|Subject:||Bariatric Surgery and Other Treatments for Clinically Severe Obesity|
|Policy #:||SURG.00024||Current Effective Date:||01/05/2016|
|Status:||Revised||Last Review Date:||11/05/2015|
This document addresses surgical and other treatments for clinically severe obesity. Clinically severe obesity is a result of persistent and uncontrollable weight gain that constitutes a present or potential threat to life. There are a variety of surgical procedures and other treatment modalities intended for the treatment of clinically severe obesity.
Gastric bypass and gastric restrictive procedures with a Roux-en-Y procedure up to 150 cm, laparoscopic adjustable gastric banding (for example, the Lap-Band® System or the REALIZE™ Adjustable Gastric Band), vertical banded gastroplasty, biliopancreatic bypass with duodenal switch, and sleeve gastrectomy (open or laparoscopic) are considered medically necessary for the treatment of clinically severe obesity for selected adults (18 years and older) who meet ALL the following criteria (1, 2, and 3):
Surgical repair following gastric bypass and gastric restrictive procedures is considered medically necessary when there is documentation of a surgical complication related to the original surgery, such as a fistula, obstruction, erosion, disruption/leakage of a suture/staple line, band herniation, or pouch enlargement due to vomiting.
Repeat surgical procedures for revision or conversion to another surgical procedure (that is also considered medically necessary within this document) for inadequate weight loss, (that is, unrelated to a surgical complication of a prior procedure) are considered medically necessary when all the following criteria are met:
Not Medically Necessary:
Stretching of a stomach pouch formed by a previous gastric bypass/restrictive surgery, due to overeating, does not constitute a surgical complication and the revision of this condition is considered not medically necessary.
Investigational and Not Medically Necessary:
Gastric bypass and gastric restrictive procedures with a Roux-en-Y procedure up to 150 cm, laparoscopic adjustable gastric banding (for example, the Lap-Band® System or the REALIZE™ Adjustable Gastric Band), vertical banded gastroplasty, biliopancreatic bypass with duodenal switch, and sleeve gastrectomy (open or laparoscopic) are considered investigational and not medically necessary when the above criteria are not met.
Gastric bypass, using a Billroth II type of anastomosis (also known as a "mini gastric bypass") is considered investigational and not medically necessary as a treatment of clinically severe obesity.
Bariatric surgical procedures including, but not limited to, laparoscopic adjustable gastric banding are considered investigational and not medically necessary for individuals with a BMI of 30-34.9 kg/m².
Malabsorptive procedures including, but not limited to, jejunoileal bypass, biliopancreatic bypass without duodenal switch, or very long limb (greater than 150 cm) gastric bypass (other than the biliopancreatic bypass with duodenal switch) are considered investigational and not medically necessary as a treatment of clinically severe obesity.
Repeat procedures for repair, revision, or conversion to another surgical procedure following a gastric bypass or gastric restrictive procedure are considered investigational and not medically necessary when the criteria listed above are not met.
All other gastric bypass/restrictive procedures and other treatment modalities not listed above as medically necessary are considered investigational and not medically necessary including, but not limited to, minimally invasive endoluminal gastric restrictive surgical techniques, such as use of the EndoGastric StomaphyX™ endoluminal fastener and delivery system, and laparoscopic gastric plication (laparoscopic greater curvature plication [LGCP]) with or without gastric banding, also the balloon systems, (such as the ReShape® Integrated Dual Balloon System) and vagus (or vagal) nerve blocking devices, (such as the MAESTRO® Rechargeable System).
A bariatric surgeon with experience in the pediatric population may request further consideration of a case of an individual under 18 years old with severe morbid obesity and unique circumstances by contacting a Medical Director. (Further information available in the Rationale section of this document).
The evidence in the peer-reviewed medical literature to support the use of gastric bypass with a Roux-en-Y procedure (RYGB) up to 150 cm and/or vertical banded gastroplasty (VBG) for the indication of clinically severe obesity suggests that these procedures are beneficial for this indication in a selected group of individuals. The Swedish Obese Subjects (SOS) intervention trial reported a large reduction in diabetes over a 5.5 year mean follow-up for the surgery group. Peri-operative mortality varies by procedure, surgeon, and center, and occurs at a rate of approximately 1 in 200 procedures. In order to minimize potential morbidity and mortality, individuals who undergo such treatment should meet specific criteria prior to undergoing the procedure. The preoperative workup should include documentation by the treating physician of active participation in a formal weight reduction program for at least 6 months duration, in the 2 years prior to surgery, that includes serial documentation of all weights, as well as dietary and exercise regimens. Conservative weight loss efforts should be fully appraised by the physician requesting surgical authorization, so that preoperative assessment of the individual's capability for appropriate behavioral changes can be determined. A 6 month preoperative assessment of anticipated postoperative dietary compliance is a prudent indicator of anticipated postoperative successful weight loss which could be maintained over time.
Results of a prospective, nonrandomized, comparative trial reported long-term outcomes of 563 VBG and 554 adjustable gastric banding (AGB) procedures performed by 2 surgeons. The mean BMI was 46.9 ± 09.9 kg/m(2) for those undergoing VBG and 46.7 ± 07.8 kg/m(2) for those in the AGB group. VBG was performed by laparotomy and AGB using laparoscopy. The Bariatric Analysis and Reporting Outcome System (BAROS) was used to evaluate postoperative health status and quality of life. The mean duration of follow-up was 92 months (range 60-134), with a minimum of 5 years. The overall follow-up rate was 92%. The 30-day mortality rate was 0.4% for VBG and 0.2% for AGB. The overall re-intervention rate in the long-term was 49.7% for VBG and 8.6% for AGB (p<0.0001). The reoperation rate was 39.9% for VBG and 7.5% for AGB (p<0.0001). The excess weight loss (EWL) was significantly greater in the VBG group (58%) than in the AGB group (42%) after 12 months (p<0.05). At 92-month follow-up, no significant difference in weight loss was found between the 2 study groups (59% for VBG and 62% for AGB, p=0.923). The BAROS score was significantly in favor of the AGB group (p<0.0001). The overall resolution rate of co-morbidities was 80% in both groups (Miller, 2007).
A retrospective cohort study of different procedures for morbid obesity was reported for: open VBG (n=125), open Scopinaro biliopancreatic diversion (BPD; n=150), open modified BPD (that is, common limb 75 cm; alimentary limb 225 cm; n=100), and laparoscopic RYGB (LRYGB; n=115). Mean follow-up was 12 years for VBG, 7 years for BPD, and 4 years for LRYGB. An excellent initial weight loss was observed at the end of the second year of follow-up in all techniques, followed by regain of weight observed in the VBG and LRYGB groups. Participants in the BPD groups maintained weight loss results. Mortality was: VBG 1.6%, BPD 1.2%, and LRYGB 0%. Early postoperative complications were: VBG 25%, BPD 20.4%, and LRYGB 20%. Late postoperative morbidity was: protein malnutrition of 11% in Scopinaro BPD, 3% in modified BPD group, and no cases reported either in the VBG group or the LRYGB group; iron deficiency was 20% for VBG, 62% for the Scopinaro BPD, 40% for the modified BPD, and 30.5% for the LRYGB group. Conversion to gastric bypass or to BPD was needed for 14.5% of the VBG group, due to 100% weight regain or vomiting. For those in the Scopinaro BPD group, revision surgery was needed to lengthen the common limb to 100 cm in 3.2% of cases, due to severe protein malnutrition. Revision surgery was also required for 0.8% of the LRYGB subjects, due to 100% weight regain. It was noted that the more complex bariatric procedures increase effectiveness but also increase morbidity and mortality. The authors concluded:
LRYGB is safe and effective for the treatment of morbid obesity. Modified BPD (75-225 cm) can be considered for the treatment of superobesity (BMI greater than 50 kg/m2), and restrictive procedures, such as VBG, should only be performed in well-selected patients, due to high rates of failure in long-term follow-up (Gracia, 2009).
There is sufficient evidence to support the use of the biliopancreatic bypass with duodenal switch (BPD/DS) for individuals who have clinically severe obesity. Mortality is similar to the RYGB procedure, and the evidence suggests that up to 70% EWL can be maintained over long-term follow-up (up to 6 years post-surgery). The evidence supporting this conclusion includes multiple large case series.
The safety and efficacy of laparoscopic adjustable gastric banding (LAGB), using FDA-approved devices, such as the Lap-Band® system or the REALIZE™ Adjustable Gastric Band, for the treatment of clinically severe obesity has been demonstrated in the peer-reviewed literature. Studies with up to 3 years follow-up have shown that an EWL of 40% to 60% can be achieved and is accompanied by improvements in quality of life measures (Jan, 2005; Myers, 2006).
