Abstract
Background
Recurrent weight gain after laparoscopic sleeve gastrectomy (LSG) is common. Revisional endoscopic sleeve gastroplasty (r-ESG) has been shown to be a promising endoscopic bariatric therapy (EBT) to treat weight recurrence after LSG. However, to date, weight loss outcomes beyond 1-year follow-up are unknown. Our study aims as follows: (1) examine 1 year, 18-month, and 24-month weight loss outcomes post-r-ESG and (2) determine if weight loss outcomes post-LSG predict clinical outcomes post-r-ESG.
Methods
This was a retrospective cohort data of patients who completed r-ESG from December 2020 to November 2023. The primary outcome was percentage of total body weight loss (TBWL) at 1-year post-r-ESG. Secondary outcomes included TBWL at 18- and 24-month post-r-ESG. Multivariable logistic regression analysis was used to determine predictors of weight loss ≥ 5% at 12 months.
Results
A total of 55 patients completed r-ESG. TBWL post-r-ESG at 12 months was 8.6% (n = 37), at 18 months was 10.7% (n = 31), and at 24 months was 12.6% (n = 18) (Table 2). There were no statistically significant variables associated with weight loss ≥ 5% at 12 months (Table 3).
Conclusions
Our study demonstrates that r-ESG is an effective and durable EBT for post-LSG weight recurrence. Further research is needed to determine optimal timing of r-ESG for weight recurrence as well as the adjunctive role of anti-obesity medications.
Introduction
Obesity is a chronic disease that affects over a third of the world’s population and is associated with chronic diseases such as metabolic dysfunction-associated steatotic liver disease (MASLD), type 2 diabetes, hypertension, obstructive sleep apnea, and some cancers [1]. Metabolic and bariatric surgery (MBS) remains the most effective treatment for obesity, with laparoscopic sleeve gastrectomy (LSG) being the most performed bariatric procedure worldwide [2]. However, suboptimal weight loss or weight recurrence (WR) can occur after LSG. While there is no formal definition of WR after LSG, which can make estimates on the incidence of WR vary based on the definition used, WR after LSG can lead to the return of weight-related comorbidities [3]. The cause of WR is often multi-factorial and includes sleeve dilation, hormonal changes, and/or lifestyle factors [4-6]. Traditionally, surgical conversion to a Roux-en-Y gastric bypass (RYGB) has been utilized to treat WR after LSG. However, patients may not always pursue surgical conversion to RYGB for a multitude of factors, including cost, perceived risk, or body mass index (BMI) criteria for surgical conversion [2, 7].
Endoscopic bariatric therapies (EBT) have been developed as an adjunctive treatment for persistent obesity and WR. Revisional endoscopic sleeve gastroplasty (r-ESG) is a promising EBT for patients with WR after LSG. r-ESG utilizes endoscopic suturing of the stomach to decrease the size of a previous laparoscopic gastric sleeve. A prior multicenter study that included 82 patients found a 15.7% total body weight loss (TBWL) at 12 months [8]. A smaller study of 34 patients found an 18.3% TBWL at 12 months with no significant adverse events [9]. However, to the best of our knowledge, weight loss outcomes beyond 1-year post r-ESG are unknown and there have been no predictors associated with clinical weight loss outcomes identified in prior studies. To address these gaps, our study aims as follows: (1) examine 12-, 18-, and 24-month weight loss outcomes among patients undergoing r-ESG and (2) determine if weight loss outcomes post-LSG predict clinical outcomes post-r-ESG. We hypothesized that following r-ESG patients would have sustained weight loss up to 24 months and that weight loss outcomes after initial LSG would predict subsequent weight loss in r-ESG.
Methods
Patient Selection and Endoscopy Procedures
A retrospective cohort study was performed after identifying all patients who underwent a r-ESG between December 2020 and November 2023 (n = 55). Patients were identified from a prospectively maintained registry of patients who underwent EBTs at the University of Texas Southwestern (UTSW). The registry was approved by the Institutional Review Board (STU-2020–0869).
