Clinical outcomes of the REALIZE Adjustable Gastric Band-C at 2 years in a United States population Article

Industry Collaboration

cited authors

  • Cunneen, Scott A., Brathwaite, Collin E. M., Joyce, Christopher, Gersin, Keith, Kim, Keith, Schram, Jon L., Wilson, Erik B., Schwiers, Michael, Gutierrez, Mario

funding text

  • This study was undertaken and financed in its entirety by the manufacturer of the Realize (TM) Adjustable Gastric Band (Ethicon Endo-Surgery, Inc., Cincinnati, OH).

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. Conclusion: 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. (Surg Obes Relat Dis 2013;9:885-893.) (c) 2013 American Society for Metabolic and Bariatric Surgery. All rights reserved.

authors

Publication Date

  • November 1, 2013

webpage

published in

category

  • SURGERY  Web of Science Category

start page

  • 885

end page

  • 893

volume

  • 9

issue

  • 6

WoS Citations

  • 2

WoS References

  • 28