In October 2011, the American Society for Metabolic & Bariatric Surgery (ASMBS) updated its position statement on sleeve gastrectomy (SG) to state that it now:
Recognizes SG as an acceptable option as a primary bariatric procedure and as a first stage procedure in high risk patients as part of a planned staged approach. Substantial comparative and long-term data are now published in the peer-reviewed literature demonstrating durable weight loss, improved medical comorbidities, long-term patient satisfaction, and improved quality of life after SG. Based on the current published literature, SG has a risk/benefit profile that lies between the LAGB and the laparoscopic RYGB.
In 2010, Himpens published long-term (6 year) results of laparoscopic sleeve gastrectomy (LSG) for 53 consecutive persons considered to be "morbidly obese" who electively underwent LSG at a single institution in Belgium between November 2001 and October 2002. Full postoperative evaluation was possible for 41 of these subjects. Median age at the time of surgery was 44 years and median preoperative BMI was 39.0 kg/m2 (range 31-57; standard deviation [SD] 5.4). Seven of the 41 trial participants admitted having preoperative conditions (5 were hypertensive, 1 had type II diabetes, and 1 suffered from symptoms of gastroesophageal reflux [GERD]). At 3 years postop, overall EWL was recorded as 72.8%. After the 6th year, weight regain was observed in 31 cases (75.6%), which resulted in a residual mean overall EWL of 57.3%. These results included 11 (of the 41 evaluated in follow-up) who underwent an additional malabsorptive procedure (duodenal switch) as a 2nd stage procedure due to weight regain and 2 underwent a re-sleeve procedure between the 3rd and 6th postop years, due to weight regain and pouch dilation. Major complications (leakage, stenosis, bleeding, hernia) occurred in 12.2% of study subjects and symptoms associated with GERD were reported in 18% in the LSG stand-alone group and 21% in the overall group of surgical subjects. One diabetic subject reported resolution of symptoms and 2 of the 5 hypertensive subjects reported being normotensive at 6 years postop. Quality of life scores were reported as a mean of 5 BAROS score at 6 years. Despite the limitations of this small study, safety and efficacy results for the stand-alone LSG-treated group appear to be relatively equivalent to those obtained from other restrictive surgical techniques. These findings are consistent with results of other small studies of LSG as a stand-alone procedure, although symptoms associated with GERD seem to be a persistent complaint at follow-up of 1-5 years (Bohdjalian, 2010; Gandsas, 2010).
There are relatively few randomized comparative studies evaluating the relative risk and benefit of each of the surgical options. Furthermore, long-term results (greater than 6 years) are not abundant for any of the bariatric procedures. Thus, the quality of evidence to guide operative choice is fair at best, based primarily on single-institution case series. At this time, there is insufficient convincing evidence in the peer-reviewed medical literature, in terms of safety, to support the use of "mini gastric bypass" and malabsorptive procedures, other than the BPD/DS, in individuals with clinically severe obesity. Therefore, these procedures cannot be recommended for such individuals. The investigational status of these procedures is based on the judgment that there is insufficient evidence to demonstrate that the increased risks of these procedures, compared specifically to the gastric bypass with the Roux-en-Y procedure, are outweighed by a significantly greater reduction in obesity-related morbidities and EWL. A new minimally invasive surgical technique is done endoscopically and is referred to as endoluminal gastric restrictive surgery or "natural orifice" transluminal endoscopic surgery (NOTES). This technique utilizes flexible endoscopy with a specialized device, the EndoGastric StomaphyX™ device (EndoGastric Solutions™ Inc., Redmond, WA). The StomaphyX device received U.S. Food and Drug Administration (FDA) clearance through the 510(k) approval process on March 9, 2007. This endoluminal fastener and delivery system is indicated for use in endoluminal trans-oral tissue approximation and ligation in the GI tract (FDA, 2007). Published evidence is currently insufficient to demonstrate the safety and efficacy of this surgical technique, as compared to conventional surgical treatment options (Swanstrom, 2005).
In January 2009, the ASMBS Emerging Technologies and Clinical Issues Committee issued a position statement on Emerging Endosurgical Interventions for Treatment of Obesity. The committee stated that:
There are currently a number of endoluminal innovations and novel devices and technologies in various stages of development or application for the elective treatment of obesity, including revisional interventions. Theoretical goals of these therapies include decreasing the invasiveness, risk, and barriers to acceptance of effective treatment for obesity, but these outcomes cannot be assumed and must be proven. Therefore, use of novel technologies should be limited to clinical trials done in accordance with the ethical guidelines of the ASMBS and designed to evaluate the risk and efficacy of the intervention.
On October 6, 2011, the ASMBS issued a policy statement on laparoscopic gastric plication, also known as laparoscopic greater curvature plication (LGCP), which is a relatively new bariatric procedure being proposed as a surgical option for the treatment of obesity. Gastric plication involves mobilizing the greater curvature of the stomach similar to the dissection for a SG and infolding (or imbricating) the stomach to achieve gastric restriction utilizing specialized surgical tools and sutures manufactured by Ethicon Endo-Surgery, Inc. (Cincinnati, OH). According to the ASMBS statement:
The rationale for this procedure addresses issues that may limit the acceptance of other bariatric procedures, specifically, gastric plication does not involve gastric resection, intestinal bypass or placement of a foreign body, and could potentially provide a lower risk alternative for patients and referring physicians.
A combination of gastric banding with LGCP has also been proposed which involves placement of an adjustable gastric band, at the time of LGCP. This combined technique has been suggested to augment the early weight loss seen after gastric banding with possible decrease in the need for band adjustments. However, based on the current lack of published data to support any definitive conclusions regarding the safety and efficacy of gastric plication procedures, the ASMBS provided the following recommendations regarding gastric plication, performed alone or in combination with adjustable gastric band placement, for the treatment of obesity:
Gastric plication procedures, performed alone or in combination with adjustable gastric banding, should be considered investigational at this time. This procedure should be performed under a study protocol with third party oversight (local or regional Ethics Committee, Institutional Review Board, Data Monitoring and Safety Board, or equivalent authority) to ensure continuous evaluation of patient safety and to review adverse events and outcomes. Reporting of short- and long-term safety and efficacy outcomes in the medical literature and scientific meetings is strongly encouraged. Data for these procedures should also be reported to a program's center of excellence database. Any marketing or advertisement for this procedure should include a statement to the effect that this is an investigational procedure.
A study conducted by the Agency for Healthcare Research and Quality (AHRQ) is purported to be the most extensive, to date, on postsurgical complications from obesity operations. The AHRQ researchers found that the complication rate among privately insured, nonelderly subjects receiving obesity surgery increased from 21.9%, while they were still hospitalized, to 39.6% by the end of the 180-day study period. Most studies of complications from obesity surgery have been limited to those that occur before hospital discharge or, at the most, up to 30 days post-discharge. This study extends the observation period up to 180 days, (that is, 6 months) after hospital discharge. The 5 most common complications were dumping syndrome, which includes vomiting, reflux, and diarrhea (nearly 20%); anastomosis complications (that is, complications resulting from the surgical joining of the intestine and stomach), such as leaks or strictures (12%); abdominal hernias (7%); infections (6%); and pneumonia (4%). The overall death rate for the entire 180-day postoperative period studied was low (0.2%). These findings were based on claims for hospital care and outpatient care for 5.6 million enrollees under age 65 in employer-sponsored health plans for 45 large employers in 49 states for the time period of 2001 and 2002. The claims data included information on 2522 bariatric procedures (AHRQ, 2009).
Of note, further information published in May 2009 reported an improvement in complication rates following bariatric surgical procedures. According to this article entitled, "Recent Improvements in Bariatric Surgery Outcomes," the AHRQ study reported that the average rate of post-surgical and other complications in those who have had obesity surgery declined 21% between 2002 and 2006. They also found that the complication rate among those initially hospitalized for bariatric surgery dropped from approximately 24% to roughly 15%, much of this driven by a reduction in the post-surgical infection rate, which plummeted 58%. Other factors believed to contribute to the improved bariatric outcomes included a mix of within-hospital volume increases, a move to laparoscopic techniques, and an increase in banding without bypass (Encinosa, 2009).
In addition to surgical complications following bariatric procedures, (for example, stricture, erosion, leakage, band slippage, etc.), it has been noted that some individuals do not achieve, or maintain, adequate weight loss post-operatively, despite documented compliance with postoperative nutritional and exercise regimens. In general, it may take up to 2 years to reach maximum weight loss following bariatric surgery. Follow-up bariatric surgery, such as conversion to RYGB, may be proposed when adequate weight loss has not occurred after 1 to 2 years following the initial surgery. There is agreement among some experts in the field that adequate weight loss has been achieved when at least 50% of EWL has been achieved, or when the body weight has reached within 30% of ideal weight ranges (by age, gender, height, etc.). Inadequate weight loss due to noncompliance with the recommended postoperative regimens is not considered to be a failure of the original surgery.
