Clinical safety and effectiveness of a swallowable gas-filled intragastric balloon system for weight loss: consecutively treated patients in the initial year of U.S. commercialization.

BACKGROUND: Obesity is the most common chronic disease in the United States today. Additional therapies are needed to improve obesity treatment. OBJECTIVE: A swallowable, gas-filled intragastric balloon system was approved for the treatment of obesity by Food and Drug Administration in September 2016 and commercialization started January 2017. A registry was made available to physicians to capture evidence of safety and effectiveness with use. SETTING: United States private clinics, surgery centers, and hospitals. METHODS: This study is a retrospective analysis of a prospective registry of patients with body mass index (BMI) ≥25 kg/m2 that initiated therapy in the first year. Data on demographics, procedural timing, weight loss, adverse events, and device deficiencies were captured. RESULTS: The final analysis comprised 1343 patients across 108 treating physicians (mean age 45.7 ± 10.8 yr, 78.6% female, baseline BMI of 35.4 ± 5.4 kg/m2). Nonserious and serious adverse events were reported in 14.2% and .15% of patients, respectively. There were 7 balloon deflations, none caused obstruction. Weight loss in the indicated use (BMI 30-40 kg/m2) was 9.7 ± 6.1 kg and 10.0 ± 6.1% total body weight loss (TBWL). Weight loss in other BMI categories was 8.2 ± 5.6 kg or 10.3 ± 7.0% total body weight loss for BMI 25 to 29.9 kg/m2 and 11.6 ± 7.8 kg or percent total body weight loss 9.3 ± 6.0 for BMI >40 kg/m2. CONCLUSIONS: This swallowable gas-filled intragastric balloon system is safe and effective at inducing weight loss and offers physicians another tool for patients whose obesity has been resistant to noninvasive treatments.

Electromyographic evaluation of the midvastus approach.

Compared with the standard median parapatellar approach, the muscle-splitting midvastus approach to the knee has led to claims of an easier and earlier recovery after total knee arthroplasty, but some investigators have questioned whether the midvastus approach damages the vastus medialis obliquus. We used electromyographic and nerve conduction studies to evaluate whether we could document any such damage. Twenty patients undergoing bilateral total knee arthroplasty were randomized prospectively for the treatment of 1 knee with each of the 2 approaches. Radiographs, electromyographies, nerve conduction studies, range-of-motion tests, and Knee Society function and pain tests were conducted preoperatively and at 6 weeks postoperatively. If the electromyography or nerve conduction tests were abnormal at 6 weeks, the tests were repeated at 12 weeks. At the final follow-up, these studies showed no evidence of muscle denervation. The midvastus approach appears to be a safe alternative for knee arthrotomy for total knee arthroplasty without concerns for damage to the vastus medialis obliquus.