Transoral outlet reduction: could additional sutures cause more harm?

BACKGROUND: The double purse-string pattern (DPSP) of transoral outlet reduction (TORe) should conceivably result in a more robust scaffolding for the gastrojejunal anastomosis (GJA). However, there is a paucity of literature pertaining to post-TORe stenosis as an adverse event. Our aim was to determine the rate of stenosis, its potential predictors, and other complications of DPSP TORe. METHODS: We performed a retrospective analysis of a prospectively maintained database of 129 consecutive patients who underwent DPSP TORe between December 2015 and August 2019. RESULTS: The adverse event rate of TORe was 17.1 % (n = 22), with a 13.3 % (n = 17) rate of stenosis. Stenosis was not significantly associated with any baseline characteristics. GJA diameter pre- and post-TORe, the difference between these values, and procedure duration were not predictive of stenosis. Of patients who developed stenosis, 10 (58.8 %) responded to endoscopic balloon dilation and 7 (41.2 %) required stent placement. CONCLUSION: As the DPSP technique is a challenging procedure, with high complication rate and limited benefit, it should not be used for TORe.

Building an endobariatric program: lessons learned.

The emphasis on treating obesity has never been more critical, yet the complexity of delivering care has become more intricate due to new procedures, variable insurance coverage, and inconsistent reimbursement. This is our experience building an endobariatric program and treating overweight and obese patients with endobariatric therapies (EBTs) over 3 years. The primary intention of this manuscript was to educate the reader on how to build an endobariatric program, identify barriers, and provide succinct solutions to establish a successful program. The secondary aim was weight loss outcomes of procedures offered at our institution. We compiled a list of lessons learned, based on the difficulties we experienced to make it easy for others embarking on this journey. Herein, we present a business development strategy to overcome impediments, whilst offering high quality service. The high cost and lack of insurance coverage are significant barriers. Marketing can be costly and is often a factor that is ignored particularly early on, when finances are limited. However, it is an integral component of growing the program. The percentage total body weight loss (%TBWL) at 6 and 12 months post ESG was 17.8 ±â€Š6.48 and 20.6 ±â€Š8.3 ( P  < 0.001), respectively. The %TBWL at 6 months post IGB was 14.9 ±â€Š9.8 for the Orbera IGB and 12.6 ±â€Š7.4 for the Reshape IGB. There was a trend of preference for ESG compared to IGB placement over the 3 years. The key to building a successful endobariatric program is a motivated physician leader, collaborative bariatric surgeons, institutional support, and marketing. Insurance coverage will likely occur in the near future and programs must be prepared to manage the massive influx of patients that will likely request these procedures.

Correction to: Anatomical Configuration of the Stomach Post-Endoscopic Sleeve Gastroplasty (ESG)-What Are the Sutures Doing?

The name of author Vivek Kumbhari was misspelled in the original article.

Cryoballoon ablation for gastric pouch and/or outlet reduction in patients with weight regain post Roux-en-Y gastric bypass.

BACKGROUND: Cryoballoon ablation could induce stricture formation to achieve outlet and pouch reduction in patients regaining weight after Roux-en-Y gastric bypass (RYGB). This pilot study aimed to assess technical feasibility and short-term efficacy. METHODS: A retrospective chart review (January - November 2018) at two academic centers identified patients with weight regain post-RYGB, treated with cryoablation if pouch > 4 cm and/or outlet > 15 mm. Patients were scheduled for surveillance endoscopies at 8 weeks. RESULTS: 22 patients presented 10.5 years (SD 4.42) post-RYGB with weight regain of 30.9 kg (SD 13.7). Technical success was 89.5 % for outlet ablation and 93.0 % for pouch ablation. From baseline to 8 weeks, the outlet was reduced from 24.1 mm (95 % confidence interval [CI] 19.8 to 28.5) to 17.1 mm (95 %CI 13.1 to 21.1; P < 0.001), and pouch from 5 cm (95 %CI 4.1 to 5.9) to 3.9 cm (95 %CI 2.6 to 5.1; P < 0.05). Total body weight loss at 8 weeks was 8.1 % (SD 12.8 %). CONCLUSION: Cryoablation appears technically feasible and effective for outlet and/or pouch reduction in the short term.

Anatomical Configuration of the Stomach Post-Endoscopic Sleeve Gastroplasty (ESG)-What Are the Sutures Doing?

