chose surgery and 2037 people chose conservative care. Each surgical patient was matched on 18 clinical variables with a patient from the registry who received nonsurgical treatment (usual care). Each surgeon chose the surgical procedure offered. Most procedures were vertical-banded gastroplasty (VBG; >70%), with gastric bypass (6%) and gastric banding (23%) procedures performed as well. Usual care in the SOS trial was the local practice of the primary care center and usually did not include pharmacologic treatment. Patients were followed at regular intervals with repeat questionnaires and physical examinations for at least 10 years.

Many publications from this trial have reported on methods, weight loss, and clinical outcomes. (3-7) The following general conclusions can be drawn from the SOS study:

Weight loss was greater with bariatric surgery than with conservative treatment. At 10 years of follow-up, weight loss in the surgery group was 16% of total body weight compared with a weight gain of 1.6% in the conservative treatment group.

There was definite improvement in glucose control for diabetics and reduced incidence of new cases of diabetes.

The effect on other cardiovascular risk factors (e.g., hypertension, lipidemia) was also positive, but less marked than that seen for diabetes.

Mortality was reduced by 29% after a mean follow-up of 10.9 years.

Quality of life improved in the 2- to 10-year follow-up period, with the degree of improvement in quality of life correlated with the amount of weight loss.

Longitudinal Assessment of Bariatric Surgery Consortium

The Longitudinal Assessment of Bariatric Surgery (LABS) Consortium study is a large prospective, longitudinal, noncomparative study of patients who underwent Roux-en-Y gastric bypass (RYGB) or laparoscopic adjustable gastric banding (LAGB) with follow-up through 3 years postprocedure. (8) The study enrolled 2458 subjects, with median a BMI 45.9 kg/m2 (interquartile range [IQR], 41.7-51.5 kg/m2). For their first bariatric surgical procedure, 1738 participants underwent RYGB, 610 LAGB, and 110 other procedures. At 3-year follow-up, for 1533 Roux-en-Y patients with available data, percentage of baseline weight lost was 31.5% (IQR, 24.6%-38.4%). For the 439 adjustable gastric banding (AGB) patients with available data at 3 years, percentage of baseline weight loss was 15.9% (IQR, 7.9%-23.0%). At 3 years postsurgery, 67.5% and 28.5% of RYGB and AGB patients, respectively, had at least partial diabetes remission. Dyslipidemia was in remission in 61.9% and 27.1% of RYGB and AGB patients, respectively. Subsequent bariatric procedures (revision or reversal) were required in 0.3% (95% confidence interval [CI], 0.1% to 0.9%) of the RYGB patients and in 17.5% (95% CI, 13.8% to 21.9%) of LAGB patients.

Systematic Reviews

Numerous systematic reviews have assessed the efficacy of bariatric surgery compared with conservative therapy, some of which are older and do not include the full range of available studies. (9, 10)

In 2014, Colquitt et al. updated 2003 and 2009 Cochrane reviews of bariatric surgery for obesity. (11) They identified 22 randomized trials that compared bariatric surgery with nonsurgical obesity management or that compared different bariatric surgery procedures, with 1798 participants (sample size range, 15-250 participants). All 7 RCTs comparing surgery with nonsurgical interventions found benefits of surgery on measures of weight change at 1- to 2-year follow-ups. However, reviewers noted that adverse event rates and reoperation rates were poorly reported across trials, and long-term follow-up (beyond 1-2 years) was limited.

Gloy et al. (2013) conducted a systematic review and meta-analysis of RCTs comparing current bariatric surgery techniques with nonsurgical treatment for patients with BMI of 30 kg/m2 or more. (12) Eleven studies (total N=796 patients) were included. Overall, patients after bariatric surgery lost more body weight than patients after nonsurgical treatment (mean difference [MD], -26 kg; 95% CI, -31 to -21 kg; p<0.001). Remission of type 2 diabetes (T2D) was more likely for bariatric surgery patients than for nonsurgical patients (relative risk [RR] of remission with T2D, 22.1; 95% CI, 3.2 to 154.3; p<0.000); similarly, remission of metabolic syndrome was more likely for bariatric surgery patients (RR=2.4; 95% CI, 1.6 to 3.6; p<0.001). After bariatric surgery, 21 (8%) of 261 patients required reoperations (5/124 after AGB, 4/69 after RYGB, 1/49 after sleeve gastrectomy [SG], 1/19 after biliopancreatic diversion [BPD]). Similar to the Colquitt meta-analysis, no studies reported longer term follow-up (>2 years) and heterogeneity between studies was high.

Chang et al. (2014) published a systematic review and meta-analysis of RCTs and observational studies to evaluate the effectiveness and risks of bariatric surgery. (13) Reviewers included 164 studies (37 RCTs, 127 observational studies), with a total of 161,756 patients. Mean presurgery BMI was 45.62 kg/m2 and, among the studies that provided information about obesity-related comorbidities, 26.2% of patients had T2D, 47.39% had hypertension, 27.97% had dyslipidemia, 7.15% had cardiovascular disease, and 25.30% had obstructive sleep apnea (OSA). Perioperative complications were relatively low, with a perioperative mortality rate in RCTs of 0.08% (95% CI, 0.01% to 0.24%) and in observational studies of 0.22% (95% CI, 0.14% to 0.31%). Complication rates were 17% (95% CI, 11% to 23%) for RCTs, and 10% for observational studies (95% CI, 7% to 13%). At 1-year follow-up, mean change in BMI was -13.53 kg/m2 (95% CI, -15.51 to -11.55 kg/m2) in RCTs and -11.79 kg/m2 (95% CI, -13.89 to -9.69 kg/m2) in observational studies. Decreases in BMI were generally sustained over 2 to 4 years of follow-up among studies reporting this outcome.

Many systematic reviews have reported improvements in specific obesity-related comorbidities following bariatric surgery. These reviews have relied primarily on the results of observational studies and included the outcomes of hypertension, T2D, hyperlipidemia, cardiovascular events, quality of life, cancer, knee pain, and liver disease. (14-29)

Puzziferri et al. (2014) conducted a systematic review of studies of bariatric surgery reporting follow-up beyond 2 years, which included 29 studies (total N=7971 patients). (30) At follow-up, which ranged from 2 to 5 years postprocedure, the mean sample size?weighted percentage of excess weight loss (EWL) was higher for gastric bypass (65.7%) than for gastric banding (45.0%). Reviewers noted that few studies reported sufficient long-term results to minimize bias.

Section Summary: Bariatric Surgery in Adults with Morbid Obesity

There is a lack of large-scale RCTs with long-term follow-up comparing bariatric surgery with nonsurgical treatment for the general population of patients with morbid obesity. Evidence from nonrandomized comparative studies and case series and from meta-analyses of existing RCTs has consistently reported that bariatric surgery results in substantially greater weight loss than nonsurgical therapy. Data from the largest comparative study (the SOS study) has reported that bariatric surgery is associated with improvements in mortality, diabetes, cardiovascular risk factors, and quality of life.

Evidence for Specific Types of Bariatric Surgery Procedures

Gastric Bypass

The body of literature on improved weight loss has been instrumental in establishing gastric bypass as the reference procedure to which other procedures are compared. Practice patterns in the United States have indicated surgeons have adopted this approach, with gastric bypass now comprising most of the bariatric procedures performed.

Comparative trials summarized in the 2003 Blue Cross Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) Assessment (31) consistently reported favorable outcomes for open gastric bypass compared with VBG, including 2 RCTs. Some nonrandomized trials that compared open gastric bypass with procedures other than VBG were also summarized in the BCBSA 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 than in those receiving a VBG. Anemia, iron deficiency, vitamin B12 deficiency, and red blood cell folate-deficiency were commonly seen. Marginal ulcerations were also seen in gastric bypasses, particularly in those whose gastric pouches were too large and included acid-secreting parietal cells.

A 2005 BCBSA TEC Assessment focused on laparoscopic gastric bypass, which intends to reproduce the open procedure via minimally invasive techniques. (32) This technically complex surgery requires a dedicated team and a relatively high degree of skill and experience in laparoscopic technique. This Assessment reviewed 7 comparative trials of open gastric bypass and laparoscopic gastric bypass, including 3 RCTs. In addition, 18 large clinical series of laparoscopic gastric bypass were included.

The 2005 BCBSA TEC Assessment concluded that weight loss at 1 year was similar for laparoscopic and open gastric bypass approaches. (32) Longer follow-up periods were less well-reported but appeared to be similar for both approaches. While comparisons of complication rates were less certain, some patterns were evident and consistent across the data examined. The profile of adverse events differed between the 2 approaches, with each having advantages and disadvantages. Laparoscopic gastric bypass offered a less invasive procedure associated with decreased hospital stay and earlier return to usual activities. Mortality might be lower with the laparoscopic approach, although both procedures had mortality rates less than 1%. Postoperative wound infections and incisional hernias were also less frequent with laparoscopic gastric bypass. On the other hand, anastomotic problems, gastrointestinal tract bleeding, and bowel obstruction appeared to be higher with the laparoscopic approach, though not markedly higher. Given these data, the overall benefit-risk profile for these 2 approaches appeared to be similar.

In 2016, Yan et al. published a systematic review of RCTs comparing gastric bypass and medical treatment in obese patients (i.e., BMI ≥30 kg/m2) with T2D. (33) The primary study outcome was remission of T2D, which was reported in 5 of the 6 studies. A pooled analysis found a significantly higher remission rate after gastric bypass than after medical treatment (odds ratio [OR], 76.37; 95% CI, 20.70 to 271.73; p<0.001). In addition, a pooled analysis found a significantly lower final BMI in the gastric bypass group than in the medical treatment group (MD = -6.54 kg/m2; 95% CI, -9.28 to -3.80 kg/m2; p<0.001).

Section Summary: Gastric Bypass

Gastric bypass has been extensively studied. BCBSA TEC Assessments and other systematic reviews found that gastric bypass improved health outcomes, including weight loss and remission of T2D. A BCBSA TEC Assessment also found similar weight loss with open and laparoscopic gastric bypass.

Laparoscopic Adjustable Gastric Banding (LAGB)

A 2006 BCBSA TEC Assessment updated the evidence on LAGB, and compared outcomes with gastric bypass. (34) This Assessment concluded that, for patients considering bariatric surgery, there was sufficient evidence to allow an informed choice between gastric bypass and LAGB. An informed patient might reasonably choose open gastric bypass or LAGB as the preferred procedure. Preoperative counseling should include education on the comparative risks and benefits (e.g., extent of weight loss and frequency and timing of potential complications) of the 2 procedures to optimize choice based on preferences and shared decision making.

Weight loss outcomes from the studies reviewed in the Assessment confirmed that weight loss at 1 year was lower for LAGB than for open gastric bypass. The percentage of EWL at 1 year was approximately 40%, compared with 60% or higher for open gastric bypass. At time points beyond 1 year, some comparative studies have reported that the difference in weight loss between LAGB and open gastric bypass narrows, but other studies did not. Weight loss outcomes from the 9 single-arm series with the most complete follow-up did not support the hypothesis that the difference in weight loss shrinks after 1 to 2 years of follow-up. It appears more likely from the current data that attrition bias might have accounted for the diminution of the difference in weight loss over time, particularly when patients with bands removed or deflated were excluded from analysis.

These studies also confirmed that short-term (perioperative) complications are very low with LAGB. Death was extremely rare, and serious perioperative complications probably occurred at rates less than 1%.

The reported rates of long-term adverse events vary considerably. In the comparative trials, reoperations were reported in approximately 25% of patients, while, in the single-arm studies, the composite rate for reoperations were approximately 50% lower (11.9%). The rates of other long-term complications were also highly variable; e.g., the range of rates for band slippage was 1% to 36%, and the range for port access problems was 2% to 20%. These data on long-term complications remain suboptimal. The reporting of long-term complications in these trials was not systematic or consistent. While impossible to determine the precise rates of long-term complications from these data, it is likely that complications have been underreported in many studies due to incomplete follow-up and lack of systematic surveillance. The rates of long-term complications reported in some studies also raise concern about the impact of these events on the overall benefit-risk profile for LAGB.

In comparing LAGB with open gastric bypass, there are tradeoffs in terms of risks and benefits. LAGB is a less-invasive procedure associated with fewer procedural complications, decreased hospital stay, and earlier return to usual activities. However, benefits defined by the amount of weight lost are lower for LAGB. The patterns of long-term complications also differ between the 2 procedures. For LAGB, longer term adverse events related to the presence of a foreign body in the abdomen will occur and will result in reoperations 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.

A 2012 systematic review by Chakravarty et al. (35) comparing LAGB with other bariatric surgery procedures had a conclusion similar to the 2006 BCBSA TEC Assessment. Reviewers included 5 RCTs. The RCTs found that patients using LAGB lost weight, but less weight than with other procedures (e.g., gastric bypass or sleeve gastrectomy [SG]). However, the short-term complication rate was lower with LAGB and no difference was found in quality of life after LAGB versus other procedures.

Section Summary: Laparoscopic Adjustable Gastric Banding

Systematic reviews of the literature have concluded that evidence suggests LAGB is a reasonable alternative to gastric bypass; there is less weight loss with LAGB, which is less invasive and is associated with fewer serious adverse events.

Sleeve Gastrectomy (SG)

Systematic Reviews

SG may be performed as a stand-alone procedure or in combination with a malabsorptive procedure, such as the BPD with duodenal switch (BPD-DS). It has also been proposed as the first step in a 2-stage procedure, with gastric bypass or BPD as the second stage.

A 2016 systematic review by Juodeikis and Brimas summarized evidence on long-term results after SG. (36) Reviewers included 1 RCT and 19 retrospective studies, with a total of 2713 patients who received SG. Mean preoperative BMI was 46.9 kg/m2. Mean duration of follow-up ranged from 5 to 11 years and mean proportion of patients followed for 5 years was 68.5%. Seventeen studies (n=1501 patients) reported 5-year follow-up data; mean percent EWL was 58.4%. At 5 years, resolution of T2D was observed in 77.8% of patients who had SG; arterial hypertension, dyslipidemia, OSA, gastroesophageal reflux disease (GERD), and degenerative joint diseases also improved in most patients. Two studies reported weight loss after 7 and 8 years; percent EWL rates were 56.6% and 54.8%, respectively.

In 2009, Brethauer et al. reviewed 36 studies (total N=2570 patients) for a systematic review of SG as a staged and primary procedure, the largest trials coming from European centers. (37) Two RCTs, 1 nonrandomized, matched cohort analysis, and 33 case series were examined. Thirteen studies (n=821 patients) reported on high-risk patients having a staged approach and 24 studies (n=1749 patients) on SG as primary procedure. Mean percentage of EWL, reported in 24 studies (n=1662 patients), was 55.4% overall (range, 33%-85%). Mean postoperative BMI, reported in 26 studies (n=1940 patients), decreased from a baseline of 51.2 to 37.1 kg/m2. Other studies reported weight loss in terms of BMI decrease, percentage of BMI lost, or percentage of total weight lost; all had significant reductions from baseline. Follow-up ranged from 3 to 60 months. Ten studies included detailed postoperative comorbidity data (n=754 patients); more than 70% of patients had improved control or remission of T2D, and significant reductions were seen in hypertension and hyperlipidemia, OSA, and joint pain. Rates of major postoperative complications ranged from 0% to 23.8% for all studies and from 0% to 15.3% in studies with more than 100 patients. Leaks (2.2%), bleeding episodes requiring reoperation (1.2%), and postoperative strictures requiring endoscopic or surgical intervention (0.6%) were reported in the 33 studies (n=2570 patients). All extracted studies reported mortality data, with 5 deaths within 30 days of surgery (overall mortality rate, 0.19%; 2 in the high-risk/staged group, 3 in the primary procedure group).

In a 2015 meta-analysis of 21 randomized and nonrandomized studies (total N=18,766 patients) comparing SG with LRYGB for morbid obesity, Zhang et al. reported no significant difference in percent EWL from 0.5- to 1.5-year follow-ups. (38) However, after 1.5 years, Roux-en-Y bypass was associated with higher percent EWL (2-year MD=5.77; 95% CI, 4.29 to 7.25; p<0.05). Adverse events were more frequent following Roux-en-Y bypass (odds ratio [OR] for major complication, 1.29; 95% CI, 1.22 to 3.22; p<0.01).

