Endoscopic therapies for patients with obesity: a systematic review and meta-analysis.

BACKGROUND: Obesity is a major threat to public health and traditional bariatric surgery continues to have low utilization. Endoscopic treatments for obesity have emerged that offer less risk, but questions remain regarding efficacy, durability, and safety. We compared the efficacy of endoscopic bariatric procedures as compared to other existing treatments. METHODS: A literature search of Embase, Cochrane Central, and Pubmed was conducted from January 1, 2014 to December 7, 2021, including endoscopic bariatric therapies that were FDA or CE approved at the time of search to non-endoscopic treatments. Thirty-seven studies involving 15,639 patients were included. Primary outcomes included % total body weight loss (%TBWL), % excess body weight loss (%EBWL), and adverse events. Secondary outcomes included quality of life data and differences in hemoglobin A1C levels. Strength of clinical trial and observational data were graded according to the Cochrane methods. RESULTS: Intragastric balloons achieved greater %TBWL with a range of 7.6-14.1% compared to 3.3-6.7% with lifestyle modification at 6 months, and 7.5-14.0% compared to 3.1-7.9%, respectively, at 12 months. When endoscopic sleeve gastroplasty (ESG) was compared to laparoscopic sleeve gastrectomy (LSG), ESG had less %TBWL at 4.7-14.4% compared to 18.8-26.5% after LSG at 6 months, and 4.5-18.6% as compared to 28.4-29.3%, respectively, at 12 months. For the AspireAssist, there was greater %TBWL with aspiration therapy compared to lifestyle modification at 12 months, 12.1-18.3% TBWL versus 3.5-5.9% TBWL, respectively. All endoscopic interventions had higher adverse events rates compared to lifestyle modification. CONCLUSION: This review is the first to evaluate various endoscopic bariatric therapies using only RCTs and observational studies for evaluation of weight loss compared with conservative management, lifestyle modification, and bariatric surgery. Endoscopic therapies result in greater weight loss compared to lifestyle modification, but not as much as bariatric surgery. Endoscopic therapies may be beneficial as an alternative to bariatric surgery.

Gastric Aspiration Improves Postprandial Glucose Tolerance Without Causing a Compensatory Increase in Appetite and Food Intake.

INTRODUCTION: AspireAssist® allows aspiration of ~30% of an ingested meal through a percutaneous gastrostomy tube, reducing caloric uptake. We evaluated the acute effects of gastric aspiration on postprandial glucose tolerance, responses of gluco-regulatory and appetite-regulating hormones, appetite sensations, and food intake. METHODS: Seven AspireAssist®-treated individuals underwent two separate experimental days each involving a mixed meal test (MMT) with double-blinded aspiration and sham aspiration, respectively. Seven age and body mass index (BMI)-matched controls underwent one MMT. MMTs were followed by an ad libitum meal. RESULTS: Postprandial glucose tolerance was improved during aspiration vs. sham visits (median [interquartile range] baseline-subtracted area under the curve (bsAUC) 170 [88.4;356] vs. 388 [239;456] mmol/L × min, p = 0.025). Reduced responses (bsAUCs) of C-peptide (113 [28.4;224] vs. 302 [215;433] nmol/L × min, p = 0.014), cholecystokinin (223 [59.4;402] vs. 467 [416;546] pmol/L × min, p = 0.005), glucose-dependent insulinotropic polypeptide (4.63 [1.49;9.04] vs. 15.4 [9.59;18.9] nmol/L × min, p = 0.025), and glucagon-like peptide 1 (532.8 [274.5;1,278] vs. 1,296 [746.2;1,618] pmol/L × min, p = 0.032) were observed during aspiration vs. sham visits. Responses of glucagon, gastrin, ghrelin and peptide YY, appetite sensations, and ad libitum food intake were unaffected by aspiration. Responses of plasma glucose, gut hormones, appetite sensations, and food intake were similar during sham and control visits. CONCLUSION: Gastric aspiration improved postprandial glucose tolerance without causing compensatory increases in appetite or food intake, pointing to acute beneficial metabolic effects of aspiration therapy together with previously reported body weight-lowering effects.

Effect of Aspiration Therapy on Obesity-Related Comorbidities: Systematic Review and Meta-Analysis.

