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 Wolfe, Robert W. O'Rourke, Ken Fujioka, Mark Takata, James M. Swain, John M. Morton, Sayeed Ikramuddin, Michael Schweitzer & 2 others Bipan Chand, Raul Rosenthal

Research output: Contribution to journalArticle

82 Citations (Scopus)

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

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Morbid Obesity
Multicenter Studies
Weight Loss
Prospective Studies
Equipment and Supplies
Safety
Control Groups
Electric Power Supplies
Therapeutics
Informed Consent
Electric Impedance
Body Mass Index
Outcome Assessment (Health Care)
Mortality

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

Cite this

Sarr, M. G., Billington, C. J., Brancatisano, R., Brancatisano, A., Toouli, J., Kow, L., ... 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

The EMPOWER Study : Randomized, prospective, double-blind, multicenter trial of vagal blockade to induce weight loss in morbid obesity. / Sarr, Michael G.; Billington, Charles J.; Brancatisano, Roy; Brancatisano, Anthony; Toouli, James; Kow, Lilian; Nguyen, Ninh T.; Blackstone, Robin; Maher, James W.; Shikora, Scott; Reeds, Dominic N.; Eagon, J. Christopher; Wolfe, Bruce; O'Rourke, Robert W.; Fujioka, Ken; Takata, Mark; Swain, James M.; Morton, John M.; Ikramuddin, Sayeed; Schweitzer, Michael; Chand, Bipan; Rosenthal, Raul.

In: Obesity Surgery, Vol. 22, No. 11, 11.2012, p. 1771-1782.

Research output: Contribution to journalArticle

Sarr, MG, Billington, CJ, Brancatisano, R, Brancatisano, A, Toouli, J, Kow, L, Nguyen, NT, Blackstone, R, Maher, JW, Shikora, S, Reeds, DN, Eagon, JC, Wolfe, B, O'Rourke, RW, Fujioka, K, Takata, M, Swain, JM, Morton, JM, Ikramuddin, S, Schweitzer, M, Chand, B & Rosenthal, R 2012, 'The EMPOWER Study: Randomized, prospective, double-blind, multicenter trial of vagal blockade to induce weight loss in morbid obesity', Obesity Surgery, vol. 22, no. 11, pp. 1771-1782. https://doi.org/10.1007/s11695-012-0751-8
Sarr, Michael G. ; Billington, Charles J. ; Brancatisano, Roy ; Brancatisano, Anthony ; Toouli, James ; Kow, Lilian ; Nguyen, Ninh T. ; Blackstone, Robin ; Maher, James W. ; Shikora, Scott ; Reeds, Dominic N. ; Eagon, J. Christopher ; Wolfe, Bruce ; O'Rourke, Robert W. ; Fujioka, Ken ; Takata, Mark ; Swain, James M. ; Morton, John M. ; Ikramuddin, Sayeed ; Schweitzer, Michael ; Chand, Bipan ; Rosenthal, Raul. / The EMPOWER Study : Randomized, prospective, double-blind, multicenter trial of vagal blockade to induce weight loss in morbid obesity. In: Obesity Surgery. 2012 ; Vol. 22, No. 11. pp. 1771-1782.
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abstract = "Background Intermittent, reversible intraabdominal vagal blockade (VBLOC{\circledR} 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{\circledR} 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.",
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T2 - Randomized, prospective, double-blind, multicenter trial of vagal blockade to induce weight loss in morbid obesity

AU - Sarr, Michael G.

AU - Billington, Charles J.

AU - Brancatisano, Roy

AU - Brancatisano, Anthony

AU - Toouli, James

AU - Kow, Lilian

AU - Nguyen, Ninh T.

AU - Blackstone, Robin

AU - Maher, James W.

AU - Shikora, Scott

AU - Reeds, Dominic N.

AU - Eagon, J. Christopher

AU - Wolfe, Bruce

AU - O'Rourke, Robert W.

AU - Fujioka, Ken

AU - Takata, Mark

AU - Swain, James M.

AU - Morton, John M.

AU - Ikramuddin, Sayeed

AU - Schweitzer, Michael

AU - Chand, Bipan

AU - Rosenthal, Raul

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N2 - 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.

AB - 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.

KW - Blood pressure

KW - Morbid obesity

KW - Neuromodulation

KW - Satiety

KW - Vagal blockade

KW - Vagal modulation

KW - Weight loss

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