In 2013, Trastulli et al. conducted a systematic review of 15 RCTs (total N=1191 patients) that compared SG with other bariatric procedures. (39) Reviewers reported mean complication rates with SG of 12.1% (range, 10%-13.2%) compared with 20.9% with LAGB (range, 10%-26.4%). Percent EWL ranged from 49% to 81% with SG and from 62.1% to 94.4% with LAGB.

Randomized Controlled Trials

Himpens et al. (2006) reported on a randomized trial comparing LAGB and laparoscopic isolated SG in 80 patients and reported 3 year follow-up. (40) Median baseline BMI was 37 kg/m2 (range, 30-47 kg/m2) in the LAGB group and 39 kg/m2 (range, 30-53 kg/m2) in the SG group. Outcomes of weight loss, feeling of hunger, sweet-eating, GERD, complications, and reoperations were recorded at 1- and 3-year follow-ups. Median decrease in BMI in the gastric bypass group was 15.5 kg/m2 (range, 5-39 kg/m2) after 1 year and 18 kg/m2 (range, 0-39 kg/m2) at 3 years after LAGB. One year after SG, decrease in BMI was 25 kg/m2 (range, 0-45 kg/m2) and 27.5 kg/m2 (range, 0-48 kg/m2) after 3 years. Median EWL in the LAGB group was 41.4% after 1 year and 48% at 3 years. Median EWL after SG was 58% and 66% at 1 and 3 years, respectively. More patients having SG than LAGB reported loss of craving for sweets, but the difference was not statistically significant; GERD appeared de novo in more SG than LAGB patients at 1 year, and the relation reversed at 3 years; between-group differences were not statistically significant at either time point. Two SG patients required reoperation for complications. Seven late complications required reoperation after LAGB, including pouch dilations treated by band removal (n=2) or conversion to RYGB (n=1), 1 gastric erosion treated by conversion to RYGB, and 3 system disconnections that required reconnection. Four patients had reoperations for lack of efficacy (2 LAGB patients underwent conversion to RYGB, 2 SG patients underwent conversion to duodenal switch). The authors noted that the number of reoperations was significant in both groups and that the severity of complications was greater in the SG group.

Karamanakos et al. (2008) carried out a double-blind RCT to compare outcomes of laparoscopic RYGB and laparoscopic sleeve gastrectomy (LSG) on body weight, appetite, fasting, and postprandial ghrelin and peptide-YY (PYY) levels at 1, 3, 6, and 12 months after surgery. (41) Thirty-two patients were randomized, half to each procedure. Decrease in body weight and BMI were marked and comparable in each group. EWL was greater after LSG than laparoscopic RYGB at 6 months (55.5% vs 50.2%; p=0.04) and 12 months (69.7% vs 60.5%; p=0.05), all respectively. Fasting PYY levels increased after both surgical procedures. Appetite decreased in both groups but decreased more after LSG.

An RCT comparing short-term outcomes of LSG with gastric bypass was published in 2012. (42) Trialists compared 30-day outcomes for 117 patients randomized to gastric bypass and 121 patients randomized to LSG. The rate of major complications (no deaths in either group) was 9.4% in the gastric bypass group compared to 5.8% in the LSG group (p=0.29). Minor complications were more common in the gastric bypass group than in the LSG group (17.1% vs 7.4%, p=0.02), as were combined major and minor complications (26.5% vs 13.2%, p=0.01).

Section Summary: Sleeve Gastrectomy

Systematic reviews of RCTs and observational studies have found that SG results in substantial weight loss and that this weight loss is durable for at least 5 years. A meta-analysis found that short-term weight loss was similar after SG or gastric bypass. Long-term weight loss was greater after gastric bypass, but SG is associated with fewer adverse events.

Biliopancreatic Bypass Diversion with Duodenal Switch (BPD With DS)

BPD may be performed with or without the duodenal switch procedure. In the duodenal switch procedure (BPD-DS), an SG is performed, preserving the pyloric sphincter. Preservation of the pyloric sphincter is intended to ameliorate the dumping syndrome and to decrease the incidence of ulcers at the duodenoileal anastomosis by providing a more physiologic transfer of stomach contents to the duodenum.

In a 2009 evidence-based review of literature, Farrell et al. summarized data on BPD with or without duodenal switch, RYGB (proximal), and AGB, and reported that at a mean 1-year follow-up, EWL for BPD with or without duodenal switch (outcomes with and without duodenal switch not reported separately) was 72% (4 studies; n=896 patients), 67% for RYGB (7 studies; n=1627 patients), and 42% for AGB (11 studies; n=4456 patients). (43) At mean follow-up of 5 years, EWL for BPD with or without duodenal switch was 73% (3 studies; n=174 patients), 58% for RYGB (3 studies; n=176 patients), and 55% for AGB (5 studies; n=640 patients). Reviewers noted that “given the marked paucity of prospectively collected comparative data among the different bariatric operations, it remains impossible to make definitive recommendations for 1 procedure over another.”

Prachand et al. (2006) published the largest comparative study of 350 super-obese patients with BMI greater than 22.7 kg (50 lb) who underwent RYGB (n=152) or Scopinaro BPD combined with the DeMeester duodenal switch (BPD-DS) (n=198). (44) In this retrospective study, the decision for surgery was made by the surgeon and/or patient. The BPD-DS patients differed from RYGB patients on weight and BMI; mean weight in pounds was 167 kg (368.2 lb; range, 267.4-596.5 lb) in BPD-DS patients and 157 kg (346.3 lb; range, 239.8-504.9 lb) in the RYGB group, and mean BMI was 26.7 kg/m2 (58.8 lb; range, 50- 96 lb) in BPD-DS patients versus 25.6 kg/m2 56.4 lb; range, 49.5-84.2 lb) in the RYGB group. At 1 year, data were reported for 143 BPD-DS patients and 81 RYGB patients. EWL was greater for BPD (64.1%) versus RYGB (55.9%; p<0.01), and the reduction in BMI was also greater for BPD (10.7 kg/m2 [23.6 lb]) versus RYGB (8.8 kg/m2 [19.4 lb]; p<0.001). Complications and data on resolution of comorbidities were not reported in this study. Strain et al. (2007) published a smaller comparative study of 72 patients who underwent RYGB (n=50) or BPD (n=22). Choice of surgery was by the surgeon and/or patient, and the patient populations differed by age and time since surgery. Weight loss at 1 year was greater for BPD, with a reduction in BMI of 10.6 kg/m2 (23.3 lb) for BPD compared with 7.5 kg/m2 (16.5 lb) for RYGB (p<0.001). (45)

The largest case series of this procedure is by Marceau et al. (2009), who reported their 15-year experience with duodenal switch in 1423 patients from 1992 to 2005. (46) Follow-up evaluations were available for 97% of patients. Survival rate was 92%. After a mean of 7 years (range, 2-15 years), 92% of patients with an initial BMI of 50 kg/m2 or less obtained a BMI of less than 35 kg/m2, and 83% of patients with BMI greater than 50 kg/m2 achieved a BMI of less than 40 kg/m2. Diabetes medication was discontinued in 92% and decreased in others. Use of continuous positive airway pressure was discontinued in 92% of patients, and the prevalence of cardiac risk index greater than 5 decreased by 86%. Operative mortality was 1%, the revision rate was 0.7%, and the reversal rate was 0.2%. Revision for failure to lose sufficient weight was needed in only 1.5% of patients. Severe anemia, vitamin deficiency, or bone damage were preventable or easily treated and without documented permanent damage.

Section Summary: BPD with Duodenal Switch

Nonrandomized comparative studies have found significantly higher weight loss after BPB-DS compared with gastric bypass at 1 year. A large case series found sustained weight loss after 7 years.

BPD Without Duodenal Switch

The available evidence on BPD-DS was reviewed in the 2006 BCBSA TEC Assessment, and BPD outcomes, with or without DS, were compared with those of gastric bypass. (34) One comparative trial and 7 single-arm series suggested that weight loss outcomes at 1 year were in the same range as for gastric bypass. While these data were not sufficient to distinguish small differences in weight loss between the 2 procedures, they did not support the hypothesis that BPD resulted in greater weight loss than open gastric bypass.

Complication rates have been poorly reported in these trials. The data have suggested that mortality is low (≈1%) and in the same range as for open gastric bypass. However, rates of other complications, especially long-term complications, cannot be determined from these data. Limited data have suggested that long-term nutritional and vitamin deficiencies occur at a high rate following BPB. Slater et al. (2004) focused specifically on vitamin and calcium deficiencies following BPB. (47) They reported high rates of vitamin and calcium abnormalities in their population over a 4-year period. By year 4, 48% of patients had 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 et al. (2004) reported similar data in a study that compared several technical variations of BPB. (48) They reported low calcium levels in 12% to 34% of patients, low vitamin D in 22.2% to 70.6%, low vitamin A in 53% to 67%, and low vitamin K in 44% to 59%. In addition, this study reported high rates of iron deficiency (11%-47%) and anemia (11%-40%).

Skroubis et al. (2006) randomized 130 patients with a BMI of 35 to 50 kg/m2 to RYGB or BPB without duodenal switch using a variant of BPB that included Roux-en-Y gastrectomy in place of SG. (49) All patients were followed for at least 2 years. Weight loss outcomes were superior for the BPD group at every interval examined up to 2 years. EWL at 1 year was 73.7% for RYGB and 83.1% for BPD (p<0.001); at 3 years, EWL was 72.6% for RYGB and 83.1% for BPD (p<0.001). There were more early complications in the RYGB group, but this difference was not statistically significant (6 complications vs 1, respectively; p=0.12). Late complications also did not differ significantly between the RYGB group (16 complications) and BPD groups (22 complications; p=0.46).

Numerous clinical series of BPD have been published but high-quality trials directly comparing outcomes of this procedure with gastric bypass are lacking. The largest experience with BPD (total N=1217 patients) was reported by Scopinaro et al. (1996), who developed the procedure. (50) With follow-up of up to 9 years, the authors reported a durable EWL of 75%, suggesting that weight loss is greater with this procedure than with gastric restrictive procedures. In addition, most patients reported disappearance or improvement of complications such as OSA, hypertension, hypercholesteremia, and diabetes. The authors considered protein malnutrition the most serious metabolic complication, occurring in almost 12% of patients and responsible for 3 deaths. This complication could require inpatient treatment with total parenteral nutrition. To address protein malnutrition, 4% of patients underwent reoperation to elongate the common limb (thus increasing protein absorption) or to have the operation reversed, restoring normal intestinal continuity. The authors also found that protein malnutrition was strongly related to ethnicity and, presumably, patient eating habits, with an increased incidence among those from southern Italy where the diet contains more starch and carbohydrates than the north. Peripheral neuropathy may occur in the early postoperative period due to excessive food limitation but may be effectively treated with large doses of thiamine. Bone demineralization, due to decreased calcium absorption, was seen in about 33% of patients during the first 4 postoperative years. All patients were encouraged to maintain an oral calcium intake of 2 g/d, with monthly vitamin D supplementation.

Section Summary: BPD Without Duodenal Switch

A BCBSA TEC Assessment reviewed the available observational studies and concluded that weight loss was similar after BPD without duodenal switch and gastric bypass. However, BPD without duodenal switch leads to complications, especially long-term nutritional and vitamin deficiencies.

Vertical-Banded Gastroplasty

VBG is a purely restrictive procedure that has been replaced by LAGB or SG. Weight loss with VBG is substantial, but there are high rates of revisions and reoperations due to staple line disruption, perforation, band erosion or disruption, and stenosis at the band site. Overall rates of revisions and reoperations at up to 10 years may be as high as 50%. (51, 52)

A small body of literature has compared outcomes between VBG and open gastric bypass. The most rigorous of these comparative trials, the Adelaide Study (1990), randomized 310 morbidly obese patients to gastric bypass, VBG, or horizontal gastroplasty. (53) The percentage of patients with greater than 50% EWL at 3-year follow-up was 67% for gastric bypass, 48% for VBG, and 17% for horizontal gastroplasty (p<0.001). There were no demonstrable differences in adverse events across groups. A second, smaller RCT by Sugerman et al. (1987) randomized 40 patients to receive a VBG or a gastric bypass procedure. (54) After 9 months, the gastric bypass patients had significantly greater weight loss that persisted at 3-year follow-up. The gastric bypass patients lost approximately 64% of excess weight, whereas the gastroplasty patients lost 37% of excess weight.

A number of other nonrandomized, comparative studies of open gastric bypass versus VBG were included in the 2003 BCBSA TEC Assessment (N=8 studies, total N=3470 patients). (31) All 8 studies reported greater amounts of weight loss with open gastric bypass. These studies reported a 44% to 70% improvement in total weight loss, a 28% to 43% improvement in the percent EWL, and 19% to 36% more patients with more than 50% EWL for those undergoing gastric bypass compared with VBG. Comparison of adverse events was difficult, because the data did not permit rigorous assessment. Nevertheless, the data suggested that the mortality rate for both surgeries was low overall. Serious perioperative adverse events were also infrequently reported, but somewhat higher for gastric bypass. Long-term adverse events were inconsistently reported, although it appeared that revision rates were higher for VBG.

Relatively high rates of complications, revisions, and reoperations led to the abandonment of VBG as a bariatric surgery procedure in the United States. An example of these results is a large case series with long-term follow-up by MacLean et al. (1990), who reported on 201 patients undergoing VBG followed for a minimum of 2 years. (55) Staple line perforation occurred in 48% of patients, and 36% underwent reoperation either to repair the perforation or to repair a stenosis at the rate-limiting orifice. However, the more than 50% of patients who maintained an intact staple line had durable weight loss of 75% to 100% of excess weight.

In 2014, Hseih et al. conducted a systematic review of studies reporting greater than 10-year follow-up for VBG, which included 3 studies with extractable data. (56) Mean EWL was 61.4% from baseline to follow-up in the 3 studies, but reviewers noted a lack of long-term evidence related to outcomes following VBG.

Section Summary: Vertical-Banded Gastroplasty

A BCBSA TEC Assessment identified 8 nonrandomized comparative studies evaluating VBG and these studies found that weight loss was significantly greater with open gastric bypass. However, VBG has relatively high rates of complications, revisions, and reoperations.

Two-Stage Bariatric Surgery Procedures

Bariatric surgeries performed in 2 stages have been proposed as a treatment option, particularly for patients with “super-obesity” defined as a BMI greater than 50 kg/m2. The rationale for a 2-stage procedure is that the risk of an extensive surgery is prohibitive in patients who are extremely obese. Therefore, procedure with low risk (usually an SG) is performed first. After the patient loses some weight, thus lowering the surgical risk, a second more extensive procedure (e.g., BPD) is performed.

The evidence on 2-stage procedures consists of case series of patients undergoing SG as the initial procedure. Many of these case series do not report on the second-stage surgery and, in those that do, only a minority of patients undergoing first-stage surgery proceed to second-stage surgery. For example, Cottam et al. (2006) reported on 126 patients with a mean BMI of 65 kg/m2 who underwent LSG as the first portion of a planned 2-stage procedure. (57) The incidence of major perioperative complications for LSG was 13%. After 1 year, mean EWL was 46%. Thirty-six (29%) patients proceeded to the second-stage procedure, which was laparoscopic gastric bypass. The incidence of major complications following the second procedure was 8%. In a similar study, Alexandrou et al. (2012) reported on 41 patients who underwent SG as the first-stage of a planned 2-stage procedure. (58) After 1-year follow-up, 12 (29%) patients achieved a BMI of less than 35 kg/m2 and were ineligible for the second-stage procedure. Of the remaining 28 patients, 10 (24%) underwent the second-stage procedure. The remaining 18 (44%) patients were eligible for, but had not undergone, the second-stage procedure at the last follow-up.