Gastric wrapping and the Garren Gastric Bubble represent obsolete techniques. The jejunoileal bypass has also been abandoned due to severe metabolic complications.
Reoperation rates have been reported to be higher for VBG, although the evidence reflects that substantial weight loss can be achieved. According to information from the Centers for Medicare and Medicaid Services (CMS), VBG has been largely replaced by AGB and is now rarely performed (CMS, 2006).
A Swedish study describes the high revision rates noted following laparoscopic VBG in a study of 486 subjects consecutively attempted, 64 of which were converted to an open procedure, with 10 year follow-up data reported. The mean BMI at time of surgery was 42.4 kg/m2. The median follow-up was 3 years (with a range of 0-11 years). All participants lost weight with a total of 104 subjects (21%) requiring revisional surgery 114 times during the follow-up period. Food intolerance/vomiting and inadequate weight loss were the most common reasons for surgical revisions. Of the 104 who underwent revisional surgery, 31 underwent repeat VBG, 10 of whom needed a second revisional surgery, and 49 required conversion to gastric bypass. None of those 49 have required any further revisional procedures. The authors concluded that laparoscopic VBG is associated with high revision rates; in the case of failed VBG, repeat VBG seems to be a poor option with conversion to gastric bypass yielding better results (Marsk, 2009).
Bariatric Surgery with BMI less than 35 kg/m2
The FDA approved (February 16, 2011) an expanded indication for the Lap-Band device for, "Weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions" based on the results of an ongoing prospective, single-arm, non-randomized, 5 year study sponsored by the manufacturer, Allergan, Inc. The study, entitled the "Effectiveness and Safety Study of LAP-BAND Treatment in Subjects With BMI ≥ 30 kg/m2 and < 40 kg/m2," is intended to determine whether the Lap-Band system is safe and effective in subjects with BMI ≥30 kg/m2 and < 40 kg/m2. The primary outcome measure was to determine the percent of subjects who attained clinically successful weight loss of ≥ 30% EWL at 1 year post Lap-Band implantation. According to the FDA Executive Summary Memorandum, a total of 151 subjects were enrolled in the study, and 149 subjects underwent Lap-Band placement. A total of 145 participants (97.3%) completed the 12-month follow-up. Over the first 12 months after device placement, the subjects underwent a mean of 6.1 band adjustments (range of 0 to 14 adjustments). The study device was determined to be clinically effective if at least 40% of subjects achieved an EWL of 30% or greater at 1 year. The 1 year study results showed that this goal was reached by 80.5% of all implanted subjects with 65.8% of evaluable subjects (n=143) having lost at least 50% of their excess weight. The mean BMI decreased from 35.4 kg/m2 at baseline to 28.8 kg/m2 at month 12 with a mean decrease from baseline of 6.5 points (p<0.0001). The proportion of subjects who were obese (≥ 30 kg/m2) decreased from 99.3% at baseline to 36.9% at 12 months. A total of 105 subjects (70.5% of the total enrolled subjects) experienced a device-related adverse event. The majority of device-related adverse events were mild in severity (n=118, 54.9%) and only 2.3% were severe (5 events in 3 subjects) with the most common device-related adverse events reported as vomiting (n=43, 20.0%), dysphagia (n=33, 15.3%), post-procedural pain (n=28, 13.0%), and gastroesophageal reflux disease (n=22, 10.2%). There was 1 occurrence of band erosion and 2 reports of esophageal dilatation in the first 12 months. Surgical revision was performed for 10 device related events in 7 subjects. This study is to continue for collection of up to 5 years of data on the study participants, subject to FDA concerns related to multiple issues, including potential selection bias possibly impairing the generalizability of outcomes data, the unclear clinical basis for the 5-year primary endpoint (defined as at least 40% of subjects with EWL% greater than or equal to 30%), and inadequate details about safety evaluations (FDA, 2011). To date, no articles have been published regarding this study which has an estimated completion date of November 2013. No additional studies were identified that are sufficiently powered to support these findings and, for this reason, use of the Lap-Band for BMI of 30-34.9 kg/m2 is considered investigational and not medically necessary, at this time.
The Agency for Healthcare Research and Quality (AHRQ) conducted an evidence-based practice center systematic review protocol entitled: "Comparative Effectiveness of Bariatric Surgery and Non-Surgical Therapy in Adults with Metabolic Conditions and Body Mass Index of 30 to 34.9 kg/m2," which examined the evidence regarding the comparative effectiveness of bariatric surgery versus conventional non-surgical therapies for treating adults with a BMI of 30 to 34.9 kg/m2 and metabolic conditions, including diabetes or impaired glucose tolerance (IGT). The effectiveness of surgery versus nonsurgical interventions in these populations was also compared. This assessment attempted to determine if certain surgical procedures are more effective than others (LAGB, RYGB, SG or BPD/DS) and also investigated other individual factors (social support, counseling, pre-operative weight loss, compliance), in terms of how they are related to successful outcomes. This research also reviewed the evidence regarding adverse effects, complication rates and long-term benefits/harms of bariatric surgery for adults with a BMI of 30 to 34.9 kg/m2 who have metabolic conditions and compared these findings to short-term outcomes (within 2 years from surgery). Twenty-four studies were included in this review which reported bariatric surgery results for the specific target populations. Two were trials comparing different procedures; three were trials of surgical versus nonsurgical interventions, and the rest were observational studies. Both weight and blood glucose improved significantly for the surgery subjects in the trials. In the observational studies, the subjects who underwent surgery showed much greater weight loss at 1 year than what was reported in systematic reviews and randomized controlled trials (RCTs) on diet, exercise, medication, and other behavioral interventions. While both behavioral interventions and medications lowered HbA1c (glycosylated hemoglobin) levels significantly, the decreases reported for the surgical subjects were much greater. Improvements in blood glucose measures were reported as early as 1 month post-surgery. Improvements in hypertension, low-density lipoprotein (LDL) cholesterol, and triglycerides were also reported in some studies. Short-term rates of adverse events associated with bariatric surgery were relatively low. One death, a case of sepsis at 20 months in an LAGB subject, was reported. Short-term complications were minor and tended not to require major intervention. The investigators commented:
Due to the dearth of long-term studies of bariatric surgery in this particular target population, few data exist about long-term adverse effects, and we found no evidence regarding major clinical endpoints, such as all-cause mortality, cardiovascular mortality and morbidity, and peripheral arterial disease.
An updated literature search through October, 2015 resulted in the inclusion of 2 additional RCT that directly compared weight loss and glucose control outcomes in subjects with diabetes, only for those trial participants with a BMI of 30.0 to 34.9 kg/m2. Results of this AHRQ Report were issued in 2013 which concluded:
There is moderate strength evidence of efficacy for RYGB, LAGB, and SG as treatment for diabetes and IGT in patients with a BMI between 30 kg/m2 and 35 kg/m2 in the short term (up to 2 years). The strength of evidence for BPD/DS is rated low because there are fewer studies, and these have smaller sample sizes. Evidence on comparative effectiveness of surgical procedures is insufficient. Short-term adverse events are relatively minor; strength of evidence is low due to small sample size with low power to detect rare events. Strength of evidence is insufficient regarding adverse events in the long-term (2 years or more post-surgery). Longitudinal studies of bariatric surgery patients are needed to assess overall safety and comparative effectiveness regarding diabetes-related morbidity, such as kidney failure and blindness (Maglione, 2013).
In 2013, the American Association of Clinical Endocrinologists, the Obesity Society, and the American Society for Metabolic & Bariatric Surgery (AACE/TOS/ASMBS) updated its practice guidelines for the Perioperative Nutritional, Metabolic, and Nonsurgical Support of the Bariatric Surgery Patient (Mechanick, 2013) which includes the following recommendation:
Patients with BMI of 30–34.9kg/m2 with diabetes or metabolic syndrome may also be offered a bariatric procedure although current evidence is limited by the number of subjects studied and lack of long-term data demonstrating net benefit:
According to this AACE/TOS/ASMBS updated guideline:
The relative risks and benefits of bariatric surgery in individuals with BMI less than 35 kg/m2 continue to be evaluated. There is a lack of high quality data currently available that demonstrates the long-term net health benefits in this population. The guidelines note that limited evidence suggests that surgery may be appropriate in patients with a BMI from 30 to 35 kg/m2 who have diabetes or metabolic syndrome.
