Endoscopic sleeve gastroplasty as an early tool against obesity: a multicenter international study on an overweight population.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) is an effective, minimally invasive gastric remodeling procedure to treat mild and moderate obesity. Early adoption of ESG may be desirable to try to halt progression of obesity, but there are few data on its efficacy and safety for overweight patients. METHODS: This was a multicenter, international, analytical case series. Six U.S., 1 Brazilian, 1 Mexican, and 1 Indian center were included. Overweight patients according to local practice undergoing ESG were considered eligible for the study. The end points were percent total weight loss (%TWL), body mass index (BMI) reduction, rate of BMI normalization, and rate of adverse events. RESULTS: One hundred eighty-nine patients with a mean age of 42.6 ± 14.1 years and a mean BMI of 27.79 ± 1.17 kg/m2 were included. All procedures were successfully accomplished, and there were 3 intraprocedural adverse events (1.5%). The mean %TWL was 12.28% ± 3.21%, 15.03% ± 5.30%, 15.27% ± 5.28%, and 14.91% ± 5.62% at 6, 12, 24, and 36 months, respectively. At 12 and 24 months, 76% and 86% of patients achieved normal BMI, with a mean BMI reduction of 4.13 ± 1.46 kg/m2 and 4.25 ± 1.58 kg/m2. There was no difference in mean %TWL in the first quartile versus the fourth quartile of BMI in any of the time points. However, the BMI normalization rate was statistically higher in the first group at 6 and 12 months (6 months, 100% vs 48.5% [P < .01]; 12 months, 86.2% vs 50% [P < .01]; 24 months, 84.6% vs 76.1% [P = .47]; 36 months, 86.3% vs 66.6% [P = .26]). CONCLUSIONS: ESG is safe and effective in treating overweight patients with high BMI normalization rates. It could help halt or delay the progression to obesity.

A commentary review on endoscopic sleeve gastroplasty: Indications, outcomes and future implications.

Metabolic and bariatric surgeries have been shown to be the most effective strategy to induce and maintain significant weight loss for people living with severe obesity. However, ongoing concerns regarding operative risks, irreversibility and excess costs limit their broader clinical use. Endoscopic bariatric therapies are pragmatic alternatives for patients who are not suitable for metabolic and bariatric surgeries or who are concerned regarding their long-term safety. Endoscopic sleeve gastroplasty has emerged as a novel technique of endoscopic bariatric therapies, which have garnered significant interest and evidence in the past few years. Its safety, efficacy and cost-effectiveness have been shown in various studies, while comparisons with sleeve gastrectomy have been widely made. This review brings together current evidence pertaining to the technicality of the procedure itself, current indications, safety and efficacy, cost-effectiveness, as well as its future role and development.

Machine learning models to predict success of endoscopic sleeve gastroplasty using total and excess weight loss percent achievement: a multicentre study.

BACKGROUND: The large amount of heterogeneous data collected in surgical/endoscopic practice calls for data-driven approaches as machine learning (ML) models. The aim of this study was to develop ML models to predict endoscopic sleeve gastroplasty (ESG) efficacy at 12 months defined by total weight loss (TWL) % and excess weight loss (EWL) % achievement. Multicentre data were used to enhance generalizability: evaluate consistency among different center of ESG practice and assess reproducibility of the models and possible clinical application. Models were designed to be dynamic and integrate follow-up clinical data into more accurate predictions, possibly assisting management and decision-making. METHODS: ML models were developed using data of 404 ESG procedures performed at 12 centers across Europe. Collected data included clinical and demographic variables at the time of ESG and at follow-up. Multicentre/external and single center/internal and temporal validation were performed. Training and evaluation of the models were performed on Python's scikit-learn library. Performance of models was quantified as receiver operator curve (ROC-AUC), sensitivity, specificity, and calibration plots. RESULTS: Multicenter external validation: ML models using preoperative data show poor performance. Best performances were reached by linear regression (LR) and support vector machine models for TWL% and EWL%, respectively, (ROC-AUC: TWL% 0.87, EWL% 0.86) with the addition of 6-month follow-up data. Single-center internal validation: Preoperative data only ML models show suboptimal performance. Early, i.e., 3-month follow-up data addition lead to ROC-AUC of 0.79 (random forest classifiers model) and 0.81 (LR models) for TWL% and EWL% achievement prediction, respectively. Single-center temporal validation shows similar results. CONCLUSIONS: Although preoperative data only may not be sufficient for accurate postoperative predictions, the ability of ML models to adapt and evolve with the patients changes could assist in providing an effective and personalized postoperative care. ML models predictive capacity improvement with follow-up data is encouraging and may become a valuable support in patient management and decision-making.