Patients who undergo 2-stage procedures are at risk for complications from both procedures. Silecchia et al. (2009) described the complication rates in 87 patients who underwent a stage I SG followed by BPD in 27 patients. (59) For the first stage, 16.5% of patients had complications of bleeding, fistula, pulmonary embolism, acute renal failure, and abdominal abscess. For the 27 patients who underwent the second-stage BPD, 29.6% had major complications, including bleeding, duodenoileal stenosis, and rhabdomyolysis.

This evidence does not indicate whether a 2-stage bariatric surgery procedure improves outcomes for patients with extreme levels of obesity. There is no evidence to suggest that weight loss is improved or that complications are reduced by this approach. Most patients who receive SG as the initial procedure lose sufficient weight during the first year that a second procedure is no longer indicated. In addition, patients undergoing a 2-stage procedure are at risk for complications from both procedures; therefore, it is likely that overall complications are increased by this approach.

Section Summary: Two-Stage Bariatric Surgery Procedures

There is a lack of evidence indicating whether 2-stage bariatric procedures improve outcomes compared with 1-stage procedures. Case series have shown a relatively high complication rates in 2-stage procedures, and patients are at risk of complications in both stages.

Laparoscopic Gastric Plication

In 2014, Ji et al. reported a systematic review of 14 studies reporting outcomes after laparoscopic gastric plication. (60) Reviewers included 1 nonrandomized matched cohort analysis, 10 uncontrolled case series, and 3 case reports (total N=1450 patients). The nonrandomized cohort study was small (N=19). The largest study, by Talebpour et al. (2012), included 800 patients enrolled over 12 years at a single institution where the technique was developed. (61) Only 3 studies identified included more than 100 patients. The longest follow-up was to 120 months in the Talebpour study; other studies that provided follow-up reported to 24 months (2 studies), 18 months (2 studies), or 12 months (9 studies). Mean preoperative BMI ranged from 31.2 to 44.5 kg/m2. Mean percent EWL after the procedure was reported in 9 studies (n=1407 patients), and ranged from 31.8% to 74.4% at follow-up times ranging from 6 to 24 months. One study reported weight loss in terms of percent decrease in BMI, with a reported decrease at 6 and 12 months of 66.4% and 60.2%, respectively. One study compared anterior plication and greater curvature plication, and reported increased weight loss with greater curvature plication (percent EWL, 53.7% vs 23.3%, respectively). Reporting of complications was heterogeneous across studies, but no deaths were reported and the rate of major postoperative complications requiring reoperation ranged from 0% to 15.4% (average, 3.7%), most commonly due to gastric obstruction or gastric preformation. Surgical techniques were not standardized. Reviewers concluded that laparoscopic gastric plication was a promising treatment for obesity, but available evidence was limited by small study size, lack of randomized trials comparing the technique with established bariatric surgery techniques, and little medium- to long-term follow-up data.

In a 2012 systematic review, Abdelbaki et al. summarized outcomes from 7 studies of laparoscopic gastric plication, 2 of which enrolled more than 100 patients (total N=307 patients). (62) At 6-month follow-up, EWL ranged from 28.4% to 54% for the 5 studies reporting weight loss outcomes. All studies reported some incidence of nausea and vomiting, most of which was mild. Twenty (6.5%) patients were readmitted, of whom 14 (4.6%) patients required reoperation, most commonly for gastric obstruction (8/14 [57%]).

In 2013, Pattanshetti et al. published results of a study that described the evolution of a LAGB plication procedure, a hybrid procedure involving both AGB and greater curvature plication developed by the authors. (63) Eighty patients were included, with a baseline mean BMI of 38.05 kg/m2. At 6, 12, 18, and 24 months postsurgery, mean percent EWL was 42.6%, 56.4%, 57.6%, and 65.8%, respectively. Five postoperative complications required reoperation.

Section Summary: Laparoscopic Gastric Plication

There is a shortage of comparative studies, especially RCTs, comparing the safety and efficacy of laparoscopic gastric plication to other bariatric surgery procedures. A 2014 systematic review identified only 1 small comparative study, which was not randomized.

Single Anastomosis Duodenoileal Bypass With Sleeve Gastrectomy (SG)

No controlled trials of single anastomosis duodenoileal bypass with SG were identified. Some case series have reported on weight loss and other clinical outcomes up to 5 years postsurgery. One larger series was published in 2015 and reported on 97 patients with obesity and T2D. (64) The authors reported that control of diabetes, defined as a hemoglobin A1c (HbA1c) levels less than 6.0%, was achieved by between 70% and 84% of patients at different time points. Remission rates were higher for patients on oral therapy than those on insulin, and were higher in patients with a shorter duration of diabetes.

Section Summary: Single Anastomosis Duodenoileal Bypass With SG

No published controlled trials have evaluated single anastomosis duodenoileal bypass with SG. There are a few case series, the largest of which had fewer than 100 patients.

Duodenojejunal Sleeve

The EndoBarrier (GI Dynamics, Lexington, MA) is a fluoropolymer sleeve that is reversibly fixated to the duodenal bulb and extends 80 cm into the small bowel, usually terminating in the proximal jejunum. A systematic review of the effect of EndoBarrier on weight loss and diabetes control outcomes was published in 2016. (65) It included 5 small RCTs (total N=235 patients; range, 18-77 patients), with follow-up ranging from 12 to 24 weeks. Comparators were diet and/or other lifestyle modifications, and 2 studies had sham controls. All studies were judged to be at high risk of bias using the Cochrane risk of bias tool. Combined results demonstrated that the EndoBarrier group had 12.6% greater EWL (95% CI, 9.0% to 16.2%) than medical therapy. For diabetes control outcomes, trends toward greater improvement in the EndoBarrier group were not statistically significant. Mean difference in HbA1c level was -0.8% (95% CI, - 1.8% to 0.3%) and the relative risk of reducing or discontinuing diabetic medications was 3.28 (95% CI, 0.54 to 10.73).

The largest single trial was a multicenter RCT published in 2014; it included 77 patients with a BMI greater than 30 kg/m2 and T2D. (66) Patients were treated for 6 months with EndoBarrier or medical therapy. At 6 months, the EndoBarrier was removed and patients were followed for an additional 6 months. Thirty-eight patients were randomized to the EndoBarrier group and 31 (82%) of 38 completed 12 months of treatment. Thirty-nine patients were randomized to medical treatment and 35 (90%) of 39 completed 12 months of treatment. At 6 months, the decrease in BMI was significantly greater in the EndoBarrier group than in the medical therapy group (3.3 kg/m2 vs 1.8 kg/m2, p<0.05), and at 12 months the difference in BMI was of marginal statistical significance (2.2 kg/m2 vs 1.3 kg/m2, p=0.06), respectively. HbA1c level was significantly lower in the EndoBarrier group at 6 months (7.0% vs 7.9%, p<0.05), but at 12 months the difference between groups did not differ significantly (7.3% vs 8.0%, p=0.95).

Section Summary: Duodenojejunal Sleeve

A systematic review of evidence on a duodenojejunal sleeve included 5 RCTs and found significantly greater short-term weight loss (12-24 weeks) with duodenojejunal sleeves compared with medical therapy. There was no significant difference in symptom reduction associated with diabetes. All RCTs had small sample sizes and were judged by the systematic reviewers to be at high risk of bias.

Intragastric Balloon Devices (IGB)

Systematic Reviews

Several systematic reviews of RCTs evaluating IGB devices for the treatment of obesity have been published; none was limited to FDA-approved devices. (67-69) Most recently, in 2017, Saber et al. identified 20 RCTs reporting weight loss outcomes after IGB implantation or a non-IGB control intervention. (67) IGB was compared with sham in 15 trials, behavioral modification in 4 trials, and pharmacotherapy in 1 trial. In 17 trials, patients received lifestyle therapy in addition to other interventions. Studies were published between 1987 and 2015 and sample sizes varied from 21 to 326 participants. Outcomes were reported between 3 and 6 months. In a meta-analysis of 7 RCTs reporting BMI loss as an outcome, there was a significantly greater BMI loss in the IGB group compared with the control group (mean effect size [ES], 1.59 kg/m2; 95% CI, -0.84 to 4.03 kg/m2; p<0.001). Findings on other outcomes were similar. A meta-analysis of 4 studies reporting percent EWL favored the IGB group (ES=14.25%; 95% CI, 2.09% to 26.4%; p=0.02). In addition, a meta-analysis of 6 studies reporting absolute weight loss favored the IGB group (ES=4.6 kg; 95% CI, 1.6 to 7.6 kg; p=0.003).

Although the review was not limited to FDA-approved devices, older devices were air-filled and newer devices, including the 2 approved by FDA in 2015, are fluid-filled. Sufficient data were available to conduct a sensitivity analysis of 3 month efficacy data. A meta-analysis of 4 studies did not find a significant difference in weight loss with air-filled IGB devices or a control intervention at 3 months (ES= 0.26; 95% CI, -0.12 to 0.64; p=0.19). In contrast, a meta-analysis of 8 studies of fluid-filled devices found significantly better outcomes with the IGB than with control (ES=0.25; 95% CI, 0.05 to 045; p=0.02).

Randomized Controlled Trials

Pivotal trials on both FDA-approved devices have been published. In 2015, Ponce et al. published a multicenter sham-controlled double-blinded trial evaluating the ReShape Duo intragastric balloon. (70) A total of 326 patients were randomized to 6 months of treatment with an IGB plus lifestyle therapy (n=187) or a sham device plus lifestyle therapy (n=126). Patients in the control group were given the option of active IGB treatment at 6 months. Key eligibility criteria were age 21 to 60 years, baseline BMI between 30 and 40 kg/m2, 1 or more obesity-related comorbidities, and failure to lose sufficient weight in the past 36 months in a medically supervised weight loss program. A total of 176 IGB and 126 control patients (90% of the randomized population) completed the initial 6-month treatment and were included in the primary end point analysis. After 6 months, 77 patients in the control group opted to receive an IGB; these patients were also included in the IGB safety analysis.

Coprimary effectiveness outcomes, assessed at 6 months, were mean percent EWL and having at least 35% of patients in the IGB group achieving at least a 25% EWL. Both primary effectiveness outcomes were met. In the intention-to-treat (ITT) analysis, the mean percent EWL at 6 months was 25.1 in the IGB group and 11.3 in the control group (p=0.004). The proportion of patients who achieved at least a 25% EWL was 48.8%, with a lower confidence bound of 41.6%. Most adverse events were anticipated accommodative symptoms (e.g., nausea, vomiting, abdominal pain), which generally resolved after 3 to 7 days; they were severe in 1% to 2% of patients and were successfully treated. Most device-related serious adverse events (75% [21/28]) were emergency department visits for treatment of accommodate symptoms. There were no deaths, intestinal obstructions, gastric perforations, or device migrations.

In 2017, Courcoulas et al. published a multicenter, pivotal RCT evaluating the Obera IGB in the United States (as noted, the device has been used in other countries). (71) A total of 317 patients were randomized and initiated 6 months of treatment with an IGB plus lifestyle therapy (n=137) or lifestyle therapy only (n=136). Patients were followed for an additional 6 months. Key eligibility criteria were age 18 to 65 years, baseline BMI between 30 and 40 kg/m2, a history of obesity for at least 2 years, and having failed previous weight loss attempts. Nineteen patients in the IGB group and 121 in the control group completed the 6-month treatment period.

Coprimary effectiveness outcomes, assessed at 9 months, were mean percent EWL and difference in mean weight loss. Mean percent EWL at 9 months was 26.4% in the IGB group and 10.1% in the control group (difference, 16.2%; 95% CI, 12.3% to 20.2%; p<0.001). Mean weight loss at 9 months was -8.8 kg (-19.4 lb) in the IGB group and -3.2 kg (-7.1 lb) in the control group (p<0.001). There were also significant between-group differences in mean weight loss and mean percent EWL at 6 and 12 months.

As in the trial on the Reshape Duo device, most adverse events in the Obera pivotal trial were anticipated accommodative symptoms. A total of 139 (87%) patients reported nausea, 121 (76%) reported vomiting, and 92 (58%) reported abdominal pain. Fewer than 5% of these adverse events were serious; most were mild or moderate. Thirty patients in the device group had the IGB removed before month 6 because of an adverse event (n=15) or patient request (n=15). There were no deaths and 9 serious adverse events unrelated to device accommodation; among others, they included 1 case of gastric outlet obstruction and 1 case of gastric perforation with sepsis.

The Courcoulas et al. pivotal trial was not blinded or sham-controlled; however, a double-blind sham-controlled RCT evaluating the BioEnterics gastric balloon (previous called the Obera device) was published by Genco et al. in 2006. (72) This crossover trial included 32 obese patients ages 25 to 50 years with a mean BMI of 47.3 kg/m2. Patients received, in random order, 3 months of an IGB and 3 months of sham. (Both groups underwent upper gastrointestinal endoscopy, but no device was placed in the sham group.) Patients who initially received the IGB had a mean BMI reduction of 5.8 kg/m2 after 3 months; after crossover to sham, they had a mean additional BMI reduction of 1.1 kg/m2. Patients initially in the sham group had an initial mean BMI reduction of 0.4 kg/m2; after crossover to an active device, they had a mean BMI reduction of 5.1 kg/m2. The between-group difference in BMI reductions was statistically significant (p<0.001). Findings on other outcomes (mean percent EWL, mean weight loss) were similar.

Case Series

A case series of patients treated with an IGB with up to 60-month follow-up was published by Kotzampassi et al. in 2012. (73) A total of 500 patients were treated with the BioEnterics IGB. Twenty-six patients did not complete the initial 6 months of treatment and another 77 patients did not comply with dietary restrictions and did not have satisfactory weight loss at 6 months. Among 352 patients with data available, BMI was 44.5 kg/m2 at baseline, 35.7 kg/m2 at device removal, 38.8 kg/m2 12 months after device removal, and 40.1 kg/m2 24 months after device removal. Mean percent EWL was 43.9% at device removal, 27.7% 12 months after device removal, and 17% 24 months after device removal. Among the 195 patients with available 5-year data, mean baseline BMI was 43.3 kg/m2, mean BMI at device removal was 33.8 kg/m2, and mean BMI at 5 years was 40.1 kg/m2. Mean percent EWL at 5 years was 13.0%. Overall, patients who initially complied with 6 months of IGB device use and lost weight, slowly gained weight over time but weighed less at final follow-up than at baseline.

Section Summary: Intragastric Balloon Devices

There are RCTs on the 2 FDA-approved devices, a case series with long-term follow-up on 1 of these devices, and systematic reviews on various IGB devices. RCTs have found significantly better weight loss outcomes with IGB devices compared with sham treatment or lifestyle therapy alone. There are some adverse events, mainly related to accommodation of the balloon in the stomach; in a minority of cases, these adverse events can be severe. One RCT followed patients for an additional 6 months after IGB removal and found sustained weight loss. A large case series with follow-up up to 5 years has suggested that patients regain weight over time. Additional long-term follow-up data are needed.

Aspiration Therapy Device

One RCT has been published. The trial, by Thompson et al. (2016), randomized 207 participants to 52 weeks of AspireAssist therapy plus lifestyle counseling (n=127) or lifestyle counseling alone (n=70). (74) Participants were between 21 and 65 years of age, with a BMI ranging from 35 to 55 kg/m2. Coprimary outcomes were mean EWL at 52 weeks and the proportion of patients with 25% or more EWL at 52 weeks. Investigators did a modified ITT analysis including all patients in the AspireAssist group who attempted tube placement (n=111) and all patients in the lifestyle counseling group who attended at least 1 therapy session (n=60). Mean EWL at 52 weeks was 31.5% in the AspireAssist group and 9.8% in the lifestyle counseling group. The difference between groups was 21.7% (95% CI, 15.3% to 28.1%), which was greater than the 10% difference needed to meet the a priori definition of success. The proportion of patients with 25% or more EWL at 52 weeks was 58.6% in the AspireAssist group and 22% in the lifestyle counseling group (p<0.001). Bulimia or binge eating disorder were exclusion criteria and, during the study, there was no evidence that patients developed bulimia or that devices were overused (i.e., used >3 times a day). Most of the adverse events (≈90%) in the AspireAssist group were associated with placement of a percutaneous endoscopic gastric tube. All 5 serious adverse events occurred in the AspireAssist group (mild peritonitis, severe abdominal pain and 1 case of product malfunction). Durability of a treatment effect beyond 1 year was not reported.

