Safe Continuation of Glucagon-like Peptide 1 Receptor Agonists at Endoscopy: A Case Series of 57 Adults Undergoing Endoscopic Sleeve Gastroplasty.

PURPOSE: Glucagon-like receptor agonists (GLP1-RAs) have raised peri-procedural concerns due to their potential to delay gastric emptying. The American Association of Anesthesiologists has advised pausing a single dose before elective endoscopy. However, a subsequent directive from multiple gastroenterology societies underscored the need for further assessment to substantiate this practice. We aimed to evaluate the frequency of serious adverse events and retained gastric products during endoscopic sleeve gastroplasty (ESG) with uninterrupted GLP1-RA use. MATERIALS AND METHODS: We conducted a retrospective evaluation of all patients undergoing ESG while on GLP1-RAs at three centers from August 2022 to February 2024. Per standard protocol, all patients had refrained from solid foods for at least 24 h and maintained nil per os for 12 h preceding their ESG. Records were reviewed for patient characteristics and medication type and doses. Primary outcomes included serious adverse events and retained gastric products based on patient records, procedure reports, and procedural videos. RESULTS: Fifty-seven consecutive adults (89.5% women, mean age of 44 ± 9 years, mean BMI of 40.1 ± 8.1 kg/m2, 35.1% with T2DM, and 26.3% with pre-T2DM) underwent ESG without stopping GLP1-RAs, which included semaglutide (45.6%), liraglutide (19.3%), dulaglutide (22.8%), and tirzepatide (12.3%). During intubation, endoscopy, and recovery, there were no instances of retained gastric solids, pulmonary aspiration, gastroesophageal regurgitation, or hypoxia. CONCLUSION: A ≥ 24-h pre-endoscopy liquid-only diet with ≥ 12-h pre-endoscopy fast may negate the need for GLP1-RA interruption for routine upper endoscopy in adults with native gastric anatomy.

How to establish an endoscopic bariatric practice.

Obesity is a chronic, progressive, and relapsing disease of excess adiposity that contributes to more than two hundred medical conditions and is projected to affect more than half the adult population of the United States by the year 2030. Given the limited penetrance of traditional bariatric surgery, as well as the cost and adherence barriers to anti-obesity medications, there is growing interest in the rapidly evolving field of endoscopic bariatric therapies (EBTs). EBTs are minimally invasive, same-day, per-oral endoscopic procedures and include endoscopic sleeve gastroplasty, intragastric balloons, and endoscopic bariatric revisional procedures. This field represents an exciting and innovative subspecialty within gastroenterology. However, building a successful endoscopic bariatric practice requires intentional, coordinated, and sustained efforts to overcome the numerous obstacles to entry. Common barriers include acquisition of the technical and cognitive skillset, practice limitations including the availability of nutrition counseling, facility capabilities, direct-to-consumer marketing, and financial pressures such as facility and anesthesia fees. As the highest-volume center for metabolic and bariatric endoscopy in the United States, we provide insights into successfully establishing an endoscopic bariatric program.

Celiac artery mesenteric fat measurement with endosonography (CAMEUS) reliably correlates with obesity and related comorbidities.

Background: Visceral fat represents a metabolically active entity linked to adverse metabolic sequelae of obesity. We aimed to determine if celiac artery mesenteric fat thickness can be reliably measured during endoscopic ultrasound (EUS), and if these measurements correlate with metabolic disease burden. Methods: This was a retrospective analysis of patients who underwent celiac artery mesenteric fat measurement with endosonography (CAMEUS) measurement at a tertiary referral center, and a validation prospective trial of patients with obesity and nonalcoholic steatohepatitis who received paired EUS exams with CAMEUS measurement before and after six months of treatment with an intragastric balloon. Results: CAMEUS was measured in 154 patients [56.5% females, mean age 56.5 ± 18.0 years, body mass index (BMI) 29.8 ± 8.0 kg/m2] and was estimated at 14.7 ± 6.5 mm. CAMEUS better correlated with the presence of non-alcoholic fatty liver disease (NAFLD) (R2 = 0.248, P < 0.001) than BMI (R2 = 0.153, P < 0.001), and significantly correlated with metabolic parameters and diseases. After six months of intragastric balloon placement, the prospective cohort experienced 11.7% total body weight loss, 1.3 points improvement in hemoglobin A1c (P = 0.001), and a 29.4% average decrease in CAMEUS (-6.4 ± 5.2 mm, P < 0.001). CAMEUS correlated with improvements in weight (R2 = 0.368), aspartate aminotransferase to platelet ratio index (R2 = 0.138), and NAFLD activity score (R2 = 0.156) (all P < 0.05). Conclusions: CAMEUS is a novel measure that is significantly correlated with critical metabolic indices and can be easily captured during routine EUS to risk-stratify susceptible patients. This station could allow for EUS access to sampling and therapeutics of this metabolic region.

