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  • Gastroenterology 2017;152:716–729

    AGA CLINICAL

    PRACTICE UPDATE

    Clinical Practice Update: Expert Review on Endoscopic Bariatric Therapies

    Barham K. Abu Dayyeh,1 Steven Edmundowicz,2 and Chris C. Thompson3

    1Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota; 2Digestive Health Center, University of Colorado Hospital, Aurora, Colorado; 3Division of Gastroenterology, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts

    Abbreviations used in this paper: CI, confidence interval; CPU, Clinical Practice Update; DJBS, duodenojejunal bypass sleeve; EBT, endoscopic bariatric therapy; ESG, endoscopic sleeve gastroplasty; GI, gastrointes- tinal; IGB, intragastric balloon; POSE, primary obesity surgery endolumi- nal; TBWL, total body weight loss; %TBWL, percentage of total body weight loss.

    BACKGROUND & AIMS:Multiple endoscopic bariatric therapies (EBTs) currently are being evaluated or are in clinical use in the United States. EBTs are well positioned to fill an important gap in the management of obesity and metabolic disease. The purpose of this expert review is to update gastroenterologists on these therapies and provide practice advice on how to incorporate them into clinical practice. METHODS: The evidence reviewed in this work is a distillation of comprehensive search of several English-language databases and a manual review of relevant publications (including systematic reviews and meeting ab- stracts). Best Practice Advice 1: EBTs should be considered in patients with obesity who have been unsuccessful in losing or maintaining weight loss with lifestyle interventions. Best Practice Advice 2: EBTs can be used in patients with severe obesity as a bridge to traditional bariatric surgery. They also can be used as a bridge to allow unrelated interventions that are unable to be performed because of weight limits (ie, or- thopedic surgery, organ transplantation). Best Practice Advice 3: Clinicians should use EBTs as part of a structured weight loss program that includes dietary intervention, exercise therapy, and behavior modification, in both the active weight loss phase and the long-term maintenance phase. Best Practice Advice 4: Clinicians should screen all potential EBT candidates with a comprehensive evaluation for medical conditions, comorbid- ities, and psychosocial or behavioral patterns that contribute to their condition before enrolling patients in a weight loss pro- gram that includes EBTs. Best Practice Advice 5: Clinicians incorporating EBTs into their clinical practice should follow up patients prospectively to capture the impact of the EBT pro- gram on weight and weight-related comorbidities, and all related adverse outcomes. Poor responders should be identified and offered a detailed evaluation and alternative therapy. Best Practice Advice 6: Clinicians embarking on incorporating EBTs into their clinical practice should have a comprehensive knowledge of the indications, contraindications, risks, benefits, and outcomes of individual EBTs, as well as a practical knowledge of the risks and benefits of alternative therapies for obesity. Best Practice Advice 7: Institutions should establish specific guidelines that are applied consistently across disci- plines for granting privileges in EBTs that reflect the necessary knowledge and technical skill a clinician must achieve before being granted privileges to perform these procedures.

    he prevalence of obesity (body mass index � 30 2

    Most current article

    © 2017 by the AGA Institute 0016-5085/$36.00

    http://dx.doi.org/10.1053/j.gastro.2017.01.035

    Tkg/m ) in adults in the United States remains high at 35%.1 Obesity is associated with multiple medical and psy- chological comorbidities, increases all-cause and cardiovascular mortality, and managing obesity and its

    comorbidities accounts for approximately 21% of the US health expenditure.2–8 Weight loss improves many obesity- related comorbidities and decreases mortality.9–12 How- ever, this improvement appears proportional to the magnitude and durability of the weight loss. This clearly is shown by the higher success rates of bariatric and metabolic surgery in both inducing weight loss ranging between 20% and 40% of total body weight loss (TBWL), and in decreasing obesity-related morbidities and mortality compared with lifestyle and pharmacologic approaches, which have modest and less durable weight loss.13–15 The advantage of surgical therapies is offset by the increased morbidity and rare mor- tality associated with these surgeries.16 Consequently, there is a need for less-invasive weight loss therapies that are more effective and durable than lifestyle interventions alone, less invasive and risky than bariatric surgery, and easily performed at a lower expense than that of surgery, thereby allowing improved access and application to a larger segment of the population with moderate obesity. Emerging endo- scopic bariatric therapies (EBTs) potentially meet these criteria and may provide an effective treatment approach to obesity in selected patients. At the time of this review, 4 such therapies have been approved by the US Food and Drug Administration. The purpose of this American Gastroentero- logical Association Clinical Practice Update (CPU) Expert Review is to review the literature on the safety and efficacy of EBTs that are in clinical practice or in advanced stages of development and regulatory approval, and to provide practice advice to gastroenterologists contemplating incorporating these therapies into clinical practice.

