The EMPOWER Study: Randomized, prospective, double-blind, multicenter trial of vagal blockade to induce weight loss in morbid obesity

Michael G. Sarr, Charles J. Billington, Roy Brancatisano, Anthony Brancatisano, James Toouli, Lilian Kow, Ninh T. Nguyen, Robin Blackstone, James W. Maher, Scott Shikora, Dominic N. Reeds, J. Christopher Eagon, Bruce M. Wolfe, Robert W. O'Rourke, Ken Fujioka, Mark Takata, James M. Swain, John M. Morton, Sayeed Ikramuddin, Michael SchweitzerBipan Chand, Raul Rosenthal

Research output: Contribution to journalArticle

Abstract

Background Intermittent, reversible intraabdominal vagal blockade (VBLOC® Therapy) demonstrated clinically important weight loss in feasibility trials. EMPOWER, a randomized, double-blind, prospective, controlled trial was conducted in USA and Australia. Methods Five hundred three subjects were enrolled at 15 centers. After informed consent, 294 subjects were implanted with the vagal blocking system and randomized to the treated (n0192) or control (n0102) group. Main outcome measures were percent excess weight loss (percent EWL) at 12 months and serious adverse events. Subjects controlled duration of therapy using an external power source; therapy involved a programmed algorithm of electrical energy delivered to the subdiaphragmatic vagal nerves to inhibit afferent/efferent vagal transmission. Devices in both groups performed regular, low-energy safety checks. Data are mean ± SEM. Results Study subjects consisted of 90 % females, body mass index of 41±1 kg/m2, and age of 46±1 years. Device-related complications occurred in 3 % of subjects. There was no mortality. 12-month percent EWL was 17± 2 % for the treated and 16±2 % for the control group. Weight loss was related linearly to hours of device use; treated and controls with ≥12 h/day use achieved 30±4 and 22±8 % EWL, respectively. Conclusions VBLOC® therapy to treat morbid obesity was safe, but weight loss was not greater in treated compared to controls; clinically important weight loss, however, was related to hours of device use. Post-study analysis suggested that the system electrical safety checks (low charge delivered via the system for electrical impedance, safety, and diagnostic checks) may have contributed to weight loss in the control group.

Original languageEnglish (US)
Pages (from-to)1771-1782
Number of pages12
JournalObesity Surgery
Volume22
Issue number11
DOIs
StatePublished - Nov 2012

Keywords

  • Blood pressure
  • Morbid obesity
  • Neuromodulation
  • Satiety
  • Vagal blockade
  • Vagal modulation
  • Weight loss

ASJC Scopus subject areas

  • Surgery
  • Endocrinology, Diabetes and Metabolism
  • Nutrition and Dietetics

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    Sarr, M. G., Billington, C. J., Brancatisano, R., Brancatisano, A., Toouli, J., Kow, L., Nguyen, N. T., Blackstone, R., Maher, J. W., Shikora, S., Reeds, D. N., Eagon, J. C., Wolfe, B. M., O'Rourke, R. W., Fujioka, K., Takata, M., Swain, J. M., Morton, J. M., Ikramuddin, S., ... Rosenthal, R. (2012). The EMPOWER Study: Randomized, prospective, double-blind, multicenter trial of vagal blockade to induce weight loss in morbid obesity. Obesity Surgery, 22(11), 1771-1782. https://doi.org/10.1007/s11695-012-0751-8