INTRODUCTION AND AIM: Endoscopic sleeve gastroplasty (ESG) is a procedure in which endoscopically placed sutures involute the stomach and promote weight loss. There is limited data on the durability of these sutures. PATIENTS AND METHODS: This was a single center series of 5 patients who underwent ESG performed by a single endoscopist. Patients underwent repeat endoscopy for different clinical indications. RESULTS: ESGs were successfully reversed at 3 weeks and 1 month following index ESG without significant fibrosis or scaring. At 8 and 14 months, a few sutures had dehisced though there were extensive areas of fibrosis. By 2 years, most of the sutures had dehisced; however, the gastric volume remained reduced. CONCLUSION: This case series offers an intriguing evaluation of the anatomical changes induced by ESG.

Endoscopic sleeve gastroplasty versus high-intensity diet and lifestyle therapy: a case-matched study.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) is a safe and effective minimally invasive bariatric procedure. This study compared weight loss in patients undergoing ESG with that of matched patients undergoing high-intensity diet and lifestyle therapy (HIDLT). METHODS: In this case-matched study, patients were matched 2/3:1 (HIDLT/ESG) by age, sex, and body mass index (BMI). One hundred five patients (30 men) who underwent ESG + low-intensity diet and lifestyle therapy (LIDLT) between 2016 and 2018 were compared with 281 patients (92 men) who underwent HIDLT at the Johns Hopkins Medical Institutions from 2013 to 2014. Weight was evaluated 1, 3, 6, and 12 months after beginning HIDLT or post-ESG to determine the mean percent total body weight loss (%TBWL). RESULTS: Mean age across both cohorts was 48.0 ± 12.1, and baseline BMI was 40.0 ± 7.7 kg/m2. In multivariable analysis controlling for age, sex, and baseline BMI, the mean %TBWL at 1, 3, 6, and 12 months was significantly higher in patients undergoing ESG than matched patients undergoing HIDLT. Specifically, at 3 months, the mean %TBWL in the ESG cohort was 14.0% compared with 11.3% in the HIDLT cohort (P <.011), and at 12 months the mean %TBWL in the ESG cohort was 20.6% versus 14.3% in the HIDLT cohort (P < .001). ESG patients with baseline BMI ≤40 kg/m2 continued to show significantly greater %TBWL than those of the same BMI group in the HIDLT group at 1, 3, 6, and 12 months after intervention (3 months, coefficient = 3.43 [P < .001]; 12 months, coefficient = 8.14 [P < .001]). CONCLUSIONS: Through 12 months of follow-up, patients who underwent ESG achieved significantly greater weight loss than patients enrolled in HIDLT. ESG appears to be a valuable alternative for patients who experience difficulty complying with HIDLT.

A Real-World, Insurance-Based Algorithm Using the Two-Fold Running Suture Technique for Transoral Outlet Reduction for Weight Regain and Dumping Syndrome After Roux-En-Y Gastric Bypass.

BACKGROUND AND AIMS: Transoral outlet reduction (TORe) by devitalization and/or endoscopic suturing (ES) has been implemented in the management of weight regain post-RYGB. This study aims to assess the efficacy and safety of TORe following an insurance-based algorithm. METHODS: A prospectively maintained database of patients who underwent TORe between September 2015 and January 2018 at a single academic center was reviewed. An algorithm was followed whereby management was based on insurance coverage. As part of the algorithm, all patients presented for a repeat endoscopy at 8 weeks. Patients did not receive any diet, lifestyle intervention, or pharmacotherapy. RESULTS: In total, 55 patients were included (median age 48 years), out of which 50 were females (90.9%). Patients presented for evaluation at a mean of 8.7 years post-RYGB. The main presenting symptom was combined dumping syndrome (DS) and weight regain (49.1%), followed by weight regain alone (45.5%). Twenty-nine patients required treatment at their second procedure, and 11 required treatment at their third procedure. Average percent total body weight loss (%TBWL) after TORe observed at 3-, 6-, 9-, and 12-month follow-up was 8.2, 9.3, 8.4, and 5.5%, respectively. The mean DS Severity Score was significantly reduced from 23.3 ± 12.4 before TORe to 16.3 ± 6.51 after TORe (p < 0.01). The adverse event rate from TORe was 14.5%. CONCLUSION: TORe is effective in halting ongoing weight regain and achieving moderate short-term weight loss as well as improving DS in post-RYGB patients. Durability at 1 year remains questionable due to weight recidivism.