In addition to the RCT, a 2016 case series by Noren and Forssell evaluated AspireAssist use by 25 obese patients. (75) Patients had 1 year of aspiration therapy and also participated in a cognitive-behavioral therapy weight loss program for the initial 3 months. Patients were instructed to aspirate 3 times a day after meals. Twenty (80%) patients completed the 1-year intervention period. Mean baseline weight was 107.4 kg. In a per protocol analysis, the mean EWL was 54.5% at 12 months. Data on 15 (60%) patients were available at 24 months; mean EWL was 61.5%.

Section Summary: Aspiration Therapy Device

The evidence consists of 1 RCT with 1-year follow-up and a small case series with up to 2 years of follow-up. The RCT found significantly greater weight loss (measured several ways) with aspiration therapy compared with lifestyle therapy at 1 year. The case series followed only 15 patients more than 1 year; at 2 years, study completers had not regained weight and instead had lost additional excess weight. The total amount of data on aspiration therapy remains limited and additional studies need to be conducted before conclusions can be drawn about the long-term effects of treatment on weight loss, metabolism, and nutrition.

Embolization of Gastric Arteries as a Treatment of Obesity

Shoar et al. (2016) performed a systematic review to evaluate the existing data in the literature for bariatric gastric artery manipulation to highlight the importance of this potential concept as a therapeutic modality. (132) Nine studies including 6 animal experiments and 3 human studies with a total of 25 patients were reviewed. Only particle embolization was used in human subjects, while animal subjects underwent chemical embolization. One human study and 5 animal studies described decreased ghrelin concentration. Significant weight change following gastric artery manipulation was noted in 3 animal experiments and 2 human studies. No serious adverse events that required surgical or interventional management were reported. Conclusions reached by the reviewers included that data regarding the potential role of gastric artery manipulation in decreasing the ghrelin and potential weight loss is scarce.

Revision Bariatric Surgery

A number of studies have evaluated the efficacy of revision procedures after failed bariatric surgery and reported satisfactory weight loss and resolution of comorbidities with somewhat higher complication rates than with primary surgery. In 2015, Sudan et al. reported safety and efficacy outcomes for reoperative bariatric surgeries using data from a national registry, the Bariatric Outcomes Longitudinal Database (BOLD). (76) The BOLD is a large, multi-institutional bariatric surgery-specific database to which data were submitted from June 2007 through March 2012 by 1029 surgeons and 709 hospitals participating in the Bariatric Surgery Centers of Excellence (BSCOE) program. Surgeries were classified as primary or reoperative bariatric. Reoperations were further divided into corrective surgeries (when complications or incomplete treatment effect of a previous bariatric operation was addressed but the initial operation was not changed) or conversions (when an index bariatric operation was changed to a different type of bariatric operation or a reversal restored original anatomy.) Of 449,473 bariatric operations in the database, 420,753 (93.6%) operations had no further reoperations (primary operations) while 28,270 (6.3%) underwent reoperations. Of the reoperations, 19,970 (69.5%) were corrective and 8750 (30.5%) were conversions. The primary bariatric operations were RYGBP (n=204,705 [49.1%]), AGB (n=153,142 [36.5%]), SG (n=42,178 [10%]), and BPD-DS (n=4260 [1%]), with the rest classified as miscellaneous. AGB was the most common primary surgery among conversions (57.5% of conversions; most often [63.5%] to RYGBP). Compared with primary operations, mean hospital length of stay was longer for corrections (2.04 days vs 1.8 days, p<0.001) and for conversions (2.86 days vs 1.8 days, p<0.001). Mean percent EWL at 1 year was 43.5% after primary operation, 39.3% after conversions, and 35.9% after corrective operations (statistical comparison not reported). One-year mortality was higher for conversions (0.31%) than for primary surgeries (0.17%; p<0.001), but not for corrections (0.24%) compared with primary surgeries (0.17%; p=NS). One-year serious adverse event rates were higher for conversions (3.61%) than for primary operations (1.87%; p<0.001), but not for corrections (1.9%) compared with primary operations (1.87%; p=NS). The authors concluded that reoperation after primary bariatric surgery is relatively uncommon, but generally safe and efficacious when it occurs.

As part of the American Society for Metabolic and Bariatric Surgery (ASMBS) Revision Task Force, Brethauer et al. (2014) conducted a systematic review of reoperations after primary bariatric surgery that included 175 studies, most of which were single-center retrospective reviews. (77) The review is primarily descriptive, but authors made the following conclusions:

“The current evidence regarding reoperative bariatric surgery includes a diverse group of patient populations and procedures. The majority of the studies are single institution case series reporting short- and medium-term outcomes after reoperative procedures. The reported outcomes after reoperative bariatric surgery are generally favorable and demonstrate that additional weight loss and co-morbidity reduction is achieved with additional therapy. The risks of reoperative bariatric surgery are higher than with primary bariatric surgery and the evidence highlights the need for careful patient selection and surgeon expertise.”

Endoscopic Revision Procedures

While bariatric surgery revision/correction can be conducted using standard surgical approaches, novel endoscopic procedures are being developed. Some procedures use devices also being evaluated for endoscopic treatment of GERD. The published data on use of these devices for treatment of regained weight is limited. Published case series have reported results using a number of different devices and procedures (including sclerosing injections) as treatment for this condition. The largest series found involved 28 patients treated with a sclerosing agent (sodium morrhuate). (78) Reported trials that used one of the suturing devices had fewer than 10 patients. For example, Herron et al. (2008) reported on a feasibility study in animals. (79) Thompson et al. (2006) reported on a pilot study with changes in anastomotic diameter and weight loss in 8 patients who regained weight and had dilated gastrojejunal anastomoses after RYGB. (80) No comparative trials were identified; comparative trials are important because of the known association between an intervention and short-term weight loss.

The StomaphyX device, which has been used in this approach, was cleared by 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 tract surgery. In 2014, Eid et al. reported results from a single-center RCT of the StomaphyX device compared with a sham procedure for revisions in patients with prior weight loss after RYGB at least 2 years earlier. (81) Enrollment was initially planned for 120 patients, but the trial was stopped prematurely after 1-year follow-up was completed by 45 patients in the StomaphyX group and 29 patients in the sham control group because preliminary analysis failed to achieve the primary efficacy end point in at least 50% of StomaphyX patients. The primary 12-month efficacy end point (reduction in pre-RYGB excess weight by ≥15%, excess BMI loss, and BMI <35 kg/m2) was achieved by 10 (22.2%) of 45 in the StomaphyX group and 1 (3.4%) of 29 in the sham control group (p<0.01).

A survey of ASMBS members (bariatric surgeons) indicated different risk tolerance and weight loss expectations for primary and revisional endoscopic procedures. (82) They were “willing to accept less weight loss and more risk for revisional endoluminal procedures than for primary endoluminal procedures.” Durability of the procedures was a concern, and most surgeons were unwilling to consider the procedures until their efficacy has been proven. A 2013 systematic review of studies reporting outcomes after endoluminal revision of primary bariatric surgery conducted by ASMBS concluded: “The literature review shows the procedures on the whole to be well tolerated with limited efficacy. The majority of the literature is limited to small case series. Most of the reviewed devices are no longer commercially available.” (83)

Section Summary: Revision Bariatric Surgery

For surgical revision of bariatric surgery after failed treatment, evidence from nonrandomized studies suggests that revisions are associated with improvements in weight similar to those seen in primary surgery. However, the published scientific literature on use of endoscopic devices and procedures in patients who regain weight after bariatric surgery is very limited.

Bariatric Surgery as a Treatment for T2D

Current indications for bariatric surgery view poorly or uncontrolled diabetes as a comorbidity whose presence supports the need for surgery in patients with a BMI of 35 to 40 kg/m2. There also is growing interest in gastrointestinal surgery to treat patients with T2D in patients with lower BMI. This section focuses on RCTs and systematic reviews of RCTs comparing bariatric surgery with medical therapy.

T2D and BMI 30 to 34.9 kg/m2

In 2016, Wu et al. published a meta-analysis of studies comparing bariatric surgery and nonsurgical interventions for patients with T2D. (84) Eight RCTs with 619 patients were included. RCTs addressed RYGB (6 studies), LAGB (3 studies), LSG (1 study), and BPD (1 study). Mean BMI across studies was 29 kg/m2 or higher; in 6 of 8 studies, mean BMI was 35 kg/m2 or higher. One study had 5-year follow-up and the others had 1 to 3 years of follow-up. The study with 5-year follow-up, by Mingrone et al. (2015), was limited to patients with a BMI of at least 35 kg/m2. (85) All 8 studies reported remission of T2D as an efficacy end point. A pooled analysis found a significantly higher rate of T2D remission in the bariatric surgery versus the nonsurgical treatment group (RR=5.76; 95% CI, 3.15 to 10.55; p<0.001). Another diabetes-related outcome (mean reduction in HbA1c levels) was significantly greater after bariatric surgery than nonsurgical treatment (MD = -1.29; 95% CI, -1.70 to -0.87). In addition, there was a significantly greater reduction in BMI with bariatric surgery than with nonsurgical treatment (MD = -5.80; 95% CI, -6.95 to -4.64; p<0.001).

Since publication of the Wu meta-analysis, 5-year follow-up has been reported for the Schauer et al. RCT, which is shown in Table 3. When the Wu et al. meta-analysis was published, only 3 year findings of the Schauer study were available. The study included patients with T2D who had BMI 27-43 kg/m2. Other RCTs evaluating bariatric surgery in patients with T2D include: Dixon et al. (2008) U.S. (89), Ikramuddin et al. (2015) U.S. (90), Liang et al. (2013) China (91), Courcoulas et al. (2015) U.S. (92), Mingrone et al. (2015) Italy (85), Wentworth et al. (2014) Australia (94) and Halperin et al. (2014) U.S. (95).

Table 3. Schauer et al. (2017) U.S. Bariatric Surgery in Patients with T2D to Control

Study

Schauer et al. (2017) U. S. (93)

Number

150

BMI Range, kg/m2

27-43

Patients with BMI ≤ 35 kg/m2

37%

Length of FU, years

5 (thru February 2017)

Definition Diabetes Remission

% HbA1c <6.0% (±meds)

Diabetes Remission Rate

Surgery (RYGB)

14/49 (29%)

Surgery (LSG)

11/49 (23%)

Control (ILI/A1C-S)

2/38 (5%)

A1C-S: HbA1c stringent goal of <6.5%; ILI: intensive lifestyle intervention; LSG: laparoscopic sleeve gastrectomy; RYGB: Roux-en-Y gastric bypass; T2D: type 2 diabetes.

Observational studies evaluating patients undergoing bariatric surgery in patients with T2D with follow-up to 3 or more years include the following studies: Scopinaro et al. (2014) Italy (96), Lanzarini et al. (2013) Chile (97), Boza et al. (2011) Chile (98), De Paula et al. (2012) Brazil (99) and Lee et al. (2008) Taiwan (100).

Muller-Stich et al. (2015) published a systematic review of RCTs and observational studies on bariatric surgery in patients with T2D and a BMI less than 35 kg/m2. (86) Eleven comparative trials of medical therapy versus bariatric surgery were included, with 5 RCTs and 6 nonrandomized comparative studies identified. Follow-up was between 1 and 3 years. The primary outcome reported was remission of diabetes. On combined analysis, bariatric surgery was associated with a higher remission rate than medical therapy (OR=14.1; 95% CI, 6.7 to 29.9; p<0.001). On secondary outcomes, surgery was associated with a greater decrease in BMI (MD = -5.5 kg/m2; 95% CI, -6.7 to -4.3 kg/m2, p<0.001), a lower HbA1c level (MD = -1.4%; 95% CI, -1.9% to -0.9%; p<0.001), lower rates of hypertension (OR=0.25; 95% CI, 0.12 to 0.50; p<0.001), and lower rates of dyslipidemia (OR=0.21; 95% CI, 0.10 to 0.44; p<0.001).

Also in 2015, Rao et al. published a meta-analysis of short-term outcomes for patients with T2D and a BMI of 35 kg/m2 or less who underwent RYGBP. (87) Nine articles were included (total N=343 patients). After 12 months, patients with T2D had a significant decrease in BMI (weighted mean difference [WMD], -7.42; 95% CI, -8.87 to -5.97; p<0.001) and improvements in HbA1c levels (WMD = -2.76; 95% CI, -3.41 to -2.11; p<0.000). Reviewers reported that longer term follow-up would be needed.

Previously, a 2012 BCBSA TEC Assessment evaluated bariatric surgery in diabetic patients with a BMI less than 35 kg/m2. (88) The evidence consisted mainly of case series. The Assessment identified only observational studies. Based on the data, the Assessment concluded that gastric bypass met TEC criteria as a treatment for diabetes in patients with a BMI less than 35 kg/m2 but that other procedures did not meet the TEC criteria for this indication:

There were no randomized trials comparing bariatric surgery to medical treatment for diabetic subjects with a BMI less than 35 kg/m2. There was only 1 randomized trial comparing 2 bariatric procedures. Therefore, studies were categorized by procedure type and presented as case series, regardless of the underlying study type.

Nine studies reported diabetes remission rates and other outcomes in subjects undergoing gastric bypass. Diabetes remission rates varied between 48% and 100% at follow-up times of 1 year and beyond. One study was a randomized clinical trial of gastric bypass versus SG; in it, diabetes remission associated with gastric bypass was 93% versus 47% for SG at 1 year.

Two studies reported outcomes of SG. Diabetes remission rates were 55% and 47% at 1 year.

One study reported outcomes of ileal interposition. The diabetes remission rate at a mean follow-up time of 39.1 months was 78.3%.

Two studies reported outcomes of gastric banding. The outcomes reported were not considered to be rigorous, because the only measure of diabetes outcome was withdrawal of diabetes medication. Reported remission rates were 27.5% and 50% at variable follow-up times.

One study of BPD reported a remission rate of 67% for subjects with a BMI between 30 and 35 kg/m2 and 27% for subjects with a BMI between 25 and 30 kg/m2 at 12-month follow-up.

One study reported outcomes of duodenojejunal exclusion. Subjects in this study had more severe diabetes than subjects enrolled in other studies; 100% were on insulin treatment and the duration of diabetes was between 5 and 15 years. The diabetes remission rate was 17% at 6 months.

Section Summary: T2D and With BMI 30 to 34.9 kg/m2

Systematic reviews of RCTs and observational studies have found that certain types of bariatric surgery are more efficacious than medical therapy as a treatment for T2D in obese patients, including those with a BMI between 30 and 34.9 kg/m2. The greatest amount of evidence assesses gastric bypass, with some comparative studies on LAGB, LSG, and BPD. Systematic reviews have found significantly greater remission rates of diabetes, decrease in HbA1c levels, and decrease in BMI with bariatric surgery than with nonsurgical treatment. The efficacy of surgery is balanced against the short-term risks of the surgical procedure. Most RCTs in this population have 1 to 3 years of follow-up; 1 RCT, which included patients with BMI between 30 and 34.9 kg/m2, had 5-year follow-up data.

Bariatric Surgery in Nondiabetic Patients with a BMI less than 35kg/m2

A 2012 BCBSA TEC Assessment evaluated laparoscopic gastric banding in individuals without diabetes who had a BMI less than 35 kg/m2. (101) This Assessment was prompted by FDA approval of LAP-BAND for this indication in 2011. The TEC Assessment concluded that LAGB did not meet TEC criteria in these patients and made the following summary statements:

The evidence on LAGB for patients with lower BMIs is limited both in quantity and quality. There is only 1 small RCT, which has methodologic limitations, 1 nonrandomized comparative study based on registry data, and several case series. Using the GRADE evaluation, the quality of evidence on the comorbidity outcomes was judged to be low and the quality of the evidence on the weight loss outcomes was judged to be moderate.

The evidence was sufficient to determine that weight loss following LAGB is greater than with nonsurgical therapy.

Direct data on improvement in weight-related comorbidities was lacking. The limited evidence was not sufficient to conclude that the amount of weight loss is large enough that improvements in weight-related comorbidities can be assumed.