The SAGES MASTERS program bariatric surgery pathway selects 10 seminal publications on adjustable gastric banding.

BACKGROUND: Bariatric surgery is one of the clinical pathways of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Masters Program, and laparoscopic adjustable gastric banding (LAGB) is one of the three anchoring bariatric procedures. To improve surgeon lifelong learning, the Masters Program seeks to identify sentinel articles of each of the 3 bariatric anchoring procedures. In this article, we present the top 10 articles on LAGB. METHODS: A systematic literature search of papers on LAGB was completed, and publications with the most citations and citation index were selected and shared with SAGES Metabolic and Bariatric Surgery Committee members for review. The individual committee members then ranked these papers, and the top 10 papers were chosen based on the composite ranking. RESULTS: The top 10 sentinel publications on LAGB contributed substantially to the body of literature related to the procedure, whether for surgical technique, novel information, or outcome analysis. A summary of each paper including expert appraisal and commentary is presented here. CONCLUSION: These seminal articles have had significant contribution to our understanding and appreciation of the LAGB procedure. Bariatric surgeons should use this resource to enhance their continual education and acquisition of specialized skills.

Comparable improvement and resolution of obesity-related comorbidities in endoscopic sleeve gastroplasty vs laparoscopic sleeve gastrectomy: single-center study.

BACKGROUND: Despite excellent surgical outcomes, a minority of qualified patients undergo weight loss surgery. Endoscopic Sleeve Gastroplasty (ESG), an incisionless procedure, has proven to be effective in achieving weight loss and comorbidity improvement. We aim to compare outcomes of ESG to those of Laparoscopic Sleeve Gastrectomy (LSG). METHOD: A retrospective review of a prospective database of patients who underwent ESG and LSG at NorthShore University HealthSystem from 2016 to 2023 was completed. Demographic and outcome data were analyzed. Pre- and post-surgical data were compared using chi-square and two-sample t tests. Improvement or resolution of obesity-related comorbidities were also assessed. RESULTS: A total of 212 LSG and 68 ESG patients were reviewed. ESG patients were older (47 ± 10 vs. 43 ± 12, p = 0.006) and less obese (BMI 37.0 ± 5.5 vs. 45.8 ± 0.4, p < 0.001) than LSG patients. Median length of stay after ESG was 0 days and after LSG 1 day (p < 0.001). Severe adverse events were seen less frequent after ESG (1.47%, vs 3.77%). LSG achieved more significant %TBWL at 6 months (25.2 ± 8.9 vs 14.9 ± 7.4), 1 year (27.5 ± 10.8 vs 14.1 ± 9.8), and 2 years (25.7 ± 10.8 vs 10.5 ± 8.8, all p < 0.001) after surgery when compared to ESG. LSG achieved significantly greater %EWL compared to ESG at 6 months (57.0 ± 20.7 vs 50.4 ± 29.2, p = 0.137), 1 year (61.4 ± 24.6 vs 46.5 ± 34.0, p = 0.026), and 2 years postoperatively (59.7 ± 25.5 vs 32.6 ± 28.2, p = 0.001). There were no statistically significant differences in rates of improvement or resolution of diabetes, obstructive sleep apnea, hyperlipidemia, or hypertension. CONCLUSION: ESG is an effective procedure for weight loss and comorbidity resolution. Obesity-related comorbidities are comparably improved and resolved following ESG vs LSG. Although the weight loss in LSG is significantly higher, patients can expect a shorter hospital length of stay and a lower rate of complications after ESG. ESG continues to show promise for long-term weight loss and improvement in health.