Endoscopic sleeve gastroplasty versus intragastric balloon insertion: efficacy, durability, and safety.

BACKGROUND: Intragastric balloon (IGB) placement and endoscopic sleeve gastroplasty (ESG) are reported to be safe and effective endoscopic bariatric therapies. This study aimed to compare the patient demographics and therapeutic outcomes between the IGB and ESG procedures. METHODS: This was a retrospective review of prospectively collected data from consecutive patients between December 2015 and October 2017 who underwent IGB or ESG at a single academic center. Fluid-filled IGBs implanted for a 6-month duration were used. IGB and ESG patients were subjected to identical post-procedure dietary instructions and follow-up protocols. Body weight was recorded at 1, 3, 6, and 12 months post-procedure. RESULTS: A total of 47 patients underwent IGB insertion and 58 underwent ESG. The IGB cohort had a lower baseline body mass index (BMI) than the ESG (34.5 vs. 41.5 kg/m2; P < 0.001) and a significantly lower proportion of men (2.1 % vs. 41.4 %; P < 0.001). IGB patients showed a mean (standard deviation [SD]) percentage total body weight loss (%TBWL) that was significantly lower than ESG patients at 1 month (6.6 % [2.6 %] vs. 9.9 % [2.4 %]; P < 0.001), 3 months (11.1 % [4.4 %] vs. 14.3 % [4.6 %]; P = 0.004), 6 months (15.0 % [7.6 %] vs. 19.5 % [5.7 %]; P = 0.01), and 12 months (13.9 % [9.0 %] vs. 21.3 % [6.6 %]; P = 0.005). The IGB cohort also experienced significantly more adverse events compared with the ESG (17 % vs. 5.2 %; P = 0.048). CONCLUSIONS: IGB placement and ESG result in clinically meaningful weight loss. However, ESG appears to provide clinically superior and more enduring weight loss with fewer adverse events compared with an IGB.

Endoscopic sleeve gastroplasty versus laparoscopic sleeve gastrectomy: a case-matched study.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) reduces the gastric lumen to a size comparable with that of laparoscopic sleeve gastrectomy (LSG). However, there is a paucity of research comparing outcomes between the 2 procedures. Our study compared the 6-month weight loss outcomes and adverse events of ESG with LSG in a case-matched cohort. METHODS: We retrospectively reviewed prospectively collected data for patients undergoing ESG or LSG at a single academic center. Weight was recorded at 1 and 6 months postprocedure, and percent total body weight loss (%TBWL) was calculated. Adverse events and new-onset Gastroesophageal Reflux Disease (GERD) were also recorded. RESULTS: A total of 54 ESG patients were matched with 83 LSG patients by age, sex, and body mass index. The proportion of patients with GERD at baseline was similar in the 2 groups (16.7% in ESG group vs 25.3% in LSG group, P = .27). At the 6-month follow-up, %TBWL (compared with baseline) was significantly lower in the ESG group compared with the LSG group (17.1% ± 6.5% vs 23.6% ± 7.6%, P < .01). ESG patients had significantly lower rates of adverse events compared with LSG patients (5.2% vs 16.9%, P < .05). New-onset GERD was also significantly lower in the ESG group compared with the LSG group (1.9% vs 14.5%, P < .05). CONCLUSIONS: ESG, a minimally invasive same-day procedure, achieved less weight loss at 6 months than LSG, with the caveat that LSG caused more adverse events and new-onset GERD than ESG.

Endoscopic Sleeve Gastroplasty (ESG) Is a Reproducible and Effective Endoscopic Bariatric Therapy Suitable for Widespread Clinical Adoption: a Large, International Multicenter Study.

