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.

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.

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.

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.

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.

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.

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.

Deep sedation versus orotracheal intubation for endoscopic sleeve gastroplasty (ESG): preliminary experience.

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is an emerging bariatric procedure currently performed under general anaesthesia with orotracheal intubation (OTI). Several studies have shown the feasibility of advanced endoscopic procedures under deep sedation (DS) without impacting patient outcomes or adverse event rates. Our goal was to perform an initial comparative analysis of ESG in DS with ESG under OTI. METHODS: A prospective institutional registry was reviewed for ESG patients between 12/2016 and 1/2021. Patients were stratified into OTI or DS cohorts, and the 1st 50 cases performed in each cohort were included for comparability. Univariate analysis was performed on demographics, intraoperative, and postoperative outcomes (up to 90 days). Multivariate analyses evaluated the relationship between anesthesia type, preclinical and clinical variables. RESULTS: Of the 50 DS patients, 21(42%) underwent primary and 29 (58%) revisional surgery. There was no significant differences in Mallampati score across groups. No DS patient required intubation. DS patients were younger (p = 0.006) and lower BMI (p = 0.002) than OTI. As expected, DS patients overall and in the primary subgroup had shorter operative time (p ≤ 0.001 and p = 0.003, respectively) and higher rates (84% DS vs. 20% OTI, p ≤ 0.001) of ambulatory procedures. There were no significant differences in the sutures used between groups (p = 0.616). DS patients required less postoperative opioids (p ≤ 0.001) and antiemetics (p = 0.006) than OTI. There were no significant differences in 3-month postoperative weight loss across cohorts. There was no rehospitalization in either group. In primary ESG cases, we found DS patients were more likely younger (p = 0.006), female (p = 0.001), and had a lower BMI (p = 0.0027). CONCLUSIONS: ESG under DS is safe and feasible in select patients. We found DS safely increased rates of outpatient care, reduced use of opioids and antiemetics, and provided the same results of postoperative weight loss. Patient selection for DS may be more clearer for durable weight loss.

Comparable Short-Term Weight Loss and Safety of Endoscopic Sleeve Gastroplasty in Diabetic and Non-diabetic Patients.

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is a highly effective endo bariatric procedure. Data on outcomes of ESG in patients with diabetes mellitus (DM) compared to non-diabetics are limited. AIMS: We aim to assess differences in clinical outcomes of ESG in DM patients in North America. METHODS: We used the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program database from 2016 to 2021 to identify all DM patients who underwent ESG as the primary procedure for weight loss. A 1:1 propensity score matched cohort of non-DM patients served as controls. Patient characteristics, clinical outcomes, and complications were compared and analyzed. Adult patients with Class I obesity and above were included. RESULTS: After matching, 310 DM and non-DM patients that underwent ESG were compared. The median % BMI decrease (3.3% vs. 3.1%, P = 0.62) and median total body weight loss (%TBWL) (4.3% vs. 4%, P = 0.75) in 30 days were similar in the DM compared to non-DM cohorts. A similar proportion of patients with major adverse events (AEs) were present after ESG in the DM (1.6% vs. 1.3%, P = 0.74) compared to the non-DM cohort. The DM cohort had more patients with 30-day readmissions (3.2% vs. 1.9%, P = 0.08) than the non-DM cohort. %TBWL was similar in patients with HbA1c < 9% compared to ≥ 9%, (4.3% each, P = 0.33) with comparable AEs. CONCLUSION: ESG is a safe procedure in DM patients, without an increase in AEs, and it shows similar short-term weight loss compared to non-DM patients.

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.

Revisional surgery after restrictive surgery: midterm outcomes of a tertiary center.

INTRODUCTION: Revisional bariatric surgery (RBS) is a challenging type of procedure for the surgeons due to its specific morbidity and efficiency. The RBS has a higher prevalence nowadays and this study may help to improve scarce data upon this specific topic. METHODS: Data from 252 patients undergoing RBS after laparoscopic adjustable gastric banding (LAGB) or laparoscopic sleeve gastrectomy (LSG) between 2005 and 2019, were analyzed at 2 years of follow up. A subgroup analysis of third procedure was also performed. RESULTS: Overall morbidity occurred in 35 patients (37%) in the LSG group and 40 patients (25%) in the LAGB group (p = 0.045). At 2 years of RBS, mean weight was 92.8 ± 26.7 kg, BMI was 33.1 ± 8.56 kg/m2 for patients who had RBS after LSG. When RBS was performed after LAGB, mean weight at 2 years was 90.1 ± 20.7 kg and BMI was 32.5 ± 6.45 kg/m2. TWL for RBS performed after LSG was 12.7 ± 16.4% versus 25.5 ± 10.3% after LAGB (p < 0.001). CONCLUSION: RBS after LSG seems to lead to higher overall morbidity whereas RBS after LAGB lead to more perioperative issues.

