Bariatric Surgery – Commercial and Individual Exchange Medical Policy

Bariatric Surgery

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UnitedHealthcare Commercial and Individual Exchange Medical Policy

Effective 03/01/2024

UnitedHealthcare

Commercial and Individual Exchange

Medical

Policy

Bariatric Surgery

Policy Number: 2024T0362MM

Effective Date: March 1, 2024

 Instructions for Use

Table of Contents Page

Application ............................................................................. 1

Coverage Rationale .............................................................. 1

Documentation Requirements ............................................... 3

Definitions .............................................................................. 3

Applicable Codes .................................................................. 4

Description of Services ......................................................... 6

Benefit Considerations .......................................................... 8

Clinical Evidence ................................................................... 9

U.S. Food and Drug Administration .................................... 44

References .......................................................................... 45

Policy History/Revision Information .................................... 56

Instructions for Use ............................................................. 58

Application

UnitedHealthcare Commercial

This Medical Policy applies to all UnitedHealthcare Commercial benefit plans.

UnitedHealthcare Individual Exchange

This Medical Policy applies to Individual Exchange benefit plans in all states except for Alabama, Colorado, Florida,

Georgia, Kansas, Louisiana, Mississippi, Missouri, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Virginia,

Washington, and Wisconsin.

Coverage Rationale

 See Benefit Considerations

The following bariatric surgical procedures are proven and medically necessary for treating obesity:

Biliopancreatic diversion/biliopancreatic diversion with duodenal switch

Gastric bypass (includes robotic-assisted gastric bypass)

Adjustable gastric banding (using open or laparoscopic approaches) for individuals > 18 years of age. Refer to the

U.S. Food and Drug Administration (FDA) section for additional information

Sleeve Gastrectomy (Vertical Sleeve Gastrectomy)

In adults age 18 years or older, bariatric surgery using one of the procedures identified above

for treating obesity

is proven and medically necessary when all of the following criteria are met:

One of the following

o BMI ≥ 40 kg/m

(or BMI ≥ 37.5 kg/m

in individuals of Asian descent); or

o BMI ≥ 35 kg/m

– 39.9 kg/m

(or BMI ≥ 32.5 kg/m

– 37.4 kg/m

in individuals of Asian descent) in the presence of

one or more of the following co-morbidities:

 Insulin resistance or Type 2 diabetes; or

 Cardiovascular disease [e.g., history of stroke and/or myocardial infarction, poorly controlled hypertension

(systolic blood pressure greater than 140 mm Hg or diastolic blood pressure 90 mm Hg or greater, despite

pharmacotherapy), coronary artery disease, hyperlipidemia]; or

Related Commercial/Individual Exchange Policies

• Minimally Invasive Procedures for Gastric and

Esophageal Diseases

• Obstructive and Central Sleep Apnea Treatment

•

Robotic-Assisted Surgery Policy, Professional

Community Plan Policy

• Bariatric Surgery

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 History of cardiomyopathy; or

 Obstructive Sleep Apnea (OSA)

confirmed on polysomnography with an AHI or RDI of > 30; or

 Evidence of Nonalcoholic Fatty Liver Disease (NAFLD)

 Idiopathic intracranial hypertension (pseudotumor cerebri)

and

The individual must also meet the following criteria:

o Both of the following:

 Completion of a preoperative evaluation that includes a detailed weight history along with dietary and physical

activity patterns; and

 Psychosocial-behavioral evaluation by an individual who is professionally recognized as part of a behavioral

health discipline to provide screening and identification of risk factors or potential postoperative challenges

that may contribute to a poor postoperative outcome

o Participation in a Multidisciplinary

surgical preparatory regimen

In adolescents age 12-17 years, the bariatric surgical procedures identified above

are proven and medically

necessary for treating obesity when all of the following criteria are met:

One of the following:

o Class III obesity; or

o Class II obesity in the presence of one or more of the following co-morbidities:

 Insulin resistance or Type 2 diabetes; or

 Poorly controlled hypertension (systolic blood pressure greater than 140 mm Hg or diastolic blood pressure

90 mm Hg or greater, despite pharmacotherapy)]; or

 Hyperlipidemia; or

 Obstructive Sleep Apnea confirmed on polysomnography with an AHI or RDI of > 30; or

 Evidence of Nonalcoholic Fatty Liver Disease (NAFLD), or

 Idiopathic intracranial hypertension (pseudotumor cerebri)

and

The individual must also receive an evaluation at, or in consultation with, a Multidisciplinary center focused on the

surgical treatment of severe childhood obesity. This may include Adolescent centers that have received accreditation

by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) or can

demonstrate similar programmatic components

A planned two-stage procedure is proven and medically necessary when all of the following criteria are met:

Initial BMI ≥ 50 kg/m

prior to first stage bariatric procedure; and

Second stage occurs within 2 years following the primary bariatric surgery procedure; and

Individual has been compliant with nutrition and exercise; and

Individual meets medical necessity criteria listed above at time of second stage procedure

Revisional Bariatric Surgery using one of the procedures identified above

is proven and medically necessary

when due to a technical failure or major complication from the initial procedure; potential failure/complications

include but are not limited to the following:

Bowel perforation (including adjustable gastric band erosion)

Adjustable gastric band migration (slippage) that cannot be corrected with manipulation or adjustment (records must

demonstrate that manipulation or adjustment to correct band slippage has been attempted)

Leak

Obstruction (confirmed by imaging studies)

Staple-line failure

Mechanical adjustable gastric band failure

Uncontrollable reflux related to sleeve gastrectomy when all the following criteria are met:

o Maximum nonpharmacological medical management failure (e.g., positional, dietary modification and behavioral

changes); and

o Maximum pharmacological medical management failure (e.g., at least one month of double dose PPI, H2 blocker,

and/or sucralfate); and

o Severe esophagitis (grade C or D

) confirmed by endoscopy despite maximum medical management

Removal of adjustable gastric band and all related components which does not result in a revisional surgery is

proven and medically necessary.

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The following procedures are unproven and not medically necessary for treating obesity due to insufficient

evidence of efficacy:

Revisional Bariatric Surgery for any other indication than those listed above

Bariatric surgery as the primary treatment for any condition other than obesity

Bariatric interventions for the treatment of obesity including but not limited to:

o Bariatric artery embolization (BAE)

o Gastric electrical stimulation with an implantable gastric stimulator (IGS)

o Intragastric balloon

o Laparoscopic greater curvature plication, also known as total gastric vertical plication

o Mini-gastric bypass (MGB)/laparoscopic mini-gastric bypass (LMGBP)/One-Anastomosis Gastric Bypass (OAGB)

o Single-anastomosis duodenal switch [also known as duodenal switch with single anastomosis, or stomach

intestinal pylorus sparing surgery (SIPS)]

o Stomach aspiration therapy

o Transoral endoscopic surgery [includes TransPyloric Shuttle

(TPS

) Device, endoscopic sleeve gastroplasty]

o Vagus nerve blocking (VBLOC

)

o Gastrointestinal liners

Documentation Requirements

Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that

may require coverage for a specific service. The documentation requirements outlined below are used to assess whether

the member meets the clinical criteria for coverage but do not guarantee coverage of the service requested.

CPT Codes*

Required Clinical Information

Bariatric Surgery

43644, 43645,

43647, 43648,

43659, 43770,

43771, 43772,

43773, 43774,

43775, 43843,

43845, 43846,

43847, 43848,

43860, 43865,

43881, 43882,

43886, 43887,

43888, 64590,

64595.

Medical notes documenting the following, when applicable:

Member height

Member weight

Preoperative evaluation that includes a detailed weight and Body Mass Index (BMI) history

along with dietary and physical activity patterns

Provider attestation of Asian ancestry, when applicable, if individual is of Asian descent

Co-morbidities

Treatments tried, failed, or contraindicated; include the dates and reason for discontinuation

(e.g., medications, diet, exercise, etc.)

Psychosocial-behavioral evaluation by a licensed behavioral health professional

Nutritional consult

Name of the facility where the procedure will be performed

In addition to the above, for staged bariatric surgery for BMI > 50, please include plan

For subsequent bariatric surgery, also provide the following, when applicable:

o Previous unsuccessful medical treatment

o Initial bariatric surgery performed and date and subsequent results or complications that

require further surgical intervention

*For code descriptions, refer to the Applicable Codes section.

Definitions

Asian: Refers to a person having origins from the Far East, Southeast Asia, or the Indian subcontinent (e.g., Cambodia,

China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam) (United States Census

Bureau, 2012).

Body Mass Index (BMI): A person's weight in kilograms divided by the square of height in meters. BMI can be used as a

screening tool but is not diagnostic of the body fatness or health of an individual (Centers for Disease Control and

Prevention [CDC], 2017).

The National Heart, Lung, and Blood Institute’s (NHLBI) Practical Guide Identification, Evaluation and Treatment of

Overweight and Obesity in Adults classifies the ranges of BMI in adults as follows:

< 18.5 - Underweight

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UnitedHealthcare Commercial and Individual Exchange Medical Policy

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18.5 to 24.9 kg/m

– Normal Weight

25-29.9 kg/m

– Overweight

30-34.9 kg/m

– Obesity Class I

35-39.9 kg/m

– Obesity Class II

> 40 kg/m

– Obesity Class III

The American Society of Metabolic and Bariatric Surgeons (ASMBS; Pratt et al., 2018), classifies severe obesity in

adolescents as follows:

Class II obesity – 120% of the 95

percentile height, or an absolute BMI of 35-39.9 kg/m

, whichever is lower*

Class III obesity – 140% of the 95

percentile height, or an absolute BMI of > 40 kg/m

, whichever is lower

*Also as defined by the American Heart Association (Kelly et al., 2013).

Los Angeles (LA) Classification of Oesophagitis:

Grade A: One (or more) mucosal break no longer than 5 mm that does not extend between the tops of two mucosal

folds

Grade B: One (or more) mucosal break more than 5 mm long that does not extend between the tops of two mucosal

folds

Grade C: One (or more) mucosal break that is continuous between the tops of two or more mucosal folds but which

involve less than 75% of the circumference

Grade D: One (or more) mucosal break which involves at least 75% of the esophageal circumference

(Lundell, et al. 1999)

Multidisciplinary: Bariatric center or regimen combining or involving several academic disciplines or professional

specializations in an approach to create a well-trained, safe, and effective environment for the complex bariatric patient.

Building the Multidisciplinary team includes staff such as the bariatric surgeon, obesity medicine specialist, registered

dietician, specialized nursing, behavioral health specialist, exercise specialist and support groups (American Society for

Metabolic and Bariatric Surgery (ASMBS) textbook of bariatric surgery).

Nonalcoholic Fatty Liver Disease (NAFLD): Condition that is evidenced by hepatic steatosis (HS) diagnosed either by

imaging or histology without a secondary cause of hepatic fat accumulation such as significant alcohol consumption, long-

term use of steatogenic medication, or monogenic hereditary disorders. (Chalasani et al., 2018)

Obstructive Sleep Apnea (OSA): The American Academy of Sleep Medicine (AASM) defines OSA as a sleep related

breathing disorder that involves a decrease or complete halt in airflow despite an ongoing effort to breathe. OSA severity

is defined as:

Mild for AHI or RDI ≥ 5 and < 15

Moderate for AHI or RDI ≥ 15 and ≤ 30

Severe for AHI or RDI > 30/hr

For additional information, refer to the Medical Policy titled Obstructive and Central Sleep Apnea Treatment.

Revisional Bariatric Surgery:

Conversion – A second bariatric procedure that changes the bariatric approach from one procedure to a different type

of procedure (e.g., sleeve gastrectomy or adjustable gastric band converted to Roux-en-Y [RYGB]). Note: This is not

the same as an intraoperative conversion (e.g., converting from laparoscopic approach to an open procedure).

Corrective – A procedure that corrects or modifies anatomy of a previous bariatric procedure to achieve the original

desired outcome or correct a complication. These procedures also address device manipulation (e.g., gastric pouch

resizing, re-sleeve gastrectomy, limb length adjustments in RYGB and gastric band replacement).

Reversal – A procedure that restores original anatomy. (Mirkin, et al. 2021)

Applicable Codes

The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all

inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered

health service. Benefit coverage for health services is determined by the member specific benefit plan document and

applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to

reimbursement or guarantee claim payment. Other Policies and Guidelines may apply.

Coding Clarification: Utilize CPT code 43775 to report laparoscopic sleeve gastrectomy rather than the unlisted CPT

code 43659.

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CPT Code

Description

0813T

Esophagogastroduodenoscopy, flexible, transoral, with volume adjustment of intragastric bariatric

balloon

43290

Esophagogastroduodenoscopy, flexible, transoral; with deployment of intragastric bariatric balloon

43291

Esophagogastroduodenoscopy, flexible, transoral; with removal of intragastric bariatric balloon(s)

43644

Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and Roux-en-Y

gastroenterostomy (roux limb 150 cm or less)

43645

Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and small intestine

reconstruction to limit absorption

43647

Laparoscopy, surgical; implantation or replacement of gastric neurostimulator electrodes, antrum

43648

Laparoscopy, surgical; revision or removal of gastric neurostimulator electrodes, antrum

43659

Unlisted laparoscopy procedure, stomach

43770

Laparoscopy, surgical, gastric restrictive procedure; placement of adjustable gastric restrictive

device (e.g., gastric band and subcutaneous port components)

43771

Laparoscopy, surgical, gastric restrictive procedure; revision of adjustable gastric restrictive device

component only

43772

Laparoscopy, surgical, gastric restrictive procedure; removal of adjustable gastric restrictive device

component only

43773

Laparoscopy, surgical, gastric restrictive procedure; removal and replacement of adjustable gastric

restrictive device component only

43774

Laparoscopy, surgical, gastric restrictive procedure; removal of adjustable gastric restrictive device

and subcutaneous port components

43775

Laparoscopy, surgical, gastric restrictive procedure; longitudinal gastrectomy (i.e., sleeve

gastrectomy)

43843

Gastric restrictive procedure, without gastric bypass, for morbid obesity; other than vertical-banded

gastroplasty

43845

Gastric restrictive procedure with partial gastrectomy, pylorus-preserving duodenoileostomy and

ileoileostomy (50 to 100 cm common channel) to limit absorption (biliopancreatic diversion with

duodenal switch)

43846

Gastric restrictive procedure, with gastric bypass for morbid obesity; with short limb (150 cm or less)

Roux-en-Y gastroenterostomy

43847

Gastric restrictive procedure, with gastric bypass for morbid obesity; with small intestine

reconstruction to limit absorption

43848

Revision, open, of gastric restrictive procedure for morbid obesity, other than adjustable gastric

restrictive device (separate procedure)

43860

Revision of gastrojejunal anastomosis (gastrojejunostomy) with reconstruction, with or without

partial gastrectomy or intestine resection; without vagotomy

43865

Revision of gastrojejunal anastomosis (gastrojejunostomy) with reconstruction, with or without

partial gastrectomy or intestine resection; with vagotomy

43881

Implantation or replacement of gastric neurostimulator electrodes, antrum, open

43882

Revision or removal of gastric neurostimulator electrodes, antrum, open

43886

Gastric restrictive procedure, open; revision of subcutaneous port component only

43887

Gastric restrictive procedure, open; removal of subcutaneous port component only

43888

Gastric restrictive procedure, open; removal and replacement of subcutaneous port component only

64590

Insertion or replacement of peripheral, sacral, or gastric neurostimulator pulse generator or receiver,

requiring pocket creation and connection between electrode array and pulse generator or receiver

64595

Revision or removal of peripheral, sacral, or gastric neurostimulator pulse generator or receiver,

with detachable connection to electrode array

64999

Unlisted procedure, nervous system

CPT

is a registered trademark of the American Medical Association

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Description of Services

Obesity

Obesity is defined clinically using the Body Mass Index (BMI). Obesity is a significant health concern due to its high

prevalence and associated health risks.

Health consequences associated with obesity include hypertension, Type II diabetes, hyperlipidemia, atherosclerosis,

heart disease, stroke, diseases of the gallbladder, liver disease, osteoarthritis, Obstructive Sleep Apnea, and other

respiratory problems. In addition, certain cancers are more prevalent in obese individuals, including endometrial, ovarian,

breast, prostate, colon cancer, renal cell carcinoma, and non-Hodgkin's lymphoma.

The U.S. Preventive Services Task Force (USPSTF) recommends screening all adults for obesity. Clinicians should offer

or refer patients with a BMI of 30 kg/m2 or higher to intensive, multicomponent behavioral interventions (USPSTF, 2012).

Bariatric Surgery in the Adolescent Population

For Adolescents, physical development and maturation may be determined utilizing the gender specific growth chart and

BMI chart developed by the CDC, National Center for Health Statistics.

First-Line Treatments for Obesity

First-line treatments for obesity include dietary therapy, physical activity, behavior modification, and medication

management; all of which have often been unsuccessful in long-term weight management for obese individuals (Lannoo

and Dillemans, 2014).

Bariatric Surgical Procedures

The goal of surgical treatment for obesity is to induce significant weight loss and, thereby, reduce the incidence or

progression of obesity-related comorbidities, as well as to improve quality of life. The purpose of performing bariatric

surgery in Adolescent patients is to reduce the lifelong impact of severe obesity.

Surgical treatment of obesity offers two main weight-loss approaches: restrictive and malabsorptive. Restrictive methods

are intended to cause weight loss by restricting the amount of food that can be consumed by reducing the size of the

stomach. Malabsorptive methods are intended to cause weight loss by limiting the amount of food that is absorbed from

the intestines into the body. A procedure can have restrictive features, malabsorptive features, or both. The surgical

approach can be open or laparoscopic. The clinical decision on which surgical procedure to use is made based on a

medical assessment of the patient's unique situation.

Roux-en-y Bypass (RYGB)/Gastric Bypass

The RYGB procedure involves creating a stomach pouch out of a small portion of the stomach and attaching it directly to

the small intestine, bypassing a large part of the stomach and duodenum.

Laparoscopic Adjustable Gastric Banding (LAGB)

The laparoscopic adjustable gastric banding procedure involves placing an inflatable silicone band around the upper

portion of the stomach. The silicone band contains a saline reservoir that can be filled or emptied under fluoroscopic

guidance to change the caliber of the gastric opening.

Vertical Sleeve Gastrectomy (VSG)

VSG can be performed as part of a two-staged approach to surgical weight loss or as a stand-alone procedure. A VSG

involves the removal of 60-75% of the stomach, leaving a narrow gastric “tube” or “sleeve.” This small remaining “tube”

cannot hold as much food and produces less of the appetite-regulating hormone ghrelin, lessening a patient’s desire to

eat. VSG is not a purely malabsorptive procedure, so there is no requirement for lifetime nutritional supplementation

(California Technology Assessment Forum, 2015).

Biliopancreatic Diversion with Duodenal Switch (BPD/DS) (also known as the

Scopinaro Procedure)

BPD is primarily malabsorptive but has a temporary restrictive component. As in RYGB, three "limbs" of intestine are

created: one through which food passes, one that permits emptying of fluids (e.g., bile) from digestive organs, and a

common limb through which both food and digestive fluids pass. This procedure involves removal of the greater curvature

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of the stomach instead of the distal portion. The two limbs meet in a common channel measuring only 50 to 100 cm,

thereby permitting relatively little absorption.

Robotic-Assisted Surgery

Robotic surgery provides surgeons with three-dimensional vision, increased dexterity and precision by downscaling

surgeon's movements enabling a fine tissue dissection and filtering out physiological tremor. It overcomes the restraint of

torque on ports from thick abdominal wall and minimizes port site trauma by remote center technology (Bindal et al.,

2015).

Transoral Endoscopic Surgery

Transoral endoscopic surgery is an option being explored for bariatric surgery. Natural orifice transluminal endoscopic

surgery (NOTES) is performed via a natural orifice (e.g., mouth, vagina, etc.), and in some cases eliminates the need for

abdominal incisions. This form of surgery is being investigated as an alternative to conventional surgery.

Transoral restorative obesity surgery (ROSE) is another endoscopic procedure. The endoscope with four channels is

inserted into the esophagus and then the stomach. Specialized instruments are placed through the channels to create

multiple folds around the existing stoma to reduce the diameter.

The Transpyloric Shuttle

(TPS

) device is a non-balloon, space occupying device with a 12-month treatment duration

that is proposed as a new endoscopic bariatric therapy. The TPS device is comprised of a spherical silicone bulb

connected to a smaller cylindrical silicone bulb by a flexible tether; it is delivered to and removed from the stomach using

transluminal endoscopic procedures in the outpatient setting (Marinos, 2014). The device was granted FDA premarket

approval on April 16, 2019, and was approved for up to 12 months weight loss therapy in patients with a BMI of 35.0

kg/m2 to 40.0 kg/m2 or a BMI of 30.0 kg/m2 to 34.9 kg/m2 with 1 or more obesity-related comorbid condition. The device

is intended to be used in conjunction with a diet and behavior modification program (ECRI, 2019).

Endoscopic Sleeve Gastroplasty (ESG) is a minimally invasive technique through the mouth that uses an endoscopic

suturing device (e.g., OverStitch) to reduce gastric capacity by sealing off most of the stomach, forcing ingested food

through an open tube of stomach tissue that connects the esophagus to the small intestine. ESG is similar to a

laparoscopic sleeve gastrectomy in which the stomach is manipulated to create a tube-shape, however no stomach tissue

is removed.

Laparoscopic Mini Gastric Bypass (LMGBP)/One-Anastomosis Gastric Bypass

(OAGB)

LMGBP/OAGB involves the construction of a gastric tube by dividing the stomach vertically, down to the antrum. As in the

RYGB, food does not enter the distal stomach. However, unlike gastric bypass surgery, digestive enzymes and bile are

not diverted away from the stomach after LMGBP/OAGB. This can lead to bile reflux gastritis which can cause pain that is

difficult to treat.

Implantable Gastric Stimulator (IGS)

IGS is a small, battery-powered device similar to a cardiac pacemaker, in a small pocket, created beneath the skin of the

abdomen using laparoscopy. The IGS is programmed externally using a controller that sends radiofrequency signals to

the device. Although the exact mechanism of action is not yet understood, gastric stimulation is thought to target ghrelin,

an appetite-related peptide hormone (Gallas and Fetissov, 2011).

Vagus Nerve Blocking Neurostimulation Therapy (VBLOC)

VBLOC uses an implanted subcutaneous neurostimulator to deliver electrical pulses to the vagus nerve, which may

suppress appetite (ECRI, 2016).

VBLOC therapy () is designed to target the multiple digestive functions under control of the vagus nerves and to affect the

perception of hunger and fullness.

Intragastric Balloon (IGB)

IGBs are acid-resistant balloons that are inserted into the stomach and expanded with saline or air. These space-

occupying devices promote weight loss by creating a feeling of fullness, which can lead to reduced consumption of food.

The devices are intended as an adjunct to diet, exercise, and behavioral counseling for the treatment of obesity (Hayes,

2021). Available clinical data and manufacturer recommendations indicate 6 months to be the current standard duration of

therapy from insertion to removal (ASMBS, 2016).

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Laparoscopic Greater Curvature Plication (LGCP) [also known as Total Gastric

Vertical Plication (TGVP)]

LGCP is a restrictive procedure that involves folding and suturing the stomach onto itself to decrease the size of the

stomach and requires no resection, bypass, or implantable device. This procedure is a modification of the gastric sleeve

which requires surgical resection of stomach.

Stomach Aspiration Therapy

Stomach aspiration therapy, such as with the AspireAssist

, uses a surgically placed tube (endoluminal device) designed

to aspirate a portion of the stomach contents after every meal (Hayes, 2021). The AspireAssist

is intended for long-term

use in conjunction with lifestyle therapy (to help patients develop healthier eating habits and reduce caloric intake) and

continuous medical monitoring. Patients must be monitored regularly for weight loss progress, stoma site heath, and

metabolic and electrolyte balance.

Bariatric Artery Embolization (BAE)

BAE is a minimally invasive procedure which is the percutaneous, catheter-directed, trans-arterial embolization of the left

gastric artery (LGA). The procedure is performed by an interventional radiologist and targets the fundus that produces the

majority of the hunger-controlling hormone ghrelin. Beads placed inside the vessels purportedly help decrease blood flow

and limit the secretion of ghrelin to minimize feelings of hunger to initiate weight loss.

Gastrointestinal Liners

Gastrointestinal liners, such as the EndoBarrier

™

system, utilize an endoscopically implanted sleeve into the stomach to

reduce the stomach size. The sleeve is then removed after weight loss has been achieved. The EndoBarrier is not

approved for use by the U.S. Food and Drug Administration (FDA) in the United States; it is limited by federal law to

investigational use only.

Single-Anastomosis Duodenal Switch (SADS)

SADS is also called single-anastomosis loop duodenal switch, single-anastomosis duodenoileal bypass with sleeve

gastrectomy, or stomach intestinal pylorus-sparing surgery—is a modification of biliopancreatic diversion with duodenal

switch (BPD-DS). SADS consists of a sleeve gastrectomy to remove most of the stomach and an intestinal bypass to

shorten the length of the small intestine and to allow bile and pancreatic digestive juices to mix with the food. SADS is

typically performed laparoscopically as an inpatient procedure.

Revisional Surgery

The indications for Revisional Bariatric Surgery vary greatly depending on the index procedure performed and the nature

of the complication. Some complications may be encountered during the acute postoperative recovery period (leaks,

abscesses, fistulae, etc.). Prior to revisional surgery, patients should undergo a thorough Multidisciplinary assessment

and consideration of their individual risks and benefits from revisional surgery (Brethauer et al., 2014). It is important to

determine if the poor response to primary bariatric surgery is due to anatomic causes that led to inadequate weight loss or

weight regain or to the patient’s postoperative behavior, such as not following the prescribed diet and lifestyle changes

(e.g., consuming large portions, high-calorie foods, and/or snacks between meals; not exercising). Uncontrollable reflux

may be a complication experienced by some patients; first-line therapy for patients who experience GERD after bariatric

surgery includes dietary and lifestyle modification, alcohol, and smoking cessation, followed by acid-reducing medications

(King et al. 2021).

The Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) is a national

accreditation standard for bariatric surgery centers. In 2012, the American College of Surgeons (ACS) and the American

Society for Metabolic and Bariatric Surgery (ASMBS) combined their individual accreditation programs into a single unified

program. MBSAQIP works to advance safe, high-quality care for bariatric surgical patients through the accreditation of

bariatric surgical centers. A bariatric surgical center achieves accreditation following a rigorous review process during

which it proves that it can maintain certain physical resources, human resources, and standards of practice. All accredited

centers report their outcomes to the MBSAQIP database (MBSAQIP, 2019).

Benefit Considerations

Most Certificates of Coverage and many Summary Plan Descriptions explicitly exclude benefit coverage for bariatric

surgery.

