Interim results at 48 weeks of LAP-BAND AP experience (APEX) study: Prospective, multicenter, open-label longitudinal patient observational study

摘要

Background: The development of laparoscopic adjustable gastric banding marked a breakthrough in minimally invasive bariatric surgery. The unique features of gastric banding, including device adjustability, lack of malabsorption, and easy reversibility, have contributed to its widespread use. Since Food and Drug Administration approval of the first laparoscopic adjustable gastric band, the device design has undergone engineering improvements. The LAP-BAND AP (LBAP) system received Food and Drug Administration approval in 2006. Little is known about the safety and efficacy of this new system. Our objective was to prospectively assess the efficacy and safety of the LBAP system in real-world clinical settings at 50 clinical centers throughout the United States. Methods: In an open-label 5-year evaluation, 508 severely or morbidly obese patients from 50 centers in the United States underwent surgery using the LBAP system. The present interim report describes the results from 323 patients after 48 weeks of follow-up. Results: By week 48, the patients had experienced a mean percentage of excess weight loss of 46% and a mean ± standard deviation reduction in the body mass index of 8.4 ± 3.69 kg/m2. Sixteen patients (3.1%) experienced a severe device- or procedure-related adverse event. There were no deaths. Conclusion: These 48-week interim data demonstrate that the LBAP system offers a safe and effective therapy to reduce weight in severely obese patients.