Intra-abdominal vagal blocking (VBLOC therapy): Clinical results with a new implantable medical device

Camilleri, M.; Toouli, J.; Herrera, M.F.; Kulseng, B.; Kow, L.; Pantoja, J.P.; Marvik, R.; Johnsen, G.; Billington, C.J.; Moody, F.G.; Knudson, M.B.; Tweden, K.S.; Vollmer, M.; Wilson, R.R.; Anvari, M.

doi:10.1016/j.surg.2008.03.015

« Previous Next »Surgery
Volume 143, Issue 6 , Pages 723-731, June 2008

Intra-abdominal vagal blocking (VBLOC therapy): Clinical results with a new implantable medical device

M. Camilleri, MD
- The Mayo Clinic, Rochester, Minnesota
- Reprint requests: Michael Camilleri, MD, Mayo Clinic, Charlton 8-110, 200 First St. S.W., Rochester, MN 55905.
- Both M. Camilleri and J. Toouli are co-lead authors.
J. Toouli, MD, PhD
- Flinders University, Adelaide, South Australia
- Both M. Camilleri and J. Toouli are co-lead authors.
M.F. Herrera, MD
- Instituto Nacional de la Nutrition, Mexico City, Mexico
B. Kulseng, MD, PhD
- St. Olav's University Hospital, Trondheim, Norway
L. Kow, MD, PhD
- Flinders University, Adelaide, South Australia
J.P. Pantoja, MD
- Instituto Nacional de la Nutrition, Mexico City, Mexico
R. Marvik, MD, PhD
- St. Olav's University Hospital, Trondheim, Norway
G. Johnsen, MD
- St. Olav's University Hospital, Trondheim, Norway
C.J. Billington, MD
- University of Minnesota, Minneapolis, Minnesota
F.G. Moody, MD
- University of Texas Medical School at Houston, Houston, Texas
M.B. Knudson, PhD
- EnteroMedics Inc, St. Paul, Minnesota
K.S. Tweden, PhD
- EnteroMedics Inc, St. Paul, Minnesota
M. Vollmer, BA
- EnteroMedics Inc, St. Paul, Minnesota
R.R. Wilson, MD
- Health Research LLC, Arden Hills, Minnesota
M. Anvari, MD, PhD
- McMaster University, Hamilton, Ontario, Canada

Accepted 14 March 2008. published online 12 May 2008.

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.

To access this article, please choose from the options below

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.

PII: S0039-6060(08)00182-7

doi:10.1016/j.surg.2008.03.015

« Previous Next »Surgery
Volume 143, Issue 6 , Pages 723-731, June 2008

Access this article on SciVerse ScienceDirect