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Some states may require coverage for bariatric surgery. Refer to the member specific benefit plan document to determine

availability of benefits for these procedures. As in all benefit adjudication, state legislated mandates must be followed.

Therefore, the applicable state-specific requirements and the member specific benefit plan document must be reviewed to

determine what benefits, if any, exist for bariatric surgery.

For Fully Insured Group Policies in Maryland Only

Use the following criteria as specified in the Code of Maryland Regulations COMAR 31.10.33.03B (Accessed on

November 27, 2023):

A Body Mass Index (BMI) above 40 kg/m2 without co-morbidity; or

A BMI of 35 kg/m2 or greater with obesity-related co-morbid medical conditions including:

o Hypertension

o Cardiopulmonary condition

o Sleep apnea

o Diabetes

o Any life threatening or serious medical condition that is weight induced

Age 18 years or older

Completion of a structured diet program, such as Weight Watchers or Jenny Craig. Either of the following in the two-

year period that immediately precedes the request for the surgical treatment of morbid obesity meets the indication:

o One structured diet program for six consecutive months; or

o Two structured diet programs for three consecutive months

A carrier or a private review agent acting on behalf of a carrier shall use flexibility with regard to defining a structured

diet program

Completion of a psychological examination of the member's readiness and fitness for surgery and the necessary

postoperative lifestyle changes

Use the following criteria as specified in the Code of Maryland Regulations COMAR 31.10.33.04

(Accessed on November

27, 2023):

Documentation of completion of a structured diet program should include:

o Physician Notes

o Notes of health care providers, other than physicians

o Receipts of payment for a structured diet program; or

o Diet or weight loss logs from a structured diet program

Clinical Evidence

The criteria for patient selection for bariatric surgery are relatively uniform among clinical studies published in the peer-

reviewed literature and broadly correspond to criteria recommended by the American Association of Clinical

Endocrinologists (AACE), the Obesity Society, and American Society for Metabolic & Bariatric Surgery (ASMB)

(Mechanick et al., 2019):

Patients with a BMI ≥ 40 kg/m2 (Obesity Class III) with or without coexisting medical problems and for whom bariatric

surgery would not be associated with excessive risk.

Patients with a BMI ≥ 35 kg/m2 (Obesity Class II) and one or more severe obesity-related co-morbidities.

Demonstration that a multidisciplinary approach with dietary, other lifestyle modifications (such as exercise and

behavioral modification), and pharmacological therapy, if appropriate, have been unsuccessful.

Refer to the Clinical Practice Guidelines

section below for additional information.

Kapeluto et al. (2020) assessed long-term glycemic outcomes in 132 patients with type 2 diabetes (T2D) that received

Biliopancreatic Diversion with Duodenal Switch (BPD/DS) surgery versus other bariatric surgeries. Inclusion criteria

consisted of patients with diagnosis of T2D and those that had underwent BPD/DS surgical procedure. Patient follow up

consisted of post-surgical assessments at week 3 and then at 4, 8, 12, 18, and 24 months and annually thereafter. Fifteen

patients were lost to death during the 10 years follow-up and two more beyond 10 years. 90% of the patients had clinical

remission of their diabetes; 3 patients had partial remission, 21 had improvement and 3 were unchanged in their status.

The authors found that BPD-DS maintained a remission rate of 10 years postop in the vast majority of patients with

advanced diabetes. The authors concluded patients that underwent BPD-DS had positive results for long-term benefits for

remission of T2D and that earlier referral for this type of surgery should be made. Limitations included late arrival of the

standard use of the HbA1C test, incomplete weight parameters due to lack of self-reported weights and retrospective

analysis.

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Khalaj et al. (2020) conducted a cohort study comparing gastric bypass (GB) to sleeve gastrectomy (SG) and the

effectiveness and safety of these two procedures. The authors evaluated 2,202 patients that underwent laparoscopic SG

and 1,085 patients who underwent laparoscopic GB. The SG procedure was performed over a 36-F bougie and reinforced

with an omental pouch; the GB procedure was performed as either RYGB or one anastomosis (OAGB). Evaluation of

weight loss included body mass index change, percent of total weight loss, and percentage of excess weight loss. Type 2

diabetes mellitus (T2DM), hypertension (HTN), and dyslipidemia, as obesity-associated comorbidities were assessed in

all patients. There were no major complications identified which was recognized by a return to the operating room,

prolonged hospital stays beyond 7 days, or the need for re-admission. Quality of life (QoL) was assessed using the

Iranian version of the Short-Form Health Survey which measured physical, social, and mental aspects of health. Patient

follow up for both types of procedures occurred at 6, 12, and 24 months after surgery. The authors found no significant

differences between the two surgical groups; patients that underwent SG had a lower FPG and HbA1C when compared to

the GB group. BMI was not significantly different between the two groups. Excess weight loss (EWL)% was 61.9 ±15.7,

74.8 ±19.1, and 75.0 ±21.9 in the SG group and 62.7 ±15.3, 77.5 ±18.4, and 80.1 ±20.8 in the GB group at 6-, 12-, and

24-month follow-ups, respectively. All patient comorbidities and QoL improved. The authors concluded that bariatric

surgery is effective and safe for treatment of obesity; while both procedures are effective for weight loss, remission of

obesity-associated comorbidities, and QoL, SG is associated with fewer complications and nutritional deficiencies.

Jung et al. (2020) conducted a systematic review and meta-analysis of 22 studies with 2,141 patients to comprehensively

evaluate the efficacy of different endoscopic bariatric procedures compared to lifestyle modification in the treatment of

morbid obesity. Intragastric balloon, duodenal-jejunal bypass liner (DJBL), aspiration therapy, primary obesity surgery

endoluminal (POSE) procedure, and botulinum toxin injection to the stomach were included and the meta-analysis

determined the percentage of weight loss (%weight loss) and percentage of excess weight loss (%EWL). The results

showed that the Obalon Balloon system was shown to have efficacy for both %weight loss and %EWL, its efficacy was

not proven due to the small number of studies and comparatively low effect size. Aspiration therapy demonstrated

effectiveness for weight reduction when compared to lifestyle modification. Gas-filled balloon and botulinum toxin injection

did not show a significant difference in %weight loss or %EWL compared with the control. The authors concluded that all

bariatric endoscopic procedures, with the exception of a gas filled balloon and botulinum toxin injection show superior

short-term efficacy compared with lifestyle modification. These findings are limited by lack of long-term efficacy and safety

quality data. (The following publications previously cited in this policy, are included in this systematic review: Abu Dayyeh

2015b, Chang 2014, Courcoulas 2017, Gersin 2010, Schouten 2010, Sullivan 2013, Thompson 2017).

O’Brien et al. (2019) performed a systematic review and meta-analysis on 33 reports containing ten or more years of

follow-up for patients that underwent bariatric surgery. The authors evaluated the long-term effectiveness of Roux-en-Y

gastric bypass (RYGB), laparoscopic adjustable gastric banding (LAGB), or BPD/DS. Results for gastric bypass surgery

showed a weighted mean % EWL of 56.7% at 10 or more years with a mean of 55.4% EWL. Eleven reports addressing

BPD/DS showed a mean of 74.1% EWL and two reports for sleeve gastrectomy showed a mean of 57.0% EWL. A

longitudinal cohort study for the patients receiving LAGB showed patient weight loss reached a peak at the 2-year follow-

up and remained relatively stable through the next 18 years with a mean weight loss of 24.8 kg representing 47.2 %EWL.

The authors concluded that RYGB, LAGB and BPD/DS lead to substantial weight loss which continued for at least 10

years. Due to patient education and lap band design changes, revisional surgery has decreased significantly over the past

eleven years. The findings are limited by lack of direct comparison between techniques and lack of comparison groups not

undergoing surgical treatments. (The following publications previously cited in this policy, are included in this systematic

review: Maciejewski 2016, Salminen 2018, Schauer 2017, Sethi 2016, Sheikh 2017, Topart 2017, Vinzens 2017).

Zhao and Jiao (2019) conducted a systematic review to determine whether LRYGB and LSG are equivalent for mid- and

long-term weight loss, resolution of comorbidities and adverse events (AEs). Eleven RCTs were included in the meta-

analysis and the authors found no significant difference in excess weight loss between LRYGB and LSG nor any

significant difference for T2D improvement. This analysis did identify more postoperative early complications for LRYGB,

but no difference between the two procedures in later postoperative period. Future studies should focus on the

comparison of complication and comorbidities. Limitations included the variation in sample size among the included

studies which may have created a bias, variation of patient age and preoperative BMIs which may have led to

heterogeneity, and failure of subgroup analysis for reoperation rate. Additional studies are needed to determine the

relative long-term efficacy of different bariatric surgeries. (Publication by Salminen 2018, which was previously cited in this

policy, is included in this systematic review).

Chaar et al. (2018) reported 30-day outcomes of SG versus RYGB based on the Metabolic and Bariatric Surgery

Accreditation and Quality Improvement Program database in a large retrospective cohort study. The authors’ evaluation

showed that the incidence of postoperative complications in the first 30 days after surgery is low for both RYGB and SG.

However, SG seems to have a better safety profile in the first 30 days postoperatively compared with RYGB. These

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findings should be considered in the preoperative evaluation and counseling of bariatric patients. Long-term follow-up is

needed to compare safety and efficacy of SG versus RYGB.

Jambhekar et al. (2018) evaluated demographic and socioeconomic factors in the United States that are predictors of

long-term weight loss after LSG in a cohort study. Prospectively collected data on 713 consecutive primary LSG

operations was included in this study. Multiple regression analyses were done to determine if gender, race, or

socioeconomic factors such as insurance and employment status correlated with postoperative weight loss. The presence

of chronic comorbidities affecting quality of life such as T2D and obstructive sleep apnea (OSA) were also recorded and

analyzed. All studied groups had similar preoperative body mass index (BMI) (mean 46 kg/m

). Race was not significantly

associated with weight loss at any postoperative interval. Male gender was associated with increased weight loss through

the first three months (48.2 +/- 12.5 lbs. vs. 40.5 +/- 11 lbs.; p = 0.0001). Patients with T2D had significantly less weight

loss at the 6 through 18-month intervals (50.4 +/- 17.9 lbs. vs. 59.6 +/- 15.6 lbs. at six months; p = 0.00032; 53.3 +/-

25.4lbs vs. 80.5 +/- 31.3lbs at 18 months; p = 0.008). Patients with OSA had significantly less weight loss at the two-year

interval (57.5 +/- 29.2 lbs.) vs. those without OSA (69.6 +/- 23.5 lbs.; p = 0.047). Finally, those patients who were students

had the greatest weight loss at two years postoperatively with the least weight loss seen in retired patients followed by

those on disability (108.0 +/-21.5 lbs. vs. 26.0 lbs. vs. 46.0 +/-19.7 lbs.; p = 0.04). Further studies are needed to evaluate

whether demographic differences impact long term weight loss. Limitations included loss to follow-up, identification, and

testing of only selected predictive factors, thus underrepresenting other socioeconomic factors, and conflicting results

were identified between the model variables.

Shoar and Saber (2017) conducted a systematic review and meta-analysis to compare long-term and midterm outcomes

of LSG versus laparoscopic RYGB (LRYGB). Fourteen studies comprising 5264 patients were eligible. Follow-up ranged

from 36 months to 75.8 ±8.4 months. The pooled result for weight loss outcomes did not show any significant difference in

midterm weight loss (standardized mean difference = -0.03; 95% confidence interval (CI), -0.38-.33; p = .88) but a

significant difference in the long-term weight loss outcome favoring LRYGB (standardized mean difference = .17; 95% CI,

.05-.28; p = .005). The pooled results demonstrated no significant difference for resolution of T2D, hypertension,

hyperlipidemia, and hypertriglyceridemia. Despite the insignificant difference between LRYGB and LSG in midterm weight

loss, LRYGB produced better weight loss in the long-term. There was no significant difference between the 2 procedures

for co-morbidity resolution. A major limitation of this study was the inclusion of short-term studies in the pooled analysis of

midterm studies but claimed to be a long-term meta-analysis.

Lager et al. (2017) retrospectively studied 30-day postoperative complications as well as changes in weight, blood

pressure, cholesterol, hemoglobin, hemoglobin A1C, and creatinine from baseline to 2, 6, 12, and 24 months

postoperatively in 383 patients undergoing RYGB and 336 patients undergoing SG. Follow-up rates were 706/719 at 2

months, 566/719 at 6 months, 519/719 at 12 months, and 382/719 at 24 months. Baseline characteristics were similar in

both groups except for higher weight and BMI in the SG group. The RYGB group experienced greater total body weight

loss at 6, 12, and 24 months (41.9 vs. 34.6 kg at 24 months, p < 0.0001). Excess weight loss was 69.7 and 51.7 %

following RYGB and SG respectively at 24 months (p < 0.0001). Blood pressure improved significantly in both groups.

Surgical complication rates were greater after RYGB (10.1 vs. 3.5 %, p = 0.0007) with no significant difference in life-

threatening or potentially life-threatening complications. Weight loss was greater following RYGB compared to SG at 2

years. The authors recommend that surgical intervention be tailored to surgical risk, comorbidities, and desired weight

loss. Limitations included retrospective design which may have impacted patient selection and other biases, incomplete

biochemical data as some patients did not return to clinic for routine blood draws and performed at specific institution.

Kang and Le (2017) conducted a systematic review and meta-analysis to determine the effectiveness of bariatric surgical

procedures. Eleven randomized controlled trials (RCTs) that met the criteria were included in the review. Of 9 trials (n =

765), the differences in mean BMI reduction were -0.76 (95% CI: -3.1 to 1.6) for RYGB versus SG, -5.8 (95% CI: -9.2 to -

2.4) for RYGB versus LAGB, and -5.0 (95% CI: -9.0 to -1.0) for SG versus LAGB. Eight RCTs (n = 656) reported

percentage excess weight-loss (%EWL), the mean differences between RYGB and SG, RYGB and LAGB, and SG and

LAGB were 3.8% (95% CI: -8.5% to 13.8%), -22.2% (95% CI: -34.7% to -6.5%), and -26.0% (95% CI: -40.6% to -6.4%),

respectively. The meta-analysis indicated low heterogeneity between studies, and the node splitting analysis showed that

the studies were consistent between direct and indirect comparisons (p > .05). The authors concluded that the RYGB and

SG were similar in weight-loss effect, and both were superior to LAGB. Other factors such as complications and patient

preference should be considered during surgical consultations.

In a systematic analysis, Osland et al. (2017a) evaluated the postoperative impact on T2D resolution following

laparoscopic vertical sleeve gastrectomy (LVSG) and LRYGB. Seven RCTs involving a total of 732 patients (LVSG n =

365, LRYGB n = 367) met inclusion criteria. Significant diabetes resolution or improvement was reported with both

procedures across all time points. Similarly, measures of glycemic control (HbA1C and fasting blood glucose levels)

improved with both procedures, with earlier improvements noted in LRYGB that stabilized and did not differ from LVSG at

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12 months postoperatively. Early improvements in measures of insulin resistance in both procedures were also noted in

the studies that investigated this. The authors suggest that both procedures are effective in resolving or improving

preoperative T2Din obese patients during the reported 3-to -5-year follow-up periods. However, further studies are

required before longer-term outcomes can be elucidated. Areas identified that need to be addressed for future studies on

this topic include longer follow-up periods, standardized definitions, and time point for reporting.

Osland et al. (2017b) conducted a systematic review of non-diabetic comorbid disease status following LRYGB and

LVSG. Six RCTs involving a total of 695 patients (LVSG n = 347, LRYGB n = 348) reported on the resolution or

improvement of comorbid disease following LVSG and LRYGB procedures. The authors concluded that this systematic

review of RCTs suggests that both LVSG and LRYGB are effective in resolving or improving preoperative nondiabetic

comorbid diseases in obese patients. While results are not conclusive, in the authors’ opinion, LRYGB may provide

superior results compared to LVSG in mediating the remission and/or improvement in some conditions such as

dyslipidemia and arthritis.

Polega et al. (2017) conducted a matched cohort study of laparoscopic BPD/DS and SG to compare 30-day outcomes. Of

the 741 patients who underwent BPD/DS or SG, 2 cohorts of 167 patients each were matched for age, sex, and BMI.

Length of stay (LOS) was longer in the BPD/DS cohort (2.5 ±.9 days versus 2.1±.7 days, p < .001). There were no

significant differences between the groups in relation to 30-day postoperative rates of leak (0.3% versus 0.6%, p > 0.99),

bleed (0% versus 0.3%, p > 0.99), reoperation (1.2% versus .6%, p > .99), or readmission (3% versus 1.2%, p = .45).

There were no mortalities. After matching for age, sex, and BMI, the authors found no significant differences between

BPD/DS and SG with regard to 30-day postoperative rates of leak, bleed, reoperation, readmission, or mortality.

Risstad et al. (2017) conducted a randomized clinical trial with 60 patients with body mass index 50-60 kg/m2 to

investigate bile acid profiles up to 5 years after RYGB and BPD/DS. Total bile acid concentrations increased substantially

over 5 years after both RYGB and BPD/DS, with greater increases in total and primary bile acids after BPD/DS. Higher

levels of total bile acids at 5 years were associated with lower body mass index, greater weight loss, and lower total

cholesterol.

In a systematic review and meta-analysis, Osland et al. (2016) evaluated the early postoperative complication rate (i.e.,

within 30-days) in 6 RCTs involving a total of 695 patients (LVSG n = 347, LRYGB n = 348). A statistically significant

reduction in relative odds of early major complications favoring the LVSG procedure was noted (p = 0.05). Five RCTs

representing 633 patients (LVSG n = 317, LRYGB n = 316) reported early minor complications. A non-statically significant

reduction in relative odds of 29 % favoring the LVSG procedure was observed for early minor complications (p = 0.4).

However, other outcomes directly related to complications which included reoperation rates, readmission rate, and 30-day

mortality rate showed comparable effect size for both surgical procedures. The authors concluded that this meta-analysis

and systematic review of RCTs suggests that fewer early major and minor complications are associated with LVSG

compared with LRYGB procedure. However, this does not translate into higher readmission rate, reoperation rate, or 30-

day mortality for either procedure.

Xie et al. (2016) prospectively evaluated Apnea-Hypopnea Index (AHI) and Functional Outcomes of Sleep Questionnaires

Scores (FOSQ) pre- and post-operatively in patients undergoing bariatric surgery. A total of 167 subjects were studied.

The median age was 46 (14-75) years and BMI 49 (36-69) kg/m2. Ninety-two (55.0%) patients were diagnosed with OSA

preoperatively. Fifty (54.0%) required positive airway pressure (PAP) therapy. The mean reduction in BMI post bariatric

surgery was 12.2 ± 4.52 kg/m2 at 6.56± 2.70 months. Eighty (87.9%) reported improved sleep quality reflected in

improved scores in all domains of the FOSQ (p < 0.001, paired t-test). Improvement in FOSQ scores remained significant

(p < 0.05) in those with and without OSA. Thirty-nine (90.7%) patients discontinued PAP due to resolution of daytime

sleepiness. In conclusion, the authors identified that weight loss following bariatric surgery has a positive impact on sleep

in patients with and without OSAS. The findings are however limited by lack of comparison group without bariatric surgery.

Giordano (2015) conducted retrospective comparative study of consecutive super-obese patients. Patients either

underwent RYGB (n = 102) or LAGB (n = 79). Early complications and weight loss outcomes were comparable between

the two groups in the short term. However, weight loss and excess weight loss percent at 6 and 12 months of follow-up

was significantly higher in patients who underwent RYGB than LAGB.

Arterburn et al. (2015) evaluated the association between bariatric surgery and long-term survival in a retrospective cohort

study of obese patients treated at the Veterans Administration (VA) health system. A cohort of surgical patients (n = 2500;

mean age, 52 years; mean body mass index [BMI] of 47), undergoing any bariatric surgery procedure, were compared

with control patients (n = 7462). At the end of 14 years, there were a total of 263 deaths in the surgical cohort group (n =

2500) and 1277 deaths in the matched controls (n = 7462). Based on Kaplan-Meier estimates, mortality rates were 2.4%

at 1 year, 6.4% at 5 years, and 13.8% at 10 years for surgical cohort patients. In the matched controls, mortality rates

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were 1.7% at 1 year, 10.4% at 5 years, and 23.9% at 10 years. Bariatric surgery was associated with reduced mortality

compared controls after 1 to 5 years (hazard ratio [HR], 0.45; 95% CI, 0.36 to 0.56) and after 5 years (HR, 0.47; 95%CI,

0.39 to 0.58). Across different subgroups based on diabetes diagnosis, sex, and period of surgery, there were no

significant differences between surgery and survival at the mid- and long-term evaluations. Limitations include lack of

randomization and retrospective design, lack of disease specificity due to inaccurate identification of comorbid conditions

with ICD-9 classification, and a small number of cases missing preoperative BMI data which may have affected the

results.

Magallares et al. (2015) conducted a meta-analysis of 21 studies evaluating the mental and physical health-related quality

of life (HR-QOL) measures with the Short Form-36 (SF-36) before and after bariatric surgery. Study authors reported that

obese patients scored less in the mental health component of SF-36 prior to bariatric surgery (n = 2680) compared with

after surgery (n = 2251). Similar results were observed in the physical health component of SF-36. Study authors

concluded that obese patients experienced strong improvement in mental and physical QOL measures following surgery.

The findings are limited by lack of comparison group.

A retrospective cohort study was conducted by Yska et al. (2015) within the Clinical Practice Research Datalink involving

2978 patients with a record of bariatric surgery, with a BMI of > 35. They identified 569 patients with T2D and matched

them to 1881 patients with T2D without bariatric surgery. Data on the use of medication and laboratory results were

evaluated. Among patients undergoing bariatric surgery, the authors found a prevalence of 19.1% for T2D. Per 1000

person-years, 94.5 T2D remissions were found in patients who underwent bariatric surgery compared with 4.9 remissions

in matched control patients. Patients with T2D who underwent bariatric surgery had an 18-fold increased chance for

remission (adjusted relative rate [RR], 17.8; 95% CI, 11.2-28.4) compared with matched control patients. The authors

conclude that bariatric surgery strongly increases the chance for remission of T2D with gastric bypass and sleeve

gastrectomy having a greater effect than gastric banding. Limitations included discrepancy between the patient’s actual

use of medication and what was recorded along with incomplete recording of clinical and laboratory testing.

A 2014 Cochrane Systematic Review of RCTs by Colquitt et al. found that surgery results in greater improvement in

weight loss outcomes and weight associated comorbidities compared with non-surgical interventions, regardless of the

type of procedures used. They noted the overall quality of evidence in this analysis to be moderate. When compared with

each other, certain procedures resulted in greater weight loss and improvements in comorbidities than others. Outcomes

were similar between RYGB and SG, and both of these procedures had better outcomes than AGB. However, in one

RCT, the LRGYB procedure resulted in greater duration of hospitalization in two RCTs (4/3.1 versus 2/1.5 days) and a

greater number of late major complications (26.1% versus 11.6%). For people with very high BMI, biliopancreatic

diversion with duodenal switch resulted in greater weight loss than RYGB. Duodenojejunal bypass with sleeve

gastrectomy and LRYGB had similar outcomes; however, this was based on one small trial. Isolated SG led to better

weight-loss outcomes than AGB after three years follow-up. This was based on one trial only. Weight-related outcomes

were similar between laparoscopic gastric imbrication and LSG in one trial. Across all studies adverse event rates and

reoperation rates were generally poorly reported. The authors also found that most trials followed participants for only one

or two years, therefore the long-term effects of surgery remain unclear. In addition, open RYGB, LRYGB and LSG led to

losses of weight and/or BMI but there was no consistent picture as to which procedure was better or worse in the seven

included trials. (The following publications previously cited in this policy, are included in this systematic review: Dixon

2008, Mingrone 2012, Schauer 2012).

A randomized, nonblinded, single-center trial, Schauer et al. (2012) evaluated the efficacy of intensive medical therapy

alone versus medical therapy plus RYGB or SG in 150 obese patients with uncontrolled T2D. The mean age of the

patients was 49 ±8 years, and 66% were women. The average glycated hemoglobin level was 9.2 ±1.5%. The primary

end point was the proportion of patients with a glycated hemoglobin level of 6.0% or less 12 months after treatment. In

obese patients with uncontrolled T2D, 12 months of medical therapy plus bariatric surgery achieved glycemic control in

significantly more patients than medical therapy alone. The authors conclude that further studies will be necessary to

assess the durability of these results.

In a systematic review and meta-analysis, Kadeli et al. (2012) evaluated whether preoperative weight loss before gastric

bypass correlates to weight loss up to 1-year post-surgery. Of the 186 studies screened, 12 were identified. A meta-

analysis was performed to further classify studies (A class, B class, regression, and rejected). The authors conclude that

losing weight leads to better outcomes because a patient entering surgery with a lower weight than someone entering

surgery without weight loss had more weight loss in total. (Publication by Still 2007, which was previously cited in this

policy, is included in this systematic review).

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Biliopancreatic Diversion/Biliopancreatic Diversion with Duodenal Switch (BPD/DS)

Strain et al. (2017) reported nine-year outcomes of BPD/DS. Initially 284 patients received a BPD/DS; 275 patients (69.8

% women) age 42.7 years, BMI 53.4 kg/m2 qualified for baseline analysis. Two hundred seventy-five patients were

available in year 1; 275 patients in year 3; 273 patients in year 5; 259 patients in year 7; and 228 patients in year 9.

Gender distribution was not different. BMI was 30.1 at 1 year and 32.0 at 9 years. Body fat was reduced to 26 % after 2

years. Nutritional problems developed in 29.8% of patients over the course of observation. There were significant positive

changes in quality of life between baseline and year 1 for most patients. Data showed that after surgery, the resolution of

comorbidities continued for the 9-year follow-up period. Weight loss during the first year was well maintained, resolving

comorbidities, and improving quality of life. According to the authors, rates of surgical complications resemble other

bariatric procedures; however long-term nutritional deficiencies are of concern. The findings are limited by lack of

comparison group.

Gastric Bypass (Roux-en-Y; Gastrojejunal Anastomosis)

Ikramuddin et al. (2018) conducted an observational follow-up of a multi-center randomized clinical trial involving 120

participants with T2D who had a hemoglobin A1c (HbA1c) level of 8.0% or higher and a BMI between 30.0 and 39.9.

Lifestyle-intensive medical management intervention was based on the Diabetes Prevention Program and Look AHEAD

trials for 2 years, with and without (60 participants each) RYGB followed by observation to year 5. Ninety-eight (82%)

patients completed 5 years of follow-up. At 5 years, 13 participants (23%) in the gastric bypass group and 2 (4%) in the

lifestyle-intensive medical management group had achieved the composite triple end point (difference, 19%; 95% CI, 4%-

34%; p = 0.01). In the 5th year, 31 patients (55%) in the gastric bypass group vs 8 (14%) in the lifestyle-medical

management group achieved an HbA1c level of less than 7.0% (difference, 41%; 95% CI, 19%-63%; p = 0.002).