Bariatric surgery for Metabolic Indications
Recently, bariatric surgery has been investigated as a treatment for type 2 diabetes mellitus (T2DM). To date, studies reporting the results of bariatric surgery on T2DM have primarily included individuals with morbid obesity (that is, with a BMI greater than or equal to 40 or 35–39.9 kg/m2 with a clinically significant obesity-related comorbidity). There have been very few studies that investigated the safety and efficacy of bariatric surgery, also referred to as metabolic surgery, in individuals with a BMI less than 35 kg/m2. In 2012, Mingrone published results of a single-center, nonblinded, RCT of 60 subjects between the ages of 30 and 60 years with a BMI of 35 or more and a history of at least 5 years of diabetes. Study participants were randomly assigned to receive conventional medical therapy or bariatric surgery (either GB or BPD). The primary endpoint was the rate of diabetes remission at 2 years (defined as a fasting glucose level of < 100 mg per deciliter [5.6 mmol per liter] and a glycated hemoglobin level of < 6.5% in the absence of pharmacologic therapy). At 2 years, diabetes remission had occurred in no subjects in the medical-therapy group versus 75% in the GB group and 95% in the BPD group (p<0.001 for both comparisons). Age, sex, baseline BMI, duration of diabetes, and weight changes were not significant predictors of diabetes remission at 2 years or of improvement in glycemia at 1 and 3 months. At 2 years, the average baseline HbA1c level (8.65 ± 1.45%) had decreased in all groups, but subjects in the 2 surgical groups had the greatest degree of improvement (average HbA1c levels, 7.69 ± 0.57% in the medical-therapy group, 6.35 ± 1.42% in the GB group, and 4.95 ± 0.49% in the BPD group). The authors concluded that, in severely obese subjects with T2DM, bariatric surgery resulted in better glucose control than did medical therapy and that preoperative BMI and weight loss did not predict the improvement in hyperglycemia seen after surgery (Mingrone, 2012).
Another recent randomized, nonblinded, single-center study evaluated the efficacy of intensive medical therapy alone versus medical therapy plus RYGB or SG in 150 obese subjects with uncontrolled T2DM. The average pre-treatment HbA1c level was 9.2 ± 1.5%, and the primary endpoint was the proportion of subjects with a HbA1c level of 6.0% or less at 12 months post treatment. Results showed that of the 150 subjects, 93% completed 12 months of follow-up. The proportion of subjects meeting the primary endpoint at 12 months was 12% (5 of 41) in the medical therapy alone group versus 42% (21 of 50) in the RYGB group (p=0.002) and 37% (18 of 49) in the SG group (p=0.008). Glycemic control improved in all 3 groups, with a mean HbA1c level of 7.5 ± 1.8% in the medical-therapy group, 6.4 ± 0.9% in the RYGB group (p<0.001), and 6.6 ± 1.0% in the SG group (p=0.003). Weight loss was greater in the RYGB group and the SG group (−29.4 ± 9.0 kg and −25.1 ± 8.5 kg, respectively) than in the medical-therapy group (−5.4 ± 8.0 kg; p<0.001) for both comparisons. It is noteworthy that during the study, use of anti-diabetic medications increased in the medical therapy group and decreased in both surgical groups. All subjects in the RYGB group who achieved the primary endpoint did so without medications, while 28% of those in the SG group who reached the primary endpoint required continued medication use. The authors concluded that in obese individuals with uncontrolled T2DM, 12 months of medical therapy plus bariatric surgery achieved glycemic control in significantly more subjects than in those treated with medical therapy alone (Schauer, 2012). However, both studies were small and limited by confounders, such as wide BMI ranges, short-term outcomes data and single center study design. Additional larger, well designed studies are needed to more fully assess the safety, efficacy and durability of therapeutic effect of any bariatric surgical procedure on T2DM.
In 2015, the California Technology Assessment Forum (CTAF) issued a final report titled, "Controversies in Obesity Management," in which the published evidence for several surgical and medical treatments for obesity were reviewed, including intragastric balloon systems and the MAESTRO vagal blocking (vBloc) system. For both of these new technologies, the CTAF report concluded that the current evidence is insufficient to demonstrate safety and efficacy, as compared to established surgical treatment options.
The CTAF report identified a total of 21 reports of good- or fair-quality RCTs (14) and prospective cohort studies (7) comparing one or multiple forms of bariatric surgery to nonsurgical management. The following information is excerpted from the final CTAF Report:
Across all the included studies, 70-80% or more of subjects were female. Consistent with the selection criteria for this evaluation, nonsurgical comparators involved some form of active diet, lifestyle, and/or medical intervention. Surgical interventions also varied in these studies. RYGB was assessed in 13 studies, followed by LAGB (6), VSG (4), and BPD±DS (3) (note: some studies involved multiple procedures). In most studies, lifestyle interventions were compared to surgical intervention alone or with limited lifestyle support; in a few, however, the intensive lifestyle intervention was provided to all subjects, and surgery was added. Studies were typically performed in all potential candidates for bariatric surgery, but some focused solely on subjects with specific comorbidities, typically T2DM. In comparison to nonsurgical management approaches, bariatric surgical procedures were associated with substantial and statistically significant improvements in measures of weight change at a median of 2 years of follow-up, irrespective of the type of procedure performed or the measure of weight change (for example, change in BMI, percentage of excess and/or total body weight lost, changes in fat mass or waist circumference). Data for weight loss beyond a median of 2 years of follow-up is lacking. The pooled mean difference in BMI at study end was 7.4 points (95% CI; 6.2, 8.6). There was a relatively high degree of heterogeneity in these estimates (I²=84%), but in this case, the variability is in the degree of treatment effect across studies; the direction of the effect of surgery in reducing BMI is quite consistent across all studies in the analysis.
Improvement and/or resolution of comorbidities was reported in 16 of 21 studies (76%); however, in some of these studies, improvement was measured only in terms of mean changes in laboratory parameters. The most frequently reported comorbidity was T2DM. Other individual comorbidities commonly evaluated in these comparative studies included hypertension and hyperlipidemia. In studies evaluating resolution of these conditions and/or discontinuation of relevant medications as a binary variable, bariatric surgery was associated with 2- to 3-fold reductions in the prevalence of these comorbidities at the end of follow-up, while nonsurgical management resulted in no appreciable change from baseline. The investigators identified 3 good- or fair-quality studies of the effects of bariatric surgery on sleep apnea.
Regarding outcomes for trial subjects with a preoperative BMI of less than 35 kg/m2, all of the 7 included studies, that measured complete T2DM resolution as a binary variable at 12-24 months of follow-up, reported substantially and statistically significantly greater resolution with surgery (range: 26-73%; median 42%) than with nonsurgical management (range: 0-16%; median 9%). While there are many long-term studies of bariatric procedures, available studies consistently suffer from quality issues that include significant loss to follow-up and a lack of appropriate statistical techniques to account for patient attrition. Many studies examine outcomes of weight reduction, weight regain, comorbidity relapse, and long-term harms only in subjects who were still enrolled in follow-up programs, that is, populations that likely differ significantly from those who dropped out of the program. Further, analyses conducted at discrete time points discard the information provided by trial subjects who were lost to follow-up between the time points of interest. The authors concluded that for patients with a BMI of 35 and above with or without clinical comorbidities, there is moderate certainty of a substantial net health benefit of bariatric surgery compared to nonsurgical management. Across a range of procedures, study designs, and duration of follow-up, bariatric surgery results in greater sustained weight loss (on average, 7-8 kg/m2, or 30-40% of total body weight) and resolution of comorbidities (primarily T2DM) than nonsurgical management. The level of certainty in these results is limited by a lack of good-quality, long-term data on durability of benefit. Rigorous, long-term studies are needed to better characterize the clinical benefits of drugs, devices, and surgical procedures for obesity, particularly in relation to durability of weight loss and comorbidity remission over the long term (CTAF, 2015).
Bariatric Surgery in Adolescents and Children
In 2013, the American Heart Association issued a scientific statement on "Severe obesity in children and adolescents: identification, associated health risks, and treatment approaches" in which the following was noted:
This paper discusses a range of various measures that have been used to define 'severe obesity' for ages 5 to 17, one of which is the BMI. Using 1999-2004 data from the National Health and Nutrition Examination Survey (NHANES), a BMI of greater than or equal to the 99th percentile has been proposed by some investigators as identifying a subgroup of youths that are at particularly high risk for an adverse cardiovascular profile. Various names and definitions have been used in the literature, but the writing group recommends that this condition be called 'severe obesity,' and it should be defined as having a BMI ≥ 120% of the 95th percentile or an absolute BMI ≥ 35 kg/m2, whichever is lower based on age and sex. The prevalence of severe obesity in youths and adolescents (aged 5 to 17) has been reported as between 4-6% in the U.S. (Kelly, 2013).