Five-year outcomes of revisional bariatric surgery: gastric band to sleeve gastrectomy or to Roux-en-Y gastric bypass.

BACKGROUND: Revisional bariatric surgery after an index adjustable gastric band (AGB) may be indicated to remedy weight relapse or band-related complications. We examined outcomes five years following revision from AGB to laparoscopic sleeve gastrectomy (AGB-LSG) or to Roux-en-Y gastric bypass (AGB-RYGB). METHODS: We conducted a retrospective review to identify patients (men and women, age 18-80) who underwent one revisional bariatric procedure with AGB as the index procedure at two medical centers in our healthcare system between January 2012 and February 2017. We only included patients with a pre-revision BMI > 30 kg/m2 for whom 5-year follow-up data were available. We compared 5-year weight loss and remission of comorbidities in patients undergoing AGB-LSG and AGB-RYGB conversion. RESULTS: A total of 114 patients met inclusion criteria (65 AGB-LSG, 49 AGB-RYGB). At 5-year post-revision, percent total weight loss (3.4% vs 19.9%; p < 0.001), percent excess weight loss (7.0% vs 50.8%; p < 0.001) and decrease in BMI (1.5 vs 8.8; p < 0.001) was greater in AGB-RYGB vs. AGB-LSG. No significant difference in remission or development of new comorbidities was observed. CONCLUSION: Conversion of AGB to RYGB is associated with superior intermediate-term weight loss compared to conversion of AGB to LSG. Future multicenter studies with larger sample sizes are necessary to further describe the intermediate-term outcomes of revisional bariatric surgery.

Short term safety of magnetic sphincter augmentation vs minimally invasive fundoplication: an ACS-NSQIP analysis.

PURPOSE: Magnetic Sphincter Augmentation (MSA) is an FDA-approved anti-reflux procedure with comparable outcomes to fundoplication. However, most data regarding its use are limited to single or small multicenter studies which may limit the generalizability of its efficacy. The purpose of this study is to evaluate the outcomes of patients undergoing MSA vs fundoplication in a national database. MATERIALS AND METHODS: The 2017-2020 American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) Registry was utilized to evaluate patients undergoing MSA or fundoplication. Patients requiring Collis gastroplasty, paraesophageal hernia repair, and emergency cases, were excluded. Patient outcomes included overall complication rates, readmissions, reoperations, and mortality. RESULTS: A total of 7,882 patients underwent MSA (n = 597) or fundoplication (n = 7285). MSA patients were younger (51 vs 57, p < 0.001), and more often male (49.6 vs 34.3%, p < 0.001). While patients undergoing MSA experienced similar rates of reoperation (1.0 vs 2.0%, p = 0.095), they experienced fewer readmissions (2.2 vs 4.7%, p = 0.005), complications (0.6 vs 4.0%, p < 0.001), shorter mean (SD) hospital length of stay(days) (0.4 ± 4.3 vs 1.8 ± 4.6, p < 0.001) and operative time(min) (80.8 ± 36.1 vs 118.7 ± 63.7, p < 0.001). Mortality was similar between groups (0 vs 0.3%, p = 0.175). On multivariable analysis, MSA was independently associated with reduced postoperative complications (OR 0.23, CI 0.08 to 0.61, p = 0.002), readmissions (OR 0.53, CI 0.30 to 0.94, p = 0.02), operative time (RC - 36.56, CI - 41.62 to - 31.49. p < 0.001) and length of stay (RC - 1.22, CI - 1.61 to - 0.84 p < 0.001). CONCLUSION: In this national database study, compared to fundoplication MSA was associated with reduced postoperative complications, fewer readmissions, and shorter operative time and hospital length of stay. While randomized trials are lacking between MSA and fundoplication, both institutional and national database studies continue to support the use of MSA as a safe anti-reflux operation.

From adjustable gastric banding to Roux-en-Y gastric bypass - case report.

