Clinical outcomes of the REALIZE adjustable gastric band-C at one year in a U.S. 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., Rodriguez, Claudio E., Gutierrez, Mario

funding text

  • This study was undertaken and financed in its entirety by the manufacturer of the REALIZE adjustable gastric band, Ethicon Endo-Surgery, Inc. (Cincinnati, OH). However, adherence to study protocol was monitored by a contract research organization (Quintiles, Inc.). Some authors (C. E. M. Braithwaite, C. Joyce, J. L. Schram, E. B. Wilson, K. Kim, S. A. Cunneen, K. Geisin) of this manuscript are consultants for Ethicon Endo-Surgery, Inc. and two (M. Gutierrez and C. Rodriguez) are clinical research professionals employed by Ethicon Endo-Surgery, Inc. The manuscript has been read and approved by all authors. E. B. Wilson is a consultant to Intuitive, Inc. and received a consulting fee; K. Kim is a speaker for Intuitive, Inc. and received an honorarium; S. A. Cunneen is a speaker/proctor/consultant to Allergen Medical and speaker/consultant to Covidien and received honoraria.

abstract

  • Background: In 2008, the REALIZE Band (RB) adopted a precurved design (RB-C). The present study is the first multi-institutional report of RB-C outcomes. Our objective was to analyze the 1-year weight loss and safety data from adult RB-C patients treated at multiple U.S. centers (7 typical U.S. bariatric practices, including academic, nonacademic, public, and private practice). Methods: Patients implanted with the RB-C (preoperative body mass index >= 40 kg/m(2) or >35 kg/m(2) with co-morbidity) were recruited. The exclusion criteria included the RB-C label contraindications for use. The outcomes parameters were the percentage of excess weight loss (%EWL), change in body mass index, number and volume of band adjustments, and incidence of complications. Results: Of the 239 patients enrolled in the 2-year study, 158 had 1-year data available for analysis in November 2010. The mean %EWL was 39.2% +/- 20.5% (range -7.7 to -116.8, P < .0001). The body mass index decreased from 44.4 +/- 5.5 kg/m(2) to 36.4 +/- 5.8 kg/m(2) (P < .0001). The variability in the %EWL was significant among the study centers (P < .0001). The average band fill volume at 1 year was 8.0 +/- 2.0 mL (range .0-11.1). The total fill volume was >11 mL in I patient. No band erosions/migrations, explants, or deaths occurred. Conclusion: RB-C appears to be as safe and effective as the first-generation RB. The near 40% EWL at 1 year was consistent with other high-quality publications of the RB. Good weight loss results are achievable, despite the varying postoperative management practices. The low morbidity and the absence of mortality at 12 months reflect positively on the RB-C characteristics. Our findings suggest that the learning curve, related to the postoperative management of the RB-C, might vary by practice and that a greater frequency and smaller band fills might result in better weight loss at 12 months. (Surg Obes Relat Dis 2012; 8:288-295.) (C) 2012 American Society for Metabolic and Bariatric Surgery. All rights reserved.

authors

Publication Date

  • May 1, 2012

webpage

published in

category

  • SURGERY  Web of Science Category

start page

  • 288

end page

  • 295

volume

  • 8

issue

  • 3

WoS Citations

  • 2

WoS References

  • 34