OBJECTIVE: Endoscopic sleeve gastroplasty (ESG), an incisionless endoscopic bariatric procedure, has shown impressive results in case series. This study examines the reproducibility, efficacy, and safety in three centers across two countries, and identifies key determinants for procedural success. DESIGN: Patients who underwent ESG between February 2016 and May 2017 at one of three centers (Australia and USA) were retrospectively analyzed. All procedures were performed on an outpatient basis using the Apollo OverStitch device (Apollo Endosurgery, Austin, TX). Primary outcomes included absolute weight loss (ΔWeight, kg), change in body mass index (∆BMI, in kg/m2), total body weight loss (TBWL, %), excess weight loss (EWL, in %), and immediate and delayed adverse events. RESULTS: In total, 112 consecutive patients (male 31%, age 45.1 ± 11.7 years, baseline BMI 37.9 ± 6.7 kg/m2) underwent ESG. At 1, 3, and 6 months, Δweight was 9.0 ± 4.6 kg (TBWL 8.4 ± 4.1%), 12.9 ± 6.4 kg (TBWL 11.9 ± 4.5%), and 16.4 ± 10.7 kg (TBWL 14.9 ± 6.1%), respectively. The proportion of patients who attained greater than 10% TBWL and 25% EWL was 62.2 and 78.0% at 3 months post-ESG and 81.0 and 86.5% at 6 months post-ESG. Weight loss was similar between the three centers. Multivariable analysis showed that male sex, greater baseline body weight, and lack of prior endoscopic bariatric therapy were predictors of greater Δweight at 6 months. Three (2.7%) severe adverse events were observed. CONCLUSIONS: ESG is an effective, reproducible, and safe weight loss therapy that is suitable for widespread clinical adoption.

Real-World Safety and Efficacy of Fluid-Filled Dual Intragastric Balloon for Weight Loss.

BACKGROUND & AIMS: Reshape Duo is a saline-filled dual, integrated intragastric balloon (IGB) approved by the Food and Drug Administration for weight loss in patients with obesity. In a prospective, randomized trial, obese patients who received the balloon had significantly greater percent excess weight loss (%EWL) compared with patients treated with diet and exercise alone. However, there are limited data on the real-world efficacy of the Reshape balloon. METHODS: We performed a retrospective study of data collected from 2 academic centers and 5 private practices in which all patients paid for the IGB and follow-up visits out of pocket. The IGB was removed after 6 months. We collected data (demographic, medical, and laboratory) from 202 adults (mean age 47.8 ± 10.8 years; 83% female) with a baseline mean body mass index of 36.8 + 8.4 kg/m2 who had IGB insertion for weight loss therapy, along with counselling on lifestyle modifications focused on diet and exercise. Primary outcomes were percent total body weight loss (%TBWL) and %EWL at 1, 3, 6, 9, and 12 months after the procedure. RESULTS: Mean %TBWL at 1, 3, 6, 9 and 12 months was 4.8 ± 2.4%, 8.8 ± 4.3%, 11.4 ± 6.7%, 13.3 ± 7.8%, and 14.7 ± 11.8%, respectively. Data were available from 101 patients at 6 months and 12 patients at 12 months; 60.4% of patients achieved more than 10% TBWL and 55.4% had more than 25% EWL. Seventeen patients (8.4%) had esophageal tears during balloon insertion, with no intervention required. Thirteen patients (6.4%) had their IGB removed before the end of the 6-month treatment period. Nausea, vomiting, and abdominal pain were the most common adverse effects, occurring in 149 (73.8%), 99 (49%), and 51 (25.2%) patients. In one patient, the IGB migrated distally leading to small intestinal obstruction requiring surgical removal. CONCLUSION: In a retrospective analysis of real-world patients who received the Reshape Duo IGB, we found it to be a safe and efficacious endoscopic method for producing weight loss, with most patients achieving greater than 10% TBWL at 6 months.

Single Fluid-Filled Intragastric Balloon Safe and Effective for Inducing Weight Loss in a Real-World Population.