Participants undergoing RYGB had more serious adverse events than did the lifestyle-medical management intervention,

66 events versus 38 events, most frequently gastrointestinal events, and surgical complications such as strictures, small

bowel obstructions, and leaks. The authors concluded that in this patient population there remained a significantly better

composite triple end point in the surgical group at 5 years. However, because the effect size diminished over 5 years,

further follow-up is needed to understand the durability of the improvement. One limitation included a poorly controlled

glycemic group of patients thus unsure if study results would be the same with a group of better controlled glycemic

patients. Additional limitations included incomplete follow up creating opportunity for bias and testing of a single type of

bariatric surgery therefore unable to apply conclusions to other bariatric surgical approaches.

In a matched observational cohort study, Liakopoulos et al. (2017) evaluated 6132 patients with a baseline BMI of 42

kg/m2 and T2D who underwent RYGB compared to patients who had not undergone RYGB. Over a 6-year follow-up

period, beneficial changes in BMI, hemoglobin A1C, blood lipids and blood pressure were seen compared with controls.

The authors concluded that improvements in risk factors might contribute to the reduction of mortality risk after RYGB in

obese individuals with type 2 diabetes, but the main effect seems to be mediated through a decrease in BMI, which could

serve as a proxy for several mechanisms.

In a retrospective analysis, Jirapinyo et al. (2017) evaluated the Bariatric Quality of Life (BQoL) scores for 56 patients who

underwent RYGB. The enrolled patients were divided into two groups: stable weight and weight regain with a review of

the BQoL Index scores for each. The authors demonstrated and found in addition to a return to comorbid illness, weight

regain was associated with worsening QoL thus showing the importance of close follow-up, early recognition, and

intervention. Limitations included lack of established definition of weight regain in the current literature, the imbalance of

weight regain and weight stable patients, and the retrospective nature of the study.

In a systematic review and meta-analysis, Yan et al. (2016) compared RYGB surgery versus medical treatment for type 2

diabetes mellitus T2D in obese patients. Six RCTs with a total of 410 patients with obesity and T2D were included, and

follow-up ranged from 12 to 60 months. The pooled analysis of T2D remission rates revealed a significantly higher

remission rate after RYGB surgery than after medical treatment alone. The meta-analysis showed a significant lower BMI

in individuals who underwent RYGB than those who received medical therapy alone. Based on the results, the authors

conclude that RYGB surgery is superior to medical treatment for short- to medium-term remission of T2D, improvement of

metabolic condition, and cardiovascular risk factors. The authors recommend well-designed studies with consistent

definition of adverse events, as well as a larger number of RCTs with long-term follow-up (> 60 months) to evaluate the

safety and long-term benefits of RYGB surgery on obese patients with T2D.

Cooper et al. (2015) assessed weight loss and occurrence of weight regain among patients (n = 300) at 1 year follow-up

who underwent RYGB at a single institution. The mean weight regain for all patients was 23.4 % of maximum weight loss.

Using categorical analysis, mean weight regain in the < 25, 25-30, 30-35, and > 35 % weight loss cohorts was 29.1, 21.9,

20.9, and 23.8 %, respectively. Excessive weight regain, defined as ≥ 25 % of total lost weight, occurred in 37 % of

patients. Despite the percentage of weight loss over the first year, all cohort patient groups regained on average between

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21 and 29 % of lost weight. Excessive weight gain was experienced by over one third of patients. Greater initial absolute

weight loss leads to more successful long-term weight outcomes.

Robotic-Assisted Gastric Bypass Surgery

Beckmann et al. (2020) conducted a retrospective analysis on 108 laparoscopic RYGB surgeries and 114 robotic RYGB

surgeries which were performed between 2016 and 2019. Analysis found operation time for the robotic RYGB was

significantly shorter, had less complications and fewer revisions were required when robotic surgery was used. The

authors concluded robotic RYGB surgery is safe and effective. Findings are limited by lack of randomization.

Gray et al. (2017) conducted a retrospective review of adult patients undergoing laparoscopic revisional bariatric surgery

(LRBS) or robotic revisional bariatric surgery (RRBS). A total of 84 patients who underwent LRBS (n = 66) or RRBS (n =

18) were included. The index operation was AGB in 39/84 (46%), sleeve gastrectomy (VSG) in 23/84 (27%), RYGB in

13/84 (16%), and vertical banded gastroplasty (VBG) in 9/84 (11%). For patients undergoing conversion from AGB (n =

39), there was no difference in operative time, length of stay, or complications by surgical approach. For patients

undergoing conversion from a stapled procedure (n = 45), the robotic approach was associated with a shorter length of

stay (5.8 ±3.3 vs 3.7±1.7 days, p = 0.04) with equivalent operative time and post-operative complications. There were

three leaks in the LRBS group and none in the RRBS group (p = 0.36). Major complications occurred in 3/39 (8%) of

patients undergoing conversion from AGB and 2/45 (4%) of patients undergoing conversion from a stapled procedure (p =

0.53) with no difference by surgical approach. RRBS is associated with a shorter length of stay than LRBS in complex

procedures and has at least an equivalent safety profile. Long-term follow-up data is anticipated.

Ayloo et al. (2016) retrospectively reviewed their experience with robotic approaches to RYGB using prospectively

maintained data. Procedures were categorized into three groups: laparoscopic, hybrid robotic (HR), and total robotic (TR).

The study included 192 consecutive patients who underwent laparoscopic, HR, or TR surgery. Mean patient age,

preoperative BMI, and preoperative weight were 40.4 ±9.3 years (range 22-64), 46. 2 ±5.9 kg/m

(range 35-64), and 130.3

±22.1 kg (range 76.7-193.4) respectively. Ninety-two patients (47.9%) had undergone previous abdominal surgery. Mean

operative time, estimated blood loss, and length of stay were 223.4 ±39.2 min (range 130-338), 21.9 ±18.8 mL (range 5-

10), and 2.6 ±1.1 days (range 2-15), respectively. There were 248 concomitant procedures such as upper endoscopy,

cholecystectomy, etc., 7 revisional surgeries, and 2 conversions to open surgery. Intraoperative complications included

one liver laceration and one bowel injury. There were two cases each of bowel obstruction, transfusions, and deep vein

thrombosis/pulmonary embolus, but no deaths or anastomotic leaks. Although there were variables such as different

concomitant procedures, the authors conclude that early experience with a total robotic approach for RYGB appears to be

safe, with similar outcomes to the laparoscopic approach. The findings are however limited by lack of randomization.

Ahmad et al. (2016) conducted a retrospective review to compare the operative and early peri-operative outcomes

between laparoscopic and robotic-assisted RYGB. There were no statistically significant differences in complication rates,

estimated blood loss, or length of stay between the two groups. There was a significant difference between the total

operative times (135.30 ±37.60 min for the laparoscopic procedure versus 154.84 ±38.44 min for the robotic procedure, p

< 0.05). There were no adverse intraoperative events, conversions to open procedures, leaks, strictures, returns to the

operating room within 30 days, or mortalities in either group. The authors concluded that both techniques are comparable

in terms of safety, efficacy, and operative and early perioperative outcomes. The findings are however limited by lack of

randomization.

In a systematic review and meta-analysis, Bindal et al. (2015) evaluated the role of robotics in bariatric surgical

procedures compared with laparoscopic approaches. Several studies showed a lower complication rate with the robotic

platform including leaks, hemorrhage, and stricture. Another advantage noted by the authors for the use of the robotic

system is improved ergonomics and lesser operator fatigue. The authors observed that the use of robotics may provide

specific advantages in some situations and overcome limitations of laparoscopic surgery. With the advent of newer

technologies in robotics the authors conclude that it will provide an empowering tool to the surgeons, which can potentially

change the way surgery is practiced. (Publication by Sanchez 2005, which was previously cited in this policy, is included

in this systematic review).

Economopoulos et al. (2015) conducted a systematic review and meta-analysis to evaluate the available literature on

patients treated with robotic RYGB and compared the clinical outcomes of patients treated with robotic RYGB with those

treated with the standard laparoscopic RYGB. Fourteen comparative and 11 non-comparative studies were included in

this study, reporting data on 5145 patients. Based on their review they found robotic-assisted RYGB was associated with

significantly less frequent anastomotic stricture events, reoperations, and a decreased length of hospital stay compared

with the standard laparoscopic procedures; however, these findings should be interpreted with caution given the low

number and poor quality of the studies currently available in the literature.

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Laparoscopic Adjustable Gastric Banding (LAGB)

In a longitudinal case series, Mistry et al. (2018) reported changes in glycemic control, blood pressure and lipids 5 years

following LAGB combined with medical care in patients with T2D. A total of 200 patients (age 47 ±9.7 years; body mass

index [BMI] 52.8 ±9.2 kg m

-2

; glycosylated hemoglobin (HbA1c) 7.9 ±1.9% [62.8 mmol mol

-1

]; women, n = 123 [61.5%];

insulin treatment, n = 71 [35.5%]) were included. The mean follow-up was 62.0 ±13.0 months (range 18-84 months).

There were significant reductions in body weight (-24.4 ±12.3% [38 ±22.7 kg]), HbA1c (-1.4 ±2.0%), systolic blood

pressure [BP] (-11.7 ±23.5 mmHg), total cholesterol and triglyceride levels. The proportion of patients requiring insulin

reduced from 36.2% to 12.3%. The overall band complication rate was 21% (21 patients). The authors concluded that

LAGB, when combined with multidisciplinary medical care, significantly improved metabolic outcomes in patients with T2D

independent of diabetes duration, and baseline BMI over 5 years. Diabetes duration and baseline BMI did not predict

changes in glycemic control, BP or lipids following LAGB. The findings are limited by lack of comparison group.

Froylich et al. (2018) conducted a retrospective case series of LAGB in 74 patients. The mean age at LAGB placement

was 50.5 ±9.6 years, and the mean BMI was 45.5 ±4.8 kg/m2. Preoperative comorbidities were diabetes mellitus (13.5%),

hypertension (32%), hyperlipidemia (12.1%), obstructive sleep apnea (5.4%), joints disease (10.8%), mood disorders

(5.4%), and gastro-esophageal reflux disease (GERD) symptoms (8.1%). The mean follow-up was 162.96 ±13.9 months;

44 patients (59.4%) had their band removed, and 22 (30%) had another bariatric surgery. The follow-up BMI was 35.7

±6.9 (p < 0.001), and the % TWL was 21.0 ±0.13. There was no improvement in any of the comorbidities. GERD

symptoms worsened at long-term follow-up (p < 0.001). Undergoing another bariatric procedure was associated with a

higher weight loss (OR 12.8; CI 95% 1.62-23.9; p = 0.02). LAGB required removal in the majority of patients and showed

poor resolution of comorbidities with worsening of GERD-related symptoms. In the authors’ opinion, patients who go on to

have another bariatric procedure have more durable weight loss outcomes.

In a retrospective case series, Khoraki et al. (2018) reported long-term outcomes from a cohort of 208 patients who

underwent LAGB. Complete follow-up was available for 90% at one year (186/207), 80% at five years (136/171), and 71%

at ten years (10/14). Percentage of EWL at one, five, and ten years was 29.9, 30, and 16.9, respectively. LAGB failure

occurred in 118 (57%) and 48 patients (23.1%) required a reoperation. Higher baseline BMI was the only independently

associated factor (OR 1.1; 95%CI 1.0-1.1; p = 0.016).

Giet et al. (2018) conducted a retrospective study of 2246 patients who underwent LAGB. Patients were followed for a

minimum of 2 years, and up to 9 years post-procedure. Operative mortality was zero and there were no in-hospital re-

operations. Mean preoperative weight and BMI were 111.2 ±22.1 kg and 39.9 ±6.7 kg/m

respectively. Mean excess %

BMI loss at 1-, 2-, 5- and 8-years of follow-up was 43.1±25.4, 47.9 ± 31.9, 52.4 ±41.7 and 57.1% ±28.6, respectively.

There was no significant difference in mean excess % BMI loss between those < 50 or ≥ 50 years old (p value = 0.23) or

between patients with an initial BMI of < or ≥ 50 kg/m

(p value = 0.65). Complications over nine years occurred in 130

(5.8%) patients and included: 39 (1.7%) slippage or pouch dilatation, 2 (0.04%) erosions and 76 (3.4%) complications

related to the access port or LAGB tubing. The overall re-operation rate for LAGB complications was 4.2% over 9 years

with a LAGB explanation rate of 1.5%. Thirty-nine LAGBs were converted to a sleeve or gastric bypass procedure, 11 of

these due to complications.

Vinzens et al. (2017) evaluated the long-term results of 405 patients (age 41 ±10 years), with a BMI of 44.3 ±6 kg/m2,

who were treated with LAGB. Mean follow-up was 13±3 years, with a follow-up rate of 85% (range 8-18 years),

corresponding to 343 patients. One hundred patients exceeded 15-year follow-up. In 216 patients (63%), sleeve

gastrectomy, gastric bypass, or biliopancreatic diversion with duodenal switch was performed as revisional surgery.

Twenty-seven patients (8%) refused revisional surgery after band removal. Finally, 100 patients (29%) still had the band

in place at the final follow-up, with a mean BMI of 35 ±7 kg/m2, corresponding to an excess BMI loss of 48 ±27%.

According to the Bariatric Analysis and Reporting Outcome System (BAROS), the failure rate was 25%, and 50% had

what was considered to be a good to excellent outcome. The authors concluded that more than 10 years after LAGB, 71%

of patients lost their bands and only 15% of the 343 followed patients with the band in place had a good to excellent

result. The findings are limited by lack of comparison group.

Angrisani et al. (2013) retrospectively evaluated the efficacy and safety of LAGB in moderately obese subjects with or

without obesity-related co-morbidities. Thirty-four patients with BMI between 30 and 35 kg/m2 and mean percentage

excess weight 48.7 ±9 %) who underwent LAGB were included. Good response was defined as BMI < 30 kg/m

percentage estimated weight loss > 50. Poor response was defined as BMI > 30 kg/m

or percentage estimated weight

loss less than 50 after a minimum of 1 year. Mean weight, BMI and percentage estimated weight loss were recorded at 1,

3, 5 and 7 years and were 77.4 ±7.6, 69.9±10.8, 70.9 ±9.3 and 73.3 ±12.0 kg; 28.8 ±2.9, 26.4 ±3.2, 26.5 ±3.4 and 27.4

±5.0 kg/m2; and 36 ±23, 46.1 ±33.8, 58.6 ±31.5 and 45 ±57, respectively (p < 0.01). Co-morbidities were diagnosed in

17/34 (50 %) patients at baseline and underwent remission or improvement in all cases after 1 year. The authors

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concluded that LAGB is a safe and effective procedure in patients with a BMI < 35 kg/m2. Small sample size and lack of

comparison group were limitations to this study.

Sleeve Gastrectomy (Vertical Gastrectomy)

Clapp et al. (2018) conducted a meta-analysis to evaluate long-term (7 or more years) outcomes of LSG. Nine studies

met the inclusion criteria, with a total of 2280 patients included initially. Only 652 patients had completed ≥ 7 years of

follow-up. At ≥ 7 years, the long-term weight recidivism rate was estimated to be 27.8% (I

= .60%; 95% CI: 22.8%-32.7%)

with a range of 14% to 37%. The overall revision rate was estimated to be 19.9% (I

= 93.8%; 95% CI: 11.3%-28.5%).

This was broken down into 13.1% (I

= 93.8%; 95% CI: 5.6%-20.6%) due to weight regain (5 studies) and 2.9% (I

60.8%; 95% CI: 1%-4.9%) due to gastroesophageal reflux disease (5 studies). Based on available data up to the

beginning of 2017, in the authors’ opinion bariatric surgeons should be aware of the long-term outcomes of the sleeve

gastrectomy, especially regarding revisions and weight regain. (Publication by Noel 2017, which was previously cited in

this policy, is included in this systematic review).

Felsenreich et al. (2017) evaluated long-term outcomes and complications following SG. 53 patients did not have

symptomatic reflux or hiatal hernia preoperatively and of the 43 patients available for follow-up, six patients (14.0%) were

converted to RYGB due to intractable reflux over a period of 130 months. Ten out of the remaining non-converted patients

(n = 26) also suffered from symptomatic reflux. Gastroscopies revealed de novo hiatal hernias in 45% of the patients and

Barrett's metaplasia in 15%. SG patients suffering from symptomatic reflux scored significantly higher in the RSI (p = 0.04)

and significantly lower in the GIQLI (p = 0.02) questionnaire. This study shows a high incidence of Barrett's esophagus

and hiatal hernias at more than 10 years after SG. Its results therefore suggest maintaining pre-existing large hiatal

hernia, GERD, and Barrett's esophagus as relative contraindications to SG. The limitations of this study include its small

sample size as well as the fact that it was based on early experience with SG-make drawing any general conclusions

about this procedure inconclusive.

Flølo et al. (2017) presented 5-year outcomes after VSG, including complications and revisions, weight change, obesity-

related diseases, and health-related quality of life (HRQOL). Of 168 operated patients (mean age, 40.3 ±10.5 years; 71%

females), 92% completed 2-year and 82% 5-year follow-up. Re-intervention for complications occurred in four patients,

whereas revision surgery was performed in six patients for weight regain and in one patient for GERD. BMI decreased

from 46.2 ±6.4 kg/m

at baseline to 30.5 ±5.8 kg/m

at 2 years and 32.9 ±6.1 kg/m

at 5 years. Remission of T2DM and

hypertension occurred in 79 and 62% at 2 years, and 63 and 60% at 5 years, respectively. The percentage of patients

treated for GERD increased from 12% preoperatively to 29% at 2 years and 35% at 5 years. Preventing weight regain and

GERD are important considerations with this procedure. The findings are limited by lack of comparison group.

Nocca et al. (2017) reported 5-year outcomes from a cohort of 1050 patients who underwent SG (mean preoperative BMI

was 44.58 kg/m

) either as the primary or revisional surgical procedure. The overall preoperative rate was 6.8%, and the

most common late complication was GERD (39.1%). After 3, 4 and 5 years of LSG, the average of %EBL was,

respectively, 75.95% (±29.16) (382 patients), 73.23% (±31.08) (222 patients) and 69.26% (±30.86) (144 patients). The

success rate at 5 years was 65.97% (95 patients). The improvement or remission of comorbidities was found,

respectively, in 88.4 and 57.2% of diabetic patients; 76.9 and 19.2% for hypertensive patients and 98 and 85% for

patients with sleep apnea syndrome. The authors conclude that five-year results are very convincing for SG, although

GERD is the main long-term complication. The findings are limited by lack of comparison group.

El Chaar et al. (2017) evaluated the incidence, indications, and outcomes of revisional surgery following LSG in adult

patients. Of the 630 LSGs performed, 481 patients were included in the analysis (mean age and BMI = 46.2 and 44.3,

respectively; 79.5 % female; 82.3 % white). A total of 12/481 patients underwent conversion to a different bariatric

procedure due to inadequate weight loss, GERD, or both. The 6/12 patients with GERD-related symptoms and failed

medical management underwent conversion to RYBG following preoperative wireless Bravo pH monitoring (Given

Imaging) to confirm the diagnosis objectively. The other 6/12 patients with inadequate weight loss received either RYBG

or BPD/DS based on personal choice. Overall, 9/12 patients underwent conversion to RYBG, and 3/12 underwent

conversion to BPD/DS. Median time from the initial surgery to conversion was 27 months (range 17-41). Median operating

room time was 168 min (range 130-268). Median length of stay was 48 h (range 24-72). The follow-up rate at 3 months

was 100 % (12/12 patients). The authors conclude that conversion to RYBG or BPD/DS may be done safely and

effectively in patients present following LSG with refractory GERD or inadequate weight loss. Longer term outcomes are

needed. The findings are limited by lack of comparison group.

Brethauer et al. (2009) performed a systematic review (n = 36 studies) of the evidence on SG as a primary or staged

procedure. Studies included a single nonrandomized matched cohort analysis, RCTs (n = 2 studies) and uncontrolled

case series (n = 33 studies). Of these studies, 13 differentiated that the SG was used as a staged procedure or as a

management strategy for a high-risk patient population. Those patients who underwent SG as a planned staged

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procedure went on to receive RYGB or BPD/DS within 2 years of SG after improvement of their co-morbidities and

surgical risk status. The mean BMI in all 36 studies was 51.2 kg/m2. The mean baseline BMI was 46.9 kg/m2 for the high-

risk patients (range 49.1-69.0) and 60.4 kg/m

for the primary SG patients (range 37.2-54.5). The follow-up period ranged

from 3–60 months. The mean %EWL after SG reported in 24 studies was 33–85%, with an overall mean %EWL of 55.4%.

The mean postoperative BMI was reported in 26 studies and decreased from a baseline mean of 51.2 kg/m

to 37.1 kg/m

postoperatively. Improvement or remission of T2D was found in more than 70% of patients. Significant improvements

were also seen in hypertension and hyperlipidemia, as well as in sleep apnea and joint pain. The mean complication rate

for a primary procedure was 6.2%, while the mean complication rate for high risk/staged procedure was 9.4%. The overall

mortality rate for all studies was 0.19% which included 0.24% for high risk/staged procedure. Despite the high surgical risk

of this patient population, report complication rates were acceptably low. The authors conclude that SG is an effective

weight loss procedure that can be performed safely as a first stage or primary procedure. Limitations include lack of long-

term follow-up for the high-risk group mainly due to patients who refused a second-stage operation or had sufficient

weight loss and co-morbidity reduction with SG alone.

Revision Surgery

Chierici et al. (2022) conducted a systematic review and meta-analysis to identify which revisional bariatric surgery

performs best after a failed primary restrictive surgery. A literature search was conducted using Embase, PubMed,

Cochrane Library, and Scopus databases which returned 39 retrospective and prospective comparative studies. Inclusion

criteria included patients undergoing revisional bariatric surgery after a failed primary restrictive surgery of LAGB, VBG, or

SG. The authors confirmed SG continues to have a low rate of immediate postoperative complications. The authors found

duodenal switch (DS) and biliopancreatic diversion (BPD) were superior when it came to %EWL and %TWL, but not free

from the risk of weight regain. Secondary SG ensures the lowest rate of early and late complications when compared to

single-anastomosis duodeno-ileal bypass (SADI) and one-anastomosis gastric bypass (OAGB), but it also provides the

worst benefits for either 1 and 3 years %EWL and % TWL thus should not be considered when planning revisional

surgery unless there are exceptional circumstances that warrants its use. RYGB is the most frequently performed

revisional surgery following a primary bariatric procedure, however this approach has not always been justified in terms of

weight loss when compared to SG. In addition, RYGB is more frequently associated with early and late complications

when compared to SG, OAGB, and SADI. Finally, the authors found the most balanced procedures were OAGB and

SADI; these two procedures were determined to have 21.16% and 14.66% more EWL, respectively, after 3 years.

Limitations included retrospective design, surgical intervention allocation bias, heterogeneity, and lack of evaluation of

important outcomes like GERD or malabsorption which could affect the patient’s quality of life. (Publication by Qiu 2018,

which was previously cited in this policy, is included in this systematic review).

Koh et al. (2020) performed at systematic review and meta-analysis to examine the impact revisional bariatric surgery has

on obesity related metabolic outcomes. The analysis included review of 33 articles which contained 1593 patients. The

outcomes examined included improvement of diabetes, hypertension (HTN), hyperlipidemia, and OSA. The surgeries

used for revision included SG, RYGB, pouch revision, duodenal switch, and mini-gastric bypass. The authors found 92%

of the patients improved their diabetes, 81% achieved improvement in HTN and 86% had improvement of OSA. The

authors concluded revisional bariatric surgery improved patient outcomes and should be considered in patients with

persistent metabolic disease after primary bariatric surgery. Limitations included lack of randomized control trials, lack of

long-term outcomes, and significant heterogeneity.

Janik et al. (2019) assessed the safety of revisional surgery to LSG compared to LRYGB after failed LAGB. Converted

LSG cases were matched (1:1) with converted LRYGB patients by age (± year), body mass index (± kg/m), sex, and

comorbidities including diabetes, hypertension, hyperlipidemia, venous stasis, and sleep apnea. A total of 2708 patients

(1354 matched pairs) were included in the study. The mean operative time in conv-LRYGB was significantly longer in

comparison to conv-LSG patients (151 ± 58 vs 113 ± 45 minutes, p < 0.001). No mortality was observed in either group.

Patients after conv-LRYGB had a clinically increased anastomotic leakage rate (2.07% vs 1.18%, p = 0.070) and

significantly increased bleed rate (2.66% vs 0.44%, p < 0.001). Thirty-day readmission rate was significantly higher in

conv-LRYGB patients (7.46% vs 3.69%, p < 0.001), as was 30-day reoperation rate (3.25% vs 1.26%, p < 0.001). The

length of hospital stay was longer in conv-LRYGB. The authors concluded that a single-stage conversion of failed LAGB

leads to greater morbidity and higher complication rates when converted to LRYGB versus LSG in the first 30 days

postoperatively. These differences are particularly notable with regard to bleed events, 30-day reoperation, 30-day

readmission, operative time, and hospital stay.

Dardamanis et al. (2018) conducted a retrospective comparative study of primary versus revisional LRYGB for insufficient

weight loss after VBG or adjustable gastric banding. Three hundred forty-two LRYGB operations were performed, 245

were primary, and 97 revisional. Median follow-up was 30 months (range 0-108 months). Mean BMI (kg/m2) before

bypass was 45.2 for primary LRYGB (pLRYGB) and 41.1 for revisional laparoscopic RYGB (rLRYGB). Median operative

time and length of stay were longer for rLRYGB 157.5 versus 235 min (p < 0.001) and 6 versus 6.5 days (p = 0.05).

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Conversion to laparotomy was performed in eight patients, 0.4% of primary and 7.2% of revisional. Morbidity rate was

6.5% in pLRYGB versus 10% in rLRYGB (NS). There was one death in the primary group. Percentage of excess BMI loss

was significantly lower in the revisional group at 12, 18, and 24 months of follow-up. The authors concluded that revisional

and primary gastric bypass have no statistical differences in terms of morbidity. The % of excess BMI loss is lower after

revisional gastric bypass during the first 2 years of follow-up. The trend of weight loss or weight regain was similar in both

groups.

