Health Outcomes and Explant Rates After Laparoscopic Adjustable Gastric Banding: A Phase 4, Multicenter Study over 5 Years.

Dixon, John B; Eaton, Laura L; Curry, Trace; Lee, Phong Ching

OBJECTIVE This study aimed to evaluate the real-world safety and effectiveness of the LAP-BAND (Apollo Endosurgery Inc., Austin, Texas) adjustable gastric banding system (LBS) for 5 years following implantation. METHODS This prospective, longitudinal, phase 4, multicenter study involved 652 patients who had implantation of the LBS system. The primary outcome was the percentage of subjects who had LBS explant over 5 years. The secondary outcomes included the rate of reoperations, clinical and biochemical measures, and patient-reported outcome measures over 5 years. RESULTS The study cohort consisted of 79.3% females with a mean age of 44 years and a mean BMI of 45.4 kg/m2 . The primary end point was met with an explant rate of 8.74% (95% CI: 6.6%-10.9%) at 5 years. The rates for completer-only analysis and imputed missing data analysis were 12.81% (95% CI: 9.7%-15.9%) and 12.85% (95% CI: 10.2%-15.5%), respectively. All were significantly lower than the historic rate of 39.4% (P < 0.001). There were 43 patients who required reoperations or revisions excluding explants (6.6%). A mean weight loss of 18.7% was maximally achieved by 2 years, and weight loss was maintained through to 5 years. All patient-reported outcomes showed improvement following LBS treatment throughout 5 years. CONCLUSIONS This study validates the long-term safety and effectiveness of LBS for the treatment of patients with obesity and its related conditions.