Transoral Outlet Reduction: Expert Tips, Tricks, and Troubleshooting.

Transoral outlet reduction (TORe) is an incisionless, endoscopic procedure to address weight recurrence after Roux-en-Y gastric bypass. Given the chronic, progressive nature of obesity and the minimally invasive, anatomy preserving technique of TORe, the procedure is expected to be met with high patient acceptance and widening clinical adoption. Nevertheless, the approach to TORe has been heterogeneous. As endoscopic bariatric therapies are increasingly incorporated into the multidisciplinary management of obesity, it is crucial to have a standardized, evidence-based framework for their implementation. In this review, based on the available literature and the authors' combined experience of over 1,000 TORe procedures, we present our approach to patient selection, procedural technique, troubleshooting, and patient aftercare unique to TORe.

Outcomes of Endoscopic Sleeve Gastroplasty Following Laparoscopic Adjustable Gastric Band: A Propensity Score-matched Analysis.

BACKGROUND: The performance of endoscopic sleeve gastroplasty (ESG) in patients with prior laparoscopic adjustable gastric band (LAGB) has not been characterized. MATERIALS AND METHODS: This is a retrospective propensity score-matched study of ESG after LAGB at 2 centers with expertise in bariatric endoscopy. The primary outcome was total weight loss (TWL) at 12 months. Secondary outcomes included TWL at 3 and 6 months, 12-month excess weight loss (EWL), procedural characteristics, predictors of TWL, and serious adverse events. RESULTS: Twenty-six adults (88.5% female, age 50.8 y, BMI 36.5 kg/m 2 ) with prior LAGB (median duration 8 y) underwent ESG at a median of 3 years after LAGB removal. A 2:1 age-matched, sex-matched, and BMI-matched comparator group was created, comprising ESG patients from the same organization and time frame but without prior LAGB. TWL for the LAGB-to-ESG cohort versus the ESG-only cohort was 10.1±5.5% versus 13.0±4.4% at 3 months ( P =0.0256), 12.4±7.2% versus 16.0±5.4% at 6 months ( P =0.0375), and 12.7±8.2% versus 18.4±6.5% at 12 months ( P =0.0149). At 12 months, the LAGB-to-ESG cohort had an EWL of 52.5±50.0%, and 75% achieved TWL ≥10%. There was no association between TWL at 3, 6, or 12 months and the following traits: age or BMI at the time of ESG, patient sex, and time from LAGB removal to ESG. No serious adverse events occurred in either cohort. CONCLUSION: ESG after LAGB facilitates safe and clinically meaningful weight loss but is attenuated compared to primary ESG.

Endoscopic revision of one-anastomosis gastric bypass (ER-OAGB) for weight recurrence: a case series of 17 adults.

Weight recurrence after one-anastomosis gastric bypass (OAGB), the third most common metabolic and bariatric surgery performed worldwide, is observed in a subset of patients due to the chronic, progressive nature of obesity. Endoscopic revision of the OAGB (ER-OAGB) through full-thickness suturing to reduce the gastrojejunal anastomosis and gastric pouch is a potential alternative to surgical revision. Here, we present a case series of ER-OAGB and long-term nutritional support at two international centers with expertise in bariatric endoscopy. Data were retrospectively evaluated from a prospectively maintained database. The primary outcome was total body weight loss (TBWL) at 12 months. Secondary outcomes included TBWL at 3, 6, and 15 months; excess weight loss (EWL) at 3, 6, 12, and 15 months; frequency of new/worsening symptoms of gastroesophageal reflux disease (GERD); and the frequency of serious adverse events. In this series, 17 adults (70.6% female, mean age 46.8 years, mean BMI 39.1 kg/m2) successfully underwent ER-OAGB an average of 8 years (range 2-21 years) after OAGB for a mean weight recurrence of 43.2% (range 10.9-86.9%). TBWL from ER-OAGB was 9.7 ± 1.8% at 3 months, 13.4 ± 3.5% at 6 months, 18.5 ± 2.1% at 12 months, and 18.1 ± 2.2% at 15 months. EWL from ER-OAGB was 30.5 ± 14.7% at 3 months, 42.6 ± 16.2% at 6 months, 54.2 ± 11.3% at 12 months, and 54.2 ± 11.7% at 15 months. There were no instances of new/worsening GERD symptoms or serious adverse events. In this small series of adults who experienced weight recurrence after OAGB, ER-OAGB facilitated safe and clinically meaningful weight loss, without new or worsening GERD symptoms, when performed by experienced bariatric endoscopists in concert with longitudinal nutritional support.

