Safety and effectiveness of LAP-BAND AP System: results of Helping Evaluate Reduction in Obesity (HERO) prospective registry study at 1 year.

BACKGROUND

Laparoscopic adjustable gastric banding has several distinctive features, including band adjustability, easy reversibility, and lack of malabsorption, which contribute to its widespread use. The LAP-BAND AP System (LBAP; Allergan, Inc.), a redesigned and improved version of the original device, was approved by the US Food and Drug Administration in 2006. Because of limited information on LBAP, this study prospectively assesses the efficacy and safety of LBAP in real-world settings at clinical centers located in North America, Europe, and Australia.

STUDY DESIGN

This interim report of the ongoing 5-year prospective, observational, international, multicenter registry, Helping Evaluate Reduction in Obesity (HERO) Study (NCT00953173), describes clinical efficacy and safety of LBAP in real-world settings at 1 year.

RESULTS

One thousand one hundred and six patients were implanted with LBAP and 1-year data were available from 834 patients for efficacy analysis. At 1 year, the mean (SD) percentage of excess weight loss was 39.8% (22.3%), of weight loss was 16.9% (9.0%), and the mean (SD) body mass index decreased to 37.7 (7.0) kg/m(2) from 45.1 (6.9) kg/m(2) at baseline. Patients with type 2 diabetes mellitus or hypertension showed significant improvements at 1 year post LBAP (both p < 0.005). The most common device-related complications were port displacement (n = 20 [1.8%]), pouch dilation (n = 12 [1.1%]), band slippage (n = 7 [0.6%]), and band erosion (n = 5 [0.5%]). Eighteen (1.6%) patients had the device explanted.

CONCLUSIONS

At 1 year post LBAP, progressive weight loss was associated with improvement and/or resolution of comorbid conditions and was safe and well tolerated. Patient follow-up continues.