Louis F Martin1, Gerard J Smits, Robert J Greenstein. 1. Weight Management Center, Louisiana State University Health Sciences Center, 533 Bolivar St, Rm 508, New Orleans, LA 70112, USA. lmarti1@lsuhsc.edu
Abstract
BACKGROUND: Morbid obesity results in multiple comorbidities and an increased mortality rate. The National Institutes of Health has stated that surgery is the most effective long-term therapy; therefore, we evaluated a laparoscopically implantable adjustable gastric band. METHODS: We reviewed 2 multicenter prospective, open-label, single-arm surgical trials--trial A (3 years) and trial B (1 year)--with ongoing safety follow-up. These trials were conducted in United States community and university hospitals (trial A = 8 sites and trial B = 12 sites). Trial A comprised 292 subjects (mean +/- SD preoperative weight: 133 kg +/- 24.4), and trial B comprised 193 subjects (129 kg +/- 20.8). Intervention included placement of a constrictive, adjustable band around the upper stomach to limit food intake and induce weight loss. Main outcome measures were the primary efficacy end point of weight loss. Secondary end-points were change in quality-of-life, safety parameters, and complications, including band slippage, reoperation, and device explantation. RESULTS: In the 2 trials, 485 devices were implanted (92% laparoscopically), and no deaths occurred. Of the patients in trial A, 206 (70.5%) completed the 3-year follow-up, and 142 (73.6%) of patients in trial B completed the 1-year follow-up. Weight-loss results, using the last value carried forward, for all 292 patients in trial A and all 193 patients in trial B demonstrated a change in mean body mass index (kg/m2) +/- SD from 47.4 +/- 7.0 to 39.0 +/- 7.3 in trial A and from 46.7 +/- 7.8 to 38.4 +/- 7.6 in trial B subjects at 1 year (P < .001 for both trials A and B), with minimal further change at 3 years (39.0 +/- 8.5) in trial A subjects. The percentage of initial body weight lost at 1 year was 17.7% +/- 9.4% for trial A subjects and 18.2% +/- 8.9% for trial B subjects, whereas the 3-year total for trial A subjects was 18.3% +/- 13.1%. At 1 year, 76% of patients in trial A and 66% of patients in trial B had complications, mostly related to upper gastrointestinal symptoms. By 9 years after surgery, 33% (96 of 292) of trial A subjects had their devices explanted because of complications or inadequate weight loss. CONCLUSIONS: These first-generation implantable adjustable gastric band results suggest that this is a viable bariatric surgery therapeutic option for the treatment of obesity.
BACKGROUND: Morbid obesity results in multiple comorbidities and an increased mortality rate. The National Institutes of Health has stated that surgery is the most effective long-term therapy; therefore, we evaluated a laparoscopically implantable adjustable gastric band. METHODS: We reviewed 2 multicenter prospective, open-label, single-arm surgical trials--trial A (3 years) and trial B (1 year)--with ongoing safety follow-up. These trials were conducted in United States community and university hospitals (trial A = 8 sites and trial B = 12 sites). Trial A comprised 292 subjects (mean +/- SD preoperative weight: 133 kg +/- 24.4), and trial B comprised 193 subjects (129 kg +/- 20.8). Intervention included placement of a constrictive, adjustable band around the upper stomach to limit food intake and induce weight loss. Main outcome measures were the primary efficacy end point of weight loss. Secondary end-points were change in quality-of-life, safety parameters, and complications, including band slippage, reoperation, and device explantation. RESULTS: In the 2 trials, 485 devices were implanted (92% laparoscopically), and no deaths occurred. Of the patients in trial A, 206 (70.5%) completed the 3-year follow-up, and 142 (73.6%) of patients in trial B completed the 1-year follow-up. Weight-loss results, using the last value carried forward, for all 292 patients in trial A and all 193 patients in trial B demonstrated a change in mean body mass index (kg/m2) +/- SD from 47.4 +/- 7.0 to 39.0 +/- 7.3 in trial A and from 46.7 +/- 7.8 to 38.4 +/- 7.6 in trial B subjects at 1 year (P < .001 for both trials A and B), with minimal further change at 3 years (39.0 +/- 8.5) in trial A subjects. The percentage of initial body weight lost at 1 year was 17.7% +/- 9.4% for trial A subjects and 18.2% +/- 8.9% for trial B subjects, whereas the 3-year total for trial A subjects was 18.3% +/- 13.1%. At 1 year, 76% of patients in trial A and 66% of patients in trial B had complications, mostly related to upper gastrointestinal symptoms. By 9 years after surgery, 33% (96 of 292) of trial A subjects had their devices explanted because of complications or inadequate weight loss. CONCLUSIONS: These first-generation implantable adjustable gastric band results suggest that this is a viable bariatric surgery therapeutic option for the treatment of obesity.
Authors: Richard John Egan; Simon J W Monkhouse; Hayley E Meredith; Sharon E Bates; Justin D T Morgan; Sally A Norton Journal: Obes Surg Date: 2011-08 Impact factor: 4.129