Endoscopic revision of one-anastomosis gastric bypass for weight recurrence The one-anastomosis gastric bypass (OAGB) is now the third most commonly performed metabolic and bariatric surgery worldwide. As with other weight loss surgeries, the OAGB is associated with weight recurrence over time that prompts patients to seek further treatment; however, revisional surgeries are known to carry increased risk. The endoscopic revision of the OAGB (ER-OAGB) is an incisionless technique that reduces the gastrojejunal anastomosis and gastric pouch to facilitate weight loss after weight recurrence in OAGB. Here, we showed in a series of 17 adults that the ER-OAGB safely helped patients lose over 18% of their body weight within the year following their revision.

Endoscopic removal of a weight-loss device with stoma closure using a tack-and-suture device.

Video 1.

Transoral outlet reduction: Outcomes of endoscopic Roux-en-Y gastric bypass revision in 284 patients at a community practice.

BACKGROUND: Transoral outlet reduction (TORe) is a minimally invasive endoscopic revision of Roux-en-Y gastric bypass (RYGB) for weight recurrence; however, little has been published on its clinical implementation in the community setting. AIM: To characterize the safety and efficacy of TORe in the community setting for adults with weight recurrence after RYGB. METHODS: This is a retrospective cohort study of argon plasma coagulation and purse-string suturing for gastric outlet reduction in consecutive adults with weight recurrence after RYGB at a single community center from September 2020 to September 2022. Patients were provided longitudinal nutritional support via virtual visits. The primary outcome was total body weight loss (TBWL) at twelve months from TORe. Secondary outcomes included TBWL at three months and six months; excess weight loss (EWL) at three, six, and twelve months; twelve-month TBWL by obesity class; predictors of twelve-month TBWL; rates of post-TORe stenosis; and serious adverse events (SAE). Outcomes were reported with descriptive statistics. RESULTS: Two hundred eighty-four adults (91.9% female, age 51.3 years, body mass index 39.3 kg/m2) underwent TORe an average of 13.3 years after RYGB. Median pre- and post-TORe outlet diameter was 35 mm and 8 mm, respectively. TBWL was 11.7% ± 4.6% at three months, 14.3% ± 6.3% at six months, and 17.3% ± 7.9% at twelve months. EWL was 38.4% ± 28.2% at three months, 46.5% ± 35.4% at six months, and 53.5% ± 39.2% at twelve months. The number of follow-up visits attended was the strongest predictor of TBWL at twelve months (R2 = 0.0139, P = 0.0005). Outlet stenosis occurred in 11 patients (3.9%) and was successfully managed with endoscopic dilation. There was one instance of post-procedural nausea requiring overnight observation (SAE rate 0.4%). CONCLUSION: When performed by an experienced endoscopist and combined with longitudinal nutritional support, purse-string TORe is safe and effective in the community setting for adults with weight recurrence after RYGB.

Performance Characteristics of Endoscopic Sleeve Gastroplasty in Patients with Prior Intragastric Balloon: Results of a Propensity Score Matched Study.