Procedurally, all r-ESGs were performed under general anesthesia by a single endoscopist at an academic medical center. Following a diagnostic upper endoscopy, the OverStitch endoscopic suturing system was attached to a 2 T therapeutic scope (Olympus, Center Valley, Pennsylvania, USA). 2–0 non-absorbable polypropylene suture was placed in an “I” pattern from the greater to lesser curve of the stomach. Patients were discharged the same day on a liquid diet with instructions to advance their diet in a structured manner.
Covariates
Baseline characteristics of the patient cohort were collected, including age, gender, race, ethnicity, year of r-ESG, and number of sutures used. We collected both pre-procedure weight (in pounds) and post-procedure weights at 1, 3, 6, 12, 18, and 24 months, when available. Pre-procedure weight was defined as the closest weight immediately prior to r-ESG. In addition, we collected the number of years from initial LSG, post-LSG weight nadir (reported as percentage of weight loss after LSG), weight recurrence after LSG (reported as the percentage of weight regained after nadir), glucagon-like peptide 1 agonist (GLP1) use (both pre- and post-procedure use), and weight change after r-ESG, reported as the percent of total body weight loss (TBWL).
Statistical Analyses
Categorical variables are presented as frequency and percentages. Continuous data variables are presented as a mean value with standard deviations. Univariable and multivariable analyses are performed to identify covariates associated with TBWL ≥ 5% at 12 months post r-ESG. Statistical analyses were conducted using SAS Version 9.4 (Cary, NC, USA) and all statistical tests were 2-tailed with a significance level of p = 0.05.
Results
Baseline Characteristics
Baseline characteristics are listed in Table 1. A total of 55 patients underwent r-ESG from 2020 to 2023. The majority were female with a mean age of 50.7 ± 8.7. 40% (n = 22) identified as non-Hispanic Black. All patients had a LSG greater than 5 years prior to r-ESG (mean 8.3 ± 2.9). The average body mass index at the time of r-ESG was 36 ± 9.26 kg/m2. The average post-LSG nadir was 28 ± 17% and average weight recurrence was 30.6 ± 44.4%. 65% of patients were on a glucagon-like peptide-1 receptor agonists (GLP-1RA) at the time of r-ESG.
Table 1.
Pre r-ESG patient characteristics and outcomes post r-ESG
| N = 55 | |
|---|---|
| Age, years (SD) | 50.7 ± 8.7 |
| Female gender, n (%) | 46 (84%) |
| Race/ethnicity | |
| Non-Hispanic White, n (%) | 22 (40%) |
| Non-Hispanic Black, n (%) | 22 (40%) |
| Hispanic, n (%) | 7 (13%) |
| Other, n (%) | 4 (7%) |
| Years from LSG- mean (SD) | 8.3 ± 2.9 |
| Weight recurrence (%, SD) | 30.6 ± 44.4 |
| Post-operative nadir (%, SD) | 28 ± 17 |
| GLP-1RA use (%) | 65 |
| BMI, pre LSG kg/m2 (SD) | 46.6 ± 8.0 |
| BMI, post LSG kg/m2 (SD) | 32.9 ± 7.8 |
| BMI, prior r-ESG kg/m2 (SD) | 36.9 ± 9.3 |
Clinical Outcomes: Total Body Weight Loss Post r-ESG
Among the 55 patients who underwent r-ESG, 37 had at least 12 months of follow-up (Fig. 1). TBWL post r-ESG at 12 months was 8.6 ± 10.3%, 10.7 ± 32.8% at 18 months (n = 31), and 12.6 ± 11.0% at 24 months (n = 18) (Table 2). Sixty percent (n = 22) achieved ≥ 5% TBWL at 12 months (Table 2).
Fig. 1.
Total body weight loss (%) at 12 months
Table 2.
Weight loss post r-ESG
| Total body weight loss, 12 months (%, SD), n = 37 | 8.6 ± 10.3 |
| Total body weight loss, 18 months (%, SD), n = 31 | 10.7 ± 32.8 |
| Total body weight loss, 24 months (%, SD), n = 18 | 12.6 ± 11.0 |
Univariable and multivariable regression was performed to identify covariates associated with TBWL ≥ 5% at 12 months post r-ESG. None of our covariates of interest (Table 3) achieved statistical significance. However, post-LSG weight nadir and weight recurrence after LSG trended toward statistical significance.
Table 3.
