Margo K. Dunlap

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 ± 11.2 years and mean body mass index 41.8 ± 8.5 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.

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 Clinics 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 (&bgr; = 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.