INTRODUCTION: The performance characteristics of endoscopic sleeve gastroplasty (ESG) for weight recurrence after intragastric balloon (IGB) are unknown. METHODS: This is a retrospective propensity score matched study of ESG after IGB (IGB-to-ESG) vs ESG without prior IGB (ESG-only). The primary outcome was total weight loss (TWL) at 12 months. Secondary outcomes included TWL at 3 and 6 months, 12-month excess weight loss (EWL), procedural characteristics, and safety. RESULTS: Thirty-nine adults underwent ESG from August 2020 to September 2022 after IGB explantation a median of 24 months (range 2-56 months) prior and a median post-IGB nadir weight increase of 100.0% (range 0 to 3200%). An ESG-only 2:1 age- sex- and BMI- propensity score matched cohort was derived from 649 patients (Pearson's goodness-of-fit: 0.86). TWL for IGB-to-ESG vs. ESG-only was 12.3 ± 13.5% vs. 12.4 ± 3.7% at 3 months (p = 0.97), 10.1 ± 7.1% vs. 15.4 ± 4.6% at 6 months (p < 0.001), and 8.7 ± 7.7% vs. 17.1 ± 5.7% at 12 months (p < 0.001). Twelve-month EWL for IGB-to-ESG vs ESG-only was 27.8 ± 46.9% vs 62.0 ± 21.0% (p < 0.001). There was no difference in mean procedural duration of ESG; however, more sutures were used with IGB-to-ESG vs. ESG-only (7 vs. 6, p < 0.0002). There were no serious adverse events in either cohort. CONCLUSION: ESG after IGB produces safe, acceptable weight loss but with an attenuated effect compared to ESG alone. Further study is required to understand the factors driving this discrepancy.

Improvements in hepatic steatosis, obesity, and insulin resistance in adults with nonalcoholic fatty liver disease after the primary obesity surgery endoluminal 2.0 procedure.

BACKGROUND: The primary obesity surgery endoluminal 2.0 (POSE 2.0) procedure involves full-thickness gastric body plications to narrow the stomach using durable suture anchor pairs. We evaluated POSE 2.0 as a treatment strategy for nonalcoholic fatty liver disease (NAFLD) in patients with obesity. METHODS: Adults with obesity and NAFLD were prospectively allocated based on their preference to undergo POSE 2.0 with lifestyle modification or lifestyle modification alone (control). Primary end points were improvement in controlled attenuation parameter (CAP) and resolution of hepatic steatosis at 12 months. Secondary end points included %total body weight loss (%TBWL), change in serum measures of hepatic steatosis and insulin resistance, and procedure safety. RESULTS: 42 adult patients were included (20 in the POSE 2.0 arm and 22 in the control arm). At 12 months, POSE 2.0 significantly improved CAP, whereas lifestyle modification alone did not (P < 0.001 for POSE 2.0; P = 0.24 for control). Similarly, both resolution of steatosis and %TBWL were significantly higher with POSE 2.0 than with control at 12 months. Compared with controls, POSE 2.0 significantly improved liver enzymes, hepatic steatosis index, and aspartate aminotransferase to platelet ratio at 12 months. There were no serious adverse events. CONCLUSION : POSE 2.0 was effective for NAFLD in patients with obesity, with good durability and safety profile.

A Protocolized Management of Walled-Off Necrosis (WON) Reduces Time to WON Resolution and Improves Outcomes.

BACKGROUND AND AIMS: Patients with infected or symptomatic walled-off necrosis (WON) have high morbidity and health care utilization. Despite the recent adoption of nonsurgical treatment approaches, WON management remains nonalgorithmic. We investigated the impact of a protocolized early necrosectomy approach compared with a nonprotocolized, clinician-driven approach on important clinical outcomes. METHODS: Records were reviewed for consecutive patients with WON who underwent a protocolized endoscopic drainage with a lumen-apposing metal stent (cases), and for patients with WON treated with a lumen-apposing metal stent at the same tertiary referral center who were not managed according to the protocol (control subjects). The protocol required repeat cross-sectional imaging within 14 days after lumen-apposing metal stent placement, with regularly scheduled endoscopic necrosectomy if WON diameter reduction was <50%. Control patients were treated according to their clinician's preference without an a priori strategy. Inverse probability of treatment weighting-adjusted analysis was used to evaluate the influence of being in the protocolized group on time to resolution. RESULTS: A total of 24 cases and 47 control subjects were included. There were no significant differences in baseline characteristics. Although numbers of endoscopies and necrosectomies were similar, cases had lower adverse event rates, shorter intensive care unit stay, and required nutritional support for fewer days. On matched multivariate Cox regression, cases had earlier WON resolution (hazard ratio, 5.73; 95% confidence interval, 2.62-12.5). This was confirmed in the inverse probability of treatment weighting-adjusted analysis (hazard ratio, 3.4; 95% confidence interval, 1.92-6.01). CONCLUSIONS: A protocolized strategy resulted in faster WON resolution compared with a discretionary approach without the need for additional therapeutic interventions, and with a better safety profile and decreased health care utilization.