There was very little data on quality of life in this population of patients.

The frequency and impact of long-term complications following LAGB were uncertain, and this uncertainty has been one of the main reasons why it is difficult to determine whether the benefit of LAGB outweighs the risk for this population. While the short-term safety of LAGB has been well-established, the long-term adverse effects occur at a higher rate and are less well-defined.

Section Summary: Bariatric Surgery in Nondiabetic Patients With a BMI Less Than 35 kg/m2 There is limited evidence for bariatric surgery in patients who are not diabetic or morbidly obese. A few small RCTs and case series have reported loss of weight and improvements in comorbidities for this population. However, the evidence does not permit conclusions on the long-term risk-benefit ratio of bariatric surgery in this population.

Bariatric Surgery in Morbidly Obese Adolescent Children

Treadwell et al. (2008) conducted a systematic review and meta-analysis of the published evidence on bariatric surgery in adolescents. (102) Their analysis included English-language articles on currently performed procedures when data were separated by procedure and there was a minimum 1-year follow-up for weight and BMI. Studies must have reported outcomes data for 3 or more patients ages 21 years or younger, representing at least 50% of pediatric patients enrolled at that center. Nineteen studies reported on between 11 and 68 patients who were 21 years or younger. Eight studies of LAGB reported data on 352 patients (mean BMI, 45.8 kg/m2; median age range, 15.6-20 years); 6 studies on RYGB included 131 patients (mean BMI, 51.8 kg/m2; median age range, 16-17.6 years); 5 studies of other procedures included 158 patients (mean BMI, 48.8 kg/m2; median age range, 15.7-21 years).

Meta-analyses of BMI at longest follow-up indicated sustained and clinically significant reductions for both LAGB and RYGB. Comorbidity resolution was sparsely reported, but surgery appeared to resolve some medical conditions, including diabetes and hypertension; 2 studies of LAGB showed large rates of diabetes resolution but low patient enrollment, and only 1 study of RYGB reporting relevant data. No in-hospital or postoperative deaths were reported in any LAGB study. The most frequently reported complications for LAGB were band slippage and micronutrient deficiency with sporadic cases of band erosion, port/tube dysfunction, hiatal hernia, wound infection, and pouch dilation. More severe complications were reported for RYGB, such as pulmonary embolism, shock, intestinal obstruction, postoperative bleeding, staple line leak, and severe malnutrition. No in-hospital deaths were reported; however, 1 patient died 9 months after the study with severe Clostridium difficile colitis; 3 others died of causes not likely to have been directly related to the bariatric surgeries. No LAGB studies reported data on the impact of surgery on growth and development. One study of RYGB reported pre- and postoperative heights and concluded that there was no evidence of growth retardation at an average follow-up of 6 years, but it could not be determined from the data whether expected growth was achieved.

In a 2013 systematic review of 23 studies, Black et al. concluded that the available literature demonstrated a high rate of significant short-term weight loss after bariatric surgery, but that complication and comorbidity rates were not well-defined. (103) In a systematic review that included 11 studies of outcomes after LAGB in adolescents, Willcox et al. (2014) found limited data on biopsychosocial outcomes. (104)

In RCT of LAGB, O’Brien et al. (2010) reported on 50 adolescents between the ages of 14 and 18 years with a BMI greater than 35 kg/m2 who received a lifestyle intervention or gastric banding and were followed for 2 years. (2) Twenty-four of 25 patients in the gastric banding group and 18 of 25 in the lifestyle group completed the study. Twenty-one (84%) in the gastric banding group and 3 (12%) in the lifestyle group lost more than 50% of excess weight. Overall, mean weight loss in the gastric banding group was 34.6 kg (95% CI, 30.2 to 39.0 kg), representing an EWL of 78.8% (95% CI, 66.6% to 91.0%). Mean losses in the lifestyle group were 3.0 kg (95% CI, 2.1 to 8.1 kg), representing an EWL of 13.2% (95% CI, 2.6% to 21.0%). The gastric banding group experienced improved quality of life with no perioperative adverse events; however, 8 (33%) surgeries were required in 7 patients for revisional procedures, either for proximal pouch dilatation or tubing injury during follow-up. This trial offers evidence that, among obese adolescent participants, use of gastric banding compared with lifestyle intervention would result in a greater percentage 50% EWL.

There are many case series of bariatric surgery in adolescents, and they have generally reported weight loss in the same range seen for adults. For example, Nadler et al. (2008) reported on 73 patients ages 13 to 17 years who had undergone LAGB since 2001 at the authors’ institution. (105) Mean preoperative BMI was 48 kg/m2. EWL at 6 months, 1 year, and 2 years postoperatively was 35%, 57%, and 61%, respectively. Six patients developed band slippage, and 3 developed symptomatic hiatal hernias. Nutritional complications included asymptomatic iron deficiency in 13 patients, asymptomatic vitamin D deficiency in 4 patients, and mild subjective hair loss in 14. In the 21 patients who entered the authors’ FDA-approved study and had reached 1-year follow-up, 51 comorbid conditions were identified, 35 of which completely resolved, 9 were improved, 5 were unchanged, and 2 were aggravated after 1 year.

In 2014, Inge et al. reported results from Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study, a prospective, multicenter observational study of bariatric surgery in patients ages 19 or younger. (106) The study enrolled 242 participants, with mean age 17.1 years and median BMI of 50.5 kg/m2 (IQR, 45.2-58.2 kg/m2) at the time of surgery. All patients had at least 1 obesity-related comorbidity, most commonly dyslipidemia (74%), followed by OSA (57%), back and joint pain (46%), hypertension (45%), and fatty liver disease (37%). Gastric bypass, LAGB and vertical SG were performed in 66.5%, 5.8%, and 27.7% of patients, respectively. Within 30 days of surgery, 20 major complications occurred in 19 (7.9%) patients, most of which were perioperative. The cohort is being followed to assess longer term outcomes.

Section Summary: Bariatric Surgery in Morbidly Obese Adolescents Children

The evidence on bariatric surgery in adolescents indicates that the percent of EWL is approximately the same as that in adults. There are greater concerns for developmental maturity, psychosocial status, and informed consent in adolescents. Guideline recommendations for bariatric surgery in adolescents lack uniformity, but generally correspond to the clinical selection criteria for adults and supplement these clinical selection criteria with greater attention to issues of maturity and psychosocial status.

Bariatric Surgery in Morbidly Obese Preadolescent Children

In 2013, Black et al. (described above) published a systematic review of 23 studies on bariatric surgery in children and adolescents. (103) Most studies were limited to adolescents; only 2 included children less than 12 years old. One study, Silberhumer et al. (2006), included 9- to 19-year-olds (mean age, 17 years); conclusions could not be drawn about the impact of bariatric surgery in this sample of preadolescent children. (107) Similarly, Alqahtani et al. (2012) included children ages 5 to 21 years (mean age, 14 years) and did not provide conclusions separately for preadolescent children. (108)

Clinical practice guidelines (e.g., from the Endocrine Society [2008] [109] and the Institute for Clinical Systems Improvement [2013] [110]) have recommended against bariatric surgery in preadolescent children.

Section Summary: Bariatric Surgery in Morbidly Obese Preadolescent Children

There are few published data and no studies were identified that focused on bariatric surgery in preadolescent children. Clinical guidelines recommend against bariatric surgery in preadolescent children.

Hiatal Hernia Repair in Conjunction with Bariatric Surgery

Hiatal hernia is associated with obesity and existing hiatal hernias may be worsened with bariatric surgery. In some studies, the presence of hiatal hernia has been associated with complications after LAGB, (111) although other studies have reported no differences in perioperative complications after LAGB in patients with GERD and/or hiatal hernia or those without GERD and/or hiatal hernia. (112) Hiatal hernias, either incidentally found at surgery or diagnosed preoperatively, are often repaired at the time of bariatric surgery. In 2013, the Society of American Gastrointestinal and Endoscopic Surgeons published guidelines on the management of hiatal hernia, recommending that, during operations for RYGB, SG, and the placement of LAGBs, all detected hiatal hernias should be repaired (grade of recommendation: weak; evidence quality moderate [further research is likely to alter confidence in the estimate of impact and may change the estimate]). (113)

There is limited evidence whether repair of hiatal hernias at the time of bariatric surgery improves outcomes after surgery; it consists primarily of cohort studies comparing outcomes for patients with hiatal hernia who underwent repair during bariatric surgery to patients without hiatal hernia.

Gulkarov et al. (2008) reported results of a prospective cohort study comparing outcomes for patients who underwent LAGB with or without concurrent hiatal hernia repair (n=1298 with AGB alone; n=520 with concurrent hiatal hernia repair). (114) The authors reported that, initially, hiatal hernias were diagnosed based on preoperative esophagram and upper endoscopy, but this was discontinued after these studies were shown to have poor predictive value for small-to-medium size hernias; subsequent patients were diagnosed at the time of surgery. It was not specified how many patients were diagnosed with each method or how many of those had symptoms before gastric banding. Fewer patients who underwent concurrent hiatal hernia repair required reoperation for a complication (3.5% vs 7.9% in the AGB alone group; p<0.001). Hiatal hernia repair added an average of 14 minutes to surgical time. Weight loss outcomes did not differ significantly between groups.

Santonicola et al. (2014) evaluated the effects of LSG with or without hiatal hernia repair on GERD in obese patients. (115) The study included 78 patients who underwent SG with concomitant hiatal hernia repair for a sliding hiatal hernia diagnosed intraoperatively, compared with 102 patients without hiatal hernia who underwent SG only. The prevalence of typical GERD symptoms did not improve from baseline to follow-up in patients who underwent concomitant hiatal hernia repair (38.4% presurgery vs 30.8% postsurgery, p=0.3). However, those in the SG only group had a significant decrease in the prevalence of typical GERD symptoms (39.2% presurgery vs 19.6% postsurgery, p=0.003).

Reynoso et al. (2011) reported outcomes after primary and revisional LAGB in patients with hiatal hernia treated at a single hospital system. (116) Of 1637 patients with hiatal hernia undergoing primary gastric banding, 190 (11.6%) underwent concurrent hiatal hernia repair; of 181 patients undergoing revision gastric banding, 15 (8.3%) underwent concurrent hiatal hernia repair. For primary procedures, there were no significant differences in mortality, morbidity, length of stay, and 30-day readmission rates for patients who underwent LAGB with and without hiatal hernia repair. However, this compares patients with hiatal hernia undergoing repair to patients without hiatal hernia. The more relevant comparison would be comparing repair to no repair in patients who have hiatal hernia.

Ardestani et al. (2014) analyzed data from the BOLD registry to compare outcomes for patients with and without hiatal hernia repair at the time of LAGB. (117) Of 41,611 patients who had LAGB from 2007 to 2010, 8120 (19.5%) had concomitant hiatal hernia repair. Those with hiatal hernia repair were more likely to have GERD preoperatively (49% vs 40% in the non?hiatal hernia repair group; p<0.001). Perioperative outcomes were similar between groups. Of those with GERD preoperatively, rates of improvement in GERD symptoms did not differ significantly at 1 year postprocedure (53% for hiatal hernia repair vs 52% for non?hiatal hernia repair; p=0.4). Although the hiatal hernia repair added minimal time (mean, 4 minutes) to surgery, the authors concluded that many repairs would have involved small hernias with limited clinical effect.

In general, studies have reported that the addition of hiatal hernia repair at the time of bariatric surgery is safe and feasible. In a small case series of 21 patients, Frezza et al. (2008) described the feasibility of crural repair at the time of LAGB for patients with hiatal hernia. (118) Al-Haddad et al. (2014) used data from the U.S. Nationwide Inpatient Sample to evaluate the surgical risk associated with hiatal hernia repair at the time of bariatric surgery. (119) For laparoscopic RYGB, there were 206,559 and 9060 patients who underwent the procedure alone or with concomitant hiatal hernia repair, respectively. For LAGB, 52,901 and 9893 patients, respectively, underwent the procedure alone or with hiatal hernia repair. The authors reported no evidence of increased risk of perioperative adverse events associated with the concomitant hiatal hernia repair. However, patients who underwent a concomitant hiatal hernia repair were less likely to have prolonged length of stay (PLOS), with an average treatment effect on the treated (ATT) of hiatal hernia repair of -0.124 (95% CI, -0.15 to -0.088) for PLOS for patients who underwent RYGB and an ATT of hiatal hernia repair of -0.107 (95% CI, -0.159 to -0.0552) for PLOS for patients who underwent LAGB.

Section Summary: Hiatal Hernia Repair in Conjunction With Bariatric Surgery

Hiatal hernia repair is frequently undertaken at the time of bariatric surgery. The evidence related to whether hiatal hernia repair improves outcomes after bariatric surgery is limited, particularly for hiatal hernias that are incidentally diagnosed at the time of surgery. No studies were identified that compared outcomes after bariatric surgery with or without hiatal hernia repair in a population of patients with known hiatal hernia. For patients with a preoperative diagnosis of hiatal hernia, symptoms related to the hernia, and indications for surgical repair, it is reasonable to undertake this procedure at the time of bariatric surgery. For other patients, it is uncertain whether repair of a hiatal hernia at the time of bariatric surgery improves outcomes.

Liver Biopsy in Conjunction with Bariatric Surgery

Mahawar et al. (2016) noted that a routine liver biopsy can help early and accurate diagnosis of an obesity-associated liver conditions. The reviewers note this has led some surgeons to argue for routine liver biopsy at the time of bariatric surgery. The article notes however, most bariatric surgeons remain unconvinced and liver biopsy is currently not routine practice with bariatric surgery. (134)

In 2014, Reha et al. performed a retrospective review to determine the prevalence of Nonalcoholic steatohepatitis (NASH), a common finding in obese population. (131) Morbidly obese patients who underwent weight reduction surgery had a liver biopsy performed at the time of surgery. Patients were excluded if they had a history of hepatitis infection or previous alcohol dependency. Results reported included: one hundred thirteen patients were analyzed; sixty-one patients had systemic hypertension (54%) and 35 patients had diabetes (31%). The prevalence of NASH in this study population was 35 per cent (40 of 113). An additional 59 patients (52%) had simple steatosis without NASH. Only 14 patients had normal liver histology. The authors noted that patient age, body mass index, hypertension, diabetes, hypercholesterolemia, and abnormal alanine aminotransferase did not predict NASH. Abnormal aspartate aminotransferase (AST) was the only predictive factor for NASH.

Spengler et al. (2015) notes that NASH occurs in 20% of patients with NAFLD, and that approximately 30-40% of patients with NASH will develop fibrosis. (135) The authors note that NAFLD is most commonly recognized through abnormal liver chemistries or incidental ultrasound findings and should be considered in the differential of any patient with elevated transaminases. Further consideration is noted regarding liver biopsies in that they are invasive, and not without risk.

In 2013, Mechanick et al. noted in the American Association of Clinical Endocrinologists (AACE), The Obesity Society (TOS), and the American Society for Metabolic & Bariatric Surgery’s (ASMBS) Clinical Practice Guidelines for the Perioperative Nutritional, Metabolic, and Nonsurgical Support of the Bariatric Surgery Patient that “Consideration can be made for liver biopsy at the time of surgery to document steatohepatitis and/or cirrhosis that may otherwise be unknown due to normal appearance and/or liver function tests (Grade D)” (122) (Grade D recommendation is made in the absence of a two-thirds consensus being reached).

Section Summary: Liver Biopsy in Conjunction with Bariatric Surgery

Liver biopsy at the time of bariatric surgery has been proposed as a method of providing an accurate diagnosis of obesity-associated liver conditions. Spengler has noted that NAFLD is commonly recognized through abnormal liver chemistries. The AACE, TOS, and ASMBS Clinical Practice Guidelines provide a grade D recommendation for liver biopsy at the time of surgery. For patients who have signs or symptoms of liver disease (e.g., history and physical, biochemical, and serological findings), liver biopsy at the time of bariatric surgery may be considered medically necessary.