This paper also reviewed multiple comorbid conditions associated with severe obesity in youths, including metabolic disorders, hypertension, non-alcoholic fatty liver disease, musculoskeletal problems and obstructive sleep apnea syndrome, and noted that severely obese youths are much more likely to become severely obese adults with commensurate risks and adverse outcomes. Various medical treatment options were also described, along with results of the available studies. Regarding bariatric surgery, it was noted that,
In light of the limited effectiveness of lifestyle modification and medical therapy, shown to date, for severe obesity, surgical procedures that have an evidence base that supports their efficacy and safety should be considered for patients who demonstrate medical necessity and psychosocial readiness… The most recent and authoritative practice recommendations (Pratt, 2009) emphasize the concept that a combination of both severe obesity and the existence of comorbidities should be present to medically justify an operation to treat obesity. There is good evidence that RYGB is reasonably safe and highly effective compared with lifestyle modification for the treatment of severe obesity. Relatively good safety and efficacy data for AGB (adjustable gastric banding) in adolescents have been reported, although a high rate of reoperation and sparse long-term data, along with a lack of FDA approval for the device, hamper recommendations for usage before adulthood. All adolescents undergoing bariatric surgery should be strongly encouraged to participate in prospective longitudinal outcomes studies to improve the evidence base to evaluate the risks and benefits of operations in this age group… Bariatric surgery is the most effective treatment for severe obesity in adolescents; however, surgery is appropriate and available for only some adolescents with severe obesity, and broadening availability will depend on the results of long-term outcome studies, currently in progress… Innovative approaches to fill the gap between lifestyle/medication and surgery are urgently needed (Kelly, 2013).
There is, at present, insufficient evidence to support the widespread use of bariatric surgery for the pediatric and adolescent population. Several small case series have shown some promising results. However, in 1 case series of 33 subjects, 5 individuals (15%) regained most or all of their weight 5 to 10 years post-surgery. Concerns about possible nutritional deficiency in growing children and adolescents also exist, and selection criteria for which surgical procedure is best and for appropriate surgical candidates are unclear. Further results are required before it is clearly known whether the benefits of surgery outweigh the risks in this population. However, in a small subset of adolescents with severe morbid obesity, the risks from comorbidities and complications are sufficiently high that bariatric surgery may be indicated. Consequently, special consideration for such surgery may be given for an adolescent with severe morbid obesity presenting with unique circumstances (O'Brien, 2010; Pratt, 2009; Treadwell, 2008). In eligible individuals under the age of 18 years, who are skeletally mature, it is the general consensus in the practice community that potential candidates for surgery be evaluated for the following:
Surgery for clinically severe obesity (bariatric surgery) falls into two categories: gastric restrictive procedures and malabsorptive procedures. The first category, gastric restrictive procedures, includes procedures in which a small pouch is created in the stomach. Weight loss occurs as the individual feels full sooner, having eaten much less than usual. The second category, malabsorptive procedures, includes procedures that rearrange the connections between the stomach and intestines, causing the food to be poorly digested and incompletely absorbed. Weight loss is due to malabsorption without necessarily requiring dietary modification.
Surgery for the treatment of clinically severe obesity may be appropriate in a select group of individuals. According to the National Institutes of Health (NIH), weight loss surgery should be reserved for individuals suffering from the complications of extreme obesity, for whom conservative medical therapy has failed. Possible surgical candidates are those with severe obesity, defined as a body mass index (BMI*) of 40 or greater, or 35 or greater with other medical complications. Such complications include, but are not limited, to the following:
*BMI is calculated by dividing an individual's weight (in kilograms) by height (in meters) squared. To convert pounds to kilograms, multiply pounds by 0.45; to convert inches to meters, multiply inches by 0.0254.
According to the National Institutes of Health (NIH), an increase of 20 percent or more above an individual's ideal body weight is the point at which excess weight becomes a health risk. Today, nearly two-thirds of Americans are overweight or obese. Nearly 15 million of those are considered to have clinically severe obesity, in which there is higher risk of one or more obesity-related health conditions that result either in significant physical disability or even death. While medical complications of obesity may occur in moderately obese people, the frequency increases dramatically as weight increases.
The first line treatment of clinically severe obesity is dietary and lifestyle changes, including regular exercise. In order to lose weight, an individual must have a caloric deficit, i.e., calories out must be greater than calories in. This can be accomplished by decreasing the calories ingested with some form of dietary restriction and by increasing the calories expended through exercise. All available therapies (dietary, behavioral, pharmacologic, and surgical) help with weight loss by changing the calories ingested, absorbed, or expended.
Surgery for clinically severe obesity is performed in a hospital setting. The number of days the individual is hospitalized is dependent on the type of surgery performed. When surgery is required for clinically severe obesity, the following are some of the more common procedures:
Gastric Restrictive Procedures
1. Vertical Banded Gastroplasty (VBG)
VBG is a restrictive procedure. The stomach is divided vertically, and a band is stapled around the top portion of the stomach to decrease its size. Because the normal flow of food is preserved, metabolic complications are rare. Complications of this procedure include esophageal reflux, as well as either widening or blockage of the narrow portion of the stomach, which may require reoperation. VBG may be performed using an open or laparoscopic approach. Many surgeons have abandoned this approach because of unsatisfactory long-term maintenance of weight loss.
2. Adjustable Gastric Banding (AGB)
AGB is a restrictive procedure. It involves surgically placing a gastric band around the exterior of the stomach; the stomach is not entered. The procedure is reversed by removing the band. Complications may include slippage of the external band or band erosion through the stomach wall (2-5% of surgeries). Furthermore, incorrect positioning of the band may result in vomiting, as well as ineffective weight loss. Mortality is generally less than with other bariatric surgical procedures, amounting to about 1 in 1000 to 1 in 2000 procedures. In June, 2001, the FDA cleared the Lap-Band® System (Allergan, Inc., Irvine, CA and sold to Apollo Endosurgery, Inc., Austin, TX, in 2013). On February 16, 2011, the FDA clearance was expanded to include:
Weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BM1 of at least 30 kg/m2 with one or more obesity related comorbid conditions. It is indicated for use in adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives (FDA, 2011).
This expanded FDA clearance is contingent upon the submission of annual post-approval reports regarding safety and effectiveness, in addition to two post-approval studies intended to evaluate the long-term effectiveness and incidence of adverse events.
On September 28, 2007 the REALIZE™ Adjustable Gastric Band modified Model 2200-X with Velocity Injection Port (Ethicon Endo-Surgery, Inc., Cincinnati, OH) received 510(k) FDA clearance through the premarket approval process for the following indications:
For use in weight reduction for morbidly obese patients and is indicated for individuals with a Body Mass Index (BMI) of at least 40 kg/m2, or a BMI of at least 35 kg/m2 with one or more co-morbid conditions. The Band is indicated for use only in morbidly obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs (FDA, 2007).
This FDA approval for the REALIZE device was based on a prospective, multi-center, single-arm trial conducted in the U.S., in which each subject served as his or her own control. Subjects were followed for 3 years post-implantation. A total of 405 subjects were screened for the study, and 276 were implanted with the device. Complete, 36-month follow-up data are available for 228 subjects. The remaining participants are categorized as discontinued. The mean percentage of EWL at 3 years post-implantation was 42.8% (one-sided t-test; p<0.001). The percent EWL increased between 4-6 weeks and 28 months and remained relatively stable between 28 months and 36 months. Starting at 8 months post-surgery, the percent EWL target of 32.6% was already achieved, and this was maintained throughout the remainder of the study. Subjects who reached 36 months of follow-up lost, on average, 42.8% of their excess body weight. The results of the U.S. clinical study demonstrated that:
The REALIZE™ Band is effective in reducing excess weight in morbidly obese subjects. At three years post implantation, the %EWL in the 228 subjects who completed the study was 42.8% with 77% of subjects having a %EWL of at least 25%...During the study, 266 (96.4%) of the subjects reported one or more adverse events. Specific adverse events associated with gastric banding reported during the course of the study included: 1 band erosion (0.4%), 7 port displacements (2.5%), 9 band slippages (3.3%), 10 pouch dilatations (3.6%), 9 esophageal dilatations (3.3%), 1 esophageal dysmotility (0.4%), 18 injection port site pain (6%), 1 band leak (0.4%), 12 port disconnections (4.3%), and 3 kinking of catheter (1.1%). Forty-three subjects (15.6%) required re-operations involving the Band including, 2 band replacements, 10 band revisions, 4 band explantations, 5 port replacements, and 22 port revisions. There was one death in the study. Causality was probably related to port replacement surgery.
Notably, FDA approval is contingent upon the results of a post-approval study to be conducted in the U.S. at up to 12 centers to evaluate the long-term safety and effectiveness of the REALIZE device. This device has been registered and marketed under the name Swedish Adjustable Gastric Band (SAGB) outside the U.S. since 1996.