Altieri et al. (2018) reported the rate of revisions or conversions (RC) in patients who originally underwent RYGB, LSG, or

LAGB. Patients were followed for at least 4 years. There were 40,994 bariatric procedures with 16,444 LAGB, 22,769

RYGB, and 1781 LSG. Rate of RC was 26.0% for LAGB, 9.8% for SG, and 4.9% for RYGB. Multiple RCs were more

common for LAGB (5.7% for LAGB, 0.5% for RYGB, and 0.2% for LSG). Band revision/replacements required further

procedures compared with patients who underwent conversion to RYGB/SG (939 compared with 48 procedures). The

majority of RCs were not performed at the initial institution (68.2% of LAGB patients, 75.9% for RYGB, 63.7% of SG). Risk

factors for multiple procedures included surgery type, as LAGB was more likely to have multiple RCs. The authors

concluded that reoperation was common for LAGB, but less common for RYGB (4.9%) and SG (9.8%). The RC rate is

almost twice after SG than after RYGB. LAGB had the highest rate (5.7%) of multiple reoperations. Conversion was the

procedure of choice after a failed LAGB.

Wijngaarden et al. (2017) identified that non-responders of LAGB showed inferior weight loss results after revisional

LRYGB compared with responders of LAGB, and primary LRYGB at all moments of follow-up (12, 24, 36 months). This is

based on an observational study of 96 non-responders, and 120 responders. In addition, the failure rate was significantly

higher after revisional LRYGB compared with primary LRYGB (10.9% no responders, 8.5% responders, and 2.5%

primary, p = 0.001).

In a retrospective review of primary LRYGB (pLRYGB) versus revisional LRYGB (rLRYGB) after failed LSG, Malinka et al.

(2017) evaluated 3-year outcomes. There were no significant differences in patient demographics or median BMI (kg/m2)

for pLRYGB or rLRYGB (42.8 ±12.1 vs. 42.3 ±11.5, respectively; p = 0.748). Coexisting comorbidities were rated similarly

in both groups. At 3 years, the percentage of excess weight loss (74.4 ±23.3 vs 52.0 ±26, respectively; p = 0.007) was

higher for pLRYGB than rLRYGB, while similar improvements of coexisting comorbidities could be observed. The authors

concluded that rLRYGB is a feasible and practical surgical approach that allows effective weight loss at 3 years of follow-

up and alleviates refractory reflux symptoms. Although weight loss is lower compared to pLRYGB, resolution or

improvement of coexisting comorbidities appears similar. According to the authors, rLRYGB appears to be a reliable

procedure to address failure after LSG.

Pinto-Bastos et al. (2017) conducted a systematic review of preoperative surgery following the failure of primary bariatric

surgery. The etiology of reasons for undergoing a second surgery includes medical (e.g., fistula, ulcer disease) and

behavioral aspects. Eating and lifestyle behaviors, difficulty in embracing the required lifestyle changes, and

reappearance of depressive and anxious symptoms have been associated with failure of weight loss or weight regain after

primary surgeries. The authors recommend that particular attention be paid to surgical candidates with a history of

difficulties in engaging in healthy eating patterns.

In a retrospective review, Fulton et al. (2017) evaluated outcomes of revisional bariatric surgery in 2769 patients. The

mean preoperative BMI was 44.7 ±9.5 in revision patients compared with 45.7 ±7.6 in primary bariatric surgery patients.

Most revision patients had a prior VBG (48%) or a LAGB (24%). Bands were removed in 36% of all LAGB patients

presenting to clinic. Of the 134 procedures performed in the revision clinic, 83 were bariatric weight loss surgeries, and 51

were band removals. Revision clinic patients experienced a significant decrease in BMI (from 44.7 ±9.5 to 33.8 ±7.5, p <

0.001); their BMI at 12-month follow-up was similar to that of primary clinic patients (34.5 ±7.0, p = 0.7). The authors

identified that complications were significantly more frequent in revision patients than primary patients (41% v. 15%, p <

0.001).

Sharples et al. (2017) conducted a systematic review and meta-analysis of outcomes after revisional bariatric surgery.

2617 patients in 36 studies underwent either adjustable gastric band to Roux-en-Y gastric bypass (B-RYGB) or band to

sleeve gastrectomy (B-SG). There was no difference between the B-RYGB and B-SG groups in morbidity, leak rate or

return to surgery. %EWL following the revisional procedure for all patients combined at 6, 12 and 24 months was 44.5,

55.7 and 59.7%, respectively. There was no statistical difference in %EWL between B-RYGB and B-SG at any time point.

The rates of remission of diabetes, hypertension and obstructive sleep apnea were 46.5, 35.9 and 80.8%, respectively.

Available observational evidence does suggest that revisional bariatric surgery is associated with outcomes similar to

those experienced after primary surgery. Further, high-quality research, particularly RCTs, is required to assess long-term

weight loss, comorbidity, and quality of life outcomes.

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Tran et al., (2016) conducted a systematic review of 24 studies and 866 patients to evaluate outcomes and complications

of different surgical methods of revision that were done after failed primary RYGB. All patients in the studies reported

significant early initial weight loss after revisional surgery. However, of the five surgical revision options considered,

biliopancreatic diversion/duodenal switch, distal RYGB, and gastric banding resulted in sustained weight loss, with what is

considered by the authors as an acceptable complication rate.

Quezada et al. (2016) conducted a retrospective analysis of SG conversion to RYGB (n = 50) due to the observation of

increased complications of SG as the number of procedures increase. Revisions were done due to weight regain, GERD,

or gastric stenosis. At follow-up (over a 3-year period), the authors reported median excess weight loss was 60.7 lbs., all

gastric stenosis symptoms had resolved, and over 90% of GERD patients reported either a resolution or improvement in

symptoms. Despite their findings, long term follow-up on this patient population is needed.

Buttelmann et al. (2015) compared outcomes for patients undergoing diet/exercise intervention with patients undergoing

surgical intervention through restorative obesity surgery-endolumenal (ROSE), band over bypass, and endoscopic gastro

gastric fistula closure. A retrospective analysis of 60 patients was performed on those who underwent gastric bypass and

failed to lose weight. Records were reevaluated at 3, 6, and 12 months after intervention for primary outcomes of, weight

loss and comorbidity resolution. The authors concluded ROSE, band over bypass, and endoscopic fistula closure results

in greater weight loss and trend toward greater comorbidity resolution compared with diet and exercise. This study is

limited by small sample size, lack of randomization, and short-term follow-up.

David et al. (2015) reported their experience in laparoscopic conversion of failed VGB to RYGB or BPD (n = 39), noting

that the reoperation rate for VGB in long-term studies is approximately 50%. Most (89%) of the conversions were

completed laparoscopically. The mean operative time was 195 and 200 min for RYGB and BPD, respectively. There was

no mortality. Complications occurred in 11 patients (28%), 5 in RYGB (19%) and 6 in BPD (42%). At the 3-year follow-up,

the mean body mass index decreased from 47 ±8 kg/m2 to 26 ±4 kg/m2 for BPD, and from 43 kg/m2 to 34 kg/m2 (p =

0.05) for RYGB. Weight (kg) decreased from 110 to 84 and to 92, and from 123 to 81 and 68, at 1 and 3 years for RYGB

and BPD, respectively. The weight loss for RYGB and BPD was equal at 1 year but tended to be better for BPD at 3 years

postoperatively. Laparoscopic conversion of failed VBG to RYGB or BPD was feasible, but it was followed by prohibitively

high complication rates in BPD patients. The authors concluded that the risk: benefit ratio of these procedures in this

series is questionable.

Brethauer et al. (2014) was part of a task force that reviewed current evidence which identified procedure-specific

indications and outcomes for reoperative procedures. 175 articles were included in the systematic review and analysis

and the majority of the published studies were single center retrospective reviews. The evidence supporting reoperative

surgery for acute and chronic complications is described along with additional guiding principles. GERD was identified as

a long-term complication that may occur following a sleeve gastroplasty. The authors indicate treatment begins with

medical management and behavioral modifications; if medical control of GERD fails, surgical revision may be required.

Pediatric and Adolescent Bariatric Surgery

Hoeltzel et al. (2021) evaluated adolescent bariatric surgeries from the Metabolic and Bariatric Surgery Accreditation and

Quality Improvement Program (MBSAQIP) database from 2015 to 2018. Participants included patients 19 years old and

younger with a BMI ≥ 30 kg/m

and underwent laparoscopic RYGB or SG. Primary outcomes included mortality and

overall complications; secondary outcomes included rates of readmission and reoperation. A total of 5068 individuals met

inclusion criteria for the study with 78.5% being females and 70.4% being white. Patients between the ages of 10 to 14

years comprised 1.5% of participants, 15 to 17 years 18.5%, and 18 to 19 years 79.9%. The mean BMI was 47.3 kg/m

and the most prevalent comorbidities were HTN, OSA, GERD, and diabetes. The 30-day analysis following surgery

demonstrated intraoperative or postop complications in only 1.2% of patients and the death of two patients which was

likely due to internal hernia. The authors concluded that bariatric surgery for adolescents was a safe and effective

procedure with low complication rate and a recommendation of future robust studies to evaluate the long-term outcomes

in this age group of patients.

Alqahtani et al. (2021) analyzed the long-term results and adverse events associated with LSG in children and

adolescents with severe obesity. 2,504 children and adolescents that underwent LSG between 2008 and 2021 were

enrolled in the program. Weight loss was reported in terms of mean weight change, percentage of weight lost, %EWL,

change in BMI, and BMI for age percentile along with assessment of comorbidity conditions. The mean standard deviation

(SD) %EWL for one to three years was 82.3%, for 4 to 6 years was 76.3% and 7 to 10 years was 71.1%; 10-year results

demonstrated that 30% of total weight was lost permanently. Prior to surgery 263 patients were diagnosed with T2D, 227

with dyslipidemia, and 377 had hypertension. After more than 7 years of follow-up, complete remission was observed in

188 patients for T2D, 130 patients for dyslipidemia, and 219 patients for HTN. Only 1% of the patients were readmitted

within the first 90 days after the operation; two patients had a staple line leak and 22 were readmitted with nausea and

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vomiting. The data showed no significant change in growth velocity, including among participants younger than age 14

years. The authors concluded long-term follow-up after LSG in children and adolescents demonstrates positive weight

loss and comorbidity resolution. The findings are however limited by lack of comparison group.

Lainas et al. (2020) conducted a study to assess whether bariatric surgery was successful for adolescents under the age

of 18. The authors evaluated 84 adolescent patients (57 females, 27 males) that underwent LSG. Surgical postop care

included blood work and diet restrictions with a discharge when oral diet was well tolerated. Patients follow-up included 4

outpatient visits the first year then annually; complete metabolic screening was done at 3 months, again at one year and

annually thereafter. The quality of life was evaluated prior to surgery using the French version of the Short Form 36

questionnaire which assessed general health, physical function, social function, emotional and mental status, and bodily

pain. The scoring ranged from 0-100 with higher scores indicating better wellbeing. All patients were contacted one-year

post-surgery to answer the same questions. Comorbidities assessed included HTN, T2D, OSA, dyslipidemia, arthralgia,

and GERD. According to the authors, the study showed LSG is a safe and effective procedure for patients under the age

of 18, resulting in significant weight loss, comorbidity remission, and improvement in quality of life. In addition, it was felt

that adherence to the medical team was an essential component for successful treatment in this group of patients.

Limitations included small sample size, retrospective design, substantial loss to follow-up thus affecting long-term

outcomes and lack of comparison group.

A Hayes (2019, updated 2022) comparativeness effective review for bariatric surgeries for treatment of obesity in

adolescents analyzed nineteen studies which compared AGB, VSG and RYGB. The authors concluded that while the

body of evidence is moderate in size with a low quality overall, these surgical procedures are superior to medical

management for promoting weight loss and improving obesity-related comorbidities in adolescents. AGB was inferior to

the others, but all three types are associated with low to moderate risk of postop complications and show similar efficacy.

Inge et al. (2018) compared glycemic control in cohorts of severely obese adolescents with T2D undergoing medical and

surgical interventions. Participants in the Teen-LABS group (n = 242) underwent a primary bariatric procedure, while

those in the Youth TODAY consortia (n = 699) were randomized to receive medication alone, or an intensive lifestyle

intervention. After selection of 30 participants from Teen-LABS with diabetes (mean [SD] age at baseline, 16.9 [1.3] years;

21 [70%] female; 18 [66%] white), 63 matched controls from TODAY were selected (mean [SD] age at baseline, 15.3 [1.3]

years; 28 [44%] female; 45 [71%] white) and the two groups were compared. During 2 years, mean hemoglobin A1c

concentration decreased from 6.8% (95% CI, 6.4%-7.3%) to 5.5% (95% CI, 4.7% -6.3%) in Teen-LABS and increased

from 6.4% (95% CI, 6.1%-6.7%) to 7.8% (95% CI, 7.2%-8.3%) in TODAY. Compared with baseline, the BMI decreased by

29% (95% CI, 24%-34%) in Teen-LABS and increased by 3.7% (95% CI, 0.8%-6.7%) in TODAY. Twenty-three percent of

Teen-LABS participants required a subsequent operation during the 2-year follow-up. Compared with medical therapy,

surgical treatment of severely obese adolescents with type 2 diabetes was associated with better glycemic control,

reduced weight, and improvement of other comorbidities. According to the authors, these data support the need for a well-

designed, prospective controlled study to define the role of surgery for adolescents with T2D, including health and surgical

outcomes.

Ryder et al. (2018) evaluated factors associated with long-term weight-loss maintenance following bariatric surgery in

adolescents (n = 50) with severe obesity who underwent RYGB. Follow-up visits at 1 year and at a visit between 5- and

12-years following surgery (follow-up of Adolescent Bariatric Surgery at 5 Plus years (FABS-5+) visit. A non-surgical

comparison group (n = 30; mean ±s.d. age and BMI = 15.3 ±1.7 years and BMI = 52 ±8 kg m

-2

) was recruited to compare

weight trajectories over time. The BMI of the surgical group declined from baseline to 1 year (-38.5 ±6.9%), which, despite

some regain, was largely maintained until FABS-5+ (-29.6 ±13.9% change). The BMI of the comparison group increased

from baseline to the FABS-5+ visit (+10.3 ±20.6%). When the surgical group was split into maintainers and re-gainers, no

differences in weight-related and eating behaviors, health responsibility, physical activity/inactivity, or dietary habits were

observed between groups. However, at FABS-5+, maintainers had greater overall QOL scores than re-gainers (87.5

±10.5 vs 65.4 ±20.2, p < 0.001) and in each QOL sub-domain (p < 0.01 all).

In a retrospective review of 79 adolescents who underwent LSG, Elhag et al. (2018) assessed preoperative levels and

postoperative changes in 4 anthropometric, 15 nutritional and 10 cardiometabolic parameters. At a mean of 24.2 months

post-LSG, significantly reduced mean weight and BMI by 51.82 ±28.1 kg and 17 ±6.24 kg/m

, respectively were observed.

The highest prevalence of post-LSG deficiencies pertained to vitamin D, albumin, and ferritin (89.3, 38, and 33.3%,

respectively). Low hemoglobin levels (29.3%) were reported only in females. Trace elements were not deficient.

Significant reductions in percentage of adolescents with elevated low-density lipoprotein (from 66.1 to 38.9%), alanine

aminotransferase (from 45.3 to 10.9%), and aspartate aminotransferase (from 24.1 to 8.6%) levels were reported. Finally,

100% remission of prediabetes cases, and 80% remission of T2Dcases were observed. The slight worsening of

preexisting nutritional deficiencies warrants careful preoperative surveillance and appropriate postoperative nutritional

supplementation.

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Benedix et al. (2017) compared the perioperative course, weight loss and resolution of comorbidities after primary LSG for

morbid obesity between adolescents (n = 362) and adults (n = 15,428). Pre-procedure BMI was similar between these

populations, but the adult cohort had a higher incidence of co-morbidities. Late adolescents experienced the highest

weight loss; resolution rate of comorbidities was lower in adults. Resolution rate of hypertension was significantly higher in

adolescents. In the authors’ opinion, the results at 12 and 24 months demonstrate that LSG is a safe therapeutic option

that can be performed in adolescents without mortality.

Beamish et al. (2017) studied bone health and body composition in 72 adolescents who underwent RYGB. Inclusion

criteria included the following: age 13-18 years and BMI > 35 kg/m2. Patients underwent dual-energy X-ray absorptiometry

and serum bone marker analyses preoperatively and annually for 2 years. Differences in body fat and lean mass

proportions were observed according to sex following RYGB. Mean BMI reduction at 2 years was 15.1 kg/m2. Body

composition changes included a reduction in fat mass (51.8% to 39.6%, p < 0.001) and relative increase in lean mass

(47.0% to 58.1%, p < 0.001). In contrast to previous studies in adults, adolescent boys lost a greater percentage of their

body fat than girls (-17.3% vs. -9.5%, p < 0.001). Individual bone mineral density Z-scores (BMD-Z) at baseline were within

or above the normal range. The mean (SD) BMD-Z was 2.02 (1.2) at baseline, decreasing to 0.52 (1.19) at 2 years.

Higher concentrations of serum CTX (p < 0.001) and osteocalcin (p < 0.001) were observed in boys throughout the study

period. Levels rose in the first year, before decreasing modestly in the second. Levels of serum markers of bone synthesis

and resorption were higher in boys, whose skeletal maturity occurs later than girls. Bone turnover increased, and BMD

decreased to levels approaching a norm for age. Long-term outcome will determine the clinical relevance.

In a systematic review and meta-analysis, Qi et al. (2017) evaluated the effects of bariatric surgery on glycemic and lipid

metabolism, surgical complications, and quality of life in adolescents with obesity. A total of 49 studies with 3007 patients

were included. RYGB (n = 1216), LAGB (n = 1028), and LSG (n = 665) were the most common bariatric surgeries

performed. At the longest follow-up (range, 12-120 months), bariatric surgery led to an overall 16.43 kg/m2 (95%

confidence interval [CI]: 14.84-18.01) and 31% (95% CI: 28%-34%) reduction in BMI. There were significant

improvements in glycemic and lipid profiles including glycosylated hemoglobin A1C, fasting blood insulin, fasting blood

glucose, total cholesterol, triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol,

postoperatively at 12 months. The remission rate of dyslipidemia was 55% (95% CI: 34%-76%), 70% (95% CI: 55%-82%),

and 95% (95% CI: 80%-100%) at 1, 3, and > 5 years after surgery. RYGB produced better improvements than other

surgical procedures. The authors concluded that bariatric surgery in adolescents may achieve significant weight loss, and

glycemic and lipid control. (Publications by Manco 2017, Serrano 2016, Inge 2016, Olbers 2017, Shah 2017, Hervieux

2017, and O’Brien 2010, which were previously cited in this policy, are included in this systematic review).

The Teen-Longitudinal Assessment of Bariatric Surgery (LABS) Study was a prospective, multicenter, observational

study, which enrolled 242 adolescents (≤ 19 years of age) who were undergoing bariatric surgery from March 2007

through February 2012 at 5 U.S. adolescent bariatric surgery centers. The patients underwent RYGB (n = 161), SG (n =

67), or LAGB (n = 14). Ryder et al. (2016) evaluated 2-year outcomes to determine the impact of bariatric surgery on

functional mobility and musculoskeletal pain. Participants completed a 400-m walk test prior to bariatric surgery (n = 206)

and at 6 months (n = 195), 12 months (n = 176), and 24 months (n = 149) after surgery. Time to completion, resting heart

rate (HR), immediate posttest HR, and HR difference (resting HR minus posttest HR) were measured and

musculoskeletal pain concerns, during and after the test, were documented. Data were adjusted for age, sex,

race/ethnicity, baseline BMI, and surgical center (posttest HR and HR difference were further adjusted for changes in time

to completion). Compared with the baseline, the post-surgery data showed an improvement in all measurements at all

times measured. The authors conclude that bariatric surgery in adolescents with extreme obesity is associated with

significant improvement in functional mobility and in the reduction of walking-related musculoskeletal pain up to 2 years

after surgery. Findings are however limited by lack of comparison group.

In a systematic review and meta-analysis, Paulus et al. (2015) evaluated the efficacy, safety, and psychosocial health

benefits of various bariatric surgical techniques (RYGB, LAGB, LSG) as a treatment for morbid obesity in adolescents. A

total of 37 peer-reviewed articles were included, although the studies were mainly observational and varied in quality.

Authors of 9 studies were contacted for additional information. All three procedures lead to significant weight loss in

morbidly obese adolescents, and weight loss is most pronounced after RYGB. For LSG studies, long-term follow-up were

not yet available. While adverse events were relatively mild and long-term complication rates were acceptable, they were

more frequent and more serious after RYGB than after LAGB. In the currently available follow-up after LSG, the rate of

adverse events appeared to be similar to that after LAGB. Although a healthy nutritional status in adolescents is important

to prevent developmental and growth deficiencies, standard postoperative vitamin supplementation regimens and the

occurrence of deficiencies were not reported in most studies (not at all in LSG studies). However, more and more severe

deficiencies occurred after RYGB than after LAGB. Reduction of comorbidity, which is pivotal for health gain, was

impressive in all techniques, and QOL consistently showed improvement, although follow-up up to 24 months may not be

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enough to capture negative long-term effects in life after bariatric surgery. A limitation of this review is the lack of high-

quality, prospective randomized controlled trials, which increases the risk of bias and therefore introduces heterogeneity.

Zitsman et al. (2015) studied a population of morbidly obese teenagers (n = 137) who underwent LAGB to evaluate its

safety and effectiveness. The mean weight gain between enrollment and LAGB was 4.7 kg. Mean preoperative weight,

body BMI, and excess BMI were 136.1 kg, 48.3 kg/m2, and 23.6 kg/m2, respectively. Mean BMI at 6, 12, 18, 24, and 36

months was 43.8, 41.6, 41.5, 40.5, and 39.3. Excess BMI loss was 28.4%, 35.9%, and 41.1% at 1, 2, and 3 years postop.

Co-morbid conditions improved or resolved with weight loss after LAGB. Thirty patients (22%) underwent one or more

additional operations for complications. Twenty-seven patients (20%) converted to other weight loss procedures or had

their bands removed. The authors concluded that morbidly obese adolescents can lose weight successfully and

experience health improvement following LAGB, but the role of LAGB in the younger population requires long-term

evaluation.

Bariatric Artery Embolization (BAE)

There is insufficient evidence for bariatric artery embolization and its outcomes for weight loss; additional robust RCTs are

warranted for safety and efficacy along with long-term follow up.

Reddy et al. (2020) conducted a single-center, sham controlled, masked RCT to evaluate the efficacy of transcatheter

bariatric embolization (TBE) for weight reduction in obesity. Participants were randomized to either sham procedure (n =

20) or TBE targeting the left gastric artery using embolic beads (n = 20). The primary efficacy endpoint was the difference

in TBWL between the two groups at 6 months. All patients entered a lifestyle counseling program and follow-up was

completed by physicians that were masked to allocated therapy. At 6 months, the TBWL for TBE in the intention to treat

(ITT) population was 7.4 kg compared to 3.0 kg for sham procedure. The change in BMI at 6 months for ITT was -2.6 in

TBE versus -1.1 in sham. The TBE ITT population did maintain the weight loss at 12 months. Patients within the sham

group were unblinded at 6 months and permitted to crossover to TBE and then only initial group was followed for 12

months. Limitations included small sample size, single center, no control group after 6 months, and possibility that the

efficacy of TBE was related to subject participation in weight management counseling as it is unknown if TBE alone would

have an impact on obesity without lifestyle counseling. Additionally, four subjects withdrew consent after randomization

and another three prior to the 6-month visit. Furthermore, the clinical significance of the effect, its long-term sustainability,

and safety are unclear.

Hafezi-Nejad et al. (2019) conducted a systematic review and meta-analysis of case series investigating the safety and

efficacy of left gastric artery (LGA) embolization as a bariatric procedure. Meta-regression was performed to assess

associations of age, sex, body mass index, and ghrelin and leptin levels with weight change after LGA embolization were

selected. Six case series published between January 2014 and April 2019, comprising 47 patients investigating the safety

and/or efficacy of LGA embolization for weight loss were included in the meta-analysis. The results showed a mean

weight loss of 8.68 kg (19.14 lbs.) after 12 months of follow-up, approximately 8% of baseline total body weight which is

superior to weight loss from diet and exercise, and comparable to other more invasive interventions. Transient superficial

mucosal ulcers were common after LGA embolization, and one case of major complications (severe pancreatitis, splenic

infarct, and gastric perforation) was identified. There were considerable variations in patient age, sex distribution, and

baseline characteristics among the studies. Significant variation was observed in the duration of follow-up, which ranged

from 3 months to 20–24 months. Limitations of this study include variations in the indications for LGA embolization, study

designs, embolization techniques, follow-up plans, dietary assessments, patient comorbidities, and availability of control

subjects, the authors concluded that LGA embolization is an investigative method and not yet proven to be effective

management for obesity. Larger studies are needed to expand these findings and determine other correlates of weight

loss after LGA embolization. (Publications by Bai 2018, Syed 2016, and Weiss 2017, which were previously cited in this

policy, are included in this systematic review).

Weiss et al. (2019) evaluated the safety and efficacy of bariatric artery embolization up to twelve months following surgery

in 20 severely obese patients (five of which are identified below in the Weiss et al. (2017) case series). The primary

endpoint was weight loss with additional end points assessed. Bariatric embolization was performed successfully in all

participants. Participants experienced mean excess weight loss of 8.2% at one month, 11.5% at 3 months, 12.8% at six

months and 11.5% at twelve months. The mean total weight loss was 7.6kg at twelve months. As a result of loss to follow-

up, 18 participants remained at three months, 16 at six months, and 15 at twelve months. No major adverse events (AE)

were identified and only eleven minor AE occurred in eight participants. The authors found bariatric embolization is well

tolerated and promotes clinically relevant weight loss in adults with severe obesity. Limitations included lack of

comparison group, small sample size, insufficient data due to lack of continuous follow up for several participants,

required weight management compliance before the embolization procedure on the first five participants only and a large

portion of participants were African American thus overrepresenting that population.

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Gastric Electrical Stimulator (GES)

While gastric electrical stimulation may provide benefit for obesity, additional well designed RCTs with long-term follow-up

are warranted to demonstrate safety and efficacy.

In this 2020 first-in-human (early feasibility) multicenter, phase 1, open prospective cohort study, (Paulus et al., 2020) the

authors assessed the safety of the Exilis

™

gastric electrical stimulation. They also sought to investigate whether the

settings can be adjusted for comfortable chronic use in Class II or III obese patients. Meal intake and gastric emptying and

motility were also evaluated. In this study, 20 obese patients were implanted with the Exilis system and amplitude was

individually set during 4 amplitude titration visits. Subjects underwent two blinded baseline test days (GES ON vs. OFF),

after which long-term, monthly follow-up continued for up to 52 weeks. The results suggested that this device is safe and

caused no patient discomfort. At baseline food intake and satiety were not significantly different when the device was on

or off, and significant weight loss occurred at week 26, with EWL of 14% at 52 weeks. The authors conclude that the data

were comparable with studies of subjects on diet and/or exercise alone, but disappointing when compared to minimally

invasive procedures, such as gastric banding or endoscopic gastroplication. Furthermore, the authors did not observe

changes in plasma glucose and insulin levels which other bariatric procedures are known to improve. The authors

concluded that considerably more basic research is required before clinical use. Limitations included small sample size,

lack of control group, and lack of long-term outcomes.

