Vargas EJ, et al. - This study was performed to examine the effectiveness and safety of Orbera Intragastric Balloon (OIB) approach for the induction of weight loss and treatment of obesity. OIB was found to be safe, effective at inducing weight loss and to reduce obesity-related co-morbidities in a real-world clinical population. Between clinical trials and the real-world population, rates of early removal (before 8 weeks) did not differ significantly, however, were affected by the use of medications.

Methods

• A post-regulatory approval study was conducted of the safety and efficacy of the OIB, and factors correlated with intolerance and response.
• Data was collected from the Mayo Clinic’s database of patient demographics, outcomes of OIB placement (weight loss, weight-related co-morbidities), 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).
• A total of 321 patients (mean age, 48.1 ± 11.9 years; 80% female; baseline body mass index, 37.6 ± 6.9) were selected for final analysis.
• The researchers performed exploratory multivariable linear and logistic regression analyses to identify predictors of success and early balloon removal.
• Percent total body weight lost (%TBWL) at 3, 6, and 9 months were the primary effectiveness outcomes.
• Rates of early balloon removal, peri-procedural complications, dehydration episodes requiring intravenous infusion, balloon migration, balloon deflation or hyper-inflation, pancreatitis, or other complications were included as primary and secondary safety outcomes.

Results

• At the time of endoscopy, 3 patients presented with contraindications for placement.
• At a median of 8 weeks after placement (range, 1-6 months), the balloon was safely removed in all instances with an early removal rate in 16.7% of patients.
• During the time of balloon placement, the use of selective serotonin or serotonin-norepinephrine re-uptake inhibitors was associated with increased odds of remove before 8 weeks (odds ratio, 3.92; 95% CI, 1.24–12.41).
• As per the outcomes, TBWL 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).
• Total body-weight losses of 5%, 10%, and 15% were achieved by 88%, 62%, 31% of patients, respectively, at 6 months.
• An association was observed between the number of follow-up visits and weight loss at 3 months with increased weight loss at 6 months (β= 0.5 and 1.2, respectively) (P < .05).
• A marked improvement was noted in the mean levels of cholesterol, triglycerides, low-density lipoprotein, and HbA1c, along with systolic and diastolic blood pressure, at 6 months after OIB placement (P < .05).