PMID- 18549888
OWN - NLM
STAT- MEDLINE
DCOM- 20080626
LR  - 20080613
IS  - 1532-7361 (Electronic)
IS  - 0039-6060 (Linking)
VI  - 143
IP  - 6
DP  - 2008 Jun
TI  - Intra-abdominal vagal blocking (VBLOC therapy): clinical results with a new 
      implantable medical device.
PG  - 723-31
LID - 10.1016/j.surg.2008.03.015 [doi]
AB  - 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/m(2)). 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/m(2)) 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 <or= .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.
FAU - Camilleri, M
AU  - Camilleri M
AD  - The Mayo Clinic, Rochester, Minnesota, USA. camilleri.michael@mayo.edu
FAU - Toouli, J
AU  - Toouli J
FAU - Herrera, M F
AU  - Herrera MF
FAU - Kulseng, B
AU  - Kulseng B
FAU - Kow, L
AU  - Kow L
FAU - Pantoja, J P
AU  - Pantoja JP
FAU - Marvik, R
AU  - Marvik R
FAU - Johnsen, G
AU  - Johnsen G
FAU - Billington, C J
AU  - Billington CJ
FAU - Moody, F G
AU  - Moody FG
FAU - Knudson, M B
AU  - Knudson MB
FAU - Tweden, K S
AU  - Tweden KS
FAU - Vollmer, M
AU  - Vollmer M
FAU - Wilson, R R
AU  - Wilson RR
FAU - Anvari, M
AU  - Anvari M
LA  - eng
PT  - Controlled Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20080509
PL  - United States
TA  - Surgery
JT  - Surgery
JID - 0417347
RN  - 59763-91-6 (Pancreatic Polypeptide)
SB  - IM
MH  - Adult
MH  - Algorithms
MH  - Autonomic Nerve Block/adverse effects/*instrumentation/*methods
MH  - Blood Pressure/physiology
MH  - Electrocardiography
MH  - *Equipment and Supplies/adverse effects
MH  - Female
MH  - Heart Rate/physiology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Obesity/physiopathology/*therapy
MH  - Pancreatic Polypeptide/blood
MH  - Prospective Studies
MH  - *Prostheses and Implants/adverse effects
MH  - Satiation/physiology
MH  - Treatment Outcome
MH  - Vagus Nerve/*physiology
MH  - Weight Loss/physiology
EDAT- 2008/06/14 09:00
MHDA- 2008/06/27 09:00
CRDT- 2008/06/14 09:00
PHST- 2007/12/07 00:00 [received]
PHST- 2008/03/14 00:00 [accepted]
PHST- 2008/06/14 09:00 [pubmed]
PHST- 2008/06/27 09:00 [medline]
PHST- 2008/06/14 09:00 [entrez]
AID - S0039-6060(08)00182-7 [pii]
AID - 10.1016/j.surg.2008.03.015 [doi]
PST - ppublish
SO  - Surgery. 2008 Jun;143(6):723-31. doi: 10.1016/j.surg.2008.03.015. Epub 2008 May 
      9.