title: Clinical outcomes of the Realize Adjustable Gastric Band-C at 2 years in a United States population.
abstract: BACKGROUND
  In 2008, the Realize Band (RB) adopted a precurved design (RB-C). We present 2-year outcomes data from the first multiinstitutional study of RB-C. The objective of this study was to analyze weight loss and safety data from bariatric practices in the United States, including academic, nonacademic, public, and private.
  
  
  METHODS
  The study included adult RB-C patients with a preoperative body mass index (BMI)≥40 kg/m(2) or >35 kg/m(2) with co-morbidity. Exclusions included RB-C's label contraindications for use. Outcomes parameters were percent excess weight loss (%EWL), BMI change, number and volume of band adjustments, and adverse events.
  
  
  RESULTS
  A total of 231 patients met inclusion/exclusion criteria. Of these, 161 had 24-month data available. Mean %EWL was 44.4%±26.9% (P<.0001). BMI decreased from 44.1±5.7 kg/m(2) to 35.3±6.9 kg/m(2) (P<.0001). Percent EWL varied by preoperative BMI (P = .0002), bariatric practice (P<.0001), aftercare frequency (P = .0004), and band fill frequency (P = .0271), but %EWL was not influenced by gender, race, or age (P>.20 each). Adverse events were dysphagia (21.2%), gastroesophageal reflux (21.6%), and vomiting (30.7%). Incidence of pouch dilation, esophageal dilation, and slippage was ≤1%. Revisions (2.2%) were for unbuckled band, tube kinking, slippage, and suspected band leak (1 each). No erosions, explants, or mortality were reported.
  
  
  CONCLUSIONS
  RB-C appears to be as well tolerated and effective as the first generation RB for weight loss. The near 45% EWL at 2 years is consistent with other high-quality publications on the RB. Preoperative BMI and frequency of postoperative care, including frequency of band fills, influence %EWL. Significant weight loss is achievable with RB-C despite variable postoperative management practices. The low morbidity and the absence of mortality at 24 months reflect positively on the RB-C characteristics.
authors: Cedars-Sinai Medical Center, Weight Loss Center, Los Angeles, California.
authors: Scott A
authors: SA
authors: Cunneen
authors: Collin E M
authors: CE
authors: Brathwaite
authors: Christopher
authors: C
authors: Joyce
authors: Keith
authors: K
authors: Gersin
authors: Keith
authors: K
authors: Kim
authors: Jon L
authors: JL
authors: Schram
authors: Erik B
authors: EB
authors: Wilson
authors: Michael
authors: M
authors: Schwiers
authors: Mario
authors: M
authors: Gutierrez
mesh_terms: D000328:Adult; D015992:Body Mass Index; D005260:Female; D005500:Follow-Up Studies; D015391:Gastroplasty / Q000009:adverse effects* / Q000295:instrumentation*; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009767:Obesity, Morbid / Q000175:diagnosis / Q000601:surgery*; D011183:Postoperative Complications / Q000503:physiopathology / Q000601:surgery; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012086:Reoperation / Q000379:methods; D012189:Retrospective Studies; D018570:Risk Assessment; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D015431:Weight Loss
keywords: Bariatric surgery; Gastric band; LAGB; Morbid obesity; Realize; Realize Adjustable Gastric Band; laparoscopic adjustable gastric band