TY - JOUR
T1 - The EMPOWER Study: Randomized, Prospective, Double-Blind, Multicenter Trial of Vagal Blockade to Induce Weight Loss in Morbid Obesity
AU - Sarr, Michael
AU - Billington, C
AU - Brancatisano, Roy
AU - Brancatisano, Anthony
AU - Toouli, James
AU - Kow, Lilian
AU - Nguyen, Ninh
AU - Blackstone, Robin
AU - Maher, James
AU - Shikora, Scott
AU - Reeds, Dominic
AU - Eagon, J
AU - Wolfe, Bruce
AU - O'Rourke, Robert
AU - Fujioka, Ken
AU - Takata, Mark
AU - Swain, James
AU - Morton, John
AU - Ikramuddin, Sayeed
AU - Ikramuddin, Sayeed
AU - Schweitzer, Michael
AU - Chand, Bipan
AU - Rosenthal, Raul
PY - 2012/11
Y1 - 2012/11
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
UR - http://www.scopus.com/inward/record.url?scp=84868201116&partnerID=8YFLogxK
U2 - 10.1007/s11695-012-0751-8
DO - 10.1007/s11695-012-0751-8
M3 - Article
SN - 0960-8923
VL - 22
SP - 1771
EP - 1782
JO - Obesity Surgery
JF - Obesity Surgery
IS - 11
ER -