    Methods A search of several English-language databases was con-

    ducted for studies published between January 1, 2000, and September 30, 2016. The databases included Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE,

    http://crossmark.crossref.org/dialog/?doi=10.1053/j.gastro.2017.01.035&domain=pdf http://dx.doi.org/10.1053/j.gastro.2017.01.035

  • March 2017 CPU: Expert Review on EBTs 717

    Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and Scopus. Controlled vocabulary supplemented with key words was used to search for studies. Articles resulting from these searches, relevant references cited in those articles, and addi- tional references identified by experts in this field were reviewed. Human trials, published in English in a peer- reviewed journal as a full-text manuscript or abstract form were included in this review.

    Review of EBTs It is now evident that anatomic manipulations of the

    stomach and small intestines produced by surgical interventions such as Roux-en-Y gastric bypass also result in physiological alterations in gut neuroendocrine signaling, gastrointestinal (GI) motility, autonomic nervous system signaling, bile acid production and absorption, and gut microbiota, all of which contribute to weight loss and to improvement in obesity and related comorbidities.17 EBTs can mimic some of the anatomic alterations created by bariatric surgery by selectively targeting the stomach or the small in- testines. Thus, in reviewing these EBTs, we separate them into gastric and small-bowel endoscopic interventions (Figure 1).

    AG A CL IN IC AL

    PR AC

    TI CE

    UP DA

    TE

    Gastric EBTs Gastric restriction is an important component of surgical

    weight loss procedures. This is accomplished through the creation of a small gastric pouch in Roux-en-Y gastric bypass surgery, through placement of an adjustable gastric band, or through the creation of a sleeve in sleeve gastrectomy surgery. In addition to inducing early satiety, it is thought that reducing the gastric reservoir capacity increases the stimulation of gastric mechanical and chemical receptors, alters gastric emptying, and modulates the level of gastric orexigenic hormones, which further contribute to weight loss.18,19 Several EBTs attempt to mimic these mechanisms by decreasing effective gastric capacity. These technologies include space-occupying devices that most commonly take the form of temporarily placed prostheses such as balloons, EBTs that alter gastric anatomy using endoscopic suturing or plication devices, and aspiration therapy.

    Intragastric Balloon Three intragastric balloons (IGBs) recently were

    approved by the Food and Drug Administration for the management of obesity. The Orbera IGB (Apollo Endo- surgery, Austin, TX), previously known as the BioEnterics Intragastric Balloon (Allergan, Irvine, CA); the ReShape Duo (ReShape Medical, San Clemente, CA); and the Obalon IGB (Obalon Therapeutics, Inc, Carlsbad, CA). All 3 balloons are approved for 6 months therapy.

    The Orbera intragastric balloon is an elastic spherical balloon made of silicone, filled with 450–700 mL of saline solution. The deflated balloon comes preloaded on a cath- eter, which blindly is advanced transorally into the stomach. An endoscope then is advanced alongside it to ensure ac- curate placement of the balloon in the stomach. Under

    direct visualization, the balloon then is inflated by injecting saline solution through the external portion of the catheter. Although not used in the pivotal US Orbera trial, methylene blue traditionally has been mixed with the saline solution. If inadvertent balloon rupture occurs, the methylene blue is systemically absorbed, causing a change in urine color, which serves as an alert that the balloon has deflated.

    The Orbera IGB has been in use outside the United States for many years, a meta-analysis of 55 studies including 6645 Orbera IGB implantations showed a pooled estimate of the percentage of TBWL (%TBWL) at 6 months of 13.2% (95% confidence interval [CI], 12.4–13.95). Rates of adverse events after implantation of