INTRODUCTION: Adjustable gastric banding (AGB) used to be a popular bariatric procedure. However, it fails in more than half of those operated on in the long term, becomes ineffective and must be removed. Therefore, the use of AGB has been in decline globally. Sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) are the most used bariatric revision surgeries when AGB is removed. CASE REPORT: We present the case of a woman after AGB removal and conversion to SG who developed a stenosis of the sleeve. Therefore, a decision was made to convert to RYGB with a good effect. CONCLUSION: Revisional procedures are more technically challenging than primary procedures and have higher complication rates. The most performed revisional operations include SG and RYGB. Stenosis of the sleeve can occur after SG, with a negative impact on the patient's nutritional status and quality of life. This can be managed by endoscopic dilatation, and where this solution proves ineffective, RYGB can be indicated.

Effect of endoscopic sleeve gastroplasty on gastric emptying, motility and hormones: a comparative prospective study.

OBJECTIVE: Endoscopic sleeve gastroplasty (ESG) has gained global adoption but our understanding of its mechanism(s) of action and durability of efficacy is limited. We sought to determine changes in gastric emptying (GE), gastric motility (GM), hormones and eating behaviours after ESG. DESIGN: A priori-designed single-centre substudy of a large US randomised clinical trial, adults with obesity were randomised to ESG or lifestyle interventions (LS) alone. We measured GE, hormones and weight loss and assessed eating behaviours. In a subset of ESG patients, we assessed GM. The primary outcome was the change in T1/2 (min) at 3 months, and secondary outcomes were changes in weight, GE, GM, hormones and eating behaviours. We used t-test analyses and regression to determine the association between GE and weight loss. RESULTS: 36 (ESG=18; LS=18) participated in this substudy. Baseline characteristics were similar between the two groups. At 3 months, T1/2 was delayed in the ESG group (n=17) compared with the LS group (n=17) (152.3±47.3 vs 89.1±27.9; p<0.001). At 12 months, T1/2 remained delayed in the ESG group (n=16) vs control group (n=14) (137±37.4 vs 90.1±23.4; p<0.001). Greater delays in GE at 3 months were associated with greater weight loss. GM was preserved and fasting ghrelin, glucagon-like peptide 1 and polypeptide YY significantly increased 18 months after ESG. CONCLUSION: ESG promotes weight loss through several key mechanistic pathways involving GE and hormones while preserving GM. These findings further support clinical adoption of this technique for the management of obesity. TRIAL REGISTRATION NUMBER: NCT03406975.

Cost-effectiveness of endoscopic, surgical and pharmacological obesity therapies: a microsimulation and threshold analyses.

OBJECTIVE: Weight loss interventions to treat obesity include sleeve gastrectomy (SG), lifestyle intervention (LI), endoscopic sleeve gastroplasty (ESG) and semaglutide. We aimed to identify which treatments are cost-effective and identify requirements for semaglutide to be cost-effective. DESIGN: We developed a semi-Markov microsimulation model to compare the effectiveness of SG, ESG, semaglutide and LI for weight loss in 40 years old with class I/II/III obesity. Extensive one-way sensitivity and threshold analysis were performed to vary cost of treatment strategies and semaglutide adherence rate. Outcome measures were incremental cost-effectiveness ratios (ICERs), with a willingness-to-pay threshold of US$100 000/quality-adjusted life-year (QALY). RESULTS: When strategies were compared with each other, ESG was cost-effective in class I obesity (US$4105/QALY). SG was cost-effective in class II obesity (US$5883/QALY) and class III obesity (US$7821/QALY). In class I/II/III, obesity, SG and ESG were cost-effective compared with LI. However, semaglutide was not cost-effective compared with LI for class I/II/III obesity (ICER US$508 414/QALY, US$420 483/QALY and US$350 637/QALY). For semaglutide to be cost-effective compared with LI, it would have to cost less than US$7462 (class III), US$5847 (class II) or US$5149 (class I) annually. For semaglutide to be cost-effective when compared with ESG, it would have to cost less than US$1879 (class III), US$1204 (class II) or US$297 (class I) annually. CONCLUSIONS: Cost-effective strategies were: ESG for class I obesity and SG for class II/III obesity. Semaglutide may be cost-effective with substantial cost reduction. Given potentially higher utilisation rates with pharmacotherapy, semaglutide may provide the largest reduction in obesity-related mortality.

Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial.