In a in a 12-month prospective multicenter study, Morales-Conde et al. (2018) monitored all participants (n = 47) up to 24

months after laparoscopic implantation of a closed-loop GES system (CLGES). Weight loss, safety, quality of life (QOL),

and cardiac risk factors were analyzed. Weight regain was limited in the 35 (74%) participants remaining enrolled at 24

months. Mean %TBWL changed by only 1.5% between 12 and 24 months, reported at 14.8% (95% CI 12.3 to 17.3) and

13.3% (95% CI 10.7 to 15.8), respectively. The only serious device-/procedure-related AEs were two elective system

replacements due to lead failure in the first 12 months, while improvements in QOL and cardiovascular risk factors were

stable thru 24 months. The authors conclude that during the 24-month follow-up, CLGES was shown to limit weight regain

with strong safety outcomes, including no serious AEs in the second year. They hypothesize that CLGES and objective

sensor-based behavior data combined to produce behavior change, and in their opinion supports GES as a safe obesity

treatment with potential for long-term health benefits. Larger well-designed randomized controlled trials are needed to

further evaluate the safety and efficacy of GES therapy in the treatment of obesity.

In a post-implant analysis, Alarcón Del Agua I, et al. (2017) evaluated possible preoperative predictors for obtaining

clinically meaningful weight loss with GES. Ninety-seven obese participants in a prospective multicenter study conducted

in nine European centers were implanted laparoscopically with the abiliti

CLGES system. The mean 12-month %EWL

with CLGES was 35.1 ±19.7%, with a success rate of 52% and a failure rate of 19%. Significant predictors of success

were BMI < 40 kg/m

and age ≥ 50 years, increasing probability of success by 22 and 29%, respectively. A low F1-

cognitive-restraint score was a significant predictor of failure (p = 0.004). The best predictive model for success included

F1-cognitive-restraint, F2-disinhibition, BMI < 40, and age ≥ 50 (p = 0.002). The authors concluded that age, preoperative

BMI, and F1-cognitive-restraint and F2-disinhibition scores from a preoperative questionnaire are predictive of weight loss

outcomes with closed-loop GES and may be used for patient selection.

In a systematic review, Cha et al. (2014) evaluated the current state regarding implantable gastric stimulators. Thirty-one

studies consisting of a total of 33 different trials were included in the systematic review for data analysis. Weight loss was

achieved in most studies, especially during the first 12 months, but only very few studies had a follow-up period longer

than 1 year. Among those that had a longer follow-up period, many were from the Transcend(

) (Implantable Gastric

Stimulation) device group and maintained significant weight loss. Other significant results included changes in

appetite/satiety, gastric emptying rate, blood pressure and neurohormone levels or biochemical markers such as ghrelin

or HbA1c, respectively. The authors conclude that although gastric electrical stimulation holds great promise, stronger

evidence is required through more studies with a standardized way of carrying out trials and reporting outcomes, to

determine the long-term effect of gastric electrical stimulation on obesity. (Publications by Shikora 2009, Sarr 2012, and

Camilleri 2008, which were previously cited in this policy, are included in this systematic review).

Intragastric Balloon (IGB)

There is mixed evidence regarding the long-term efficacy and safety for intragastric balloons and their use with obesity;

additional well designed RCTs and long-term data are warranted.

Based on a clinical evidence assessment by ECRI (2022), the evidence for the Spatz3

IGB is inconclusive. Assessment

of two RCTs, three nonrandomized comparison studies, two case series, and two chart reviews assessing weight loss

and adverse events for Spatz3

in adults with obesity revealed short-term clinically significant weight loss but whether

these results were long-term remains to be seen. Limitations included small sample sizes, retrospective design of studies,

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lack of randomization, masking, and controls along with single-center focus. Large robust studies with long-term results

are warranted and several ongoing clinical trials may address this in the future.

Zou et al. (2021) performed a systematic review and meta-analysis to evaluate the efficacy of the intragastric balloon

(IGB) as an obesity management tool for metabolic dysfunction-associated fatty liver disease (MAFLD). Thirteen

observational studies and one RCT met the inclusion criteria (624 participants in total). The results showed that over time,

IGB therapy significantly improved the serum markers homeostasis model assessment of insulin resistance (HOMA-IR),

alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transpeptidase (GGT) levels

from baseline to follow-up. The authors concluded that IGB has the potential to become a multidisciplinary management

tool of MAFLD, however IGB is a temporary measure, and if the patient cannot maintain an active lifestyle after the first

balloon is removed, relapse of MAFLD is expected. Limitations include lack of comparison group; further RCT’s are

needed.

Hayes (2018, updated 2022) low-quality evidence suggests that IGB have mixed results with regard to weight loss over

the short term when used as an adjunct to diet and exercise. These devices are consistently associated with high AE and

all studies analyzed lacked long term follow up on maintaining weight loss and safety concerns.

A 2021 ECRI clinical evidence assessment on the Orbera

Intragastric Balloon System concluded that the evidence is

inconclusive with mixed results, and shows the use of Orbera results in short-term, clinically significant weight loss in most

patients; however, most patients regain weight, and by 1 year, the sustained weight loss has unclear clinical significance.

Additional randomized studies are needed to determine whether Orbera use can reduce bariatric surgery risks for patients

who are not surgery candidates and/or use the device to lose weight to become eligible for surgery. Additional studies that

directly compare Orbera with other IGBs would also be useful.

In a multicenter, open-label industry-sponsored RCT, Abu Dayyeh et al. (2021, included in ECRI 2022 report above)

investigated the safety and efficacy of the Spatz IGB in adults with obesity. 288 patients were randomly assigned to

receive either the IGB plus dietary and exercise counselling or dietary and exercise counselling alone for 32 weeks.

Inclusion criteria were patients aged 22-65 years, BMI of 30 kg/m

or greater for past two years, history of unsuccessful

non-surgical weight loss methods and willingness to participate in the required dietary restrictions. The IGB was implanted

via esophagogastroduodenoscopy (EGD) under conscious or monitored anesthesia sedation; depending on the patient’s

height an initial volume of 400 ml, 450 ml, 500 ml, or 550 ml was utilized. During the 32 weeks, all patients followed a

1000–1200 kcal/day diet and exercise plan. After 32 weeks, the IGB was removed and patients were followed for another

24 weeks. Primary outcomes consisted of %TBWL and clinical responder rate, which was achieved by a decrease of at

least 5% total bodyweight loss at 32 weeks. Mean %TBWL at 32 weeks was 15·0% (95% CI 13·9-16·1) in the IGB group

versus 3·3% (2·0-4·6) in the control group (p < 0·0001). The authors found the adjustable IGB combined with lifestyle

modification enabled significant weight loss over a period of 6 months with an observed acceptable safety profile.

Limitations included no masking or sham intervention, and an approximately 20% loss to follow-up at 32 weeks. Future

studies should assess the long-term safety of the device.

ECRI (2020) Health Technology Assessment focused on the safety and efficacy of the Elipse

™

and Obalon

, two

ingestible IGBs. The evidence was inconclusive citing RCTs would be beneficial to determine whether any differences

exist in weight loss and serious AE risks. Available clinical guideline recommendations on IGB are mixed and none pertain

to ingestible IGB. Thus, major evidence gaps remain and additional comparative studies of ingestible and conventional

IGB are needed.

Moore et al. (2019, included in the ECRI report above) performed a retrospective analysis of patients that underwent the

Obalon Balloon System (OBS), a swallowable, gas-filled intragastric balloon system for weight loss. A web-based registry

was accessed for the data on 1,343 patients with a starting BMI ≥ 25 kg/m

. Nonserious and serious adverse events were

reported in 14.2% and 0.15% of patients, respectively. Weight loss in the indicated use (BMI 30-40 kg/m2) was 9.7 ±6.1

kg and 10.0 ±6.1% TBWL. Weight loss in other BMI categories was 8.2 ±5.6 kg or 10.3 ±7.0% total body weight loss for

BMI 25 to 29.9 kg/m2; and 11.6 ±7.8 kg or percent total body weight loss 9.3 ±6.0 for BMI > 40 kg/m2. The authors

concluded that the OBS safe and effective at stimulating weight loss and provides practitioners with another tool to treat

obese patients who have failed other weight loss programs. Limitations included lack of comparison group, the possible

bias of a manufacturer-sponsored study, variation with loss and behavior modification data collection, and lack of data

collection for co-morbidities and metabolic data resulting in inability of data analysis for these areas.

Coffin et al. (2017, included in the Hayes 2021 report above) published findings from their multicenter randomized

controlled trial, in which they compared 6 months of IGB or standard medical care (low-calorie diet, with bimonthly

dietician evaluations) as bridge therapies to laparoscopic gastric bypass in super-obese patients (> 45 kg/m2). The

surgery was performed at 6 months, shortly after removal of the IGB, and assessments were undertaken through 12

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months. While the BMIs between groups were comparable at baseline, IGBs significantly reduced BMI by 6 months

compared with standard care, with median BMI of 47.9 kg/m2 for IGB patients and 50.7 kg/m2 for control patients (p <

0.001). However, while the implanted IGB was effective on the short term, having the IGB before surgery did not impact

postsurgical outcomes after 12 months (approximately 6 months post-surgery), the groups’ BMIs were not significantly

different at this time point (median BMI:IGB, 38.1 kg/m2 versus standard care, 37.6 kg/m2; p = 0.56). The authors

concluded that IGB insertion before LGBP induced weight loss but did not improve the perioperative outcomes or affect

postoperative weight loss. Limitations of the study included short duration of the IGB intervention, poor recruitment rate, a

higher-than-expected use of ICU facilities, and the poor weight loss in the IGB group.

Nunes et al. (2017) conducted a retrospective review of 2002 patients who underwent an IGB procedure to determine its

effectiveness with different degrees of obesity. A total of 946 patients were lost to follow-up. Overall, 40 (3.78%) had

device removal due to intolerance, and 1016 patients completed the 6-month treatment. The mean weight loss was

18.9%, excess weight loss 60.1% and a BMI reduction of 6.76 points. Six months after removal of the balloon 842 patients

had continued follow-up (82.8%). At this time, weight loss was 19.84%, excess weight loss was 59.49%, and BMI

reduction of 7.06 points. In all groups there was statistical difference between the times T0 and T1 and between T1 and

T2 (p < 0.001). There was no statistical difference between T2 and T3, in any group. The authors concluded that IGB

provided sustained weight loss in patients who remained in dietary follow-up for 1 year. The study is limited by lack of

comparison group and high lost-to-follow up rate. Longer term outcomes with well-designed randomized clinical controlled

trials are needed to further evaluate the IGB.

Saber et al. (2017) conducted a systematic review and meta-analysis to evaluate the efficacy and safety of intragastric

balloon (IGB) treatment. A total of 20 RCTs involving 1,195 participants were identified. Weight loss results before and

after 3 months were analyzed separately. The weight loss results of patients with and without IGB treatment were

compared. A significant effect size was calculated that favored fluid filled IGBs over air-filled IGBs. Flatulence, abdominal

fullness, abdominal pain, abdominal discomfort, and gastric ulcer were significantly more prevalent among IGB patients

than among non-IGB control patients. No mortality was reported from IGB treatment. In the authors’ opinion, IGB

treatment, in addition to lifestyle modification, is an effective short-term modality for weight loss. However, there is not

sufficient evidence confirming its safety or long-term efficacy.

The REDUCE pivotal trial (Ponce et al., 2015, included in the Hayes 2021 report above, and Jung 2020 systematic

review) was a prospective, randomized controlled pivotal trial of a dual intragastric balloon to evaluate the safety and

effectiveness of a dual balloon system plus diet and exercise in the treatment of obesity compared to diet and exercise

alone. Participants (n = 326) with body mass index (BMI) 30-40 kg/m

were randomized to endoscopic dual balloon

system (DBS) treatment plus diet and exercise (DUO, n = 187) or sham endoscopy plus diet and exercise alone (DIET, n

= 139). Co-primary endpoints were a between-group comparison of %EWL and DUO subject responder rate, both at 24

weeks. Thereafter DUO patients had the DBS retrieved followed by 24 additional weeks of counseling; DIET patients were

offered DBS treatment. Mean BMI was 35.4. Both primary endpoints were met. DUO weight loss was over twice that of

DIET. DUO patients had significantly greater %EWL at 24 weeks (25.1% intent-to-treat (ITT), 27.9% completed cases

(CC, n = 167) compared with DIET patients (11.3% ITT, p = .004, 12.3% CC, n = 126). DUO patients significantly

exceeded a 35% response rate (49.1% ITT, p < .001, 54.5% CC) for weight loss dichotomized at 25%EWL.

Accommodative symptoms abated rapidly with support and medication. Balloon deflation occurred in 6% without

migrations. Early retrieval for non-ulcer intolerance occurred in 9%. Gastric ulcers were observed; a minor device change

led to significantly reduced ulcer size and frequency (10%). The authors concluded that the dual balloon system was

significantly more effective than diet and exercise in causing weight loss with a low adverse event profile. Additional RCT

with longer follow-up are needed.

Laparoscopic Greater Curvature Plication (LGCP)

While laparoscopic greater curvature plication may appear to be safe for weight loss, additional robust RCTs with

comparison groups and long-term data are needed.

In a 2023 single center retrospective analysis Park and Kim presented the weight loss and revision surgery rate outcomes

of 75 patients following laparoscopic gastric greater curvature plication (LGGCP) surgery. The results showed that 13 out

of 75 patients underwent revision surgery. The main reason for revision was weight regain, however chronic intermittent

GERD, dyspepsia and chronic relapsing melena were also reasons. The mean body weight and BMI at initial LGGCP

surgery were 207 lbs. (± 24) and 35.6 (± 3.9 kg/m2) respectively. Mean nadir body weight after LGGCP was 149 lbs. (±

13), and BMI was 25.8 (± 2.8 kg/m2). At revision, mean body weight was 196 lbs. (± 25) and BMI was 33.9 (± 4.2 kg/m2).

The results showed that after 5 years, there was weight gain close to pre-surgery levels. The authors concluded that

LGGCP as a primary surgery, results in high rate of weight gain and the need for revisional surgery.

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Doležalova-Kormanova et al. (2017) reported outcomes in a cohort of LGCP patients at 5-year follow-up. Patients with

complete weight data through 5-year follow-up was 86.9%, (212/244). The ANOVA database indicated a significant BMI

reduction out to 2 years (p < 0.001), a plateau at 3 and 4 years, and a moderate but significant BMI increase at 5 years (p

< 0.01). Excess BMI loss at 1, 2, 3, 4, and 5 years was as follows: 50.7 ±9.1%, 61.5 ±8.1%, 60.2 ±7.0%, 58.5 ±7.0%, and

56.8 ±6.3%. At 5 years, 79.2% (168/212) of patients were successful; 20.8% (44/212) experienced a suboptimal weight

outcome; mean weight regain, 9.2%. Cluster analysis identified four distinct LGCP patient profiles. Diabetes improvement

rate was 65.5%. There were 12 reoperations (4.9%): 4 emergency (1.6%) and 8 (3.3%) elective. There was no mortality.

The authors concluded that based on their original cohort and a 56.8% Excess BMI loss and low rate of complications,

LGCP proved to be safe and effective. The findings are limited by lack of comparison group. Additional long-term

outcomes are needed to evaluate LGCP in comparison to other bariatric procedures.

In an 18-month prospective, observational, open-label study, Bužga et al. (2017) reported outcomes of 127 patients; 84

underwent LSG and 43, LGCP. LSG and LGCP were then compared during long-term follow-ups in terms of glycemic

control, hormone and lipid secretion, and changes in body composition. Significant weight-loss and an improved body

composition resulted from either procedure vs. baseline (i.e., pre-surgery), with levels of fasting glucose and glycated

hemoglobin also showing statistically significant reductions (at 3 and 18 months for either surgery). Intergroup

comparisons for glycemic parameters yielded no statistically significant differences. However, a dramatic reduction in

ghrelin was detected following LSG, falling from pre-surgery levels of 140.7 to 69.6 ng/L by 6 months (p < 0.001).

Subsequently, ghrelin levels increased, reaching 107.8 ng/L by month 12. Conversely, after LGCP, a statistically

significant increase in ghrelin was seen, rising from 130.0 ng/L before surgery to 169.0 ng/L by month 12, followed by a

slow decline. The authors concluded that although the data showed good metabolic outcomes following LGCP, this

method was less effective than LSG, possibly due to its preservation of the entire stomach, including secretory regions.

Grubnik et al. (2016) compared two-year outcomes in a European prospective randomized controlled trial comparing

LGCP versus LSG. A total of 54 patients with morbid obesity were allocated either to LGCP group (n = 25) or LSG group

(n = 27). Main exclusion criteria were ASA > III, age > 75 and BMI > 65 kg/m

. There were 40 women and 12 men, and

the mean age was 42.6 ±6.8 years (range 35-62). Data on the operation time, complications, hospital stay, BMI loss,

%EWL, loss of appetite and improvement in comorbidities were collected during the follow-up examinations. One year

after surgery, the mean %EWL was 59.5 ±15.4 % in LSG group and 45.8 ±17 % in LGCP group (p > 0.05). After 2 years,

mean %EWL was 78.9 ±20 % in the LSG group and 42.4 ±18 % in the LGCP group (p < 0.01). After 3 years, mean

%EWL was 72.8 ±22 in the LSG group and only 20.5 ±23.9 in the LGCP group (p < 0.01). Loss of feeling of hunger after 2

years was 25 % in LGCP group and 76.9 % in the LSG group (p < 0.05). The comorbidities including diabetes, sleep

apnea and hypertension were markedly improved in both groups after surgery. The authors concluded that the short-term

outcomes demonstrated equal effectiveness of the both procedures, but 2-year follow-up showed that LGCP is not as

effective as LSG as a restrictive procedure for weight loss.

Tang et al. (2015) conducted a meta-analysis to compare LGCP with LSG in terms of efficacy and safety. Eligible studies

included one randomized controlled trial and three non-randomized controlled trials involving 299 patients. The meta-

analysis demonstrated a significantly greater %EWL after LSG than LGCP at the follow-up time points of 3 months (Z =

2.26, p = 0.02), 6 months (Z = 4.49, p < 0.00001), and 12 months (Z = 6.99, p < 0.00001). The difference in the resolution

of diabetes mellitus between these two approaches did not reach statistical significance (p = 0.66). According to the

pooled data, LGCP was associated with more adverse events than was LSG (p = 0.01). The operation time (p = 0.54) and

postoperative hospital stay (p = 0.44) were comparable between the two groups. LGCP is inferior to LSG not only in

terms of providing effective weight loss but also in terms of safety.

Mini-Gastric Bypass (MGB)/Laparoscopic Mini-Gastric Bypass (LMGB)/One-

Anastomosis Gastric Bypass (OAGB)

Currently there is insufficient evidence regarding the long-term effectiveness and safety of mini-gastric bypass for obesity

and weight loss; additional well designed RCTs are needed along with long-term effects, and safety and efficacy results.

In a 2023 systematic review and meta-analysis, Li et al. assessed the efficacy and safety outcomes of one anastomosis

gastric bypass (OAGB) compared to the Roux-en-Y (RNY) procedure in eight randomized controlled trials that comprised

a total of 931 patients. The mean preoperative BMI ranged from 42.6 to 53.5 kg/m

. Due to inconsistent outcome

measures being described in each study, the authors performed a meta-analysis using the post operative outcome

measures of BMI, percent of excess weight loss (%EWL), or excess body mass index loss (EBMIL). The results showed

that 6 months after surgery, BMI and %EWL did not show a statistically significant difference. Twelve months post-

surgery, 4 articles showed OAGB resulted in better weight loss than RYGB for %EWL, and two articles showed OAGB

had superior BMI reduction. Two articles reported 5-year outcomes and showed Five years no statistically significant

differences in %EBIML and BMI. Two articles reported intraoperative complications for which there were no statistically

significant differences between the two procedures. Three articles were included in the early postoperative complications

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OAGB showed fewer complications than RNY, 3 versus 8 serious complications, respectively. There was inconsistent

reporting of obesity related illnesses across the studies, but articles that did report them, included diabetes, hypertension,

hyperlipidemia, and gastroesophageal reflux disease (GERD), and all showed a high rate of remission. The authors

concluded that OAGB is not inferior to RNY in terms of weight loss and remission of comorbidities during the first 2 years

post operatively but may have a higher incidence of malnutrition. Additional large sample and long-term randomized

controlled trials are needed to verify these findings. (Eskandaros 2021, and Musella 2017 previously cited in this policy

were included in this review)

Parmar et al. (2020) evaluated the role of One Anastomosis/Mini Gastric Bypass (OAGB-MGB) as a revisional/secondary

procedure in patients who needed revisional bariatric surgery (RBS). A total of 17 studies were included in this systematic

review with a total of 1075 patients. The mean age was 43 years and 75% were female. The follow-up ranged from 6 to

60 months with a mean of 29 months. The following identifies the breakout of primary procedures performed: LAGB - 569

patients, SG – 397 patients, VBG – 105 patients, and lap gastric plication - 5 patients. The most common reason for RBS

was poor response in 81%, followed by gastric band failure in almost 36% of patients. The mean BMI prior to RBS was

41.6 kg/m

. Following the OAGB-MGB procedure, the mean %EWL was 50.8% at 6 months, 65.2% at one year, 68.5% at

24 months and 71.6% at 5 years. The author’s conclusion suggests that OAGB-MGB is a safe and an effective choice for

revisional surgery, however randomized studies and large prospective studies with long term follow-up are needed to

validate these findings. Limitations included lack of comparison group or RCTs in analysis along with race and ethnicity

differences which may have impacted the patient’s eating habits, education, compliance, and expectations.

In a comparative effectiveness review from Hayes (2019) for primary bariatric surgery, the mini gastric bypass-one

anastomosis gastric bypass (MGB-OAGB) was compared to RYGB and LSG separately. Data from two systematic

reviews and 4 RCTs suggest an overall increase in percentage of weight loss with the MGB-OAGB procedure when

compared to RYGB and LSG. The evidence also suggested MGB-OAGB may have a positive impact on resolution of T2D

and HTN. However, additional long-term follow-up is warranted for further research on long-term follow-up, complications,

adverse effects, and impact on nutrition.

Carbajo et al. (2018) conducted a prospective, single-center case series to analyze weight evolution in 100 patients from

the first pre-surgery appointment through a 2-year follow-up after one anastomosis gastric bypass. No surgical

complications were observed in the patients studied. The patients’ mean pre-surgery BMI was 42.61±6.66 kg/m

. Greatest

weight loss was observed at 12 months post-surgery (68.56 ±13.10 kg). Relative weight loss showed significant positive

correlation, with greatest weight loss at 12 months and %excess BMI loss > 50% achieved from the 3-month follow-up in

92.46% of patients.

The authors reported that in this series, 48% of patients had normal weight (BMI > 18.5 < 25 kg/m

) at

24 months post-surgery. A limitation of this study is the lack of comparison group, short-term follow-up of the sample

selected; patient evolution should be completed with medium- and long-term data.

In a prospective, case series of 150 morbidly obese patients who underwent laparoscopic OAGB, lipid profiles were

evaluated preoperatively and at different intervals during a 2-year follow-up. The authors (Carbajo et al., 2017) reported a

mean weight loss of 48.85 kg ±15.64 and mean %EWL of 71.87 ±13.41. kg. Total cholesterol and low-density lipoprotein

(LDL) levels significantly decreased, and high-density lipoprotein (HDL) levels significantly increased which the authors

believe translate into theoretical relevant cardiovascular risk benefits. The findings are limited by lack of comparison

group. Long-term randomized studies are needed to fully evaluate the impact of this procedure.

Lessing et al. (2017) conducted a retrospective analysis of all patients (n = 407) who underwent OAGB, reporting an

average excess weight loss 1 year following surgery as 88.9 ±27.3 and 72.8 ±43.5% in patients that underwent primary

and revision OAGB, respectively. Study limitations include lack of comparison group and single center data.

Wang et al. (2017) conducted a systematic review and meta-analysis to compare the safety and efficacy between

laparoscopic mini-gastric bypass (MGB) and laparoscopic SG. Thirteen studies met the inclusion criteria of comparative

studies between MGB and SG; patients were adults, with age ranging from 20 to 70 years old; at least one of the following

endpoints was included: operation time, mortality, overall early complications, specific early complications, overall late

complications, specific late complications, hospital stay, revision rate, remission rate of comorbidities, 1-year %EWL or 5-

year %EWL. The authors observed that patients receiving mini-gastric bypass had more advantageous indexes than

patients receiving sleeve gastrectomy, such as higher 1-year EWL% (excess weight loss), higher 5-year EWL%, higher

T2D remission rate, higher hypertension remission rate, higher OSA remission rate, lower osteoarthritis remission rate,

lower leakage rate, lower overall late complications rate, higher ulcer rate, lower GERD rate, shorter hospital stay and

lower revision rate. No significant statistical difference was observed on overall early complications rate, bleed rate,

vomiting rate, anemia rate, and operation time between MGB and SG. In their opinion, due to the biased data, small

sample size and short follow-up time, the results of this review may be unreliable. RCTs with larger samples sizes are

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needed to compare the effectiveness and safety between MGB and SG. (Publications by Kansou 2016 and Plamper

2017, which were previously cited in this policy, are included in this systematic review).

Piazza et al. (2015) reported their experience with laparoscopic mini-gastric bypass (LMGB) as a revisional procedure for

failed primary LAGB. From June 2007 to November 2012, 48 patients, who had undergone LAGB, underwent revisional

surgery to LMGB. The revisions to a MGB were completed laparoscopically in all cases except in four, when the MGB

was deferred because of gastric tube damage. Mean age was 38 years (range 20-59), and BMI was 43.4 ±4.2 kg/m

; 82

% of patients were females. Revision was performed after a mean of 28.6 months. The mean hospital stay was 3.25 days.

Within 60 days of the MGB, mortality and morbidity were nil. They observed a significant difference in mean BMI after 6

months' follow-up (p < 0.001). Diabetes remission was observed in 88 % of patients, apnea remission in 66 %, and

hypertension remission in 66 % after LMGB (p < 0.001). Moreover, four patients with GERD reported symptom resolution.

All LAGB patients had positive outcomes after the conversion to MGB, with a mean gain of 1.7 points in the bariatric

analysis and reporting outcome system questionnaire. The authors suggest that based on their results, LMGB is a safe,

feasible, effective and easy-to-perform revisional procedure for failed LAGB. The findings are however limited by lack of

comparison group.