Summary of Evidence

Adults With Morbid Obesity

For individuals who are adults with morbid obesity who receive gastric bypass, the evidence includes randomized controlled trials (RCTs), observational studies, and systematic reviews. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Blue Cross Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) (2003) Assessment and other systematic reviews of RCTs and observational studies found that gastric bypass improves health outcomes, including weight loss and remission of type 2 diabetes (T2D). A BCBSA TEC (2005) Assessment found similar weight loss with open and laparoscopic gastric bypass. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who are adults with morbid obesity who receive laparoscopic adjustable gastric banding (LAGB), the evidence includes RCTs, observational studies, and systematic reviews. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Systematic reviews of RCTs and observational studies have found that LAGB is a reasonable alternative to gastric bypass; there is less weight loss with LAGB, but the procedure is less invasive and is associated with fewer serious adverse events. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who are adults with morbid obesity who receive sleeve gastrectomy (SG), the evidence includes RCTs, observational studies, and systematic reviews. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Systematic reviews of RCTs and observational studies have found that SG results in substantial weight loss and that this weight loss is durable for at least 5 years. A meta-analysis found that short-term weight loss was similar after SG or gastric bypass. Long-term weight loss was greater after gastric bypass but SG is associated with fewer adverse events. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who are adults with morbid obesity who receive biliopancreatic diversion (BPD) with duodenal switch, the evidence includes observational studies and a systematic review. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Non-randomized comparative studies found significantly higher weight loss after BPD with duodenal switch compared with gastric bypass at 1 year. A large case series found sustained weight loss after 7 years. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who are adults with morbid obesity who receive BPD without duodenal switch, the evidence includes observational studies and systematic reviews. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. A BCBSA TEC Assessment reviewed the available observational studies and concluded that weight loss was similar after BPD without duodenal switch or gastric bypass. However, there are concerns about complications associated with BPD without duodenal switch, especially long- term nutritional and vitamin deficiencies. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who are adults with morbid obesity who receive vertical-banded gastroplasty (VBG), the evidence includes observational studies and systematic reviews. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. A TEC Assessment identified 8 nonrandomized comparative studies evaluating VBG and these studies found that weight loss was significantly greater with open gastric bypass. Moreover, VBG has relatively high rates of complications, revisions, and reoperations. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who are adults with morbid obesity who receive 2-stage bariatric surgery procedures, the evidence includes observational studies and systematic reviews. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. There is a lack of evidence that 2-stage bariatric procedures improve outcomes compared with 1-stage procedures. Case series have shown relatively high complication rates in 2-stage procedures, and patients are at risk of complications in both stages. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who are adults with morbid obesity who receive laparoscopic gastric plication, the evidence includes observational studies and systematic reviews. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. A 2014 systematic review identified only 1 small comparative study (unrandomized) comparing laparoscopic gastric plication with other bariatric surgery procedures. Additional comparative studies and especially RCTs are needed to permit conclusions about the safety and efficacy of laparoscopic gastric plication. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who are adults with morbid obesity who receive single anastomosis duodenoileal bypass with SG, the evidence includes observational studies and systematic reviews. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. No controlled trials were published evaluating single anastomosis duodenoileal bypass with SG. There are a few case series, the largest of which had fewer than 100 patients. Comparative studies and especially RCTs are needed to permit conclusions about the safety and efficacy of single anastomosis duodenoileal bypass with SG. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who are adults with morbid obesity who receive duodenojejunal sleeve, the evidence includes RCTs and systematic reviews. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. A systematic review of duodenojejunal sleeves included 5 RCTs and found significantly greater short-term weight loss (12-24 weeks) with the sleeves compared with medical therapy. There was no significant difference in symptoms associated with diabetes. All RCTs were small and judged by systematic reviewers to be at high risk of bias. High-quality comparative studies are needed to permit conclusions on the safety and efficacy of the procedure. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who are adults with morbid obesity who receive intragastric balloon (IGB) devices, the evidence includes RCTs, systematic reviews, and case series. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. RCTs on the 2 IGB devices approved by the Food and Drug Administration have found significantly better weight loss with IGB compared with sham treatment or lifestyle therapy alone after 6 months (maximum length of device use). There are some adverse events, mainly related to accommodation of the balloon in the stomach; in a minority of cases, these adverse events were severe. One RCT followed patients for an additional 6 months after IGB removal and found sustained weight loss. There are limited data on the durability of weight loss in the long term. Comparative data are lacking. A large case series found that patients gradually regained weight over time. Moreover, it is unclear how 6 months of IGB use would fit into a long-term weight loss and maintenance intervention. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who are adults with morbid obesity who receive an aspiration therapy device, the evidence includes 1 RCT and case series. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. The RCT found significantly greater weight loss with aspiration therapy than lifestyle therapy at 1 year. One small case series reported on 15 patients at 2 years. The total amount of data on aspiration therapy remains limited and additional studies are needed before conclusions can be drawn about the effects of treatment on weight loss, metabolism and nutrition and long-term durability of treatment. The evidence is insufficient to determine the effects of the technology on health outcomes.

Adults With T2D

For individuals who are diabetic and not morbidly obese who receive gastric bypass, sleeve gastrectomy, biliopancreatic diversion, or adjustable gastric banding, the evidence includes RCTs, nonrandomized comparative studies, and case series. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Systematic reviews of RCTs and observational studies have found that certain types of bariatric surgery are more efficacious than medical therapy as a treatment for T2D in obese patients, including those with a BMI between 30 and 34.9 kg/m2. The greatest amount of evidence is on gastric bypass. Systematic reviews have found significantly greater remission rates of diabetes, decrease in HbA1c levels, and decrease in BMI with bariatric surgery than with nonsurgical treatment. The efficacy of surgery is balanced against the short-term risks of the surgical procedure. Most of the RCTs in this population have 1 to 3 years of follow-up; 1 RCT that included patients with BMI between 30 and 34.9 kg/m2 had 5-year follow-up data. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

However, there are clinical concerns about durability and long-term outcome at 5-10 years as well as potential variation in observed outcomes in community practice versus clinical trials. As a result, bariatric surgery for individuals who are diabetic and not morbidly obese is considered experimental, investigational and/or unproven.

Nondiabetic and Nonobese Adults

For individuals who are not diabetic and not morbidly obese who receive any bariatric surgery procedure, the evidence includes RCTs, nonrandomized comparative studies, and case series. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. There is limited evidence for bariatric surgery in patients who are not diabetic or morbidly obese. A few small RCTs and case series have reported loss of weight and improvements in comorbidities for this population. However, the evidence does not permit conclusions on the long-term risk-benefit ratio of bariatric surgery in this population. The evidence is insufficient to determine the effects of the technology on health outcomes.

Adolescent Children With Morbid Obesity

For individuals who are adolescent children with morbid obesity who receive gastric bypass or LAGB, the evidence includes RCTs, observational studies, and systematic reviews. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Systematic reviews of studies on bariatric surgery in adolescents, who mainly received gastric bypass or LAGB, found significant weight loss and reductions in comorbidity outcomes with bariatric surgery. For bariatric surgery in the adolescent population, although data are limited on some procedures, studies have generally reported that weight loss and reduction in risk factors for adolescents is similar to that for adults. Most experts and clinical practice guidelines have recommended that bariatric surgery in adolescents be reserved for individuals with severe comorbidities, or for individuals with a BMI greater than 50 kg/m2. In addition, greater consideration should be placed on patient development stage, on the psychosocial aspects of obesity and surgery, and on ensuring that the patient can provide fully informed consent. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Preadolescent Children With Morbid Obesity

For individuals who are preadolescent children with morbid obesity who receive bariatric surgery, the evidence includes no studies focused on this population. Relevant outcomes are overall survival, change in disease status, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Several studies of bariatric surgery in adolescents have also included children younger than 12 years old, but findings were not reported separately for preadolescent children. Moreover, clinical practice guidelines have recommended against bariatric surgery for preadolescent children. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

American Association of Clinical Endocrinologists, et al.

In 2017, the American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) jointly published a comprehensive diabetes type 2 management algorithm. (120) The document states: “Bariatric surgery should be considered for adult patients with a BMI [body mass index] of 35 kg/m2 or more and comorbidities, especially if therapeutic goals have not been reached using other modalities.”

In 2016, AACE and ACE jointly published comprehensive clinical practice guidelines on medical care of patients with obesity. (121) The guidelines addressed 9 broad clinical questions with 123 recommendations. The authors noted that the 2013 guidelines specifically on bariatric surgery (see below) were considered adequate in the current form. With regard to bariatric surgery for these guidelines, the following recommendations were added to those in the 2013 guideline:

Recommendation 35: “Patients with obesity (BMI ≥30 kg/m2) and diabetes who have failed to achieve targeted clinical outcomes following treatment with lifestyle therapy and weight-loss medications may be considered for bariatric surgery, preferably Roux-en-Y gastric bypass, sleeve gastrectomy, or biliopancreatic diversion.” (Grade B; BEL1 [best evidence level], downgraded due to evidence gaps)

Recommendation 121. “Patients with a BMI of ≥35 kg/m2 and 1 or more severe obesity-related complications, including type 2 diabetes, hypertension, obstructive sleep apnea, obesity-hypoventilation syndrome, Pickwickian syndrome, nonalcoholic fatty liver disease or nonalcoholic steatohepatitis, pseudotumor cerebri, gastroesophageal reflux disease, asthma, venous stasis disease, severe urinary incontinence, debilitating arthritis, or considerably impaired quality of life may also be considered for a bariatric surgery procedure. Patients with BMI of 30 to 34.9 kg/m2 with diabetes or metabolic syndrome may also be considered for a bariatric procedure, although current evidence is limited by the number of patients studied and lack of long-term data demonstrating net benefit.

o BMI ≥35 kg/m2 and therapeutic target of weight control and improved biochemical markers of CVD [cardiovascular disease] risk (Grade A; BEL 1).

o “BMI ≥30 kg/m2 and therapeutic target of weight control and improved biochemical markers of CVD risk (Grade B; BEL 2).

o BMI ≥30 kg/m2 and therapeutic target of glycemic control in type 2 diabetes and improved biochemical markers of CVD risk (Grade C; BEL 3).”

Recommendation 122. “Independent of BMI criteria, there is insufficient evidence for recommending a bariatric surgical procedure specifically for glycemic control alone, lipid lowering alone, or CVD risk reduction alone (Grade D).”

Recommendation 62: “Roux-en-Y gastric bypass should be considered as the bariatric surgery procedure of choice for patients with obesity and moderate to severe gastroesophageal reflux symptoms, hiatal hernia, esophagitis, or Barrett’s esophagus.” (intermediate recommendation, intermediate evidence). This recommendation also states, “Intragastric balloon for weight loss may increase gastroesophageal reflux symptoms and should not be used for weight loss in patients with established gastroesophageal reflux” (strong recommendation; strong evidence).

Joint guidelines on the bariatric surgery patient were published by AACE, the Obesity Society, and American Society for Metabolic and Bariatric Surgery (ASMBS) in 2013. (122) Recommendations on the following questions are summarized below.

Which patients should be offered bariatric surgery?”

“Patients with a BMI≥40 kg/m2 without coexisting medical problems and for whom bariatric surgery would not be associated with excessive risk should be eligible for 1 of the procedures.”

“Patients with a BMI≥35 kg/m2 and 1 or more severe obesity-related comorbidities.…”

“Patients with BMI of 30-34.9 kg/m2 with diabetes or metabolic syndrome may also be offered a bariatric procedure although current evidence is limited by the number of subjects studied and lack of long-term data demonstrating net benefit.”

“There is insufficient evidence for recommending a bariatric surgical procedure specifically for glycemic control alone, lipid lowering alone, or cardiovascular disease risk reduction alone, independent of BMI criteria.”

Which bariatric surgical procedure should be offered?”

“The best choice for any bariatric procedure (type of procedure and type of approach) depends on the individualized goals of therapy (e.g., weight loss and/or metabolic [glycemic] control), available local-regional expertise (surgeon and institution), patient preferences, and personalized risk stratification.... At this time, there is still insufficient evidence to generalize in favor of one bariatric surgical procedure for the severely obese population.”

American College of Cardiology, et al.

In 2013, the American College of Cardiology (ACC), American Heart Association (AHA), and the Obesity Society published joint guidelines on the management of obesity and overweight in adults. (123) The guidelines made the following recommendations related to bariatric surgery:

“Advise adults with a BMI ≥40kg/m2 or BMI ≥35 kg/m2 with obesity-related comorbid conditions who are motivated to lose weight and who have not responded to behavioral treatment with or without pharmacotherapy with sufficient weight loss to achieve targeted health outcome goals that bariatric surgery may be an appropriate option to improve health and offer referral to an experienced bariatric surgeon for consultation and evaluation. NHLBI Grade A (Strong); AHA/ACC COR [class of recommendation]: IIa; AHA/ACC LOE [level of evidence]: A”

“For individuals with a BMI <35 kg/m2, there is insufficient evidence to recommend for or against undergoing bariatric surgical procedures. NHLBI Grade N (No Recommendation)”

Institute for Clinical Systems Improvement

In 2013, the Institute for Clinical Systems Improvement (ICSI) published health care guidelines on the prevention and management of obesity in adults. (110) The following were current indications for bariatric surgery:

BMI >40 kg/m2,

BMI >35 kg/m2 with significant comorbidity (diabetes, hypertension, dyslipidemia, sleep apnea, cardiovascular disease, gastroesophageal reflux, and pseudotumor cerebri),

Need for significant weight loss prior to solid organ transplantation, abdominal wall hernia repair, or joint replacement,

Medical management to exclude untreated endocrinopathies, stabilize hypertension or type 2 DM, and demonstrate patient compliance,

Psychological stability, as determined by an experienced practitioner

American Society for Metabolic and Bariatric Surgery (ASMBS)

In 2016, ASMBS published a position statement on intragastric balloon therapy (the statement was also endorsed by the Society of American Gastrointestinal and Endoscopic Surgeons [SAGES]). (124) The statement did not include specific recommendations for or against using these devices. A summary of key recommendations is as follows:

There is level 1 data from RCTs on the “efficacy [and] safety of intragastric balloon therapy for obesity … [and] lower-level evidence [suggesting] that weight loss can be maintained … for some finite time into the future.”

It is difficult to separate the effect from the intragastric “balloon alone from those of supervised diet and lifestyle changes….” This has been addressed in recent FDA pivotal trials. “In general, any obesity treatment, including intragastric balloon therapy, would benefit from a multidisciplinary team….”

“…serious complications are rare. Early postoperative tolerance challenges … can be managed with pharmacotherapy in the majority of patients….”

In 2012, ASMBS published a position statement on sleeve gastrectomy. (125) This updated statement provided the following conclusions:

“Substantial comparative and long-term data have now been published in the peer-reviewed studies demonstrating durable weight loss, improved medical co-morbidities, long-term patient satisfaction, and improved quality of life after SG.

The ASMBS therefore recognizes SG as an acceptable option as a primary bariatric procedure and as a first-stage procedure in high-risk patients as part of a planned staged approach.

From the current published data, SG has a risk/benefit profile that lies between LAGB and the laparoscopic RYGB [Roux-en-Y gastric bypass]. As with any bariatric procedure, long-term weight regain can occur and, in the case of SG, this could be managed effectively with reintervention. Informed consent for SG used as a primary procedure should be consistent with consent provided for other bariatric procedures and should include the risk of long-term weight gain.

Surgeons performing SG are encouraged to continue to prospectively collect and report outcome data in the peer-reviewed scientific literature.”

Society of American Gastrointestinal and Endoscopic Surgeons (SAGES)

In 2013, SAGES issued evidence-based guidelines for the management of hiatal hernia, which included a recommendation about repair of hiatal hernias incidentally detected at the time of bariatric surgery. (113) These guidelines stated: “During operations for Roux-en-Y gastric bypass, sleeve gastrectomy and the placement of adjustable gastric bands, all detected hiatal hernias should be repaired” (moderate quality evidence, weak recommendation).

Professional Guidelines and Position Statements for Children and Adolescents

American Society for Metabolic and Bariatric Surgery (ASMBS)

In 2012, ASMBS best practice guidelines found that current evidence was insufficient to discriminate between specific bariatric procedures, but allowed that there is an increasing body of data showing safety and efficacy of Roux-en-Y gastric bypass and adjustable gastric band for the pediatric population. (126) Bariatric surgery was recommended for pediatric patients with morbid obesity and the following comorbidities:

Strong indications:

Type 2 diabetes mellitus,

Moderate or severe obstructive sleep apnea (apnea-hypopnea index >15),

Nonalcoholic steatohepatitis,

Pseudotumor cerebri.