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is an endolumenal, organ-sparing therapy for obesity, with wide global adoption. We aimed to explore the efficacy and safety of ESG with lifestyle modifications compared with lifestyle modifications alone. METHODS: We conducted a randomised clinical trial at nine US centres, enrolling individuals aged 21-65 years with class 1 or class 2 obesity and who agreed to comply with lifelong dietary restrictions. Participants were randomly assigned (1:1·5; with stratified permuted blocks) to ESG with lifestyle modifications (ESG group) or lifestyle modifications alone (control group), with potential retightening or crossover to ESG, respectively, at 52 weeks. Lifestyle modifications included a low-calorie diet and physical activity. Participants in the primary ESG group were followed up for 104 weeks. The primary endpoint at 52 weeks was the percentage of excess weight loss (EWL), with excess weight being that over the ideal weight for a BMI of 25 kg/m2. Secondary endpoints included change in metabolic comorbidities between the groups. We used multiple imputed intention-to-treat analyses with mixed-effects models. Our analyses were done on a per-protocol basis and a modified intention-to-treat basis. The safety population was defined as all participants who underwent ESG (both primary and crossover ESG) up to 52 weeks. FINDINGS: Between Dec 20, 2017, and June 14, 2019, 209 participants were randomly assigned to ESG (n=85) or to control (n=124). At 52 weeks, the primary endpoint of mean percentage of EWL was 49·2% (SD 32·0) for the ESG group and 3·2% (18·6) for the control group (p<0·0001). Mean percentage of total bodyweight loss was 13·6% (8·0) for the ESG group and 0·8% (5·0) for the control group (p<0·0001), and 59 (77%) of 77 participants in the ESG group reached 25% or more of EWL at 52 weeks compared with 13 (12%) of 110 in the control group (p<0·0001). At 52 weeks, 41 (80%) of 51 participants in the ESG group had an improvement in one or more metabolic comorbidities, whereas six (12%) worsened, compared with the control group in which 28 (45%) of 62 participants had similar improvement, whereas 31 (50%) worsened. At 104 weeks, 41 (68%) of 60 participants in the ESG group maintained 25% or more of EWL. ESG-related serious adverse events occurred in three (2%) of 131 participants, without mortality or need for intensive care or surgery. INTERPRETATION: ESG is a safe intervention that resulted in significant weight loss, maintained at 104 weeks, with important improvements in metabolic comorbidities. ESG should be considered as a synergistic weight loss intervention for patients with class 1 or class 2 obesity. This trial is registered with ClinicalTrials.gov, NCT03406975. FUNDING: Apollo Endosurgery, Mayo Clinic.

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.

Endoscopic Sleeve Gastroplasty in Those With a Body Mass Index of 27-30.

INTRODUCTION: Endoscopic sleeve gastroplasty (ESG) is safe and effective in patients with a body mass index (BMI) more than 30, with few cases reported in patients with overweight (BMI 27-30). However, evidence is lacking in the overweight group because the procedure is not currently performed routinely for such patients. In this study, we aim to evaluate the safety and efficacy of ESG in patients with a BMI between 27 and 30 who failed other weight loss modalities and/or had weight-related comorbidities. METHODS: This was a subgroup analysis of data pertaining to adults with a BMI between 27 and 30 who underwent ESG as a primary weight loss intervention. Data were abstracted from our longitudinal, prospective single-center registry. We analyzed weight loss, comorbidity resolution, adverse events, revisions, and quality of life using the Bariatric Analysis and Reporting Outcome System. RESULTS: Of 3,797 ESG procedures, 656 patients (17%) had a BMI of 27-30. The mean age was 33 ± 9 years and women comprised 94% (n = 616) of the sample. The mean % total weight loss at 6, 12, 24, and 36 months after ESG was 11.0 ± 7.2, 15.5 ± 6.3, 15.1 ± 8.3%, and 13.3 ± 9.9%, respectively. Eight of 22 patients with diabetes (36%) and 9 of 51 patients (18%) with hypertension experienced complete remission. Two patients were hospitalized with bleeding. Twenty-three patients (3.5%) underwent revision to laparoscopic sleeve gastrectomy or repeat ESG. Six more patients underwent suture removal. A total of 214 of 261 patients (82%) rated quality of life after ESG as good or better. DISCUSSION: ESG seems to be well tolerated, safe, and effective in patients with a BMI of 27-30.