Single-Anastomosis Duodenal-Ileal Switch (SADI-S/SADI/SADS)

There is insufficient evidence regarding the safety and efficacy of the single-anastomosis duodenal switch (SADS) for

obesity; additional robust RCTs with comparison groups along with long-term results are needed. Several clinical trials are

in progress for the single-anastomosis duodenal switch; information can be found at https://www.clinicaltrials.gov.

In a 2021 retrospective cohort study, Iranmanesh et al. compared short- and medium-term outcomes between the

standard double-anastomosis duodenal switch (DADS), and single-anastomosis duodenal switch (SADS). Data of 107

patients was collected in the Ontario Bariatric Registry from a Canadian bariatric center of excellence between 2010 and

2019, with the primary outcome measurement weight loss at 1- and 2-years post-surgery. Short-term secondary

outcomes included operative times, intra- and early postoperative complications, hospital LOS, and 30-day readmissions.

Medium-term secondary outcomes included late postoperative complications as well as nutritional deficiencies and

persistent diarrhea at 1- and 2-years post-surgery. Of the 107 patients, 25 received SADS surgery and 82 received

DADS. Follow up data was available for 59 patients at one year, and 47 after 2 years. The results showed similar %TWL

at 1 year (23.6 versus 26.2) and 2 years (24.8 versus 30.2,) after surgery. Short- and medium-term outcomes were similar

between groups. This study is limited by a small number of patients receiving the SADS procedure and large rate of lost-

to-follow-up. Additional high-quality studies with longer follow up are necessary to validate these retrospective findings.

Pereira et al. (2021) conducted a prospective, observational cohort study of 112 patients receiving SADS or BPD/DS.

Primary endpoints were BMI and TWL, and secondary endpoints included remission of obesity related disorders (T2D,

hypertension and dyslipidemia), nutritional deficiencies and post-operative complications. 83 patients received SADS and

29 BPD/DS. There were no statistically significant differences between groups’ demographic characteristics or clinical

features, except for baseline weight and BMI, which were significantly higher in the BPD/DS group. Follow up times for

SADS and BPD/DS ranged from an average of 40 months to 23 months, respectively. The results showed no significant

differences in BMI and percent excess BMI loss (%EBMIL) between the groups, although the percentages of total weight

loss observed from 12, 24, and 36months were significantly higher after BPD/DS. Obesity related comorbidities resolved

numerically better in the BPD/DS group than the SADS group, but it was not statistically significant. Nutritional status was

not consistently significant between the two procedures, and no differences were observed in surgical complications.

Operative time and hospital stay was shorter for the SADS group. The authors concluded SADS is a simpler technique

and shows similar results to BPD/DS. They acknowledged several limitations, including that there was a considerable

numerical imbalance between the two groups, and the number of patients with a follow-up was small. Large-scale,

randomized controlled clinical trials with long-term data are needed to confirm these results.

In a Medtronic funded study, Cottam et al. (2020) evaluated weight loss and one-year nutritional outcomes of the SADS

procedure. 120 patients at six different sites were enrolled; participant inclusion criteria included BMI of 35-40 kg/m2 with

one obesity related comorbidity or a BMI of 40-60 kg/m2 with no related comorbidity. Weight loss, comorbidities, quality of

life, and AEs were followed post-procedure for 12 months. The authors found SADS to be an effective weight loss

operation and the ability to reduce comorbid conditions, particularly diabetes. Limitations included lack of comparative

cohort, patient loss to follow up and lack of long-term results for efficacy.

In a retrospective cohort study, Surve et al. (2017) compared biliopancreatic diversion with duodenal switch (BPD-DS)

with single anastomosis duodenal switch (SIPS-stomach intestinal pylorus sparing surgery) at a single institution with two-

year follow-up. One-hundred eighty-two patients received either a BPD-DS (n = 62) or SIPS (n = 120) procedure. BPD-DS

and SIPS had weight loss at 3 months that were not statistically significantly different but %EWL was more with BPD-DS

than SIPS at 6, 9, 12, 18, and 24 months. Patient lost a mean BMI of 23.3 (follow-up: 69%) and 20.3 kg/m2 (follow-up:

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71%) at 2 years from the BPD-DS and SIPS surgery, respectively. However, patients who had undergone SIPS procedure

had significantly shorter operative time, shorter length of stay, fewer perioperative and postoperative complications than

BPD-DS (p < 0.001). There was no statistical difference between 2 groups for postoperative nutritional data such as

vitamins D, B1, B12, serum calcium, fasting blood glucose, glycosylated hemoglobin (HbA1C), insulin, serum albumin,

serum total protein, and lipid panel. The authors noted that as the BPD-DS procedures were done prior to SIPS, learning

curve and experience may account for the post-operative complications. RCTs with larger patient populations and longer

follow-up periods are needed to evaluate the SIPS procedure.

Cottam et al. (2016) conducted a retrospective matched cohort analysis to compare RYGB with SADS with 18-month

follow-up. One-hundred eight patients received either a RYGB (n = 54) or SADS (n = 54). Regression analysis was used

to compare weight loss outcomes as measured by BMI and weight loss percentages. The results failed to show

statistically significant differences between the two procedures on weight loss at 18 months (39.6 vs 41 % weight loss,

respectively). However, there were significantly more nausea complaints (26 vs 5), diagnostic endoscopies (EGD) (21 vs

3) and ulcers (6 vs 0) with the RYGB than the SADS. The 2-year outcomes for this same patient cohort had similar results

(Cottam et al., 2017). RCTs with larger patient populations and longer follow-up periods are needed to validate these

findings.

Stomach Aspiration Therapy

Currently there is insufficient evidence regarding the safety and efficacy of stomach aspiration therefore additional robust

RCTs with comparison groups are needed along with long-term results.

A 2021 ECRI clinical evidence assessment on AspireAssist Gastric Aspiration Port (Aspire Bariatrics, Inc.) noted that

evidence is somewhat favorable for AspireAssist when adding to lifestyle modification. It was noted to improve weight loss

at 1 year which was maintained at up to 4 years, however, these findings are based on low-quality evidence from 2

systematic reviews and 1 single-arm extension of an RCT. It is unknown if AspireAssist therapy contributes to abnormal

eating behaviors as only one single-arm extension of RCT reported too few events. Evidence limitations included risk of

bias in most studies included in the systematic reviews due to small study size, lack of control group, or both. Additional

larger RCTs are needed to confirm findings, especially in the long term, as well as to compare AspireAssist with other

minimally invasive treatments.

Jirapinyo et al. (2020) conducted a systematic review and meta-analysis of 5 studies with a total of 590 patients to assess

the outcomes of aspiration therapy (AT) (AspireAssist

) on obesity related comorbidities at one year follow up.

Comorbidities included hypertension, hyperlipidemia, T2D, and NAFLD. Secondary outcomes were the amount of weight

loss up to four years post operatively, and pooled serious adverse events (SAEs). The results showed after one year

hypertension, hyperlipidemia, HbA1C, and NAFLD significantly improved. Weight loss at one year was 17% TWL (296

patients), 2 years 18.3% (174 patients), 3 years 18.6% (88 patients), and 4 years 18.6% (27 patients). The pooled SAEs

rate was 4.1% and included buried bumper, peritonitis severe abdominal pain, abdominal pain secondary to pre-pyloric

ulcer and device malfunction requiring A tube replacement. Two studies reported a rate of persistent fistula following A-

tube removal. The authors concluded that at 1 year AT resulted in significant improvement in metabolic function

parameters and 4 years, patients maintained their significant weight loss of 18.6% of their baseline weight, meeting the

definition of successful weight loss maintenance, and may improve access to treatment in obese patients with

concomitant comorbidities. The authors acknowledge the limitations of this study. The number of studies is small (to

account for this, conference abstracts that met the a priori inclusion criteria were included in the analysis), and most of

them were retrospective and observational in nature. Larger, high-quality studies with longer follow-up are required to

validate these findings. (Publications by Sullivan 2013, Thompson 2017, and Nyström 2018, which were previously cited

in this policy, are included in this systematic review).

In the post study of the PATHWAY Trial, Thompson et al. (2019) provide 4-year outcomes of the AT patients from the

initial trial. 58 participants were enrolled in the follow up study; of these 55 had achieved at least 10% TWL at the end of

the first year. Of the 58 patients who enrolled in the follow-up study, 15, 21, and 7 patients elected to have the A tube

removed between years 1 and 2, 2 and 3, and 3 and 4, respectively, thus withdrawing from the study but no loss to follow-

up. The 43 patients who withdrew from the study between years 2 and 4, 25 (58.1%) achieved at least 10% TWL. The

mean %EWL of AT participants at years 1, 2, 3, and 4 was 37.1 ±27.6 (n/n = 81/110), 40.8 ±25.3 (n/n = 42/55), 44.7 ±29.7

(n/n = 22/55), and 50.8 ±31.9 (n = 15/55), respectively. The clinical success rate for patients participating in the follow-up

study was 40/58 (69%) at 4 years from A-tube placement. The authors concluded the AT is a safe and effective

intervention for people with class II and III obesity and can achieve weight loss along with improvement of quality of life.

Limitations of this study are the relatively small number of participants by the fourth year, participant commitment and the

absence of weight loss data after A-tube removal. Additionally, the findings are limited by the design that only allowed

continued follow-up of participants maintained at least 10% TWL from baseline at each year end and lack of comparison

group for the long-term.

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Norén and Forssel (2016) reported 1 and 2-year outcomes from their prospective observational study of 25 obese

subjects to evaluate weight reduction and safety of AT with AspireAssist

™

. Twenty of the original 25 subjects completed

the initial 1-year treatment. These 20 subjects lost mean 54% of their excess weight. At 2 years, 15 subjects had lost

mean 61% of their excess weight. This weight loss surpassed our expectation and is nearly at the level of gastric bypass

procedure and other major abdominal surgery for obesity. The subjects reported improved quality of life during treatment.

There was neither mortality nor any event more severe than grade III-a according to Clavien-Dindo grading system.

Limitation of this study is the combination of AT and cognitive behavioral therapy (CBT) without any control group. Long

term patency is still unknown.

Forssell and Norén (2015) conducted an observational study of 25 obese patients (BMI 39.8 ± 0.9 kg/m2) who after

following a very low-calorie diet for 4 weeks had the AspireAssist gastrostomy tube placed. A low-profile valve was

installed 14 days later, and aspiration of gastric contents was performed approximately 20 minutes after meals three times

per day. Cognitive behavioral therapy was also started. At 6 months, mean weight lost was 16.5 ±7.8 kg in the 22 subjects

who completed 26 weeks of therapy (p = 0.001). The mean percentage excess weight lost was 40.8 ±19.8 % (p = 0.001).

Two subjects were hospitalized for complications: one subject for pain after gastrostomy tube placement, which was

treated with analgesics, and another because of an aseptic intra-abdominal fluid collection 1 day after gastrostomy tube

placement. No clinically significant changes in serum potassium or other electrolytes occurred. The authors concluded

that the results suggest the potential of the AspireAssist as an attractive therapeutic device for obese patients. Further

research with randomized controlled trials is needed to validate these findings.

Transoral Endoscopic Surgery [Including Transpyloric Shuttle

(TPS) Device]

The evidence for transoral endoscopic surgery for bariatric surgery is limited; additional studies including RCTs, long-term

data including the safety and efficacy of the procedure are warranted.

In a 2023 retrospective study, Gudur et al. analyzed over 600, 000 patients in the Metabolic and Bariatric Surgery

Accreditation and Quality Improvement Program database and compared short term (30 days) adverse events (AEs),

readmissions, reoperations, and reinterventions in patients that underwent endoscopic sleeve gastroplasty (ESG)

compared to sleeve gastrectomy (SG). A total of 6054 patients underwent ESG, and 597463 SG. The results showed that

there was no significant difference in major AEs, but patients undergoing ESG had more readmissions, reoperations, and

reinterventions. An additional analysis showed that chronic steroid use, renal insufficiency, and anticoagulation therapy

contributed the most to the AEs in both groups. Race did not impact AEs after ESG, with an increased risk of AEs

identified for black patients after SG. This retrospective study is limited by a very short follow up period. The authors

concluded that further prospective long-term evaluations of ESG versus SG with regards to safety and efficacy are

needed.

In a brief from ECRI (2019), the evidence for the Transpyloric Shuttle

(TPS) device is inconclusive. The evidence is

limited indicating longer-term follow-up data is warranted. The RCT reviewed appeared to have a low risk of bias but

results from a single trial were not conclusive and need independent confirmation in another controlled trial. The case

series had a very high risk of bias due to small sample size, lack of a control group and randomization, and blinding. Both

the RCT and case series report relatively short follow-up.

In a prospective, multicenter, single-arm, feasibility trial, Sandler et al. (2018) evaluate 32 obese subjects with a trans-oral

endoscopic gastrointestinal bypass device. The device is a cuff attached to the distal esophagus by transmural anchors

and connected to a 120-cm sleeve diverting undigested nutrients to the jejunum. Baseline data collected included

bodyweight, vital signs, AEs, medications, HbA1c, fasting glucose, and lipids in addition to follow-up visits. The device

status was endoscopically assessed every 6 months. At 12 months, the 32 subjects had lost an average of 44.8% of

excess body weight, 17.6% of total body weight, 20.8 kg, and 7.5 BMI points. The authors concluded this study

demonstrated the feasibility, safety, and efficacy of a fully trans-oral gastrointestinal bypass implant and that this

endoscopic device may provide a valuable addition to the available treatment for the management of morbid obesity.

However, this study is limited by lack of comparison group, small sample size and short-term follow-up.

Marinos et al. (2014) conducted a prospective, open-label, nonrandomized, single-center investigational clinical trial

performed to evaluate the safety and efficacy of the transpyloric shuttle (TPS) device. The study enrolled twenty patients

meeting the criteria in 2 cohorts with treatment periods of 3 and 6 months. Patients were required to be ≥ 18 and ≤ 55

years of age with a BMI between 30 and 50 kg/m2. Before device placement, patients were provided with nutritional

guidelines for a low-calorie diet and no additional dietary counseling was given after the initial consultation. Patients were

placed under general anesthesia and the devices were deployed and retrieved with no complications. All 20 patients

enrolled in the study had lost weight at the time of device removal. Both the 3- and 6-month patients had statistically

significant improvements to the overall IWQOL-Lite score that exceeded the 7.7- to 12-point threshold to define a clinical

change. All but two patients completed the planned treatment period; both patients had the device removed due to

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complaints of epigastric pain. Limitations of the study were small participant size and short treatment duration. The

authors concluded the TPS is a promising technology that has potential to benefit obese patients seeking to lose weight.

Eid et al. (2014) conducted a prospective, single-center, randomized, single-blinded study from July 2009 through

February 2011, to investigate the safety and effectiveness of endoscopic gastric plication with the StomaphyX device vs a

sham procedure for revisional surgery in RYGB patients to reduce regained weight. Enrollment was closed prematurely

because preliminary results indicated failure to achieve the primary efficacy end point in at least 50% of StomaphyX-

treated patients. One-year follow-up was completed by 45 patients treated with StomaphyX and 29 patients in the sham

treatment group. Primary efficacy outcome was achieved by 22.2% (10) with StomaphyX vs 3.4% (1) with the sham

procedure (p < 0.01). Patients undergoing StomaphyX treatment experienced significantly greater reduction in weight and

BMI at 3, 6, and 12 months (p ≤ 0.05). There was one causally related adverse event with StomaphyX, that required

laparoscopic exploration and repair.

A case series by Mullady et al. (2009) evaluated 20 patients who underwent restorative obesity surgery, endoluminal

(ROSE) procedure due to weight regain post gastric bypass, with a confirmed dilated pouch and gastrojejunal

anastomosis (GJA) on endoscopy. Seventeen of 20 (85%) patients had an average reduction in stoma diameter of 16 mm

(65% reduction) and an average reduction in pouch length of 2.5 cm (36% reduction). The mean weight loss in successful

cases was 8.8 kg at 3 months. The authors concluded that the ROSE procedure is effective in reducing not only the size

of the gastrojejunal anastomosis but also the gastric pouch and may provide an endoscopic alternative for weight regain

in gastric bypass patients. This study is limited by lack of comparison group, small sample size and short-term follow-up.

Endoscopic Sleeve Gastroplasty (OverStitch)

There is insufficient quality evidence regarding the safety and efficacy of endoscopic sleeve gastroplasty for obesity.

Future studies including RCTs are needed to assess the safety and efficacy of this procedure along with long-term results.

Current evidence in an evolving technology report from Hayes (2022) identified four comparative studies and two

systematic reviews which revealed minimal support for endoscopic sleeve gastroplasty (ESG) with the OverStitch device.

Even though the OverStitch device is associated with clinically significant weight loss and fewer AEs, studies did not

suggest the weight loss was more beneficial than an LSG.

Abu Dayyeh et al. (2022) conducted a randomized clinical trial to explore the safety and efficacy of endoscopic sleeve

gastroplasty (ESG) with lifestyle modifications compared to lifestyle modification alone for the treatment of Class 1 and 2

obesity. Inclusion criteria was aged 21-65 with a BMI of 30 to less than 40 with a history of failure with non-surgical weight

loss methods, and who agreed to comply with lifelong dietary restrictions required by this procedure. The primary outcome

on efficacy was %EWL at 52 weeks. Secondary efficacy outcomes included proportion of patients with 25% or more EWL,

% of total weight loss, and the proportion of patients with 5% or more and 10% or more of total weight loss. The effect of

ESG on obesity related comorbidities and safety were also assessed. Seventy-seven participants were randomized to the

ESG plus moderate-intensity lifestyle modifications (ESG group), and 110 to the moderate-intensity lifestyle modifications

alone (control group). During the first year, 12 follow up visits were completed at weeks 1 and 4, and then every 4 weeks

until the 52-week visit. The results showed ESG with lifestyle modifications, compared with lifestyle modifications alone,

resulted in significant improvements in terms of weight loss, and metabolic comorbidities with no GERD incidence as seen

with other bariatric surgeries. Adverse events included gastrointestinal symptoms such as pain, heartburn, nausea and

vomiting which is not unexpected when acclimating post procedure. Three participants had a Clavien-Dindo grade 3

device or procedure related adverse event requiring intervention and included abscess, GI bleeding and one case of

malnutrition requiring reversal of the ESG. The authors concluded that as a minimally invasive alternative to surgical

sleeve gastrectomy, ESG is a safe and effective option for individuals that prefer a non-surgical option. This study is

limited by the impact of the COVID-19 pandemic on study follow-up and participant retention, as well as a small number of

participants.

Singh (2020) conducted a systematic review and found eight studies addressing the OverStitch

™

device which included a

total of 1,859 patients. Studies were all observational and included single center and multicenter experiences. Primary

outcomes measured were %TWL), %EWL, and SAE. The authors found the pooled mean %TWL at 6, 12, and 24 months

was 14.86, 16.43, and 20.01. Similarly, %EWL at 6, 12, and 24 months was 55.75, 61.84, and 60.40. The incidence of

SAE was 2.26%, and no mortality was reported. Gastrointestinal bleeding was the most common documented SAE and

was usually managed conservatively with packed red blood cell transfusion. Based on the analysis, the authors concluded

that ESG is a promising technique with effective weight loss outcomes. Limitations included lack of controlled studies, lack

of standardization definition for SAE and lack of long-term follow up data. (Publication by Lopez-Hava 2017, which was

previously cited in this policy, was included in this systematic review).

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Hedjoudje et al. (2020) conducted a systematic review and meta-analysis from eight studies which included 1,772 patients

that underwent ESG. Primary outcome measurements included relative weight loss, decrease in BMI and relative

estimated weight loss. Serious adverse events were reported in all studies with an occurrence of 2.2% and included 18

patients with pain or nausea that required hospitalization, 9 patients that experience upper GI bleeding, 8 patients with

perigastric leak or collection, one patient experienced pneumoperitoneum and one patient had a pulmonary embolism.

The authors found the data suggested ESG gave way to significant sustained weight loss and safety. Patients had a BMI

decrease of 5.6 kg/m

, mean TBWL was 15.1% and relative EWL of 57.7%. These results appear to be sustained through

18-24 months of follow-up. Limitations included lack of control group, large loss to follow-up, lack of reporting for mild

adverse events and lack of long-term outcomes; future studies are warranted.

Neto et al. (2020) evaluated 233 patients that underwent ESG between April 2017 and December 2018. The ESG

procedure was performed using the OverStitch

™

device. The authors found average weight loss was approximately 17%

at six months and 19% at 12 months. The short-term results suggest that ESG is safe and effective, however additional

studies are warranted.

Vagus Nerve Blocking

Currently there is insufficient quality evidence supporting the long-tern effectiveness of vagus nerve blocking for obesity

treatment; additional robust studies including randomization are warranted.

Apovian et al. (2017) reported the two-year outcomes from the ReCharge study among participants initially randomized to

an active intervention. At 24 months, 123 (76%) vBloc participants remained in the trial. Participants who presented at 24

months (n = 103) had a mean EWL of 21% (8% TWL); 58% of participants had ≥ 5% TWL and 34% had ≥ 10% TWL.

Among the subset of participants with abnormal preoperative values, significant improvements were observed in mean

LDL (-16 mg/dL) and HDL cholesterol (+4 mg/dL), triglycerides (-46 mg/dL), HbA1c (-0.3%), and systolic (-11 mmHg) and

diastolic blood pressures (-10 mmHg). QOL measures were significantly improved. Heartburn/dyspepsia and implant site

pain were the most frequently reported AEs. The primary related serious AE rate was 4.3%. The findings are limited by

lack of comparison group.

Morton et al. (2016) reported 12-month outcomes from the ReCharge study. Fifty-three participants were randomized to

vBloc and 31 to sham. Qualifying obesity-related comorbidities included dyslipidemia (73%), hypertension (58%), sleep

apnea (33%), and T2D (8%). The vBloc group achieved a %EWL of 33% (11% %TWL) compared to 19% EWL (6% TWL)

with sham at 12 months (treatment difference 14 percentage points, 95% CI, 7-22; p < 0.0001). Common AEs of vBloc

through 12 months were heartburn/dyspepsia and implant site pain; the majority of events were reported as mild or

moderate. The authors concluded that vBloc therapy resulted in significantly greater weight loss than the sham control

among participants with moderate obesity and comorbidities, and with a well-tolerated safety profile. Longer-term

outcomes are needed to demonstrate the continued durability of this procedure.

Shikora et al. (2016) reported two-year outcomes from the VBLOC DM2 study, a prospective, case series of 28 subjects

with T2D and BMI between 30 and 40 kg/m

who underwent a VBLOC procedure. At 24 months, the mean percentage of

EWL was 22% (95% CI, 15 to 28, p < 0.0001) or 7.0% TWL (95% CI, 5.0 to 9.0, p < 0.0001). Hemoglobin A1c decreased

by 0.6 percentage points (95% CI, 0.2 to 1.0, p = 0.0026) on average from 7.8% at baseline. Fasting plasma glucose

declined by 15 mg/dL (95% CI, 0 to 29, p = 0.0564) on average from 151 mg/dL at baseline. Among subjects who were

hypertensive at baseline, systolic blood pressure declined 10 mmHg (95% CI, 2 to 19, p = 0.02), diastolic blood pressure

declined by 6 mmHg (95% CI, 0 to 12, p = 0.0423), and mean arterial pressure declined 7 mmHg (95% CI, 2 to 13, p =

0.014). Waist circumference was significantly reduced by 7 cm (95% CI, 4 to 10, p < 0.0001) from a baseline of 120 cm.

The most common AEs were mild or moderate heartburn, implant site pain, and constipation. The authors concluded that

improvements in obesity and glycemic control were largely sustained after 2 years of treatment with VBLOC therapy with

a well-tolerated risk profile. The findings are limited by lack of comparison group. Randomized controlled studies with

larger patient populations are needed to validate these findings.

The ReCharge pivotal study, sponsored by the manufacturer, (Ikramuddin et al., 2014), was a prospective, randomized,

double-blind, sham-controlled, multi-center trial to evaluate the safety and effectiveness of the Maestro system in treating

obesity. The trial enrolled subjects who had a BMI 40-45 kg/m

or a BMI 35-39.9 kg/m

with at least one obesity-related

co-morbid condition, and who had failed a more conservative weight reduction alternative. A total of 239 subjects were

enrolled at 10 investigational sites; 162 subjects were randomized to the device group, and 77 were randomized to the

sham control group. Subjects randomized to the sham control group underwent a surgical procedure consisting of

anesthesia, implantation of a non‐functional neuroregulator, and the same number of incisions an investigator would use

during the laparoscopic placement of the leads. The study authors noted that the trial met its primary safety endpoint and

helped more than half of patients lose at least 20% of their excess weight. The use of vagal nerve block therapy

compared with a sham control device did not meet either of the prespecified coprimary efficacy objectives which were to

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determine whether the vagal nerve block was superior in mean percentage excess weight loss to sham by a 10-point

margin with at least 55% of patients in the vagal block group achieving a 20% loss and 45% achieving a 25% loss.

Gastrointestinal Liner (EndoBarrier

)

Currently there is insufficient evidence regarding the effectiveness and safety of gastrointestinal liners for obesity and

weight loss; additional well designed RCTs are needed along with long-term effects, and safety and efficacy results.

Several clinical trials are in progress for the Endobarrier

device; information can be found at https://www.clinicaltrials.gov.

Ruban et al. (2022) conducted an RCT to study the clinical efficacy and safety of the duodenal-jejunal bypass liner

(DJBL). Participants aged 18 to 65 years, with a BMI of 30 to 50 kg/m2 and confirmed diagnosis of T2D for at least 1 year

with inadequate glycemic control and on glucose-lowering medications were included in the trial. 170 patients were

originally selected but due to several participants dropping out, 55 and 58 patients (DJBL and control arms, respectively)

were included in the primary analysis at one year and 58 and 51 patients were included at year two. All participants

received dietary and physical activity counselling. The primary outcome was to achieve an HbA1c reduction of 20% at 12

months post intervention. Secondary outcomes included lowered blood pressure, and a reduction in total body weight loss

and the number of medications taken. The authors found that while the addition of the DJBL resulted in superior weight

loss and improvement in cardiovascular risk factors, it did not make a significant impact on the patients’ HbA1c. The

findings are limited by the open-label design of the study and large loss to follow up that could have introduced biases.

Quezada et al. (2018) conducted a single-arm, open-label, case series to evaluate the safety and efficacy of

endoscopically placed DJBL over a 3-year period. Of 80 patients enrolled in the study, (age: 35 ±10 years; 69% female;

weight: 109 ±17 kg; BMI: 42 ±5.4 kg/m

), 72 AEs were observed in 55 patients (68%). Nine subjects required a prolonged

hospital stay and three subjects required major interventions. At 52 weeks (71 patients), 104 weeks (40 patients), and 156

weeks (11 patients), the mean %EWL were 44 ±16, 40 ±22, and 39 ±20, respectively (p < 0.001). This study shows

significant and sustained weight loss after 3 years of treatment with the new DJBL. However, the high frequency and

severity of AEs preclude the use of this prototype for periods longer than 1 year.