3. Gastric Bypass (RYGB)
RYGB combines gastric restrictive and malabsorptive features. It involves a horizontal or vertical partitioning of the stomach, which results in a 90% restriction. It is followed by a Roux-en-Y procedure, in which the small intestine is reconfigured into a Y consisting of two limbs and a common channel. The proximal small bowel remains attached to the stomach and duodenum below the gastric division or partition. This limb is called the pancreatico-biliary conduit (or limb) and it drains bile, digestive enzymes, and gastric secretions. The other limb, sometimes called the Roux limb, is attached to and drains the small proximal gastric pouch, and so carries only food. The Y is created at the point where the pancreatico-biliary conduit and the Roux limb are connected. At this point, the digestive juices and food mix and go on together, passing through the remaining arm of the Y, known as the common channel. Gastric bypass not only prevents the ability to ingest larger volumes at any one meal, but also induces a "dumping syndrome." This "dumping syndrome" occurs when a large amount of partially digested food is delivered directly to part of the small intestine from the stomach and can cause nausea, weakness, sweating, faintness, abdominal pain and vomiting. Surgical complications include leakage and stomal stricture. Since a major portion of digestion occurs in the stomach – specifically the process of breaking down food into nutrients – the amount of nutrients available for absorption is also reduced. As a result, this procedure requires that individuals take vitamin and mineral supplements. Gastric bypass may be performed using an open or laparoscopic approach.
4. Mini Gastric Bypass
Recently a variant of the gastric bypass, called the "mini gastric bypass" has been popularized. Using a laparoscopic (periscope-type) approach, the stomach is divided, similar to a traditional gastric bypass, but instead of creating a Roux-en-Y connection, the jejunum is anastomosed directly to the stomach, similar to a Billroth II procedure to the stomach. The unique aspect of this procedure is not based on its laparoscopic approach, but rather the type of anastomosis used. While this surgical approach may result in shorter operating time, it creates the risk of biliary reflux gastritis, in which bile flows back into the stomach and causes irritation. That is one of the reasons that this procedure has been abandoned in favor of the RYGB.
5. Sleeve Gastrectomy (SG)
This alternative surgical approach to gastrectomy involves resection of the greater curvature of the stomach resulting in a stomach remnant shaped like a tube or "sleeve." It can be performed by open or laparoscopic technique and can be done as a stand-alone procedure or as the first in a two-stage procedure subsequently followed by a malabsorptive procedure, such as biliopancreatic diversion with duodenal switch (BPD/DS). It has been proposed by some surgeons for very high risk individuals where weight loss following SG may improve the overall medical status and reduce risk for subsequent more extensive malabsorptive procedures.
1. Biliopancreatic Bypass Procedure (also known as the Scopinaro procedure) BPB
The BPB procedure, developed and used extensively in Italy, was designed to address some of the drawbacks of the original intestinal bypass procedures that have been abandoned, due to unacceptable metabolic complications. Many of the complications were thought to be related to bacterial overgrowth and toxin production in the bypassed segment of the intestine. In contrast, BPB consists of a subtotal gastrectomy and diversion of the biliopancreatic juices into the small intestine by a long Roux-en-Y procedure. This results in a 200 cm long alimentary tract and a 300 to 400 cm biliary tract. After these 2 tracts are joined at the distal anastomosis, there is only a 50 cm common absorptive alimentary tract. Because of the high incidence of gallstones associated with the procedure, subjects typically have their gallbladders removed at the same time as the surgery. There are many potential complications related to BPB, including iron deficiency anemia, protein malnutrition, hypocalcemia, and bone demineralization. Protein malnutrition may require treatment with total parental nutrition. In addition, there have been several case reports of liver failure resulting in death or requiring liver transplant.
2. Biliopancreatic Bypass with Duodenal Switch (BPD/DS)
The duodenal switch procedure is essentially a variant of the biliopancreatic bypass described above. However, instead of performing a distal gastrectomy, a "sleeve" gastrectomy (SG) is performed along the vertical axis of the stomach, preserving the pylorus and initial segment of the duodenum, which is then anastomosed to a segment of the ileum to create the alimentary limb. Preservation of the pyloric sphincter is designed to be more physiologic. The SG decreases the volume of the stomach and also decreases the parietal cell mass, with the intent of decreasing the incidence of ulcers at the duodenoileal anastomosis. The basic principle of this procedure is similar to that of the BPB, which promotes weight loss by producing selective malabsorption by limiting the food digestion and absorption to a short common ileal segment. The potential for metabolic complications still exist with this procedure; however, this potential is not as great as with BPB. Individuals undergoing the duodenal switch procedure require long-term medical follow-up and regular monitoring of fat soluble vitamins, vitamin B-12, iron and calcium. There is some disagreement among surgeons about how long to make the alimentary and common channels. In some series, the common channel was created to be 100 cm for all subjects. In another series that obtained good results, the small bowel segments varied according to the original length of the bowel. In that series, the alimentary limb segment (excluding the common channel) is about 40% of the total length of the small bowel, with the common limb being about 10% of the length of the total original small bowel length in increments of 25 cm. The common limb, therefore, is usually 50 cm, 75 cm, or 100 cm long depending on the individual. The important consideration is to make the channels long enough to prevent malnutrition and short enough to result in effective EWL.
3. Long Limb Gastric Bypass (i.e., greater than 150 cm)
Recent variations of gastric bypass procedures have been described, primarily consisting of long limb Roux-en-Y procedures. The stomach may be bypassed in a variety of ways, i.e. either by resection or stapling along the horizontal or vertical axis. Unlike the traditional gastric bypass, which is essentially a gastric restrictive procedure, these very long limb RYGB procedures function essentially as a malabsorptive procedure, more similar in concept to the BPB. In the BPB, the ileum is used as the alimentary limb, while in long limb gastric bypass, the jejunum functions as the alimentary limb. The long limb gastric bypass is designed to reduce the incidence of metabolic complications, but the potential complications are similar to those of the BPB.
Additional devices and systems have obtained FDA clearance for weight reduction with specific indications. The ReShape® Integrated Dual Balloon System (ReShape Medical, Inc., San Clemente, CA) is a temporary, nonsurgical, balloon system which is an endoscopically implanted intragastric device intended for temporary use for a period of 6 months. The system consists of two attached balloons that are filled and sealed separately. The balloons are endoscopically placed into the stomach through the mouth using mild sedation. Once in place, the balloons are filled with about 2 cups of salt water (saline) and a blue dye (methylene blue). If a balloon breaks, blue dye will appear in the individual's urine. When it is time to remove the balloons, they are first deflated and then removed endoscopically. The FDA clearance was based on a single study of 326 obese subjects at 8 investigational sites in the United States. Of the 326 trial participants, 187 received the device and 139 underwent an endoscopic sham procedure. All study participants received diet and exercise counseling. Over the 6-month outcomes period, subjects who had received the device lost an average of 14.3 pounds (25.1% of their excess weight and 6.8% of their total body weight), and those subjects who had not received the device lost an average of 7.2 pounds (11.3% of their excess weight and 3.3% of their total body weight). Based on these findings, the FDA cleared the device for the following indications:
The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 – 40 kg/m2 and one or more obesity-related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone (FDA, 2015).
The ReShape Integrated Dual Balloon System is not indicated for individuals who have had prior gastrointestinal (GI) or bariatric surgery nor for those with a history of additional GI tract pathology, such as bleeding, tumor, hernia, motility or inflammatory disorders. Additional similar balloon systems have also been recently cleared by the FDA, such as the ORBERA™ Intragastric Balloon System (Apollo Endosurgery, Inc., Austin, TX) for very similar indications and temporary 6-month use.
Another device intended for weight reduction is the MAESTRO® Rechargeable System (EnteroMedics, Inc., St. Paul, MN) which provides vagal blocking (VBLOC®) therapy by delivering intermittent, controllable, electrical blocking signals to the abdominal anterior and posterior nerve trunks of the vagus nerve. This system consists of multiple external components and internal components that are surgically implanted in the abdominal wall. The external components include controls for recharging the device and also setting adjustments for physician use. The FDA clearance was based on results of two randomized controlled trials, the first of which included 233 subjects with a BMI of 35 or greater. The weight loss and adverse events of 157 individuals who received the active Maestro device were compared to 76 subjects in the control group who received a Maestro electrical pulse generator that was not activated. The 12-month outcomes data found that the trial participants in the group with the activated device lost 8.5% more excess weight than the control group (with the inactivated device). The investigators noted that approximately half (52.5%) of the subjects in the activated device group lost at least 20% of their excess weight, while 38.3% of subjects with the activated device lost at least 25% of their excess weight. However, the study did not meet its original endpoint, which was for the group with the activated device to lose at least 10% more excess weight than the control group (Sarr, 2012). In the second study, the ReCharge trial, all participants had devices implanted but no leads were placed in the sham group. Primary efficacy outcomes were not met in either of these trials (Ikramuddin, 2014). A subsequent FDA Advisory Committee (the Gastroenterology and Urology Devices Panel) found the 18-month outcomes data supportive of sustained weight loss and agreed that the benefits of the device outweighed the risks for select use in individuals who met the criteria in the device's proposed indications. As a result, the MAESTRO System was cleared by the FDA, subject to results of a 5-year post-approval study of safety and efficacy, for the following indications:
For use in weight reduction in patients aged 18 years through adulthood who have a Body Mass Index (BMI) of 40 to 45 kg/m2 , or a BMI of 35 to 39.9 kg/m2 with one or more obesity related co-morbid conditions, and who have failed at least one supervised weight management program within the past five years (FDA, 2015).