UK cost-effectiveness analysis of endoscopic sleeve gastroplasty versus lifestyle modification alone for adults with class II obesity.

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is a minimally invasive procedure that has been demonstrated in the MERIT randomised, controlled trial to result in substantial and durable additional weight loss in adults with obesity compared with lifestyle modification (LM) alone. We sought to conduct the first cost-effectiveness analysis of ESG versus LM alone in adults with class II obesity (BMI 35.0-39.9 kg/m2) from a national healthcare system perspective in England based on results from this study. METHODS: A 6-state Markov model was developed comprising 5 BMI-based health states and an absorbing death state. Baseline characteristics, utilities, and transition probabilities were informed by patient-level data from the subset of patients with class II obesity in MERIT. Adverse events (AEs) were based on the MERIT safety population. Mortality was estimated by applying BMI-specific hazard ratios from the published literature to UK general population mortality rates. Utilities for the healthy weight and overweight health states were informed from the literature; disutility associated with increasing BMI in the class I-III obesity health states was estimated using MERIT utility data. Disutility due to AEs and the prevalence of obesity-related comorbidities were based on the literature. Costs included intervention costs, AE costs, and comorbidity costs. RESULTS: ESG resulted in higher overall costs than LM alone but led to an increase in quality-adjusted life years (QALYs). The incremental cost-effectiveness ratio (ICER) for ESG vs LM alone was £2453/QALY gained. ESG was consistently cost effective across a wide range of sensitivity analyses, with no ICER estimate exceeding £10,000/QALY gained. In probabilistic sensitivity analysis, the mean ICER was £2502/QALY gained and ESG remained cost effective in 98.25% of iterations at a willingness-to-pay threshold of £20,000/QALY. CONCLUSION: Our study indicates that ESG is highly cost effective versus LM alone for the treatment of adults with class II obesity in England.

Laparoscopic adjustable gastric banding with liraglutide in adults with obesity and type 2 diabetes (GLIDE): a pilot randomised placebo controlled trial.

INTRODUCTION: Obesity drives type 2 diabetes (T2DM) development. Laparoscopic adjustable gastric banding (LAGB) has lower weight reduction than other bariatric procedures. Liraglutide, a GLP-1 receptor agonist, improves weight and glycaemic control in patients with T2DM. This study aimed to determine the efficacy and safety of liraglutide 1.8 mg in participants undergoing LAGB. METHODS: GLIDE, a pilot randomised, double-blind, placebo-controlled trial, evaluated LAGB with either liraglutide 1.8 mg or placebo in participants with T2DM and obesity. Participants were randomised (1:1) to 6-months therapy post-LAGB, with further 6 months off-treatment follow-up. The primary outcome was change in HbA1c from randomisation to the end of treatment, secondary outcomes included body weight change. A sample size of 58 (29 per group) had 80% power to detect a 0.6% difference in HbA1c between groups. RESULTS: Twenty-seven participants were randomised to liraglutide (n = 13) or placebo (n = 14). Multivariate analysis showed no difference between placebo and liraglutide arms in HbA1c at 6 months (HbA1c:0.2 mmol/mol, -11.3, 11.6, p = 0.98) however, at 12 months HbA1c was significantly higher in the liraglutide arm (HbA1c:10.9 mmol/mol, 1.1, 20.6, p = 0.032). There was no difference between arms in weight at 6 months (BW:2.0 kg, -4.2, 8.1, p = 0.50), however, at 12 months weight was significantly higher in the liraglutide arm (BW:8.2 kg, 1.6, 14.9, p = 0.02). There were no significant differences in adverse events between groups. CONCLUSIONS: Our pilot data suggest no additional improvement in glycaemic control or BW with LAGB and liraglutide therapy. However, this trial was significantly underpowered to detect a significant change in the primary or secondary outcomes. Further trials are needed to investigate whether GLP-1 agonists, and particularly with more effective weekly agents (i.e. semaglutide or tirzepatide), are of benefit following metabolic surgery. CLINICAL TRIAL REGISTRATION: EudraCT number 2015-005402-11.