Forner et al. (2017) evaluated the outcomes of 114 obese patients treated with a DJBL. Mean total body weight change

from baseline was 12.0 kg (SD 8.5 kg, p < 0.001). Over an average of 51 weeks, the mean %TWL was 10.5% (SD 7.3%).

Mean HbA1c was not significantly improved, but of 10 patients on insulin, 4 ceased insulin and 4 reduced insulin dosages.

There was a significant decrease in hemoglobin and total cholesterol and a significant increase in serum alkaline

phosphatase. Seventy-four percent of patients experienced at least one AE, some of them serious including 6 device

obstructions, 5 gastrointestinal hemorrhages, 2 liver abscesses, and 1 acute pancreatitis. Seventy-four percent of patients

experienced weight gain after removal with a mean 4.5 ±6.1 kg (p < 0.0001) within the first 6 months after explanation.

The authors conclude that the DJBL provides significant but highly variable weight loss, and variable glycemic control.

Most patients experienced an adverse event and most regained significant weight after device removal. In addition, the

authors observed that major adverse events can occur, including the potentially life-threatening complications of hepatic

abscess and gastrointestinal hemorrhage. The findings are limited by lack of comparison group. Further studies are

needed to determine the long-term safety and efficacy of this procedure.

In a retrospective review, Betzel et al. (2017) evaluated the efficacy and safety profile of the DJBL. Inclusion criteria for

treatment with a DJBL were age 18-70 years, BMI 28-45 kg/m2, and T2D with a HbA1c > 48 mmol/mol. Primary outcomes

were changes in HbA1c and body weight. Secondary outcomes included changes in blood pressure, lipids, and anti-

diabetic medication. Predictive factors for success of treatment with the DJBL were determined. The authors reported that

185 out of 198 patients successfully underwent a DJBL implantation procedure, with an intended implantation time of 12

months. In these 185 patients, body weight decreased by 12.8 ±8.0 kg (total body weight loss of 11.9 ±6.9%, p < 0.001),

HbA1c decreased from 67 to 61 mmol/mol (p < 0.001) despite a reduction in anti-diabetic medication, and blood pressure

and serum lipid levels all decreased. In total, 57 (31%) DJBLs were explanted early after a median duration of 33 weeks.

AE occurred in 17% of patients. C-peptide ≥ 1.0 nmol/L and body weight ≥ 107 kg at screening were independent

predictive factors for success. The authors concluded that treatment with the DJBL in patients with T2D and obesity

resulted in improvement in glucose control, a reduction in anti-diabetic medication, and significant weight loss. The largest

changes are observed within the first 3-6 months. Initial C-peptide levels and body weight may help to select patients with

the greatest chance of success. The findings are limited by lack of comparison group.

Vilarrasa et al. (2017) evaluated the efficacy and safety of Endobarrier

in grade 1 obese patients with T2D and poor

metabolic control and the role of gastro-intestinal hormone changes on the metabolic outcomes. Twenty-one patients

aged 54.1±9.5 years, diabetes duration 14.8 ±8.5 years, BMI 33.4 ±1.9 kg/m2, and HbA1c 9.1 ±1.3 %, under insulin

therapy, were implanted with Endobarrier

. Fasting concentrations of PYY, ghrelin and glucagon, and AUC for GLP-1

after a standard meal test were determined prior to and at months 1 and 12 after implantation. They found that the

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Endobarrier

in in this subset of patients is associated with significant weight decrease and moderate reduction in HbA1c

at month 12. Longer term outcome data is needed, and the findings are limited by lack of comparison group.

In a systematic review and meta-analysis, Rohde et al. (2016) evaluated the efficacy and safety of the DJBS. Five RCTs

(235 subjects) and 10 observational studies (211 subjects) were included. The risk of bias was evaluated as high in all

studies. The mean BMI ranged from 30 to 49.2 kg/m2 and 10-100% of the subjects had T2D. Meta-analysis showed that

the DJBS was associated with significant mean differences in body weight and excess weight loss of -5.1 kg [95%

confidence interval (CI) -7.3, -3.0; four trials; n = 151; I(2) = 37%] and 12.6% (95% CI 9.0, 16.2; four trials; n = 166; I(2)

= 24%), respectively, compared with diet modification. The mean differences in glycated hemoglobin (-0.9%; 95% CI -1.8,

0.0) and fasting plasma glucose (-3.7 mM; 95% CI -8.2, 0.8) among subjects with T2D did not reach statistical

significance. Adverse events consisted mainly of abdominal pain, nausea, and vomiting. No deaths occurred. Future high-

quality long-term RCTs are needed to further assess efficacy and safety of the DJBS for obesity.

Clinical Practice Guidelines

American Diabetes Association (ADA)

The American Diabetes Association (ADA) Standards of Medical Care in Diabetes – 2022 states that metabolic surgery

should be recommended as an option to treat type 2 diabetes in appropriate surgical candidates with a BMI of 40 kg/m2

(BMI 37.5 kg/m2 in Asian Americans), regardless of the level of glycemic control or complexity of glucose-lowering

regimens, and in adults with a BMI of 35.0–39.9 kg/m2 (32.5–37.4 kg/m2 in Asian Americans) when hyperglycemia is

inadequately controlled despite lifestyle and optimal medical therapy. Metabolic surgery may be considered as an option

for adults with type 2 diabetes and a BMI of 30.0–34.9 kg/m2 (27.5–32.4 kg/m2 in Asian Americans) if hyperglycemia is

inadequately controlled despite nonsurgical methods. They strongly recommend that long-term lifestyle support and

routine monitoring of micronutrient and nutritional status be provided to patients after surgery, according to guidelines for

postoperative management of metabolic surgery by national and international professional societies. The ADA’s 2017

Standards of Medical Care in Diabetes noted that the ADA now refers to bariatric surgery as metabolic surgery.

The joint statement by international diabetes organizations on metabolic surgery in the treatment algorithm for type 2

diabetes (American Diabetes Association, International Diabetes Foundation, Diabetes UK, Chinese Diabetes Society,

and Diabetes India) made the following recommendations:

Metabolic surgery is recommended as an option to treat T2D in patients with the following conditions:

o Class III obesity (BMI ≥ 40 kg/m

), regardless of the level of glycemic control or complexity of glucose-lowering

regimens.

o Class II obesity (BMI 35.0 – 39.9 kg/m

) with inadequately controlled hyperglycemia despite lifestyle and optimal

medical therapy.

Metabolic surgery should also be considered and an option to treat T2D in patients with class I obesity and

inadequately controlled hyperglycemia despite optimal medical treatment by either oral or injectable medications.

All BMI thresholds used in these recommendations should be reconsidered depending on the ancestry of the patient.

For example, for patients of Asian descent, the BMI values above should be reduced by 2.5 kg/m

The organizations note that additional studies are needed to further demonstrate long-term benefits (Rubino et al., 2016).

American College of Gastroenterology (ACG)

In an ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease (Katz, et al. 2022),

the following recommendations are made:

For refractory GERD, recommend optimization of PPI therapy as the first step in management of refractory GERD

(Moderate quality of evidence/strong strength of evidence)

For GERD management, recommend maintenance PPI therapy indefinitely or antireflux surgery for patients with LA

grade C or D esophagitis (Moderate quality of evidence/strong strength of evidence)

American Gastroenterological Association (AGA)

In 2021, the AGA conducted a technical review on intragastric balloons (IGB) for the management of morbid obesity

(Muniraj et al., 2021).

The review suggests that IGB therapy with lifestyle modification is an effective weight-loss intervention and seems to

result in improvements in metabolic parameters and medical comorbidities. Several evidence gaps were addressed in this

review and include long-term efficacy of IGB therapy compared with SOC beyond 1 year, variables such as the filling

medium (fluid vs gas) the potential efficacy of an ongoing dietary intervention, pharmacotherapy, or the need for

sequential balloon placement for sustained weight loss, and the role of exercise in weight-loss sustainability. Although the

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risk of serious adverse events appears to be relatively low, early removal due to device intolerance seems to be relatively

common. The AGA makes the following recommendations:

• In individuals with obesity seeking a weight-loss intervention who have failed a trial of conventional weight-loss

strategies, suggest the use of IGB therapy with lifestyle modification over lifestyle modification alone. (Conditional

recommendation, moderate certainty)

• In individuals with obesity undergoing IGB therapy, recommend moderate- to high-intensity concomitant lifestyle

modification interventions to maintain and augment weight loss. (Strong recommendation, moderate certainty)

• In individuals undergoing IGB therapy, recommend prophylaxis with proton pump inhibitors. (Strong recommendation,

moderate certainty)

• In individuals undergoing IGB therapy, suggest using the intraoperative anesthetic regimens associated with the

lowest incidence of nausea along with perioperative antiemetics; suggest a scheduled antiemetic regimen for 2 weeks

after IGB placement. (Conditional recommendation, low certainty)

• In individuals undergoing IGB therapy, suggest against perioperative laboratory screening for nutritional deficiencies.

(Conditional recommendation, low certainty)

• Suggest daily supplementation with 1–2 adult dose multivitamins after IGB placement. (Conditional recommendation,

very low certainty)

• After IGB removal, suggest subsequent weight loss or maintenance interventions that include dietary interventions,

pharmacotherapy, repeat IGB or bariatric surgery; the choice of weight loss or maintenance method after IGB is

determined based on patient’s context and comorbidities following a shared decision-making approach. (Conditional

recommendation, low certainty)

American Society for Gastrointestinal Endoscopy (ASGE)

The ASGE Technology Committee conducted a systematic review and meta-analysis to evaluate whether endoscopic

technologies have met appropriate thresholds outlined by ASGE by the Preservation and Incorporation of Valuable

endoscopic Innovations (PIVI) document (Abu Dayyeh et al., 2015a). The study authors evaluated Orbera intragastric

balloon (IGB) (Apollo Endosurgery) and the EndoBarrier duodenal-jejunal bypass sleeve (DJBS) (GI Dynamics). Results

of the meta-analysis (17 studies, n = 1683) indicate that the Orbera IGB satisfies the PIVI thresholds for therapy for

primary and non-primary bridge obesity. The percentage of EWL (%EWL) associated with the Orbera IGB at 12 months

was 25.44% (95% CI, 21.45 to 29.41%) with a mean difference over controls of 26.9% (%EWL) (95% CI, 15.66% to

38.24%; p ≤ 0.01) in a total of 3 RCTs. The pooled %TWL after use of Orbera IGW was 13% at 6 months (95% CI,

12.37% to 13.95%) and 11.27% (95% CI, 8.17% to 14.36%), both which exceed the PIVI threshold of 5% TBWL for

nonprimary bridge obesity therapy.

In its position statement on EBTs in clinical practice, the ASGE states that EBTs that have been approved by the FDA and

meet thresholds of efficacy and safety as defined in the ASGE/ASMBS Preservation and Incorporation of Valuable

Endoscopic Innovations should be included in the obesity treatment algorithm as adjunctive therapies to a lifestyle

intervention program as outlined in the 2013 American Heart Association(AHA)/American College of Cardiology(ACC)/The

Obesity Society (TOS) guidelines for the management of overweight and obesity in adults. ASGE advises that

endoscopists performing EBT have a mechanism to enroll patients in long-term follow-up care for weight loss

maintenance (Sullivan et al., 2015).

American Association of Clinical Endocrinologists (AACE)/Obesity Society/American

Society for Metabolic and Bariatric Surgery (ASMBS)

In a clinical practice guideline for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery

patient, the AACE, the Obesity Society, and the ASMBS (Mechanick, et al., 2019) cite the following:

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.

Patients with a BMI ≥ 35 kg/m2 and one or more severe obesity-related complications remediable by weight loss,

including type 2 diabetes (T2D), high risk for T2D (insulin resistance, prediabetes, and/or metabolic syndrome), poorly

controlled hypertension, nonalcoholic fatty liver disease/nonalcoholic steatohepatitis, obstructive sleep apnea,

osteoarthritis of the knee or hip, and urinary stress incontinence, should be considered for a bariatric procedure.

Patients with the following comorbidities and BMI ≥ 35 kg/m2 may also be considered for a bariatric procedure,

though the strength of evidence is more variable: obesity-hypoventilation syndrome and Pickwickian syndrome after a

careful evaluation of operative risk; idiopathic intracranial hypertension; gastroesophageal reflux disease; severe

venous stasis disease; impaired mobility due to obesity; and considerably impaired quality of life.

Patients with BMI of 30–34.9 kg/m2 and T2D with inadequate glycemic control despite optimal lifestyle and medical

therapy should be considered for a bariatric procedure; current evidence is insufficient to support recommending a

bariatric procedure in the absence of obesity.

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The body mass index criterion for bariatric procedures should be adjusted for ethnicity (e.g., 18.5 to 22.9 kg/m

normal range, 23 to 24.9 kg/m

overweight, and ≥ 25 kg/m

obesity for Asians).

Interventions should first include a multidisciplinary approach, including dietary change, physical activity, behavioral

modification with frequent follow up; and then if appropriate, pharmacologic therapy and/or surgical revision.

Selection of a bariatric procedure should be based 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.

In addition, they recommend that all patients seeking bariatric surgery have a comprehensive preoperative evaluation.

This assessment is to include an obesity-focused history, physical examination, and pertinent laboratory and diagnostic

testing. A detailed weight history should be documented, including a description of the onset and duration of obesity, the

severity, and recent trends in weight. Causative factors to note include a family history of obesity, use of weight-gaining

medications, and dietary and physical activity patterns.

A brief summary of personal weight loss attempts, commercial plans, and physician-supervised programs should be

reviewed and documented, along with the greatest duration of weight loss and maintenance. This information is useful in

substantiating that the patient has made reasonable attempts to control weight before considering obesity surgery. The

guidelines state that preoperative weight loss should be considered for patients in whom reduced liver volume can

improve the technical aspects of surgery.

American Association of Clinical Endocrinologists (AACE)/American College of

Endocrinology (ACE)

The AACE and the ACE developed comprehensive clinical practice guidelines for the medical care of patients with obesity

(Garvey, et al., 2016) based on diligent review of clinical evidence with “transparent incorporation of subjective factors.”

The final recommendations recognize that obesity is a complex, adiposity-based chronic disease, where management

targets both weight-related complications and adiposity to improve overall health and quality of life. The detailed evidence-

based recommendations allow for nuanced clinical decision-making that addresses real-world medical care of patients

with obesity, including screening, diagnosis, evaluation, selection of therapy, treatment goals, and individualization of

care. The goal is to facilitate high-quality care of patients with obesity and provide a rational, scientific approach to

management that optimizes health outcomes and safety. Included in their clinical guideline are the following

recommendations pertaining to BMI:

Patients with a BMI of ≥ 40 kg/m2 without coexisting medical problems and for whom the procedure would not be

associated with excessive risk should be eligible for bariatric surgery.

Patients with a BMI of ≥ 35 kg/m2 and 1 or more severe obesity-related complications, including T2DM, 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 a BMI of 30-34.9 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.

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.

American Heart Association/American College of Cardiology (AHA/ACC)/Obesity

Society

The AHA/ACC and the Obesity Society published an updated 2013 Practice Guideline and Management of Overweight

and Obesity in Adults (Jensen et al., 2014). The updated guidelines reflect such consensus and offer update regarding

treatment for patients who are overweight or obese. While the focus remains on sustained weight loss and decreased

waist circumference, the authors also recommend use of bariatric surgery for patients with a BMI > 40, or BMI > 35 with

comorbidities.

In a scientific statement on severe obesity in children and adolescents the American Heart Association (Kelly et al., 2013),

summarized that RYGB has been associated with improvement or resolution of numerous comorbid conditions, including

OSAS, T2DM, features of metabolic syndrome, pseudotumor cerebri, and psychosocial functioning. Controlled,

prospective adult studies demonstrate a marked effect of bariatric surgery on mortality, comorbidity reversal, and

prevention of comorbidity over ensuing decades; these beneficial effects of bariatric surgery help to inform clinical

decision making for severely obese adolescents when no other treatments have demonstrated long-term effectiveness.

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American Society for Metabolic & Bariatric Surgery (ASMBS)

Presurgical Evaluations

The ASMBS published recommendations for the presurgical psychosocial evaluation of bariatric surgery patients (Sogg et

al., 2016). They recommend that bariatric behavioral health clinicians with specialized knowledge and experience be

involved in the evaluation and care of patients both before and after surgery. Given the importance of long-term follow up

after weight loss surgery (WLS), the preoperative psychosocial assessment provides a valuable opportunity for patients to

establish a trusted connection to a behavioral health provider as an additional resource and integral participant in their

postoperative care. The need to ensure that postoperative psychosocial care is available has been noted in established

practice guidelines and evidence suggests that such care is associated with better outcomes after surgery.

In a 2016 position statement on preoperative supervised weight loss requirements, the ASMBS noted that there is no data

from any randomized controlled trial, large prospective study, or meta-analysis to support the practice of mandated

preoperative weight loss. Further, there is no Level I data in the surgical literature, or consensus in the medical literature

(based on over 40 published RCTs) that has clearly identified any one dietary regimen, duration or type of weight loss

program that is optimal for patients with clinically severe obesity. Finally, they recommend that patients seeking surgical

treatment for clinically severe obesity should be evaluated based on their initial BMI and co-morbid conditions.

Nutritional Impact of Bariatric Surgery

In an updated guideline on the integrated health nutritional guidelines for surgical weight loss, the ASMBS (Parrott et al.,

2017) states that optimizing postoperative patient outcomes and nutritional status begins preoperatively. Patients should

be educated before and after WLS on the expected nutrient deficiencies associated with alterations in physiology.

Although surgery can exacerbate preexisting nutrient deficiencies, preoperative screening for vitamin deficiencies has not

been the norm in the majority of WLS practices. Screening is important because it is common for patients who present for

WLS to have at least 1 vitamin or mineral deficiency preoperatively.

Data continue to suggest that the prevalence of micronutrient deficiencies is increasing, while monitoring of patients at

follow-up is decreasing. The ASMBS recommends that their guideline be considered a reasonable approach to patient

nutritional care based on the most recent research, scientific evidence, resources, and information available. It is the

responsibility of the registered dietitian nutritionist and WLS program to determine individual variations as they relate to

patient nutritional care.

Indications for Surgery

In a joint update, the ASMBS and the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO)

released revised guidelines on indications for metabolic and bariatric surgery (MBS) (Eisenberg et al., 2023). Updates to

the guidelines include:

MBS is recommended for individuals with a BMI ≥ 35 kg/m

, regardless of presence, absence, or severity of

comorbidities

MBS should be considered for individuals with metabolic disease and BMI of 30-34.9 kg/m

BMI thresholds should be adjusted in the Asian population such that a BMI ≥ 25 kg/m

suggests clinical obesity, and

individuals with BMI ≥ 27.5 kg/m

should be offered MBS

Long-term results of MBS consistently demonstrate safety and efficacy

Appropriately selected children and adolescents should be considered for MBS

Specific Bariatric Procedures

The ASMBS (2016, updated 2019) has approved, and supports the use of the following bariatric procedures and

associated devices:

Roux-en-Y Gastric Bypass

BPD/Duodenal Switch

Intragastric Balloon

Sleeve Gastrectomy

Adjustable Gastric Banding

Single Anastomosis Duodeno-ileostomy with Sleeve

Bariatric Reoperative Procedures

A 2017 ASMBS updated position statement on sleeve gastrectomy (SG) as a bariatric procedure (Ali et al., 2017)

summarized that:

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Substantial long-term outcome data published in the peer-reviewed literature including studies comparing outcomes of

various surgical procedures, confirm that sleeve gastrectomy (SG) provides significant and durable weight loss,

improvements in medical co-morbidities, improved quality of life, and low complication and mortality rates for obesity

treatment.

SG is now the most commonly performed procedure in the United States (~53.8% of all bariatric procedures),

followed by Roux-en-Y gastric bypass (RYGB; 23.1% of all procedures) (Chaar et al., 2018).

In terms of initial early weight loss and improvement of most weight-related co-morbid conditions, SG and RYGB

appear similar.

SG is an acceptable option for a primary bariatric procedure or as a first-stage procedure in high-risk patients as part

of a planned, staged approach.

The effect of SG on GERD is less clear because GERD improvement is less predictable, and GERD may worsen or

develop de novo. Preoperative counseling specific to GERD-related outcomes is recommended for all patients

undergoing SG.

Based on safety and efficacy data, there is a trend toward SG as the procedure of choice for adolescents, although

both RYGB and SG are routinely performed in teen weight loss surgery programs.

As with any bariatric procedure, long-term weight regain can occur after SG and may require one or more of a variety

of re-interventions.

In an updated statement (Kallies and Rogers, 2020) on the single-anastomosis duodenal switch (SADS), the ASMBS has

concluded that single-anastomosis duodenoileal bypass with sleeve gastrectomy (SADI-S) provides for similar outcomes

to those for the classic biliopancreatic diversion with duodenal switch (BPD-DS) procedure and therefore should be

recognized. The society conclusion is that the current available peer-reviewed literature does not suggest outcomes will

differ substantially from those seen with classic DS procedure. While the ASMBS endorses SADI-S as an appropriate

bariatric surgical procedure, the society indicates publication of long-term safety and efficacy outcomes is still needed and

is strongly encouraged; concerns remain about intestinal adaptation, nutritional issues, and long-term weight loss/regain

following this procedure.

The ASMBS Clinical Issues Committee position statement on intragastric balloon therapy endorsed by SAGES (Ali, et al.,

2016) includes the following summary and recommendations:

Level 1 data regarding the clinical utility, efficacy, and safety of intragastric balloon therapy for obesity are derived

from randomized clinical studies.

Implantation of intragastric balloons can result in notable weight loss during treatment.

Although utilization of intragastric balloons results in notable weight loss, separating the effect of the balloon alone

from those of supervised diet and lifestyle changes may be challenging. Of note, recent FDA pivotal trials

demonstrated a benefit to balloon use compared with diet alone in their study populations. In general, any obesity

treatment, including intragastric balloon therapy, would benefit from a multidisciplinary team that is skilled and

experienced in providing in-person medical, nutritional, psychological, and exercise counseling.

The safety profiles for intragastric balloons indicate a safe intervention, with serious complications being rare. Early

postoperative tolerance challenges can be significant but can be controlled with pharmacotherapy in the majority of

patients, thereby minimizing voluntary balloon removals. These early symptoms should be discussed with the patient

before the procedure.

Although therapy with prolonged balloon in situ time and the use of sequential treatments with multiple balloons have

been studied, awareness and adherence to absolute and relative contraindications of use and timely removal optimize

device safety.

Based on current evidence, balloon therapy is FDA approved as an endoscopic, temporary (maximum 6 months) tool

for the management of obesity. Further review will evaluate the impact of diet, lifestyle changes, and

pharmacotherapy during and after balloon removal.

The ability to perform appropriate follow-up is essential when intragastric balloons are used for weight loss to enhance

their safety and avoid complications related to spontaneous deflation and bowel obstruction.

The ASMBS (Moore and Rosenthal, 2018) released an addendum to their intragastric balloon therapy position statement

in response to the FDA’s warnings on complications not identified during initial clinical trials, and worldwide mortalities

associated with intragastric balloons. They recommend that:

As with all procedures, it is important that patients give informed consent and are aware of potential adverse events.

Laypeople may need to be counseled to correct a misperception that endolumenal treatments are nonsurgical and

thus risk-free.

When less powerful treatments are chosen, behavioral modification increases in importance and there is risk of weight

regain after the device is retrieved. The ASMBS routinely advocates for multidisciplinary care and support of the

weight loss patient, and this recommendation is even more crucial for intragastric balloon recipients.

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The ASMBS, in their 2015 position statement on vagal blocking therapy for obesity (Papasavas et al., 2016), conclude

that the quantity of the data available at this time (6 published studies; approximately 600 implanted devices) and the

length of follow-up indicate adequate safety and efficacy in the short term. More prospective studies with longer follow-up

are required to establish the clinically significant efficacy and patient tolerance of this device.

In a 2015 position statement on intragastric balloon therapy endorsed by SAGES, the ASMBS acknowledges that

although utilization of intragastric balloons results in notable weight loss, separating the effect of the balloon alone from

those of supervised diet and lifestyle changes may be challenging (Ali et al., 2016).

Bariatric Surgery in Adolescents

The updated ASMBS pediatric metabolic and bariatric surgery guidelines (Pratt et al., 2018) state that the disease of

obesity has become recognized as a metabolic disease controlled by genetic factors, with clear evidence that the

physiologic control of weight is through neuroendocrine pathways that regulate body mass by affecting satiety, hunger,

and metabolism. The recognition that weight is largely not under volitional control leads to a strong need to offer effective,

sustainable, proven therapies to children with obesity.

The summary of major changes in the guideline includes:

Patient selection criteria of a BMI ≥ 20% of the 95th percentile with a co-morbidity or a BMI ≥ 140% of the 95th

percentile should be used when determining weight cut offs for adolescents to undergo metabolic and bariatric

surgery (MBS). In their opinion, Tanner stage and linear growth should not be used to determine readiness for MBS.

Preoperative attempts at diet and exercise: there are no data that the number of weight loss attempts correlates with

success after MBS. Compliance with a multi- disciplinary preoperative program may improve out-comes after MBS but

prior attempts at weight loss should be removed as a barrier to definitive treatment for obesity.

Requiring adolescents with a BMI > 40 to have a co-morbidity (as in the old guidelines) puts children at a significant

disadvantage to attaining a healthy weight. Earlier surgical intervention (at a BMI < 45 kg/m2) can allow adolescents

to reach a normal weight and avoid lifelong medication therapy and end organ damage from co-morbidities.

Certain co-morbidities should be considered in adolescents, specifically the psychosocial burden of obesity, the

orthopedic diseases specific to children, GERD, and cardiac risk factors. Given the poor outcomes of medical

therapies for type 2 diabetes in children, these co-morbidities may be considered an indication for MBS in younger

adolescents or those with lower obesity percentiles.

Nonalcoholic fatty liver disease (NAFLD) and steatohepatitis (NASH): NAFLD may be present in at least 59% of

adolescent patients referred for MBS. Given complete resolution of NASH in approximately 85% of patients who

undergo VSG or RYGB, NAFLD should be considered a strong indication for MBS in adolescents with severe obesity.

OSA has been shown to cause significantly decreased health-related quality of life (HRQoL) with increased risk of

morbidity and mortality in adolescents. MBS in adolescents results in significant improvement or resolution of OSA.

Thus, OSA should be considered a strong indication for MBS.

Adolescents who suffer from severe obesity and have failed medical management of idiopathic intracranial

hypertension should be considered for MBS.