BACKGROUND/AIMS: Aspiration therapy (AT) involves endoscopic placement of a gastrostomy tube with an external device that allows patients to drain 30% of ingested calories after meals. Its efficacy for inducing weight loss has been shown. This study aimed to assess the effect of AT on obesity-related comorbidities. METHODS: A meta-analysis of studies that assessed AT outcomes was conducted through December 2018. Primary outcomes were changes in comorbidities at 1 year following AT. Secondary outcomes were the amount of weight loss at up to 4 years and pooled serious adverse events (SAEs). RESULTS: Five studies with 590 patients were included. At 1 year, there were improvements in metabolic conditions: mean difference (MD) in systolic blood pressure: -7.8 (-10.7 - -4.9) mm Hg; MD in diastolic blood pressure: -5.1 (-7.0 - 3.2) mm Hg; MD in triglycerides: -15.8 (-24.0 - -7.6) mg/dL; MD in high-density lipoprotein: 3.6 (0.7-6.6) mg/dL; MD in hemoglobin A1c (HbA1c): -1.3 (-1.8 - -0.8) %; MD in aspartate transaminase: -2.7 (-4.1 - -1.3) U/L; MD in alanine transaminase: -7.5 (-9.8 - -5.2) U/L. At 1 (n=218), 2 (n=125), 3 (n=46), and 4 (n=27) years, the patients experienced 17.8%, 18.3%, 19.1%, and 18.6% total weight loss (TWL), corresponding to 46.3%, 46.2%, 48.0%, and 48.7% excess weight loss (EWL) (p<0.0001 for all). Subgroup analysis of 2 randomized controlled trials (n=225) showed that AT patients lost more weight than did controls by 11.6 (6.5-16.7) %TWL and 25.6 (16.0-35.3) %EWL and experienced greater improvement in HbA1c and alanine transaminase by 1.3 (0.8-1.8) % and 9.0 (3.9-14.0) U/L. The pooled SAE rate was 4.1%. CONCLUSION: Obesity-related comorbidities significantly improved at 1 year following AT. Additionally, a subgroup of patients who continued to use AT appeared to experience significant weight loss that persisted up to at least 4 years.

Efficacy of Endoscopic Interventions for the Management of Obesity: a Meta-analysis to Compare Endoscopic Sleeve Gastroplasty, AspireAssist, and Primary Obesity Surgery Endolumenal.

BACKGROUND AND AIMS: Novel endoscopic procedures (endoscopic sleeve gastroplasty (ESG), AspireAssist (AA), and primary obesity surgery endolumenal (POSE)) have been developed for treatment of obesity. We aimed to conduct a systematic review and meta-analysis to evaluate and compare the efficacy of these three endoscopic procedures. METHODS: Main outcomes of interest were percent excess weight loss (%EWL) and percent total body weight loss (%TBWL). Weighted pooled means (WPMs) were calculated and analyzed using random effects model. Mean differences (MDs) were calculated to compare these procedures. RESULTS: Twelve studies with 1149 patients were included. WPMs for %EWL at 6 and 12 months with ESG were 49.67 (45.67, 53.66) and 52.75 (43.52, 61.98), respectively, while %TBWLs at 6 and 12 months with ESG were 16.01 (15.10, 16.92) and 17.41 (17.08, 17.74), respectively. WPMs for %EWL at 6 and 12 months with POSE were 43.79 (40.17, 47.42) and 44.91 (40.90, 48.92), respectively. WPM for %EWL at 12 months with AA was 50.85 (46.03, 55.68). While comparing ESG and POSE, at 6 months and 12 months, MD for %EWL was 6.17 (1.07, 11.26; P = 0.01) and 7.84 (- 2.05, 17.71; P = 0.06) in favor of ESG. No difference in %EWL was observed while comparing ESG with AA (P = 0.29). Likewise, MD for %EWL to compare AA and POSE was not significant (P = 0.68). CONCLUSIONS: During a follow-up of 6-12 months, both AA and ESG had excellent efficacy in achieving significant and sustained weight loss; however, ESG was found to be superior in terms of weight loss when compared with POSE.

New Era: Endoscopic treatment options in obesity-a paradigm shift.

