Background: A new medical device uses high-frequency electrical algorithms to create intermittent vagal blocking (VBLOC therapy). The aim is to assess the effects of vagal blocking on excess weight loss (EWL), safety, dietary intake, and vagal function. Methods: An open-label, 3-center study was conducted in obese subjects (body mass index [BMI] 35-50 kg/m2). Electrodes were implanted laparoscopically on both vagi near the esophagogastric junction to provide electrical block. Patients were followed for 6 months for body weight, safety, electrocardiogram, dietary intake, satiation, satiety, and plasma pancreatic polypeptide (PP) response to sham feeding. To specifically assess device effects alone, no diet or exercise programs were instituted. Results: Thirty-one patients (mean BMI, 41.2 ± 1.4 kg/m2) received the device. Mean EWL at 4 and 12 weeks and 6 months after implant was 7.5%, 11.6%, and 14.2%, respectively (all P < .001); 25% of patients lost >25% EWL at 6 months (maximum, 36.8%). There were no deaths or device-related serious adverse events (AEs). Calorie intake decreased by >30% at 4 and 12 weeks and 6 months (all P ≤ .01), with earlier satiation (P < .001) and reduced hunger (P = .005). After 12 weeks, plasma PP responses were suppressed (20 ± 7 vs 42 ± 19 pg/mL). Average percent EWL in patients with PP response <25 pg/mL was double that with PP response >25 pg/mL (P = .02). Three patients had serious AEs that required brief hospitalization, 1 each for lower respiratory tract, subcutaneous implant site seroma, and Clostridium difficile diarrhea. Conclusions: Intermittent, intra-abdominal vagal blocking is associated with significant EWL and a desirable safety profile.
Bibliographical noteFunding Information:
The study was supported by EnteroMedics grants. The excellent secretarial support of Mrs. Cindy Stanislav is gratefully acknowledged. The authors gratefully acknowledge the contributions of Drs James W. Freston, Samuel Klein, Melissa S. Martinson, and Frank G. Moody in monitoring safety and initial study design; C.C. Pulling and T.M. Yurik for statistical analysis; Dr M.D. Bierk for surgical support; Jane Collins, Magnus Strommen, and Dr Ricardo Fernandez Riera for study coordination; and Nicholas Wray for nutritional assessment.
M.C. receives consulting fees as part of a business alliance between Mayo Clinic and EnteroMedics, Inc. M.A., C.J.B., F.G.M., and R.R.W. are consultants of EnteroMedics Inc. K.S.T., M.V., and M.B.K. are employees of EnteroMedics Inc. This work was completely funded by EnteroMedics Inc.