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.

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.