Multivariable analysis for predicting weight loss ≥ 5% at 12 months
| Odds ratio (95% CI) | |
|---|---|
| Age at time of r-ESG* | 0.97 (0.87–1.09) |
| Race | |
| Non-Hispanic White | Ref |
| Non-Hispanic Black* | 0.75 (0.09–6.16) |
| Hispanic* | 0.40 (0.02–9.18) |
| Other* | 0 (0.01–999) |
| Gender | |
| Female | Ref |
| Male | 0.79 (0.05–13.00) |
| Years from LSG* | 1.39 (0.92–2.09) |
| Percentage of weight regained* | 1.01 (0.98–1.03) |
| Percentage of initial weight loss (nadir)* | 1.00 (0.95–1.05) |
| GLP-1 use | |
| No GLP-1 | Ref |
| GLP-1 | 2.40 (0.23–25.60) |
Continuous variables
Discussion
Our study included 55 patients who underwent r-ESG since December 2020. We found that the mean TBWL at 12 months was 8.6% and that TBWL continued to decline at both 18- and 24-month post r-ESG.
To our knowledge, this is the first series assessing weight loss outcomes at greater than 1 year post r-ESG. The largest study to date includes a multicenter study published in 2021 that included 82 patients in the cohort [8]. While this study focused on 1 year weight loss outcomes, they found a 15.7% TBWL at the end of their study period. While our study did not achieve similar TBWL results, our results do show that patients can consistently lose weight after r-ESG beyond the 1-year mark.
There were no socioeconomic or clinical variables that were associated with ≥ 5% TBWL in multivariable analysis. However, post-LSG nadir % (OR 0.99, 95% CI 0.95–1.05) and weight recurrence after LSG (OR 1.01, 95% CI 0.98–1.03) trended toward statistical significance. We hypothesize that post-LSG nadir (%) as well as % of weight recurrence may be statistically significant predictors of post-r-ESG weight loss with larger sample sizes. Future studies should focus on whether these variables are clinically significant and impactful.
There has also been increased attention regarding the use of GLP-1RA (semaglutide, liraglutide, tirzepatide) for the treatment of obesity. These medications have shown substantial weight reduction in patients and have gained widespread appeal due to their effectiveness and cardiometabolic benefits beyond weight reduction [10]. However, a recent study comparing cost-effectiveness and weight loss between primary endoscopic sleeve gastroplasty (ESG) and semaglutide found ESG resulted in greater weight loss and reduced costs of > $30,000 compared to semaglutide over 5 years [11]. Although this study looked at primary ESG for weight loss rather than r-ESG, it emphasizes the benefit of endoscopic therapy and the continued need for multimodal solutions following weight regain post-LSG.
Our study had a few limitations. Firstly, our study was a single center study with a small cohort size of 55 patients. This may have limited the statistical significance of our multivariable regression model. Secondly, most (65%) of our patients were on stable doses of GLP-1RAs at time of r-ESG. Given the difficulty in controlling for the change in dose of GLP-1RAs over the study period, this is one potential area that could introduce bias. However, we accounted for GLP-1RA use in our multivariable model and we believe that future studies should prospectively enroll and control for GLP-1RA use throughout the study period.
In conclusion, r-ESG is an effective and durable treatment for weight regain following LSG. Further studies comparing the use of anti-obesity medications and endoscopic therapies are needed to delineate the adjunctive use of anti-obesity medications in the chronic treatment of obesity.
Key Points.
There is no data regarding the efficacy of r-ESG past 1 year.
Our study illustrates that r-ESG is an effective EBT with sustained weight loss up to 2 years.
There were no statistically significant covariates associated with weight loss ≥ 5% at 12 months.
Funding
Anna Tavakkoli is supported by NIH 1K23DK132409-01A1. Shannon Shiffer’s department of Clinical Informatics is supported by NIH UL1TR003163
Footnotes
Competing Interests Jaime P. Almandoz, MD, MBA has received advisory/consulting fees and/or other support from Novo Nordisk A/S, Boehringer Ingelheim, Nestlé, Wave Life Sciences, and Eli Lilly and Company.
Data Availability
No datasets were generated or analysed during the current study.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
No datasets were generated or analysed during the current study.