Less strong indications:

Cardiovascular disease,

Metabolic syndrome.

The guidelines stated that depression and eating disorders should not be considered exclusion criteria for bariatric surgery. The guidelines also noted that depression should be monitored following the procedure and that eating disorders should be treated and the patient stabilized prior to the procedure.

European Society for Gastroenterology, Hepatology and Nutrition, et al.

A joint position paper published by the European Society for Gastroenterology, Hepatology and Nutrition and the North American Society for Gastroenterology, Hepatology and Nutrition in 2015 made the following recommendations on indications for bariatric surgery in adolescents (127):

“BMI > 40 kg/m2 with severe comorbidities

Type 2 diabetes mellitus

Moderate-to-severe sleep apnea

Pseudotumor cerebri

NASH [nonalcoholic steatohepatitis] with advanced fibrosis (ISHAK score > 1)

BMI > 50 kg/m2 with mild comorbidities

Hypertension

Dyslipidemia

Mild obstructive sleep apnea

Chronic venous insufficiency

Panniculitis

Urinary incontinence

Impairment in activities of daily living

NASH

Gastroesophageal reflux disease

Severe psychological distress

Arthropathies related to weight”

Additional criteria included:

“Have attained 95% of adult stature

Have failed to attain a healthy weight with previously organized behavioral/medical treatments

Demonstrate commitment to psychological evaluation perioperatively

Avoid pregnancy for 1 year after surgery…

Have decisional capacity and will provide informed assent/consent, as age appropriate”

Endocrine Society

The Endocrine Society published recommendations on the prevention and treatment of pediatric obesity in 2008. These guidelines recommended the following (109):

“We suggest that bariatric surgery be considered only under the following conditions:

1. The child has attained Tanner 4 or 5 pubertal development and final or near-final adult height.

2. The child has a BMI > 50 kg/m2 or has BMI above 40 kg/m2 and significant, severe comorbidities.

3. Severe obesity and comorbidities persist, despite a formal program of lifestyle modification, with or without a trial of pharmacotherapy.

4. Psychological evaluation confirms the stability and competence of the family unit.

5. There is access to an experienced surgeon in a medical center employing a team capable of long-term follow-up of the metabolic and psychosocial needs of the patient and family, and the institution is either participating in a study of the outcome of bariatric surgery or sharing data.

6. The patient demonstrates the ability to adhere to the principles of healthy dietary and activity habits.

We recommend against bariatric surgery for preadolescent children, for pregnant or breast- feeding adolescents, and for those planning to become pregnant within 2 yr of surgery; for any patient who has not mastered the principles of healthy dietary and activity habits; for any patient with an unresolved eating disorder, untreated psychiatric disorder, or Prader-Willi syndrome.”

Institute for Clinical Systems Improvement (ICSI)

In 2013, ICSI published guidelines on the prevention and management of obesity in children and adolescents. (110) The guidelines stated that there is limited long-term efficacy and safety data on bariatric surgery for the pediatric population, and that bariatric surgery should only be considered under the following conditions:

“The child has a BMI > 40 kg/m2 or has BMI above 35 kg/m2 with a significant, severe comorbidities such as type 2 diabetes mellitus, obstructive sleep apnea, or pseudotumor cerebri.”

“The child has attained Tanner 4 or 5 pubertal development or has a bone age ≥13 years in girls or ≥15 years in boys.”

“Failure of ≥6 months of organized attempts at weight management….”

“The adolescent should have decisional capacity and also demonstrate commitment to comprehensive medical and psychological evaluation before and after surgery.”

“A supportive family environment….”

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 4.

Table 4. Summary of Key Trials

NCT Number

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT02741674

National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study

100,000

Jan 2018

NCT02881684a

Weight Reduction by Aspiration Therapy in Asian Patients with Morbid Obesity

15

Dec 2018

NCT01766037a

Pivotal Aspiration Therapy with Adjusted Lifestyle Therapy Study

171

Jun 2019

NCT02142257

Gastric Bypass Procedure and AspireAssist Aspiration Therapy System for the Treatment of Morbid Obesity, Observational Study over 5 Years

100

May 2020

a Denotes industry-sponsored or cosponsored trial.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

00797, 43236, 43633, 43644, 43645, 43659, 43770, 43771, 43772, 43773, 43774, 43775, 43842, 43843, 43845, 43846, 43847, 43848, 43886, 43887, 43888, 43999, 47379

HCPCS Codes

S2083

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.

A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

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44. Prachand VN, Davee RT, Alverdy JC. Duodenal switch provides superior weight loss in the super-obese (BMI > or =50 kg/m2) compared with gastric bypass. Ann Surg. Oct 2006; 244(4):611-619. PMID 16998370

45. Strain GW, Gagner M, Inabnet WB, et al. Comparison of effects of gastric bypass and biliopancreatic diversion with duodenal switch on weight loss and body composition 1-2 years after surgery. Surg Obes Relat Dis. Jan-Feb 2007; 3(1):31-36. PMID 17116424

46. Marceau P, Biron S, Hould FS, et al. Duodenal switch improved standard biliopancreatic diversion: a retrospective study. Surg Obes Relat Dis. Jan-Feb 2009; 5(1):43-47. PMID 18440876

47. Slater GH, Ren CJ, Siegel N, et al. Serum fat-soluble vitamin deficiency and abnormal calcium metabolism after malabsorptive bariatric surgery. J Gastrointest Surg. Jan 2004; 8(1):48-55; discussion 54-45. PMID 14746835

48. Dolan K, Hatzifotis M, Newbury L, et al. A clinical and nutritional comparison of biliopancreatic diversion with and without duodenal switch. Ann Surg. Jul 2004; 240(1):51-56. PMID 15213618

49. Skroubis G, Anesidis S, Kehagias I, et al. Roux-en-Y gastric bypass versus a variant of biliopancreatic diversion in a non-superobese population: prospective comparison of the efficacy and the incidence of metabolic deficiencies. Obes Surg. Apr 2006; 16(4):488-495. PMID 16608616

50. Scopinaro N, Gianetta E, Adami GF, et al. Biliopancreatic diversion for obesity at eighteen years. Surgery. Mar 1996; 119(3):261-268. PMID 8619180

51. Balsiger BM, Poggio JL, Mai J, et al. Ten and more years after vertical banded gastroplasty as primary operation for morbid obesity. J Gastrointest Surg. Nov-Dec 2000; 4(6):598-605. PMID 11307094

52. Miller K, Pump A, Hell E. Vertical banded gastroplasty versus adjustable gastric banding: prospective long-term follow-up study. Surg Obes Relat Dis. Jan-Feb 2007; 3(1):84-90. PMID 17116427

53. Hall JC, Watts JM, O'Brien PE, et al. Gastric surgery for morbid obesity. The Adelaide Study. Ann Surg. Apr 1990; 211(4):419-427. PMID 2181950

54. Sugerman HJ, Starkey JV, Birkenhauer R. A randomized prospective trial of gastric bypass versus vertical banded gastroplasty for morbid obesity and their effects on sweets versus non-sweets eaters. Ann Surg. Jun 1987; 205(6):613-624. PMID 3296971

55. MacLean LD, Rhode BM, Forse RA. Late results of vertical banded gastroplasty for morbid and super obesity. Surgery. Jan 1990; 107(1):20-27. PMID 2296754

56. Hsieh T, Zurita L, Grover H, et al. 10-year outcomes of the vertical transected gastric bypass for obesity: a systematic review. Obes Surg. Mar 2014; 24(3):456-461. PMID 24379176

57. Cottam D, Qureshi FG, Mattar SG, et al. Laparoscopic sleeve gastrectomy as an initial weight-loss procedure for high-risk patients with morbid obesity. Surg Endosc. Jun 2006; 20(6):859-863. PMID 16738970

58. Alexandrou A, Felekouras E, Giannopoulos A, et al. What is the actual fate of super-morbid-obese patients who undergo laparoscopic sleeve gastrectomy as the first step of a two-stage weight-reduction operative strategy? Obes Surg. Jul 26 2012; 22(10):1623-1628. PMID 22833137

59. Silecchia G, Rizzello M, Casella G, et al. Two-stage laparoscopic biliopancreatic diversion with duodenal switch as treatment of high-risk super-obese patients: analysis of complications. Surg Endosc. May 2009; 23(5):1032-1037. PMID 18814005

60. Ji Y, Wang Y, Zhu J, et al. A systematic review of gastric plication for the treatment of obesity. Surg Obes Relat Dis. Nov-Dec 2014; 10(6):1226-1232. PMID 24582413

61. Talebpour M, Motamedi SM, Talebpour A, et al. Twelve year experience of laparoscopic gastric plication in morbid obesity: development of the technique and patient outcomes. Ann Surg Innov Res. 2012; 6(1):7. PMID 22913751

62. Abdelbaki TN, Huang CK, Ramos A, et al. Gastric plication for morbid obesity: a systematic review. Obes Surg. Oct 2012; 22(10):1633-1639. PMID 22960951

63. Pattanshetti S, Tai CM, Yen YC, et al. Laparoscopic adjustable gastric banded plication: evolution of procedure and 2-year results. Obes Surg. Nov 2013; 23(11):1934-1938. PMID 24013809

64. Sanchez-Pernaute A, Rubio MA, Cabrerizo L, et al. Single-anastomosis duodenoileal bypass with sleeve gastrectomy (SADI-S) for obese diabetic patients. Surg Obes Relat Dis. Sep-Oct 2015; 11(5):1092-1098. PMID 26048517

65. Rohde U, Hedback N, Gluud LL, et al. Effect of the EndoBarrier Gastrointestinal Liner on obesity and type 2 diabetes: a systematic review and meta-analysis. Diabetes Obes Metab. Mar 2016; 18(3):300-305. PMID 26537317

66. Koehestanie P, de Jonge C, Berends FJ, et al. The effect of the endoscopic duodenal-jejunal bypass liner on obesity and type 2 diabetes mellitus, a multicenter randomized controlled trial. Ann Surg. Dec 2014; 260(6):984- 992. PMID 25072436

67. Saber AA, Shoar S, Almadani MW, et al. Efficacy of first-time intragastric balloon in weight loss: a systematic review and meta-analysis of randomized controlled trials. Obes Surg. Feb 2017; 27(2):277-287. PMID 27465936

68. Moura D, Oliveira J, De Moura EG, et al. Effectiveness of intragastric balloon for obesity: A systematic review and meta-analysis based on randomized control trials. Surg Obes Relat Dis. Feb 2016; 12(2):420-429. PMID 26968503

69. Zheng Y, Wang M, He S, et al. Short-term effects of intragastric balloon in association with conservative therapy on weight loss: a meta-analysis. J Transl Med. Jul 29 2015; 13:246. PMID 26219459

70. Ponce J, Woodman G, Swain J, et al. The REDUCE pivotal trial: a prospective, randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity. Surg Obes Relat Dis. Jul-Aug 2015; 11(4):874-881. PMID 25868829

71. Courcoulas A, Abu Dayyeh BK, Eaton L, et al. Intragastric balloon as an adjunct to lifestyle intervention: a randomized controlled trial. Int J Obes (Lond). Jan 24 2017. PMID 28017964

72. Genco A, Cipriano M, Bacci V, et al. BioEnterics Intragastric Balloon (BIB): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients. Int J Obes (Lond). Jan 2006; 30(1):129-133. PMID 16189503

73. Kotzampassi K, Grosomanidis V, Papakostas P, et al. 500 intragastric balloons: what happens 5 years thereafter? Obes Surg. Jun 2012; 22(6):896-903. PMID 22287051

74. Thompson CC, Abu Dayyeh BK, Kushner R, et al. Percutaneous gastrostomy device for the treatment of class ii and class iii obesity: results of a randomized controlled trial. Am J Gastroenterol. Dec 06 2016. PMID 27922026

75. Noren E, Forssell H. Aspiration therapy for obesity; a safe and effective treatment. BMC Obes. 2016; 3:56. PMID 28035287

76. Sudan R, Nguyen NT, Hutter MM, et al. Morbidity, mortality, and weight loss outcomes after reoperative bariatric surgery in the USA. J Gastrointest Surg. Jan 2015; 19(1):171-178; discussion 178-179. PMID 25186073

77. Brethauer SA, Kothari S, Sudan R, et al. Systematic review on reoperative bariatric surgery: American Society for Metabolic and Bariatric Surgery Revision Task Force. Surg Obes Relat Dis. Sep-Oct 2014; 10(5):952-972. PMID 24776071

78. Catalano MF, Rudic G, Anderson AJ, et al. Weight gain after bariatric surgery as a result of a large gastric stoma: endotherapy with sodium morrhuate may prevent the need for surgical revision. Gastrointest Endosc. Aug 2007; 66(2):240-245. PMID 17331511

79. Herron DM, Birkett DH, Thompson CC, et al. Gastric bypass pouch and stoma reduction using a transoral endoscopic anchor placement system: a feasibility study. Surg Endosc. Apr 2008; 22(4):1093-1099. PMID 18027049

80. Thompson CC, Slattery J, Bundga ME, et al. Peroral endoscopic reduction of dilated gastrojejunal anastomosis after Roux-en-Y gastric bypass: a possible new option for patients with weight regain. Surg Endosc. Nov 2006; 20(11):1744-1748. PMID 17024527

81. Eid GM, McCloskey CA, Eagleton JK, et al. StomaphyX vs a sham procedure for revisional surgery to reduce regained weight in Roux-en-Y gastric bypass patients: a randomized clinical trial. JAMA Surg. Apr 2014; 149(4):372-379. PMID 24554030

82. Brethauer SA, Pryor AD, Chand B, et al. Endoluminal procedures for bariatric patients: expectations among bariatric surgeons. Surg Obes Relat Dis. Mar-Apr 2009; 5(2):231-236. PMID 19136306

83. Dakin GF, Eid G, Mikami D, et al. Endoluminal revision of gastric bypass for weight regain--a systematic review. Surg Obes Relat Dis. May-Jun 2013; 9(3):335-342. PMID 23561960

84. Wu GZ, Cai B, Yu F, et al. Meta-analysis of bariatric surgery versus non-surgical treatment for type 2 diabetes mellitus. Oncotarget. Dec 27 2016; 7(52):87511-87522. PMID 27626180

85. Mingrone G, Panunzi S, De Gaetano A, et al. Bariatric-metabolic surgery versus conventional medical treatment in obese patients with type 2 diabetes: 5 year follow-up of an open-label, single-centre, randomised controlled trial. Lancet. Sep 05 2015; 386(9997):964-973. PMID 26369473

86. Muller-Stich BP, Senft JD, Warschkow R, et al. Surgical versus medical treatment of type 2 diabetes mellitus in nonseverely obese patients: a systematic review and meta-analysis. Ann Surg. Mar 2015; 261(3):421-429. PMID 25405560

87. Rao WS, Shan CX, Zhang W, et al. A meta-analysis of short-term outcomes of patients with type 2 diabetes mellitus and BMI ≤ 35 kg/m2 undergoing Roux-en-Y gastric bypass. World J Surg. Jan 2015; 39(1):223-230. PMID 25159119

88. Bariatric Surgery In Patients With Diabetes And Body Mass Index Less Than 35 kg/m2. Chicago, Illinois; Blue Cross Blue Shield Association Technology Evaluation Center (TEC) Assessments. 2012; Volume 27:Tab 2.