Operator Dependence in the Safety and Efficacy of Bariatric Procedures
Evidence from a number of reports and case series exists for "operator dependence" in determining the risks and benefits of any bariatric procedure. It is important that the surgeon be extensively trained in the respective procedure and that the initial surgeries are supervised by an experienced bariatric surgeon during the early "learning curve." It is also important that these surgeries be performed in facilities that are appropriately qualified to support peri-operative and post-op services by an appropriately trained, multi-disciplinary team to ensure maximal success.
Body mass index (BMI): The key index for relating body weight to height. The BMI is a person's weight in kilograms (kg) divided by their height in meters (m) squared. (See the definition below for obesity for further information.)
Excess body weight: This term refers to the difference between an individual's actual (measured) and ideal body weight. Ideal body weight ranges are established based on height, body frame, gender and age; an example is available from the National Heart Lung and Blood Institute [NHLBI] at: http://www.nhlbi.nih.gov/guidelines/obesity/bmi_tbl.htm
Gastric balloon (Gastric bubble): This device is inserted into the stomach to reduce the stomach's capacity and produce early satiety. It was generally considered obsolete and was originally intended for temporary use as an adjunct to diet and behavior modification to assist with weight loss. Recently, new balloon systems have been cleared by the FDA (see information in the above Background section).
Gastric banding: This surgical procedure is intended to help a person lose weight. A band is placed around the upper part of the stomach, creating a small pouch that can hold only a small amount of food. The narrowed opening between the stomach pouch and the rest of the stomach controls how quickly food passes from the pouch to the lower part of the stomach. This system helps the person to eat less by limiting the amount of food that can be eaten at one time and increasing the time it takes for food to be digested.
Gastric bypass: This surgical procedure reduces the stomach capacity and diverts partially digested food from the duodenum to the jejunum (section of the small intestine extending from the duodenum).
Gastroplasty: A surgical procedure that decreases the size of the stomach.
Laparoscopic gastric plication (laparoscopic greater curvature plication [LGCP]): This is a gastric restrictive bariatric procedure, which is performed alone or in combination with adjustable gastric banding, where the stomach's volume is reduced by dissecting the greater omentum and short gastric vessels, and the greater curvature is invaginated using multiple rows of non-absorbable sutures performed over a bougie or endoscope to ensure a patent lumen. This investigational procedure is proposed as a minimally invasive surgical alternative to conventional bariatric surgical procedures.
Obesity: The state of being well above one's normal weight which is measured and determined by the Body Mass Index (BMI). Severe obesity is defined by the National Institutes of Health (NIH) as a BMI of 40 kg/m2 or greater, or a BMI of 35 kg/m2 or greater along with other medical complications. The NIH defines obesity as a BMI of greater than or equal to 30 kg/m2 and considers a person overweight with a BMI of 25 to 29.9 kg/m2.
Repair: Refers to a subsequent surgical procedure performed to correct an anatomic complication, and in this document is used to refer to a complication, resulting from a prior gastric bypass or gastric restrictive procedure.
Revision: Refers to a surgical procedure performed either to anatomically reverse a prior bypass/restrictive procedure or to anatomically convert the organs from a prior bypass/restrictive procedure to another procedure, (e.g., from a prior vertical banded gastroplasty to a conventional Roux-en-Y bypass procedure).
Sleep apnea: The temporary stoppage of breathing during sleep, often resulting in daytime sleepiness.
The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
When services may be Medically Necessary when criteria are met:
|00797||Anesthesia for intraperitoneal procedures in upper abdomen, including laparoscopy; gastric restrictive procedure for morbid obesity|
|43644||Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and Roux-en-Y gastroenterostomy (roux limb 150 cm or less)|
|43645||Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and small intestine reconstruction to limit absorption|
|43770||Laparoscopy, surgical, gastric restrictive procedure; placement of adjustable gastric restrictive device (eg, gastric band and subcutaneous port components)|
|43771||Laparoscopy, surgical, gastric restrictive procedure; revision of adjustable gastric restrictive device component only|
|43772||Laparoscopy, surgical, gastric restrictive procedure; removal of adjustable gastric restrictive device component only|
|43773||Laparoscopy, surgical, gastric restrictive procedure; removal and replacement of adjustable gastric restrictive device component only|
|43774||Laparoscopy, surgical, gastric restrictive procedure; removal of adjustable gastric restrictive device and subcutaneous port components|
|43775||Laparoscopy, surgical, gastric restrictive procedure; longitudinal gastrectomy (ie, sleeve gastrectomy)|
|43842||Gastric restrictive procedure, without gastric bypass, for morbid obesity; vertical-banded gastroplasty|
|43843||Gastric restrictive procedure, without gastric bypass, for morbid obesity; other than vertical-banded gastroplasty|
|43845||Gastric restrictive procedure with partial gastrectomy, pylorus-preserving duodenoileostomy and ileoileostomy (50 to 100 cm common channel) to limit absorption (biliopancreatic diversion with duodenal switch)|
|43846||Gastric restrictive procedure, with gastric bypass for morbid obesity; with short limb (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)|
|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|
|0DP60CZ||Removal of extraluminal device from stomach, open approach|
|0DP64CZ||Removal of extraluminal device from stomach, percutaneous endoscopic approach|
|0DV60CZ||Restriction of stomach with extraluminal device, open approach|
|0DV64CZ||Restriction of stomach with extraluminal device, percutaneous endoscopic approach|
|0DV60ZZ||Restriction of stomach, open approach|
|0DV64ZZ||Restriction of stomach, percutaneous endoscopic approach|
|0DW60CZ||Revision of extraluminal device in stomach, open approach|
|0DW64CZ||Revision of extraluminal device in stomach, percutaneous endoscopic approach|
When services may also be Medically Necessary when criteria are met:
|For the following codes when specified as bariatric procedures:|
|0D160ZA||Bypass stomach to jejunum, open approach|
|0D160ZB||Bypass stomach to ileum, open approach|
|0D164ZA||Bypass stomach to jejunum, percutaneous endoscopic approach|
|0D164ZB||Bypass stomach to ileum, percutaneous endoscopic approach|
|0D164Z9||Bypass stomach to duodenum, percutaneous endoscopic approach|
|0D190ZB||Bypass duodenum to ileum, open approach|
|0DB60Z3||Excision of stomach, open approach, vertical|
|0DB64Z3||Excision of stomach, percutaneous endoscopic approach, vertical|
|0DB68Z3||Excision of stomach, via natural or artificial opening endoscopic, vertical|
|0DB60ZZ||Excision of stomach, open approach|
|0DB64ZZ||Excision of stomach, percutaneous endoscopic approach|
|E66.01||Morbid (severe) obesity due to excess calories|
|E66.09||Other obesity due to excess calories|
|E66.2||Morbid (severe) obesity with alveolar hypoventilation (Pickwickian syndrome)|
|Z46.51||Encounter for fitting and adjustment of gastric lap band|
|Z68.35-Z68.39||Body mass index (BMI) 35.0-39.9, adult|
|Z68.41-Z68.45||Body mass index (BMI) 40 or greater, adult|
|Z68.51-Z68.54||Body mass index (BMI) pediatric (special consideration)|
|Z98.84||Bariatric surgery status|
When services are Not Medically Necessary or Investigational and Not Medically Necessary:
For the procedure codes listed above when criteria are not met, for the following diagnoses, or when the code describes a procedure indicated in the Position Statement section as not medically necessary or investigational and not medically necessary.
