ONE YEAR EVALUATION OF EFFECTIVENESS AND DEVICE COMPLICATION OUTCOMES IN THE HELPING EVALUATE REDUCTION IN OBESITY (HERO) STUDY
Author(s)
Cobourn C1, Torre MO2, Degboe AN3, Burk CT4, Robinson JM2, Diegidio RF51Surgical Weight Loss Centre, Mississauga, Ontario, Canada, 2Allergan Medical, Goleta, CA, USA, 3Allergan, Inc., Irvine, CA, USA, 4Allergan, Inc., Laguna Beach, CA, USA, 5Allergan, Inc., Bedminster, NJ, USA
OBJECTIVES: To evaluate real-world effectiveness and device complication outcomes of the LAP-BAND AP® System adjustable gastric band (LAGB) one year after surgical implantation. METHODS: HERO study is a 5-year registry of 1,106 severely or morbidly obese subjects from 29 centers in North America, Europe, and Australia implanted with LAGB. In the current analyses, the mean change in body mass index (BMI) and percentage excess weight loss (%EWL) at 1 year are determined. Rates of device complication events as well surgical revisions and explants at 1 year are also reported. RESULTS: The mean age of subjects was 43.1 years and females constituted 79.3%. The mean(SD) weight and BMI at baseline was 126.2(24.1) kg and 45.1(6.9) kg/m2 respectively. At 1 year, the mean (SD) BMI decreased by 7.7(4.4) kg/m2 and the average(SD) %EWL was 39.8(22.3)%. One (0.1%) death occurred from liver cancer and was deemed not related to the device. Of 47 subjects with 53 device complication events at 1 year, 18 (1.6%) experienced an event at 3-months, 9 (0.8%) at 6-months, and 20 (1.8%) at 1-year. Subjects who reported device complications were port displacement (1.8%), pouch dilatation (0.8%), band erosion (0.5%), device-related infection (0.5%), band slippage (0.4%), port leak (0.1%), and both band slippage and pouch dilatation (0.3%). Eighteen (1.6%) subjects had explants and 3 (0.3%) had the LAGB surgically revised and replaced. The indications for explants included band erosion, band slippage, band intolerance, esophageal dilatation, pouch dilatation, device-related infection, abdominal pain, dysphagia, and small bowel obstruction. Minor device related revisions included access port revision 23(2.1%) and reposition of LAGB 4(0.4%). CONCLUSIONS: LAGB was associated with significant weight loss, with less than 2% of subjects undergoing explantation of the device within year 1 of this 5-year on-going study. Many reported device complications were considered to be non-serious and could be corrected in an outpatient setting.
Conference/Value in Health Info
2012-11, ISPOR Europe 2012, Berlin, Germany
Value in Health, Vol. 15, No. 7 (November 2012)
Code
PMD8
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Diabetes/Endocrine/Metabolic Disorders