title: Safety and effectiveness of LAP-BAND AP System: results of Helping Evaluate Reduction in Obesity (HERO) prospective registry study at 1 year.
abstract: 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.
  
  
  METHODS
  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.
authors.affiliation: Surgical Weight Loss Centre, Mississauga, ON, Canada. Electronic address: chcobourn@rogers.com.
authors.forename: Chris
authors.initials: C
authors.lastname: Cobourn
authors.forename: Arnold
authors.initials: A
authors.lastname: Degboe
authors.forename: Paul A
authors.initials: PA
authors.lastname: Super
authors.forename: Marcio
authors.initials: M
authors.lastname: Torre
authors.forename: James
authors.initials: J
authors.lastname: Robinson
authors.forename: Jin
authors.initials: J
authors.lastname: Jin
authors.forename: Francesco
authors.initials: F
authors.lastname: Furbetta
authors.forename: Sunil
authors.initials: S
authors.lastname: Bhoyrul
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D005260:Female; D015391:Gastroplasty / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000601:surgery*; D011446:Prospective Studies; D012042:Registries; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
keywords: %EWL; %WL; AE; BMI; DBP; HERO; Helping Evaluate Reduction in Obesity Study; LAGB; LAP-BAND AP System; LBAP; SBP; T2DM; adverse event; body mass index; diastolic blood pressure; laparoscopic adjustable gastric banding; percentage of excess weight loss; percentage of weight loss; systolic blood pressure; type 2 diabetes mellitus