BACKGROUND & AIMS: The Orbera intragastric balloon (OIB) is a single fluid-filled intragastric balloon approved for the induction of weight loss and treatment of obesity. However, little is known about the effectiveness and safety of the OIB outside clinical trials, and since approval, the Food and Drug Administration has issued warnings to health care providers about risk of balloon hyperinflation requiring early removal, pancreatitis, and death. We analyzed data on patients who have received the OIB since its approval to determine its safety, effectiveness, and tolerance in real-world clinical settings. METHODS: We performed a postregulatory approval study of the safety and efficacy of the OIB, and factors associated with intolerance and response. We collected data from the Mayo Clinic's database of patient demographics, outcomes of OIB placement (weight loss, weight-related comorbidities), technical aspects of insertion and removal, and adverse events associated with the device and/or procedure, from 8 centers (3 academic, 5 private, 4 surgeons, and 4 gastroenterologists). Our final analysis comprised 321 patients (mean age, 48.1 ± 11.9 y; 80% female; baseline body mass index, 37.6 ± 6.9). Exploratory multivariable linear and logistic regression analyses were performed to identify predictors of success and early balloon removal. Primary effectiveness outcomes were percentage of total body weight lost at 3, 6, and 9 months. Primary and secondary safety outcomes were rates of early balloon removal, periprocedural complications, dehydration episodes requiring intravenous infusion, balloon migration, balloon deflation or hyperinflation, pancreatitis, or other complications. RESULTS: Four patients had contraindications for placement at the time of endoscopy. The balloon was safely removed in all instances with an early removal rate (before 6 months) in 16.7% of patients, at a median of 8 weeks after placement (range, 1-6 mo). Use of selective serotonin or serotonin-norepinephrine re-uptake inhibitors at the time of balloon placement was associated with increased odds of removal before 6 months (odds ratio, 3.92; 95% CI, 1.24-12.41). Total body weight lost at 3 months was 8.5% ± 4.9% (n = 204), at 6 months was 11.8% ± 7.5% (n = 199), and at 9 months was 13.3% ± 10% (n = 47). At 6 months, total body weight losses of 5%, 10%, and 15% were achieved by 88%, 62%, and 31% of patients, respectively. Number of follow-up visits and weight loss at 3 months were associated with increased weight loss at 6 months (ß = 0.5 and 1.2, respectively) (P < .05). Mean levels of cholesterol, triglycerides, low-density lipoprotein, and hemoglobin A1c, as well as systolic and diastolic blood pressure, were significantly improved at 6 months after OIB placement (P < .05). CONCLUSIONS: In an analysis of a database of patients who received endoscopic placement of the OIB, we found it to be safe, effective at inducing weight loss, and to reduce obesity-related comorbidities in a real-world clinical population. Rates of early removal (before 8 weeks) did not differ significantly between clinical trials and the real-world population, but were affected by use of medications.

Endoscopic suturing for the management of recurrent dislodgment of percutaneous endoscopic gastrostomy-jejunostomy tube.

OBJECTIVE: To describe a novel technique for the prevention of recurrent percutaneous endoscopic gastrostomy-jejunostomy (PEG-J) tube dislodgements and assess its feasibility and efficacy. This technique utilizes endoscopic suturing to secure the PEG-J tube to the gastric wall. METHODS: This was a retrospective analysis of consecutive cases of recurrent PEG-J tube dislodgements referred to a single endoscopist between June 2016 and June 2017, using an endoscopic suturing system to secure the PEG-J tube directly to the gastric wall. Technical success rates, the procedure time and related adverse events were analyzed. RESULTS: There were five patients in total (three females). The procedure was technically successful in all patients. There were no procedure-related adverse events. The mean duration of follow-up was 7.8 ± 5.1 months. Two patients had accidental dislodgement at 8.5 and 12 months, respectively. There were no other unintended dislodgements. CONCLUSION: Endoscopic suturing with internal fixation of PEG-J tube is a safe and feasible approach to manage recurrent unintended dislodgements.

Endoscopic sleeve gastroplasty: the learning curve.

BACKGROUND AND STUDY AIMS: Endoscopic sleeve gastroplasty (ESG) is gaining traction as a minimally invasive bariatric treatment. Concern that the learning curve may be slow, even among those proficient in endoscopic suturing, is a barrier to widespread implementation of the procedure. Therefore, we aimed to define the learning curve for ESG in a single endoscopist experienced in endoscopic suturing who participated in a 1-day ESG training program. PATIENTS AND METHODS: Consecutive patients who underwent ESG between February 2016 and November 2016 were included. The performing endoscopist, who is proficient in endoscopic suturing for non-ESG procedures, participated in a 1-day ESG training session before offering ESG to patients. The outcome measurements were length of procedure (LOP) and number of plications per procedure. Nonlinear regression was used to determine the learning plateau and calculate the learning rate. RESULTS: Twenty-one consecutive patients (8 males), with mean age 47.7 ±â€Š11.2 years and mean body mass index 41.8 ±â€Š8.5 kg/m 2 underwent ESG. LOP decreased significantly across consecutive procedures, with a learning plateau at 101.5 minutes and a learning rate of 7 cases ( P  = 0.04). The number of plications per procedure also decreased significantly across consecutive procedures, with a plateau at 8 sutures and a learning rate of 9 cases ( P  < 0.001). Further, the average time per plication decreased significantly with consecutive procedures, reaching a plateau at 9 procedures ( P  < 0.001). CONCLUSIONS: Endoscopists experienced in endoscopic suturing are expected to achieve a reduction in LOP and number of plications per procedure in successive cases, with progress plateauing at 7 and 9 cases, respectively.