Endoscopic sleeve gastroplasty: early results of a minimally invasive procedure in patients with obesity.

OBJECTIVES: We aimed to analyze the efficacy and safety of endoscopic sleeve gastroplasty at 3 months as well as to determine factors influencing post-procedural weight loss. METHODS: Seventy-three patients with obesity classes I, II and III (BMI 31.1-46.6 kg/m2) underwent ESG between September 2021 and April 2022 at a tertiary care hospital using Overstitch (Apollo Endosurgery, Austin, TX). ESG's efficacy and safety was evaluated at 1 and 3 months post-procedure with regard to excess weight loss (EWL) and total weight loss (TWL). Categorical variables were expressed as percentages and compared with chi-square test while continuous variables were expressed as mean ± standard deviation and compared with paired t test and analysis of variance (ANOVA) as applicable. Pearson's correlation was used to determine association between factors at baseline and weight loss. RESULTS: Mean age was 49.2 ± 9.7 years with 61 (83.6%) patients being female. Mean initial weight was 105.7 ± 15.7 kg, and mean BMI was 38.6 ± 3.5 kg/m2. Median hospitalization was 2.0 ± 1.8 days with 62 (84.9%) patients discharged after 24 h. One patient had accidental suturing of the stomach to the abdominal wall and diaphragm which was managed laparoscopically. Mean %EWL was 25.4 ± 7.1 and 36.3 ± 11.4, and %TBWL was 11.2 ± 2.6 and 15.8 ± 4.2 at 1 and 3 months, respectively. Significant excess weight loss at 3 months was only observed in patients with BMI < 40 kg/m2 (p = 0.001). CONCLUSIONS: ESG is safe and effective to manage obesity. Significant weight loss at 3 months was only observed in patients with obesity class I and class II.

Early postoperative weight loss predicts nadir weight and weight regain after laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass.

BACKGROUND: Weight regain (WR) post bariatric surgery affects almost 20% of patients. It has been theorized that a complex interplay between physiologic adaptations and epigenetic mechanisms promotes WR in obesity, however, reliable predictors have not been identified. Our study examines the relationship between early postoperative weight loss (WL), nadir weight (NW), and WR following laparoscopic Roux-en-Y gastric bypass (LRYGB) and sleeve gastrectomy (LSG). METHODS: A retrospective review of prospectively collected data was conducted for LRYGB or LSG patients from 2012 to 2016. Demographics, preoperative BMI, procedure type, and postoperative weight at 6, 12, 24, 36, and 48 months were recorded. WR was defined as > 20% increase from NW. Univariate and multivariate linear and logistic regression models were used to determine the association between early postoperative WL with NW and WR at 4 years. RESULTS: Thousand twenty-six adults were included (76.8% female, mean age 44.9 ± 11.9 years, preoperative BMI 46.1 ± 8); 74.6% had LRYGB and 25.3% had LSG. Multivariable linear regression models showed that greater WL was associated with lower NW at 6 months (Coef - 2.16; 95% CI - 2.51, - 1.81), 1 year (Coef - 2.33; 95% CI - 2.58, - 2.08), 2 years (Coef - 2.04; 95% CI - 2.25, - 1.83), 3 years (Coef - 1.95; 95% CI - 2.14, - 1.76), and 4 years (Coef - 1.89; 95% CI - 2.10, - 1.68), p ≤ 0.001. WR was independently associated with increased WL between 6 months and 1 year (Coef 1.59; 95% CI 1.05,2.14; p ≤ 0.001) and at 1 year (Coef 1.24; 95% CI 0.84,1.63;p ≤ 0.001) postoperatively. The multivariable logistic regression model showed significantly increased risk of WR at 4 years for patients with greater WL at 6 months (OR 1.20, 95% CI 1.08,1.33; p = 0.001) and 1 year (OR 1.14; 95% CI 1.06,1.23; p ≤ 0.001). CONCLUSION: Our findings demonstrate that higher WL at 6 and 12 months post bariatric surgery may be risk factors for WR at 4 years. Surgeons may need to follow patients with high early weight loss more closely and provide additional treatment options to maximize their long-term success.