Prospective Multicenter Study of the Primary Obesity Surgery Endoluminal (POSE 2.0) Procedure for Treatment of Obesity.

BACKGROUND & AIMS: The Primary Obesity Surgery Endoluminal (POSE) 2.0 procedure involves a novel pattern of full-thickness gastric body plications to shorten and narrow the stomach using durable suture anchor pairs. Our prospective, multicenter trial examined the safety, efficacy, durability, and physiologic effects of POSE 2.0 in adults with obesity. METHODS: Adults with obesity underwent POSE 2.0 at 3 centers. Primary outcomes were percent total body weight loss (%TBWL) and proportion of patients achieving >5% TBWL at 12 months. Secondary outcomes included change in obesity comorbidities, satiety, quality of life at 6 months, and durability of plications at 12 and 24 months. Subjects were followed for adverse events throughout the study duration. RESULTS: 44 patients (61% female; mean age, 45 ± 9.7 years; mean body mass index, 37 ± 2.1 kg/m2) were enrolled. This procedure used an average of 19 suture anchor pairs, with a mean duration of 37 ± 11 minutes, and was technically successful in all subjects. Mean %TBWL at 12 months was 15.7% ± 6.8%. At 12 months, %TBWL >5%, >10%, and >15% was achieved in 98%, 86%, and 58% of patients, respectively. Improvements in lipid profile, liver biochemistries, and hepatic steatosis were seen at 6 months. Improvements in hepatic steatosis persisted for 24 months in a subgroup of patients (P < .01). POSE 2.0 reduced maximum tolerated meal volume (P = .03) and was associated with increased fullness (P < .01) and improved eating behavior (P < .01) at 6 months. Impact of weight on quality-of-life questionnaire improved at 6 months (2.23 vs 1.23; P < .01). Repeat assessment at 24 months (n = 26) showed fully intact plications. No serious adverse events occurred. CONCLUSION: POSE 2.0 is an effective and durable endoscopic bariatric therapy which may influence physiologic pathways impacting satiety. Larger comparative studies are needed to further elucidate these initial findings. CLINICALTRIALS: gov Identifier: NCT03721731.

Novel classification system for walled-off necrosis: a step toward standardized nomenclature and risk-stratification framework.

BACKGROUND AND AIMS: The optimal therapeutic approach for walled-off necrosis (WON) is not fully understood, given the lack of a validated classification system. We propose a novel and robust classification system based on radiologic and clinical factors to standardize the nomenclature, provide a framework to guide comparative effectiveness trials, and inform the optimal WON interventional approach. METHODS: This was a retrospective analysis of patients who underwent endoscopic management of WON by lumen-apposing metal stent placement at a tertiary referral center. Patients were classified according to the proposed QNI classification system: quadrant ("Q"), represented an abdominal quadrant distribution; necrosis ("N"), denoted by the percentage of necrosis of WON; and infection ("I"), denoted as positive blood culture and/or systemic inflammatory response syndrome reaction with a positive WON culture. Two blinded reviewers classified all patients according to the QNI system. Patients were then divided into 2 groups: those with a lower QNI stratification (≤2 quadrants and ≤30% necrosis; group 1) and those with a higher stratification (≥3 quadrants, 2 quadrants with ≥30% necrosis, or 1 quadrant with >60% necrosis and infection; group 2). The primary outcome was mean time to WON resolution. Secondary procedural and clinical outcomes between the groups were compared. RESULTS: Seventy-one patients (75% men) were included and stratified by the QNI classification; group 1 comprised 17 patients and group 2, 54 patients. Patients in group 2 had a higher number of necrosectomies, longer hospital stays, and more readmissions. The mean time to resolution was longer in group 2 than in group 1 (79.6 ± 7.76 days vs 48.4 ± 9.22 days, P = .02). The mortality rate was higher in group 2 (15% vs 0%, P = .18). CONCLUSIONS: Despite the heterogeneous nature of WON in severe acute pancreatitis, a proposed QNI system may provide a standardized framework for WON classification to inform clinical trials, risk-stratify the disease course, and potentially inform an optimal management approach.

Effects on physiologic measures of appetite from intragastric balloon and endoscopic sleeve gastroplasty: results of a prospective study.