|Z68.20-Z68.29||Body mass index (BMI) 20.0-29.9, adult|
|Z68.30-Z68.34||Body mass index (BMI) 30.0-34.9, adult|
When services are Investigational and Not Medically Necessary:
|43632||Gastrectomy, partial distal; with gastrojejunostomy (Billroth II) [when specified as bariatric surgery]|
|43659||Unlisted laparoscopy procedure, stomach [when specified as gastric plication (laparoscopic greater curvature plication [LGCP]) with or without gastric banding]|
|43999||Unlisted procedure, stomach [when specified as endoluminal gastric restrictive surgery or placement of intragastric balloon device]|
|0D160ZA||Bypass stomach to jejunum, open approach [when specified as Billroth II)|
|0DV60DZ||Restriction of stomach with intraluminal device, open approach|
|0DV63DZ||Restriction of stomach with intraluminal device, percutaneous approach|
|0DV64DZ||Restriction of stomach with intraluminal device, percutaneous endoscopic approach|
|0DV67DZ||Restriction of stomach with intraluminal device, via natural or artificial opening|
|0DV68DZ||Restriction of stomach with intraluminal device, via natural or artificial opening endoscopic|
|0DP60DZ||Removal of intraluminal device from stomach, open approach|
|0DP63DZ||Removal of intraluminal device from stomach, percutaneous approach|
|0DP64DZ||Removal of intraluminal device from stomach, percutaneous endoscopic approach|
|0DP67DZ||Removal of intraluminal device from stomach, via natural or artificial opening|
|0DP68DZ||Removal of intraluminal device from stomach, via natural or artificial opening endoscopic|
|E66.01||Morbid (severe) obesity due to excess calories|
|E66.09||Other obesity due to excess calories|
|E66.2||Morbid (severe) obesity with alveolar hypoventilation (Pickwickian syndrome)|
|Z46.51||Encounter for fitting and adjustment of gastric lap band|
|Z68.20-Z68.29||Body mass index (BMI) 20.0-29.9, adult|
|Z68.30-Z68.34||Body mass index (BMI) 30.0-34.9, adult|
|Z68.35-Z68.39||Body mass index (BMI) 35.0-39.9, adult|
|Z68.41-Z68.45||Body mass index (BMI) 40 or greater, adult|
|Z68.51-Z68.54||Body mass index (BMI) pediatric (special consideration)|
|Z98.84||Bariatric surgery status|
When services are also Investigational and Not Medically Necessary:
|0312T||Vagus nerve blocking therapy (morbid obesity); laparoscopic implantation of neurostimulator electrode array, anterior and posterior vagal trunks adjacent to esophagogastric junction (EGJ), with implantation of pulse generator, includes programming|
|0313T||Vagus nerve blocking therapy (morbid obesity); laparoscopic revision or replacement of vagal trunk neurostimulator electrode array, including connection to existing pulse generator|
|0314T||Vagus nerve blocking therapy (morbid obesity); laparoscopic removal of vagal trunk neurostimulator electrode array and pulse generator|
|0315T||Vagus nerve blocking therapy (morbid obesity); removal of pulse generator|
|0316T||Vagus nerve blocking therapy (morbid obesity); replacement of pulse generator|
|0317T||Vagus nerve blocking therapy (morbid obesity); neurostimulator pulse generator electronic analysis, includes reprogramming when performed|
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
|Websites for Additional Information|
Adjustable Gastric Banding
Adjustable Silicone Gastric Banding
Biliopancreatic Bypass, with Duodenal Switch
Clinically Severe Obesity
Duodenal Switch Procedure
Gastric Restrictive Procedures
Laparoscopic gastric plication
Laparoscopic greater curvature plication [LGCP]
Long Limb Gastric Bypass
MAESTRO Rechargeable System
Morbid Obesity, Surgical Treatment of
ORBERA Intragastric Balloon System
REALIZE Adjustable Gastric Band
ReShape Integrated Dual Balloon System
Swedish Adjustable Gastric Band
Vertical Banded Gastroplasty
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.
|Revised||11/05/2015||Medical Policy & Technology Assessment Committee (MPTAC) review. The title was changed to include additional treatment modalities beyond surgery from the former title: Surgery for Clinically Severe Obesity to: Bariatric Surgery and Other Treatments for Clinically Severe Obesity. An investigational and not medically necessary statement was added for clarification when criteria are not met. The balloon systems, (such as the ReShape Integrated Dual Balloon System) and vagal nerve blocking devices, (such as the MAESTRO Rechargeable System) were added to the list of investigational and not medically necessary devices and procedures. The Rationale and Background sections were updated with newly FDA cleared devices and treatment modalities and the findings of a 2015 CTAF Report. Coding and References sections were updated. Removed ICD-9 codes from Coding section.|
|Revised||11/13/2014||MPTAC review. The medically necessary criteria were revised to indicate that active participation in a formal preoperative weight loss program must be documented for at least 6 continuous months in the 2 years prior to surgery. The criteria for repeat procedures were clarified to indicate that ALL initial medically necessary criteria must again be met. The Rationale and References were updated.|
|Reviewed||11/14/2013||MPTAC review. The Rationale, Background and References were updated.|
|Revised||11/08/2012||MPTAC review. No change to criteria except for addition of laparoscopic gastric plication to the procedures considered investigational and not medically necessary. The Rationale, Definitions, Coding and Reference Sections were updated.|
|Reviewed||11/17/2011||MPTAC review. Definitions and References were updated.|
|Revised||08/18/2011||MPTAC review. The medically necessary statement about LAGB adjustments has been removed. References have been updated. Updated Coding section to include 10/01/2011 ICD-9-CM changes.|
|Revised||05/19/2011||MPTAC review. A new investigational and not medically necessary statement was added for bariatric surgical procedures for BMI of 30-34.9. The attachment Physician Verification form was removed. The Rationale and References were also updated.|
|Revised||11/18/2010||MPTAC review. The criteria were revised to now consider sleeve gastrectomy (by open or laparoscopic approach) to be medically necessary when all other criteria are met. The requirement that biliopancreatic bypass with duodenal switch must be done as a single surgery has been removed from the position statement. The Rationale, Definitions, Coding and Reference sections were updated.|
|Reviewed||08/19/2010||MPTAC review. A link was added to the medical necessity criteria for repeat procedures to a standard table of height/weight from the NHLBI. The Rationale and References were updated. Updated Coding section with 10/01/2010 ICD-9 changes.|
|01/01/2010||Updated Coding section with 01/01/2010 CPT changes.|
|Revised||08/27/2009||MPTAC review. A position statement has been added regarding repeat surgical revisions or conversions to another surgical procedure for inadequate weight loss as medically necessary when criteria are met. A position statement has been added regarding adjustments to laparoscopic banding procedures as medically necessary when criteria are met. The comorbid conditions considered medically necessary for patients with a BMI of 35 or greater have been reordered and clarified to indicate that an obesity-related comorbid condition of any severity would meet medical necessity. The investigational and not medically necessary statement regarding repeat procedures for repair, revision, or conversion to another procedure has been clarified. The Rationale section has been updated with information regarding vertical banded gastroplasty and also about complication rates and indications for repeat bariatric surgeries. References were also updated. Updated Coding section with 10/01/2009 ICD-9 changes.|
|Reviewed||02/26/2009||MPTAC review. Sleeve gastrectomy was added to the surgical procedures considered investigational and not medically necessary for clarification. References were updated.|
|Revised||02/21/2008||MPTAC review. No change to the medical necessity criteria except for the addition of the REALIZE™ device to the medical necessity statement regarding laparoscopic adjustable gastric banding and the addition of band herniation and pouch enlargement due to vomiting to the surgical repair criteria considered medically necessary. Information was added to the Background section about the newly FDA-approved REALIZE™ Adjustable Gastric Band device. References and coding were also updated.|
MPTAC review. The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary."
This document was returned to MPTAC for discussion of issue regarding the pre-op BMI requirements when the patient performs pre-operative dieting with results that place the patient's pre-op BMI below the required ranges to meet medical necessity. References were updated. Coding section updated to include 01/01/2008 CPT changes.
|Revised||08/23/2007||MPTAC review. A new endoluminal surgical technique using the StomaphyX™ device was added to the surgical procedures considered investigational/not medically necessary. References and coding were also updated.|
|Revised||05/17/2007||MPTAC review. Position statements were added regarding repairs and revisions to prior bypass or restrictive procedures for clarification. The 'Note' regarding LapBands being limited to patients with maximum BMI less than 50 has been deleted. Rationale, Definitions, References and Coding sections were also updated.|
|01/01/2007||Updated Coding section with 01/01/2007 CPT/HCPCS changes.|
|Reviewed||09/14/2006||MPTAC review. Background, References and Coding sections were updated.|
Updated Coding section with 01/01/2006 CPT/HCPCS changes
|11/22/2005||Added references for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).|
Revised Position Statement: Included under medical necessity statement that the physician requesting authorization for the surgery must also confirm the following:
|Revised||04/28/2005||MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.|
|Pre-Merger Organizations||Last Review Date||Document Number||Title|
|SURG.00024||Surgery for Clinically Severe Obesity|
|WellPoint Health Networks, Inc.|
|3.06.02||Surgical Treatment of Morbid Obesity|