The prevalence of obesity continues to rise, and along with it comes a multitude of health-related consequences. The healthcare community has consistently struggled with providing treatment options to obese patients, in part due to the reluctance of patients in pursuing the more effective (yet invasive) surgical approaches such as sleeve gastrectomy and Rou-en-Y gastric bypass. On the other hand, the less invasive approach such as lifestyle/behavioral interventions and pharmacotherapy (Orlistat, Phenteramine, Phentermine/Topiramate, Locaserin, Naltrexon/Buproprion, and Liraglutide) have very limited efficacy, especially in the morbidly obese patients. Despite our best efforts, the epidemic of obesity continues to rise and pose enormous costs on our healthcare system and society. Bariatric endoscopy is an evolving field generated to combat this epidemic through minimally invasive techniques. These procedures can be performed in an ambulatory setting, are potentially reversible, repeatable, and pose less complications than their invasive surgical counterparts. These modalities are designed to alter gut metabolism by means of space occupation, malabsorption, or restriction. In this review we will discuss different bariatric endoscopic options (such as intragastric balloons, endoscopic sleeve gastroplasty, endoscopic aspiration therapies and gastrointestinal bypass sleeves), their advantages and disadvantages, and suggest a new paradigm where providers may start incorporating this modality in their treatment approach for obese patients.

Conversion of AspireAssist System® to Sleeve Gastrectomy: Technical Video Description.

PURPOSE: The AspireAssist System® (Aspire Bariatrics, Inc. King of Prussia, PA) is a new endoscopic procedure used to treat obese patients. The aim of this dedicated video is to present a case that required revision surgery due to failure of the AspireAssist System®, and to show how the cannula was removed from the abdomen, and why sleeve gastrectomy (SG) was a good option for revisional surgery in that patient. We aim to discuss technical aspects. PATIENT AND METHODS: A 43-year-old female patient who underwent a placement in 2016. Her initial BMI (body mass index) was 38 kg/m2, with a follow-up period of 26 months. A revisional surgery was performed including dissection of the previous gastric fistula and adhesiolysis from the previous AspireAssist System® placement. A complete dissection of the gastrostomy, including removal of all the system, was done. A decision was made, once the incisura angularis and the placement of a 40 Fch bougie showed that the transection could be performed. SG was done. Patients showed an uneventful postoperative course and 4 months follow-up with 45% EWL. CONCLUSION: In case of having the device in place, the surgeon must be aware to remove intraoperatively or endoscopically, the device. Surgeons should consider endoscopic removal of the AspireAssist System® before conversion to another procedure (SG or GBP) at least 6 months of the removal. Removal of the AspireAssist System® should be performed endoscopically but direct conversion to another bariatric procedure can be considered, either to SG or GBP depending on the technical intraoperative aspects.

Aspiration Therapy for Obesity.

Aspiration therapy is a weight loss therapy in the United States for patients with a body mass index between 35 kg/m2 and 55 kg/m2. Aspiration therapy allows patients to remove up to one-third of calories consumed at a meal and causes patients to eat fewer calories than prior to starting treatment. Studies demonstrate 14.2% to 21.5% total body weight loss in participants who complete 1 year of treatment and maintenance of weight loss in patients treated for 2 years. Aspiration therapy is a safe and effective new treatment of obesity.

The role of endoscopic therapy in obesity management: intragastric balloons and aspiration therapy.

Weight management is increasingly incorporating endoscopic bariatric therapy (EBT). As the global burden of obesity and its comorbidities has increased, it is evident that novel therapeutic approaches will be necessary to address the obesity epidemic. EBTs offer greater efficacy than diet and lifestyle modification and lower invasiveness than bariatric surgery. The US Food and Drug Administration has approved two intragastric balloons and aspiration therapy for the treatment of obesity: Apollo Orbera is indicated for the treatment of Class I and Class II obesity, Re Shape Integrated Dual Balloon system is indicated for the same range with a comorbidity, and Aspire Bariatrics AspireAssist is approved for patients with a body mass index of 35-55 kg/m2. These devices have proven safe and effective in clinical trials and are gaining commercial acceptance in the USA; the Orbera has been used extensively outside the USA for over 20 years. These devices will need to be delivered in the context of a multidisciplinary weight loss program, integrating comprehensive care of obesity. Patient selection is important, and ensuring appropriate patient expectations and understanding of alternatives such as pharmacologic therapy and surgery is essential. With several EBTs on the horizon, patients with obesity will have an even broader array of safe and effective options for weight management in the future.