LAP-BAND® for Lower BMI: 2-Year Results from the Multicenter Pivotal Study

Objective: The goal of this study was to examine the safety and effectiveness of the LAP-BAND (R) System for patients with 30-39.9 BMI and associated comorbidities. Design and Methods: In this prospective, multicenter, interventional cohort study, subjects with a BMI between 30 and 39.9 who had failed prior weight loss attempts were recruited from 7 surgical centers. The primary effectiveness endpoint required that >40% of subjects achieve >= 30% excess weight loss (EWL) at 1 year. Secondary endpoints included assessment of comorbidities and quality-of-life. Results: Of 149 subjects, 90.6% were female, with mean BMI of 35.3kg/m(2). At 1 year, 84.6% of subjects achieved >= 30% EWL (P < 0.0001), with 65.0% mean EWL; 66.4% of subjects were no longer obese (BMI < 30). Baseline comorbidities improved at 1 year for 64.4% with dyslipidemia, 59.6% with hypertension, and 85.7% with diabetes. Quality-of-life (IWQOL-Lite) also improved (P < 0.0001). The Year 1 results were maintained or improved at 2 years. Regression analysis indicates that each additional 10% weight loss at Year 2 was associated with an increase in IWQOL-Lite by 7.1 points and a decrease in triglycerides by 13.7 mg/dL, fasting glucose by 3.5 mg/dL, and systolic blood pressure by 3.3 mmHg. Most adverse events were mild to moderate and resolved without sequelae within 1 month. Five subjects (3.4%) had explantations. Conclusion: LAGB is safe and effective for people with 30-39.9 BMI, with weight loss and comorbidity improvement through at least 2 years.