Adolescents with severe obesity have significant risk factors for cardiovascular disease (CVD), including,

hyperlipidemia, elevated inflammatory markers, hypertension, and insulin resistance. MBS significantly improves

these risk factors, and therefore would be expected to decrease morbidity and mortality from CVD long term.

Multidisciplinary teams should stabilize and treat preexisting eating disorders, assure stable social support, assess,

and assist with nutrition and activity knowledge, and consider the addition of medications when appropriate.

The Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) guidelines should

be followed when building an adolescent MBS program. It is the responsibility of the adolescent MBS program to have

a transition plan in place for adolescents to transition to an adult MBS program for lifelong care.

The ASMBS Pediatric Committee (Michalsky et al., 2012) best practice guidelines state that the associated risk/benefit

analysis of bariatric surgery in adolescents should also include the consideration of the potential long-term health risks of

untreated or inadequately treated obesity for the individual candidate. In addition, patients with a greater BMI and more

serious medical illness are at increased risk of complications after bariatric surgery. Providing access to bariatric surgery

earlier in life when the disease burden and severity is lower might decrease the operative risk, morbidity, and mortality.

Additionally, earlier surgical intervention alters the natural course of many obesity-related co-morbidities that otherwise

would put the patient at risk of long-term complications and early mortality.

Impact of Obesity and Obesity Treatment on Fertility and Fertility Therapy

In a position statement endorsed by the American College of Obstetricians and Gynecologists (ACOG) and the Obesity

Society (Kominiarek et al., 2017), the ASMBS summarized that:

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Bariatric surgery is effective in achieving significant and sustained weight loss in morbidly obese women and has

been shown in case-control studies to improve fertility.

Pregnancy is not recommended during the rapid weight-loss phase after bariatric surgery; therefore, counseling and

follow-up regarding contraception during this period is important.

The specific impact of either medical weight-loss treatments or bariatric surgery on the responsiveness to subsequent

treatments for infertility in both men and women is not clearly understood at this time.

Revisional Bariatric Surgery

In a systematic review of reoperative bariatric surgery, the ASMBS Revision Task Force (Brethauer et al., 2014) states

that the indications and outcomes for reoperative bariatric surgery are procedure-specific, but the current evidence does

support additional treatment for persistent obesity, co-morbid disease, and complications. Additional surgical therapy may

benefit patients who present with insufficient weight loss, continued co-morbid disease, or weight gain after the index

bariatric procedure. A thorough evaluation should be conducted by a multi-disciplinary program to determine the potential

causes for their poor responses.

As the risks of reoperative bariatric surgery are higher than with the primary procedure, evidence suggests the need for

careful patient selection. In addition, the specific type of reoperative procedure performed should be based on the

patient’s primary procedure, the patient’s anatomy, the patient’s weight and co-morbidities, and the experience of the

surgeon.

An ASMBS Task Force (Sudan et al., 2015) on reoperative surgery provided the updated definitions for reoperative

surgery as follows:

Any operation after the first bariatric operation which qualified toward center of excellence volume requirements is

considered a reoperation. Reoperations were further divided into corrective operations or conversions.

An operation is considered corrective when complications or incomplete treatment effect of a previous bariatric

operation was addressed but the initial operation was not changed.

Conversions involve changing an index bariatric operation (first operation) to a different type of bariatric operation,

and reversal restored original anatomy.

The Task Force also conducted a systematic review to evaluate morbidity, mortality, and weight loss outcomes after

reoperative bariatric surgery. Data on reoperations was compared to that from patients who had initial bariatric operations

but did not undergo reoperations. Reoperations were subdivided into corrective operations and conversions.

Out of 449,753 bariatric operations, 28,720 (6.3%) underwent reoperations of which 19,970 (69.5%) were corrective

and 8,750 (30.5%) were conversions.

The mean % EBWL after conversion to a different bariatric operation was 39.3% and was 35.9% after a corrective

operation. Although this % EBWL was lower than that after a primary operation (43.5%), it is still considered by the

Task Force to be substantial and excellent weight loss. However, not all reoperations will result in further weight loss

or resolution of comorbidity.

Restorative operations necessitated by intolerable side effects or complications of the index procedure such as

removal of the laparoscopic adjustable gastric band for band intolerance or dilated esophagus or reversing a

duodenal switch or a gastric bypass for severe malabsorption, may in fact result in weight gain and return of

comorbidities.

Elderly patients (> 60 years of age) comprised 11% of the primary and 12% of the reoperative group of patients. The

data suggests an overall improvement in the rates of morbidity and mortality after bariatric operations in recent years,

even for higher risk populations.

The Task Force concluded that although most patients do not require reoperative surgery, among those who do, the

complication rate is low, and outcomes are clinically comparable to primary procedures.

American Academy of Pediatrics (AAP)

In 2023, the AAP published the first edition of the clinical practice guideline for evaluation and management of children

and adolescents with overweight and obesity. This document recommends metabolic and bariatric surgery for pediatric

patients over the age of 12 for the following:

Class II obesity, BMI ≥ 35 or 120% of the 95

percentile for age and sex, whichever is lower with clinically significant

disease, including but not limited to:

o T2DM

o Idiopathic intracranial hypertension

o Non-alcoholic steatohepatitis

o Blount’s Disease

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o Slipped capital femoral epiphysis

o GERD

o OSA with an AHI > 5

o Cardiovascular disease risks

o Depressed health related QOL

Class III obesity, BMI ≥ 40 or 140% of the 95th percentile for age and sex, whichever is lower

Furthermore, the following is stated:

The determination of eligibility for metabolic and bariatric surgery should rely heavily on a multicomponent and

individualized approach between members of the metabolic and bariatric surgery team, the patient, and the patient’s

parents or guardians.

A referral should be to a comprehensive metabolic and bariatric surgery center with experience and expertise in

treatment of patients younger than 18 years.

Evaluation for metabolic and bariatric surgery should include a holistic view of the patient and family, including

individual needs (physical and psychosocial) and social risk factors.

American Society for Metabolic and Bariatric Surgery (ASMBS)/National Lipid

Association (NLA)/Obesity Medicine Association (OMA)

The ASMBS, NLA and OMA published a 2-part joint scientific statement on lipids and bariatric procedures. Part 1

concluded that bariatric procedures reduce body fat and have favorable effects on adipocyte and adipose tissue function,

which contributes to improvement in metabolic diseases such as dyslipidemia, high glucose levels, and high blood

pressure. Among the mechanisms by which bariatric procedures may improve dyslipidemia includes favorable alterations

in endocrine and inflammatory homeostasis. Bariatric procedures may also have favorable effects on bile acid metabolism

and the intestinal microbiome, which may also improve dyslipidemia (Bays et al., 2016a).

Part 2 of this joint scientific statement summarized that the principles that apply to bariatric procedures and lipid levels

include the following: (1) The greater the fat mass loss, the greater the improvement in lipid parameters such as

triglycerides and especially LDL cholesterol; (2) bariatric procedures allow for a decrease in the use of drug treatment for

dyslipidemia; and (3) after bariatric procedures, HDL cholesterol may transiently decrease for the first 3–6 months after

the procedure, which is usually followed by an increase in HDL cholesterol above the baseline value before the bariatric

procedure. Finally, the authors observed that data are scarce regarding the effects of bariatric procedures on some of the

lipid parameters such as non-HDL cholesterol, apolipoprotein B, and lipoprotein particle number and remnant lipoproteins

(Bays et al., 2016b).

Endocrine Society

In its updated guideline for the assessment, prevention, and treatment of pediatric obesity (Styne et al., 2017) the

Endocrine Society’s recommendations include the following:

Diagnose a child or adolescent > 2 years of age as overweight if the BMI is ≥ 85th percentile but < 95th percentile for

age and sex, as obese if the BMI is ≥ 95th percentile, and as extremely obese if the BMI is ≥ 120% of the 95th

percentile or ≥ 35 kg/m

Children or adolescents with a BMI of ≥ 85th percentile should be evaluated for potential comorbidities.

Insulin concentrations should not be utilized when evaluating children or adolescents for obesity.

Bariatric surgery is suggested only under the following conditions:

o The patient has attained Tanner 4 or 5 pubertal development and final or near-final adult height, the patient has a

BMI of > 40 kg/m2 or has a BMI of > 35 kg/m

and significant, extreme comorbidities.

o T2DM, moderate to extreme sleep apnea, pseudotumor cerebri, debilitating orthopedic problems, and

nonalcoholic steatohepatitis with advanced fibrosis.

o Extreme obesity and comorbidities persist despite compliance with a formal program of lifestyle modification, with

or without pharmacotherapy.

o BMI of > 40 kg/m2 with mild comorbidities (hypertension, dyslipidemia, moderate orthopedic problems, mild sleep

apnea, nonalcoholic steatohepatitis, and extreme psychological distress that is secondary to their obesity).

o Psychological evaluation confirms the stability and competence of the family unit [psychological distress due to

impaired quality of live (QOL) from obesity may be present, but the patient does not have an underlying untreated

psychiatric illness].

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

o There is access to an experienced surgeon in a pediatric bariatric surgery center of excellence that provides the

necessary infrastructure for patient care, including a team capable of long-term follow-up of the metabolic and

psychosocial needs of the patient and family.

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Bariatric surgery should not be performed in preadolescent children, pregnant or breast-feeding adolescents (and

those planning to become pregnant within 2 years of surgery), and in any patient who has not mastered the principles

of healthy dietary and activity habits and/or has an unresolved substance abuse, eating disorder, or untreated

psychiatric disorder.

Society of American Gastrointestinal and Endoscopic Surgeons (SAGES)

A 2010 guideline by SAGES states that due to concerns for higher failure rates after fundoplication in the morbidly obese

patient (BMI > 35 kg/m

) and the inability of fundoplication to address the underlying problem (obesity) and its associated

co-morbidities, gastric bypass should be the procedure of choice when treating GERD in this patient group. The benefits

in patients with BMI > 30 is less clear and needs further study (Stefanidis et al., 2010).

In its 2008 Guidelines for Clinical Application of Laparoscopic Bariatric Surgery, endorsed by the ASMBS, SAGES

confirms that bariatric surgery is medically indicated for morbidly obese patients who fail to respond to dietary, behavioral,

nutritional, and medical therapies, with clear evidence of efficacy and safety. BMI and age-based candidacy guidelines

should not limit access for patients suffering with progressive or poorly controlled obesity-related comorbidities if the risk-

versus-benefit analysis favors surgery. Laparoscopic RGB, AGB, and BPD have all been proven effective. They do not

make a definitive recommendation for one procedure over another and note that at the present time, decisions are driven

by patient and surgeon preferences, as well as considerations regarding the degree and timing of necessary outcomes

versus tolerance of risk and lifestyle change.

Further, the 2008 guidelines state that there are no absolute contraindications to bariatric surgery. Relative

contraindications to surgery may include severe heart failure, unstable coronary artery disease, end-stage lung disease,

active cancer diagnosis/treatment, cirrhosis with portal hypertension, uncontrolled drug or alcohol dependency, and

severely impaired intellectual capacity. Crohn’s disease may be a relative contraindication to Roux-en-Y gastric bypass

and biliopancreatic diversion.

Multidisciplinary Care Task Group

Greenberg et al. (2005) found a high incidence of depression, negative body image, eating disorders, and low quality of

life (QoL) in patients with severe obesity and that perceived obesity-related health problems, motivation, and sense of

coherence (SoC) predicted better weight loss. Although their investigation showed there are no predictive relationships

between preoperative psychological evaluations and postoperative weight loss, the Behavioral and Psychological

subgroup of the Multidisciplinary Care Task Group recommended that all bariatric surgery candidates be evaluated by a

licensed mental health care provider experienced in the treatment of severely obese patients and working with a

multidisciplinary team. Although research supports the association of psychological problems such as depression and

personality disorder with less successful obesity surgery outcomes, rarely are the psychological problems cited as

contraindications for surgery (Greenberg et al., 2005).

National Institute for Health and Care Excellence (NICE)

The National Institute for Health and Care Excellence (NICE) 2014 guideline on obesity identification, assessment and

management offers bariatric surgery as a treatment option for people with obesity when they have: a BMI of 40 kg/m2 or

more, or between 35 kg/m2 and 40 kg/m2 and other significant disease (for example, type 2 diabetes or high blood

pressure) that could be improved if they lost weight; all appropriate non-surgical measures have been tried but the person

has not achieved or maintained adequate, clinically beneficial weight loss; have a multi-disciplinary team approach; the

person is generally fit for surgery and anesthesia; and the person commits to the need for long-term follow-up. In addition,

the NICE guideline notes that bariatric surgery is the option of choice (instead of lifestyle interventions or drug treatment)

for adults with a BMI of more than 50 kg/m2 when other interventions have not been effective. Further, surgical

intervention is not generally recommended in children or young people, however it may be considered only in exceptional

circumstances, and if they have achieved or nearly achieved physiological maturity.

A 2015 NICE interventional procedure guidance on managing type 2 diabetes states that current evidence on the safety

and efficacy of implantation of a duodenal–jejunal bypass liner for managing type 2 diabetes is limited in quality and

quantity. Therefore, the procedure should only be used in the context of research. Further research should give details of

patient selection, including information about use of the procedure in patients with different levels of BMI. The research

should provide information on complications; reasons for early removal of the device; medication used for treating type 2

diabetes, both when the device is in place and after its removal; and control of type 2 diabetes after device removal. In

2018, the following statement was added to this guidance: The device used in this procedure (EndoBarrier) no longer has

a current CE mark. The CE mark is necessary for medical devices to be marketed in the European Union. A non-CE

marked device can only be used in the context of clinical investigations with MHRA and research ethical approval.

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Interventional procedures guidance [IPG569] from NICE (2016) states that the current evidence on the safety of single-

anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI

‐S

) for treating morbid obesity shows that there are

well-recognized complications. The evidence on efficacy is limited in both quality and quantity. Therefore, this procedure

should only be used with special arrangements for clinical governance, consent and audit or research.

A 2020 NICE interventional procedure guidance on swallowable gastric balloon for weight loss states that the evidence on

efficacy is inadequate and this procedure should only be done in a research setting.

American Academy of Sleep Medicine (AASM)

The American Academy of Sleep Medicine commissioned a task force of experts in sleep medicine, otolaryngology, and

bariatric surgery to develop recommendations based on a systematic review of the literature (Kent, 2021). The following

are recommendations intended as a guide for clinicians who treat overweight adults with OSA:

Recommend clinicians discuss referral to a sleep surgeon with adults with OSA and BMI < 40 who are intolerant or

unaccepting of CPAP (STRONG).

Recommend clinicians discuss referral to a bariatric surgeon with adults with OSA and obesity (class II/III, BMI ≥35)

who are intolerant or unaccepting of PAP (STRONG).

Suggest clinicians discuss referral to a sleep surgeon with adults with OSA, BMI < 40 and persistent inadequate PAP

adherence due to pressure-related side effects (CONDITIONAL).

Suggest clinicians recommend PAP as an initial therapy for adults with OSA and a major upper airway anatomic

abnormality prior to consideration of referral for upper airway surgery (CONDITIONAL).

Department of Veterans Affairs (VA)/Department of Defense (DoD)

The 2020 guideline from the VA/DoD (Mayer et al., 2020) for the management of adult overweight or obesity makes the

following suggestions or recommendations:

In patients with a body mass index of ≥ 30 kg/m2 and type 2 diabetes mellitus, suggest offering the option of

metabolic/bariatric surgery, in conjunction with a comprehensive lifestyle intervention.

In adult patients with a body mass index ≥ 40 kg/m2 or those with body mass index ≥ 35 kg/m2 with obesity-

associated condition(s), suggest offering the option of metabolic/bariatric surgery, in conjunction with a

comprehensive lifestyle intervention, for long-term weight loss/maintenance and/or to improve obesity-associated

condition(s).

In patients with obesity (body mass index ≥ 30 kg/m2) who prioritize short-term (up to six months) weight loss,

suggest offering intragastric balloons in conjunction with a comprehensive lifestyle intervention.

There is insufficient evidence to recommend for or against metabolic/bariatric surgery to patients over age 65.

There is insufficient evidence to recommend for or against percutaneous gastrostomy devices for weight loss in

patients with obesity.

There is insufficient evidence to recommend for or against intragastric balloons for long-term weight loss to support

chronic weight management or maintenance.

Thoracic Society

In a clinical practice guideline from the Thoracic Society (Hudgel, 2018), the following recommendations are made for

patients who are overweight and suffer from OSA:

Reduced-calorie diet, and

Exercise or increased physical activity, and

Behavioral guidance.

In addition, it was stated that pharmacological therapy and bariatric surgery are appropriate for selected patients who

require further assistance with weight loss.

U.S. Food and Drug Administration (FDA)

This section is to be used for informational purposes only. FDA approval alone is not a basis for coverage.

Bariatric surgical procedures are not subject to FDA regulation. FDA approval information for several devices related to

bariatric surgery is described below.

The FDA approved the ORBERA

™

Intragastric Balloon System (Apollo Endosurgery, Inc.) on August 5, 2015. The

ORBERA System is indicated for use as an adjunct to weight reduction in obese adults with BMI ≥ 30 and ≤ 40 kg/m2. It is

to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the

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likelihood of significant long-term weight loss and weight loss maintenance. It is indicated for adults who have failed

conservative weight reduction strategies, such as supervised diet, exercise, and behavior modification program. ORBERA

has a maximum placement period of 6 months. For more information, refer to:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=p140008

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140008S016

(Accessed August 24, 2023)

Gastric banding involves the use of an adjustable or nonadjustable gastric band, which is subject to FDA marketing

approval. In 2001, the BioEnterics

LAP-BAND System was approved by FDA for marketing under the premarket

approval process. According to the FDA labeling, this is approved for surgical treatment for severely obese adults for

whom more conservative treatments (e.g., diet, exercise, behavioral modification) have failed. 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 co-morbid conditions, or those who are 100 lbs. 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.

In February 2011, the FDA approved the Lap-Band Adjustable Gastric Banding System, by Allergan, for weight reduction

in obese patients, with a Body Mass Index (BMI) of at least 40 kg/m2 or less obese patients who have at least a body

mass index (BMI) of 30 kg/m2 and one or more additional obesity-related co-morbid condition, such as diabetes or

hypertension. Additional information is available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/p000008s017a.pdf

(Accessed August 24, 2023)

Adjustable gastric bands are contraindicated in patients younger than 18 years of age.

Surgical stapling devices are used in all bariatric surgical procedures except gastric banding. These devices have been

approved by FDA for use in various general surgical procedures. One device is the Endo Gia Universal Auto Suture,

which inserts six parallel rows of staples into tissue. Other surgical staplers are manufactured by Ethicon Endo-Surgery.

Additional information, product code GDW and GAG, is available at:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/listing.cfm

. (Accessed August 24, 2023)

The OverStitch

™

Endoscopic Suturing System was granted 510(k) marketing approval on June 27, 2018. According to the

FDA, it is intended for endoscopic placement of suture(s) and approximation of soft tissue within the gastrointestinal tract.

The device can utilize either a single- or dual-channel endoscope. Additional information is available at:

https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181141.pdf

. (Accessed August 24, 2023)

The TransPyloric Shuttle/TransPyloric Shuttle Delivery Device was granted Premarket Approval on April 18, 2019, and is

indicated for weight reduction in adult patients with obesity with a BMI of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2

with one or more obesity related comorbid conditions and intended to be used in conjunction with a diet and behavior

modification program. https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180024a.pdf

. (Accessed August 24, 2023)

In August of 2018, the FDA granted GI Dynamics Inc., Boston, MA an Investigational Device Exemption for the

EndoBarrier

gastrointestinal liner. Additional information is available at: https://www.fda.gov/medical-devices/how-study-

and-market-your-device/investigational-device-exemption-ide. (Accessed August 24, 2023)

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Policy History/Revision Information

Date

Summary of Changes

07/01/2024

Related Policies

Removed reference link to the Medicare Advantage Coverage Summary titled Obesity:

Treatment of Obesity, Non-Surgical and Surgical (Bariatric Surgery) (retired July 1, 2024)

03/01/2024

Coverage Rationale

Revised list of proven and medically necessary indications for treating obesity; removed

“vertical banded gastroplasty”

Added language to indicate a planned two-stage procedure is proven and medically necessary

when all of the following criteria are met:

o Initial BMI ≥ 50 kg/m2 prior to first stage bariatric procedure

o Second stage occurs within 2 years following the primary bariatric surgery procedure

o Individual has been compliant with nutrition and exercise

o Individual meets medical necessity criteria listed above at time of second stage procedure

Replaced language indicating “gastrointestinal liners (EndoBarrier

) are investigational,

unproven, and not medically necessary for treating obesity due to lack of U.S. Food and Drug

Administration (FDA) approval and insufficient evidence of efficacy” with “gastrointestinal liners

are unproven and not medically necessary for treating obesity due to insufficient evidence of

efficacy”

Revised list of unproven and not medically necessary indications for treating obesity; replaced:

o “Mini-gastric bypass (MGB)/Laparoscopic mini-gastric bypass (LMGBP)” with “mini-gastric

bypass (MGB)/Laparoscopic mini-gastric bypass (LMGBP)/One-Anastomosis Gastric

Bypass (OAGB)”

o “Stomach aspiration therapy (AspireAssist

)” with “stomach aspiration therapy”

Adults

Revised language to indicate in adults age 18 years or older, bariatric surgery using one of the

procedures identified [in the policy] for treating obesity is proven and medically necessary when

all of the following criteria are met:

o One of the following:

 BMI ≥ 40 kg/m

(or BMI ≥ 37.5 kg/m

in individuals of Asian descent); or

 BMI ≥ 35 kg/m

– 39.9 kg/m

(or BMI ≥ 32.5 kg/m

– 37.4 kg/m

in individuals of Asian

descent) in the presence of one or more of the following co-morbidities:

Insulin resistance or Type 2 diabetes; or

Bariatric Surgery

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UnitedHealthcare Commercial and Individual Exchange Medical Policy

Effective 03/01/2024

Date

Summary of Changes

Cardiovascular disease [e.g., history of stroke and/or myocardial infarction, poorly

controlled hypertension (systolic blood pressure greater than 140 mm Hg or

diastolic blood pressure 90 mm Hg or greater, despite pharmacotherapy), coronary

artery disease, hyperlipidemia]; or

History of cardiomyopathy; or

Obstructive Sleep Apnea (OSA) confirmed on polysomnography with an AHI or RDI

of ≥ 30; or

Evidence of Nonalcoholic Fatty Liver Disease (NAFLD), or

Idiopathic intracranial hypertension (pseudotumor cerebri)

and

o The individual must also meet the following criteria:

 Both of the following:

Completion of a preoperative evaluation that includes a detailed weight history

along with dietary and physical activity patterns; and

Psychosocial-behavioral evaluation by an individual who is professionally

recognized as part of a behavioral health discipline to provide screening and

identification of risk factors or potential postoperative challenges that may

contribute to a poor postoperative outcome

 Participation in a Multidisciplinary surgical preparatory regimen

Adolescents

Revised language to indicate in adolescents age 12-17 years, the bariatric surgical procedures

identified [in the policy] are proven and medically necessary for treating obesity when all of the

following criteria are met:

o One of the following:

 Class III obesity; or

 Class II obesity in the presence of one or more of the following co-morbidities:

Insulin resistance or Type 2 diabetes; or

Poorly controlled hypertension (systolic blood pressure greater than 140 mm Hg or

diastolic blood pressure 90 mm Hg or greater, despite pharmacotherapy); or

Hyperlipidemia; or

Obstructive Sleep Apnea confirmed on polysomnography with an AHI or RDI of ≥

30; or

Evidence of Nonalcoholic Fatty Liver Disease (NAFLD), or

Idiopathic intracranial hypertension (pseudotumor cerebri)

and

o The individual must also receive an evaluation at, or in consultation with, a Multidisciplinary

center focused on the surgical treatment of severe childhood obesity; this may include

adolescent centers that have received accreditation by the Metabolic and Bariatric Surgery

Accreditation and Quality Improvement Program (MBSAQIP) or can demonstrate similar

programmatic components

Documentation Requirements

Updated list of CPT codes with associated documentation requirements; removed 43842

Updated list of required clinical information:

o Added:

 Provider attestation of Asian ancestry, when applicable, if individual is of Asian descent

 For staged bariatric surgery for Body Mass Index (BMI) > 50, include [surgical] plan

o Removed:

 Diet history

o Replaced:

 “Detailed weight and BMI history” with “preoperative evaluation that includes a detailed

weight and BMI history along with dietary and physical activity patterns”

 “Psychological evaluation by a licensed behavioral health professional” with

“psychosocial-behavioral evaluation by a licensed behavioral health professional”

Definitions

Added definition of:

o Asian

Bariatric Surgery

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UnitedHealthcare Commercial and Individual Exchange Medical Policy

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Date

Summary of Changes

o Nonalcoholic Fatty Liver Disease (NAFLD)

Removed definition of “Adolescent”

Applicable Codes

Removed CPT codes 43842 and 43999

Benefit Considerations

For Fully Insured Group Policies in Maryland Only

Revised criteria specified in the Code of Maryland Regulations (COMAR) 31.10.33.03B:

o Added criterion requiring the individual is age 18 years or older

o Replaced criterion requiring “documentation that dietary attempts at weight control have

been ineffective through completion of a structured diet program” with “completion of a

structured diet program”

Added criteria specified in the COMAR 31.10.33.04 requiring documentation of completion of a

structured diet program, including:

o Physician notes; or

o Notes of health care providers other than physicians; or

o Receipts of payment for a structured diet program; or

o Diet or weight loss logs from a structured diet program

Supporting Information

Updated Description of Services, Clinical Evidence, FDA, and References sections to reflect the

most current information

Archived previous policy version 2024T0362LL

Instructions for Use

This Medical Policy provides assistance in interpreting UnitedHealthcare standard benefit plans. When deciding coverage,

the member specific benefit plan document must be referenced as the terms of the member specific benefit plan may

differ from the standard plan. In the event of a conflict, the member specific benefit plan document governs. Before using

this policy, please check the member specific benefit plan document and any applicable federal or state mandates.

UnitedHealthcare reserves the right to modify its Policies and Guidelines as necessary. This Medical Policy is provided for

informational purposes. It does not constitute medical advice.

This Medical Policy may also be applied to Medicare Advantage plans in certain instances. In the absence of a Medicare

National Coverage Determination (NCD), Local Coverage Determination (LCD), or other Medicare coverage guidance,

CMS allows a Medicare Advantage Organization (MAO) to create its own coverage determinations, using objective

evidence-based rationale relying on authoritative evidence (Medicare IOM Pub. No. 100-16, Ch. 4, §90.5

UnitedHealthcare may also use tools developed by third parties, such as the InterQual

criteria, to assist us in

administering health benefits. UnitedHealthcare Medical Policies are intended to be used in connection with the

independent professional medical judgment of a qualified health care provider and do not constitute the practice of

medicine or medical advice.