89. Dixon JB, O'Brien PE, Playfair J, et al. Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial. JAMA. Jan 23 2008; 299(3):316-323. PMID 18212316

90. Ikramuddin S, Billington CJ, Lee WJ, et al. Roux-en-Y gastric bypass for diabetes (the Diabetes Surgery Study): 2-year outcomes of a 5-year, randomised, controlled trial. Lancet Diabetes Endocrinol. Jun 2015; 3(6):413-422. PMID 25979364

91. Liang Z, Wu Q, Chen B, et al. Effect of laparoscopic Roux-en-Y gastric bypass surgery on type 2 diabetes mellitus with hypertension: a randomized controlled trial. Diabetes Res Clin Pract. Jul 2013; 101(1):50-56. PMID 23706413

92. Courcoulas AP, Belle SH, Neiberg RH, et al. Three-year outcomes of bariatric surgery vs lifestyle intervention for type 2 diabetes mellitus treatment: a randomized clinical trial. JAMA Surg. Oct 2015; 150(10):931-940. PMID 26132586

93. Schauer PR, Bhatt DL, Kirwan JP, et al. Bariatric surgery versus intensive medical therapy for diabetes - 5-year outcomes. N Engl J Med. Feb 16 2017; 376(7):641-651. PMID 28199805

94. Wentworth JM, Playfair J, Laurie C, et al. Multidisciplinary diabetes care with and without bariatric surgery in overweight people: a randomised controlled trial. Lancet Diabetes Endocrinol. Jul 2014; 2(7):545-552. PMID 24731535

95. Halperin F, Ding SA, Simonson DC, et al. Roux-en-Y gastric bypass surgery or lifestyle with intensive medical management in patients with type 2 diabetes: feasibility and 1-year results of a randomized clinical trial. JAMA Surg. Jul 2014; 149(7):716-726. PMID 24899464

96. Scopinaro N, Adami GF, Papadia FS, et al. Effects of gastric bypass on type 2 diabetes in patients with BMI 30 to 35. Obes Surg. Jul 2014; 24(7):1036-1043. PMID 24647849

97. Lanzarini E, Csendes A, Gutierrez L, et al. Type 2 diabetes mellitus in patients with mild obesity: preliminary results of surgical treatment. Obes Surg. Feb 2013; 23(2):234-240. PMID 23054574

98. Boza C, Munoz R, Salinas J, et al. Safety and efficacy of Roux-en-Y gastric bypass to treat type 2 diabetes mellitus in non-severely obese patients. Obes Surg. Sep 2011; 21(9):1330-1336. PMID 21744283

99. DePaula AL, Stival AR, DePaula CC, et al. Surgical treatment of type 2 diabetes in patients with BMI below 35: mid-term outcomes of the laparoscopic ileal interposition associated with a sleeve gastrectomy in 202 consecutive cases. J Gastrointest Surg. May 2012; 16(5):967-976. PMID 22350720

100. Lee WJ, Wang W, Lee YC, et al. Effect of laparoscopic mini-gastric bypass for type 2 diabetes mellitus: comparison of BMI>35 and <35 kg/m2. J Gastrointest Surg. May 2008; 12(5):945-952. PMID 17940829

101. Laparoscopic adjustable gastric banding in patients with body mass index less than 35 kg/m2 with weight-related comorbidity. Chicago, Illinois; Blue Cross Blue Shield Association Technology Evaluation Center (TEC) Assessments. 2012; Volume 27:Tab 3.

102. Treadwell JR, Sun F, Schoelles K. Systematic review and meta-analysis of bariatric surgery for pediatric obesity. Ann Surg. Nov 2008; 248(5):763-776. PMID 18948803

103. Black JA, White B, Viner RM, et al. Bariatric surgery for obese children and adolescents: a systematic review and meta-analysis. Obes Rev. Aug 2013; 14(8):634-644. PMID 23577666

104. Willcox K, Brennan L. Biopsychosocial outcomes of laparoscopic adjustable gastric banding in adolescents: a systematic review of the literature. Obes Surg. Sep 2014; 24(9):1510-1519. PMID 24849913

105. Nadler EP, Youn HA, Ren CJ, et al. An update on 73 US obese pediatric patients treated with laparoscopic adjustable gastric banding: comorbidity resolution and compliance data. J Pediatr Surg. Jan 2008; 43(1):141-146. PMID 18206472

106. Inge TH, Zeller MH, Jenkins TM, et al. Perioperative outcomes of adolescents undergoing bariatric surgery: the Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study. JAMA Pediatr. Jan 2014; 168(1):47-53. PMID 24189578

107. Silberhumer GR, Miller K, Kriwanek S, et al. Laparoscopic adjustable gastric banding in adolescents: the Austrian experience. Obes Surg. Aug 2006; 16(8):1062-1067. PMID 16901361

108. Alqahtani AR, Antonisamy B, Alamri H, et al. Laparoscopic sleeve gastrectomy in 108 obese children and adolescents aged 5 to 21 years. Ann Surg. Aug 2012; 256(2):266-273. PMID 22504281

109. August GP, Caprio S, Fennoy I, et al. Prevention and treatment of pediatric obesity: an Endocrine Society clinical practice guideline based on expert opinion. J Clin Endocrinol Metab. Dec 2008; 93(12):4576-4599. PMID 18782869

110. Fitch A, Fox C, Bauerly K, et al. Health Care Guideline: Prevention and Management of Obesity for Children and Adolescents. Institute for Clinical Systems Improvement. 2013; Available at <https://www.icsi.org> (accessed January 19, 2017).

111. Greenstein RJ, Nissan A, Jaffin B. Esophageal anatomy and function in laparoscopic gastric restrictive bariatric surgery: implications for patient selection. Obes Surg. Apr 1998; 8(2):199-206. PMID 9730394

112. Pilone V, Vitiello A, Hasani A, et al. Laparoscopic adjustable gastric banding outcomes in patients with gastroesophageal reflux disease or hiatal hernia. Obes Surg. Feb 2015; 25(2):290-294. PMID 25030091

113. Kohn GP, Price RR, DeMeester SR, et al. Guidelines for the management of hiatal hernia. Surg Endosc. Dec 2013; 27(12):4409-4428. PMID 24018762

114. Gulkarov I, Wetterau M, Ren CJ, et al. Hiatal hernia repair at the initial laparoscopic adjustable gastric band operation reduces the need for reoperation. Surg Endosc. Apr 2008; 22(4):1035-1041. PMID 18080712

115. Santonicola A, Angrisani L, Cutolo P, et al. The effect of laparoscopic sleeve gastrectomy with or without hiatal hernia repair on gastroesophageal reflux disease in obese patients. Surg Obes Relat Dis. Mar-Apr 2014; 10(2):250-255. PMID 24355324

116. Reynoso JF, Goede MR, Tiwari MM, et al. Primary and revisional laparoscopic adjustable gastric band placement in patients with hiatal hernia. Surg Obes Relat Dis. May-Jun 2011; 7(3):290-294. PMID 21130046

117. Ardestani A, Tavakkoli A. Hiatal hernia repair and gastroesophageal reflux disease in gastric banding patients: analysis of a national database. Surg Obes Relat Dis. May-Jun 2014; 10(3):438-443. PMID 24680760

118. Frezza EE, Barton A, Wachtel MS. Crural repair permits morbidly obese patients with not large hiatal hernia to choose laparoscopic adjustable banding as a bariatric surgical treatment. Obes Surg. May 2008; 18(5):583-588. PMID 18317857

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Policy History:

Date Reason
2/1/2019 Document updated with literature review. The following changes were made to Coverage: 1) Added embolization of gastric arteries as a treatment of obesity to the group of bariatric procedures that are considered experimental, investigational and/or unproven as a treatment of morbid obesity, 2) Added sub header for procedures performed simultaneously with bariatric surgery, with additional criteria addressing repair of hiatal hernia and liver biopsy, and 3) Added sub header under the Miscellaneous Procedure Coverage Statements dividing sections into Complications and Repeat/Revisions, with modifications to criteria under both sections 4) As a primary procedure was added as clarification of various types of bariatric surgeries being considered experimental, investigational and/or unproven for the treatment of any condition other than morbid obesity, 5) Willingness to comply with was added to the following statement: Documentation from the surgeon attesting that the patient has been educated in and understands the post-operative regimen, which should include willingness to comply with ALL the following components. Added references 131-137.
3/1/2018 Document updated with literature review. Coverage in the Patient Selection Criteria has had the following added to Osteoarthritis: “in weight bearing joints”. Coverage for adolescent individuals has been added and bariatric surgery may be considered eligible for benefit coverage when criteria are met. Specific Coverage for adult and adolescents have been delineated. Any devices used for bariatric surgery must be used in accordance with the FDA-approved indications. The following coverage statement for preadolescent children has been added: Bariatric surgery is considered experimental, investigational and/or unproven for the treatment of morbid obesity in preadolescent children. The following NOTE: has been added to the Coverage section for clarification: NOTE: A bariatric procedure that has to be aborted (i.e., no bariatric procedure is completed), but is then performed at a later date, is not considered a staged procedure. The patient must meet benefit coverage, contractual eligibility and coverage criteria at the time the bariatric procedure is completed.
3/15/2017 Document updated with literature review. The following changes were made to Coverage:1) The words include, but are not limited to, have been added to the following sentence: The following bariatric procedures considered experimental, investigational and/or unproven as a treatment of morbid obesity. 2) The following has been added to the experimental, investigational and/or unproven procedure list: Single anastomosis duodenoileal bypass with sleeve gastrectomy and AspireAssist® device. 3) The following statements have been added to the MISCELLANEOUS PROCEDURE COVERAGE STATEMENTS section: Reoperation related to previous bariatric surgery may be considered medically necessary for complications such as stricture, obstruction, or erosion except when the members benefit plan excludes coverage of such complications, and Removal of an adjustable gastric band may be considered medically necessary for complications not resolved by band deflation, including but not limited to obstruction, erosion, aspiration pneumonia, GERD, night cough, Barrett’s esophagus, persistent vomiting, or persistent pain except when the members benefit plan excludes coverage of such complications. 4) Or when the member’s benefit plan does not allow for coverage, has been added to the following coverage statement: New bariatric surgery following a previous different bariatric procedure: A Roux-en-Y procedure following a previously approved vertical banded gastroplasty or laparoscopic adjustable banded gastroplasty is not eligible for coverage for patients who have been substantially noncompliant with a prescribed nutrition and exercise program following the original procedure or when the member’s benefit plan does not allow for coverage. 5) Examples have been changed in the technical failure statement in the MISCELLANEOUS PROCEDURE COVERAGE STATEMENTS section. Previously examples were: break down of gastric pouch, slippage, breakage or erosion of gastric band, bowel obstruction, staple line failure, etc.
9/1/2015 Document updated with literature review. The following procedures were added to the Coverage section as experimental, investigational and/or unproven: Insertion of a gastric balloon, endoscopic gastroplasty, or use of an endoscopically placed duodenojejunal sleeve as a primary bariatric procedure or as a revision procedure (i.e., to treat weight gain after bariatric surgery to remedy large gastric stoma or large gastric pouches) and Laparoscopic gastric plication. The following Coverage statements were added: Repair of a hiatal hernia at the time of bariatric surgery may be considered medically necessary for patients who have a preoperatively-diagnosed symptomatic hiatal hernia. Repair of a hiatal hernia that is diagnosed at the time of bariatric surgery, or repair of a preoperatively diagnosed hiatal hernia in patients who do not have indications for surgical repair, is considered not medically necessary.
2/1/2015 CPT/HCPCS code(s) updated.
6/15/2014 Coverage revised. Section 2: Documentation from the Requesting surgical program: changed from “Patient has completed an evaluation by a licensed professional counselor, psychologist or psychiatrist within the 12 months preceding the request for surgery” to: “Patient has completed an evaluation by a masters level or higher behavioral healthcare provider acting within the scope of their licensure under applicable state law, within the 12 months preceding the request for surgery”.
3/1/2014 Document updated with literature review. The following coverage changes have been made: 1) under the “PATIENT SELECTION CRITERIA FOR COVERAGE” for a BMI equal to or greater than 35kg/meters² the requirements have changed from: at least two (2) of the following comorbid conditions related to obesity that have not responded to maximum medical management and that are generally expected to be reversed or improved by bariatric treatment; to: at least one (1) of the following clinically significant obesity-related diseases or complications that are not controlled by best practice medical management. The following has been added to the coverage section: 2) Bariatric surgery is considered experimental, investigational and/or unproven for patients with a BMI less than 35 kg/m2. 3) Gastric bypass using a Roux-en-Y anastomosis, adjustable gastric banding, sleeve gastrectomy or biliopancreatic bypass (Scopinaro procedure) with duodenal switch are considered experimental, investigational and/or unproven for the treatment of any condition other than morbid obesity, including but not limited to metabolic syndrome, gastroesophageal reflux disease and sleep apnea. 4) Two-stage bariatric surgery procedures (e.g., sleeve gastrectomy as initial procedure followed by biliopancreatic diversion at a later time) has been added to the list of procedures considered experimental, investigational and/or unproven as a treatment of morbid obesity. The following has been removed from the coverage section: 5) Bariatric surgery is considered experimental, investigational and unproven as a cure for type-2 diabetes mellitus. 6) References to “for morbid obesity that has not responded to the required conservative measures” have been removed from the coverage section.
2/1/2012 Document updated with literature review. The patient selection requirement for a pre-surgical weight loss program for at least six (6) months, occurring within the twenty-four (24) months prior to the proposed surgery has been replaced with “Documentation from the surgeon attesting that the patient has been educated in and understands the post-operative regimen”.
3/15/2011 Document updated with literature review. The following changes were made: Vertical banded gastroplasty is considered not medically necessary; added NOTES and TOGA procedures as examples of procedures considered experimental, investigational and unproven as a treatment of morbid obesity: added Transoral ROSE procedure (Restorative Obesity Surgery) as an example of a procedure considered experimental, investigational and unproven for treating weight gain after bariatric surgery; original procedure must have been under the current benefit plan for a repeat/revision to be considered; non-surgical weight loss management has been changed to six months.
7/1/2010 Document updated with literature review. The following change was made: Open or laparoscopic sleeve gastrectomy may be conditionally medically necessary.
9/15/2009 Policy updated with literature review, to include changes in required weight loss criteria, comorbid conditions, and bariatric surgery used for treatment of Type 2 Diabetes mellitus. Additional coverage position added for biliopancreatic bypass with duodenal switch. Policy title change from Surgery for Morbid Obesity to Bariatric Surgery.
6/1/2009 Coverage revised
11/15/2008 Policy reviewed without literature review; new review date only. This policy is no longer scheduled for routine literature review and update.
7/1/2007 CPT/HCPCS code(s) updated
12/1/2006 Revised/updated entire document
9/1/2006 Coverage revised
7/1/2006 Coverage revised. New CPT/HCPCS code(s) added
1/1/2006 New CPT/HCPCS code(s) added
1/18/2005 Coverage revised
11/1/2004 Coverage revised/ New CPT/HCPCS code(s) added
10/6/2004 Coverage revised
4/9/2004 Revised/updated entire document
8/15/2003 Revised/updated entire document
5/1/1999 Revised/updated entire document
6/1/1998 Revised/updated entire document
5/1/1996 Revised/updated entire document
1/1/1993 Revised/updated entire document
9/1/1990 New medical document

Archived Document(s):

Title:Effective Date:End Date:
Bariatric Surgery03-01-201801-31-2019
Bariatric Surgery03-15-201702-28-2018
Bariatric Surgery09-01-201503-14-2017
Bariatric Surgery02-01-201508-31-2015
Bariatric Surgery06-15-201401-31-2015
Bariatric Surgery03-01-201406-14-2014
Bariatric Surgery02-01-201202-28-2014
Bariatric Surgery03-15-201101-31-2012
Bariatric Surgery07-01-201003-14-2011
Bariatric Surgery09-15-200906-30-2010
Surgery for Morbid Obesity07-01-200909-14-2009
Surgery for Morbid Obesity06-01-200906-30-2009
Surgery for Morbid Obesity11-15-200805-31-2009
Surgery for Morbid Obesity07-01-200711-14-2008
Surgery for Morbid Obesity12-01-200606-30-2007
Surgery for Morbid Obesity09-01-200611-30-2006
Surgery for Morbid Obesity07-01-200608-30-2006
Surgery for Morbid Obesity01-18-200506-30-2006
Surgery for Morbid Obesity10-06-200401-17-2005
Surgery for Morbid Obesity04-09-200410-05-2004
Surgery for Morbid Obesity08-15-200304-08-2004
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