BACKGROUND: Endoscopic bariatric therapies can help address widening management gaps in obesity. Their ability to facilitate weight loss is largely tied to influences on appetite through perturbations of gastric emptying and accommodation. As these tools gain traction in obesity therapy, their physiologic underpinnings require exploration, which may enhance efficacy, tolerance, and patient-tailored care. METHODS: We prospectively assessed consecutive subjects with fluid-filled intragastric balloons (IGBs) ( n  = 18) placed between October 2016 and June 2017 or underwent endoscopic sleeve gastroplasty (ESG) ( n  = 23) from March 2018 to June 2018. Patients underwent physiologic appraisal at 3 months with 13 C-spirulina-based gastric emptying breath test to determine time to half emptying (T50), as well as maximum tolerated volume (MTV) of a standard nutrient drink test. Changes in T50 and MTV at 3 months were compared with percent total body weight loss (%TBWL) at 3 and 6 months using best-fit linear regression. RESULTS: The change in T50 at 3 months correlated with %TBWL at 3 months for IGB ( P  = 0.01) and ESG ( P  = 0.01) but with greater impact on %TBWL in IGB compared to ESG ( R2  = 0.42 vs . 0.26). Change in T50 at 3 months was predictive of weight loss at 6 months for IGB ( P  = 0.01) but not ESG ( P  = 0.11). ESG was associated with greater decrease in MTV compared to IGB (340.25 ±â€Š297.97 mL vs. 183.00 ±â€Š217.13 mL, P  = 0.08), indicting an enhanced effect on satiation through decreased gastric accommodation. Changes in MTV at 3 months did not correlate with %TBWL for either IGB ( P  = 0.26) or ESG ( P  = 0.49) but trended toward significance for predicting %TBWL at 6 months for ESG ( P  = 0.06) but not IGB ( P  = 0.19). CONCLUSION: IGB and ESG both induce weight loss but likely through distinct gastric motor function phenotypes, and gastric emptying may predict future weight loss in patients with IGB.

Endoscopic suturing and plication in the stomach for weight loss.

The prevalence of obesity has been increasing on a global scale. However, less than 1% of patients eligible for bariatric surgery actually undergo weight loss surgery. Endobariatric therapies (EBTs) have emerged to bridge the obesity treatment gap, as they are less invasive, highly effective, and more broadly applicable to patients with mild to moderate obesity. Endoscopic sleeve gastroplasty and primary obesity surgery endoluminal are the two most promising EBTs, altering stomach physiologies mimicking bariatric surgery. This review focuses on these two EBT approaches.

Adjustable intragastric balloon for treatment of obesity: a multicentre, open-label, randomised clinical trial.

BACKGROUND: Intragastric balloons are anatomy-preserving, minimally invasive obesity therapies. Enhanced tolerance and durability could help broaden clinical adoption. We investigated the safety and efficacy of an adjustable intragastric balloon (aIGB) in adults with obesity. METHODS: In this prospective, multicentre, open-label, randomised clinical trial done at seven US sites, adults aged 22-65 years with obesity were randomly assigned (2:1) to aIGB with lifestyle intervention or lifestyle intervention alone (control) for 32 weeks. Balloon volume could be increased to facilitate weight loss or decreased for tolerability. Coprimary endpoints included mean percentage total bodyweight loss and responder rate (≥5% total bodyweight loss) at 32 weeks. We used a multiple imputed intention-to-treat population analysis. This study was registered with ClinicalTrials.gov, NCT02812160. FINDINGS: Between Aug 9, 2016, and Dec 7, 2018, we randomly assigned 288 patients to aIGB (n=187 [65%]) or control (n=101 [35%]) groups. Mean total bodyweight loss at 32 weeks was 15·0% (95% CI 13·9-16·1) in the aIGB group versus 3·3% (2·0-4·6) in the control group (p<0·0001). Clinical response was observed in 171 (92%) patients in the aIGB group. Adjustments to the aIGB occurred in 145 (80%) patients for weight loss plateau or intolerance. Upward volume adjustment facilitated an additional mean 5·2% (4·5-5·8) total bodyweight loss. Downward volume adjustment allowed 21 (75%) patients in the aIGB group to complete the full duration of therapy. Intolerance caused early removal of the device in 31 (17%) patients. No micronutrient deficiencies were observed in the aIGB cohort. Device-related serious adverse events were observed in seven (4%) patients, without any deaths. INTERPRETATION: When aIGB was combined with lifestyle modification, significant weight loss was achieved and maintained for 6 months following removal. Balloon volume adjustability permitted individualised therapy, maximising weight loss and tolerance. FUNDING: Spatz Medical.