Efficacy of endoscopic resuturing versus pharmacotherapy to treat weight recidivism after endoscopic sleeve gastroplasty.

BACKGROUND AND AIMS: A subset of patients experience weight recidivism after primary endoscopic sleeve gastroplasty (P-ESG). Available options for management of weight regain include initiation of antiobesity medications (AOMs) or redo ESG (R-ESG). The comparative effectiveness of these options is not clear. METHODS: This was a retrospective analysis of a prospectively maintained database of patients undergoing ESG. From 2013 to 2021, 79 patients who were started on AOM or underwent R-ESG for management of weight recidivism after P-ESG were included. The primary outcome of this study was final total body weight loss (TBWL) at the end of follow-up. RESULTS: Fifty-five patients were started on AOM and 24 patients underwent R-ESG. Age, gender distribution, and baseline body mass index did not differ significantly between groups. The proportion of noncompliant patients (defined as patients who missed their first post-ESG follow-up visit) was significantly higher in the AOM group compared with the R-ESG group (67% vs 35%, P = .012). The additional TBWL after R-ESG was significantly (both clinically and statistically) better than after initiation of AOM (9.5% ± 7.2% vs 2.1% ± 8.6%, respectively; P = .001). Final TBWL clearly favored R-ESG over AOM for treatment of weight recidivism (19.9% ± 10.4% vs 13.6% ± 9.2%, P = .028). CONCLUSIONS: R-ESG is an effective treatment to induce weight loss after experiencing weight recidivism. These results highlight an important advantage of ESG as a repeatable minimally invasive procedure.

Comparison of endoscopic sleeve gastroplasty versus surgical sleeve gastrectomy: a Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database analysis.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) is an incisionless, transoral, restrictive bariatric procedure designed to imitate sleeve gastrectomy (SG). Comparative studies and large-scale population-based data are limited. Additionally, no studies have examined the impact of race on outcomes after ESG. This study aims to compare short-term outcomes of ESG with SG and evaluate racial effects on short-term outcomes after ESG. METHODS: We retrospectively analyzed over 600,000 patients in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database from 2016 to 2020. We compared occurrences of adverse events (AEs), readmissions, reoperations, and reinterventions within 30 days after procedures. Multivariate regression evaluated the impact of patient factors, including race, on AEs. RESULTS: A total of 6054 patients underwent ESG and 597,463 underwent SG. AEs were low after both procedures with no significant difference in major AEs (SG vs ESG: 1.1% vs 1.4%; P > .05). However, patients undergoing ESG had more readmissions (3.8% vs 2.6%), reoperations (1.4% vs .8%), and reinterventions (2.8% vs .7%) within 30 days (P < .05). Race was not significantly associated with AEs after ESG, with black race associated with a higher risk of AEs in SG. CONCLUSIONS: ESG demonstrates a comparable major AE rate with SG. Race did not impact short-term AEs after ESG. Further prospective studies long-term studies are needed to compare ESG with SG.

A pilot study of implementation of endoscopic sleeve gastroplasty (ESG) in Norway.

BACKGROUND AND AIM: Bariatric surgery is the most effective treatment for obesity but is invasive and associated with serious complications. Endoscopic sleeve gastroplasty (ESG) is a less invasive weight loss procedure to reduce the stomach volume by full-thickness sutures. ESG has been adopted in many countries, but implementation at Scandinavian centres has not yet been documented. We performed a clinical pilot trial at a Norwegian centre with the primary objective to assess the feasibility of the ESG procedure. PATIENTS AND METHODS: We included the first 10 patients treated with ESG at a Norwegian centre in a single-arm pilot study. The eligibility criteria were either a body mass index (BMI) of 40-49.9 kg/m2, BMI 35-39.9 kg/m2 and at least one obesity-related comorbidity, or BMI 30-34.9 kg/m2 and type 2 diabetes. Patient follow-up resembled the scheme used for bariatric surgery at the center, including dietary plans and outpatient visits. RESULTS: All procedures were technically successful except for one patient who had adhesions between the stomach and anterior abdominal wall, related to a prior hernia repair, resulting in less-than-intended stomach volume reduction. Mean total body weight loss (TBWL) after 26 and 52 weeks was 12.2% (95% CI 8.1-16.2) and 9.1% (95% CI 3.3 - 15.0). One patient experienced a minor suture-induced diaphragmatic injury, which was successfully managed conservatively. CONCLUSIONS: This first Scandinavian clinical trial of ESG, documenting the implementation of the procedure at a Norwegian center, demonstrated acceptable feasibility and safety, with large variations in individual weight loss during the 52-week follow-up period.

Endoscopic Sleeve Gastroplasty Assisted by Postgraduate Medical Trainees: An Early Safety Analysis.

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is an emerging bariatric intervention with comparable safety and efficacy to surgical sleeve gastrectomy (SG). As ESG is utilized more commonly, postgraduate medical training in bariatric endoscopy has expanded to train physicians in this technically complex procedure. Prior studies have analyzed procedural outcomes of bariatric surgery assisted by medical trainees, but no such analysis has been performed with ESG. AIMS: This study aims to evaluate the short-term safety of ESG in cases assisted by postgraduate medical trainees. METHODS: We retrospectively analyzed over 2000 patients in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database from 2016 to 2020. Cases of ESG performed with the assistance of postgraduate medical trainees (residents and/or fellows) were propensity matched (1:1) to cases of ESG performed without trainee involvement. We compared the occurrences of adverse events (AE), readmissions, re-interventions, and re-operations between these matched cohorts of ESG. Secondary outcomes included procedure time, length of stay (LOS), and total body weight loss (TBWL). RESULTS: A total of 1204 cases of ESG assisted by postgraduate medical trainees were compared to 1204 matched cases without trainee involvement. Procedures performed by attending physicians alone had fewer AE (0.7% vs 2.0%, p = 0.014) and rates of re-operations (0.8% vs 2.4%, p = 0.004) compared to procedures assisted by trainees. There were no significant differences in readmissions (4.0% vs 4.4%, p = 0.684) or reinterventions (3.8% vs. 4.6%, p = 0.416) at 30 days. Cases involving trainees had longer duration (71 vs 51 min, p < 0.001) and LOS (1.11 vs. 0.5 days, p < 0.001). TBWL at 30 days was greater in procedures performed with trainees (4.1% vs 3.4%, p = 0.033). CONCLUSION: ESG is a technically complex procedure that can be safely performed with trainee assistance. Academic medical centers may continue supporting the expansion of training in bariatric endoscopy as an advanced endoscopic skill.

Skill-level classification and performance evaluation for endoscopic sleeve gastroplasty.

BACKGROUND: We previously developed grading metrics for quantitative performance measurement for simulated endoscopic sleeve gastroplasty (ESG) to create a scalar reference to classify subjects into experts and novices. In this work, we used synthetic data generation and expanded our skill level analysis using machine learning techniques. METHODS: We used the synthetic data generation algorithm SMOTE to expand and balance our dataset of seven actual simulated ESG procedures using synthetic data. We performed optimization to seek optimum metrics to classify experts and novices by identifying the most critical and distinctive sub-tasks. We used support vector machine (SVM), AdaBoost, K-nearest neighbors (KNN) Kernel Fisher discriminant analysis (KFDA), random forest, and decision tree classifiers to classify surgeons as experts or novices after grading. Furthermore, we used an optimization model to create weights for each task and separate the clusters by maximizing the distance between the expert and novice scores. RESULTS: We split our dataset into a training set of 15 samples and a testing dataset of five samples. We put this dataset through six classifiers, SVM, KFDA, AdaBoost, KNN, random forest, and decision tree, resulting in 0.94, 0.94, 1.00, 1.00, 1.00, and 1.00 accuracy, respectively, for training and 1.00 accuracy for the testing results for SVM and AdaBoost. Our optimization model maximized the distance between the expert and novice groups from 2 to 53.72. CONCLUSION: This paper shows that feature reduction, in combination with classification algorithms such as SVM and KNN, can be used in tandem to classify endoscopists as experts or novices based on their results recorded using our grading metrics. Furthermore, this work introduces a non-linear constraint optimization to separate the two clusters and find the most important tasks using weights.