Progress in implantable gastric stimulation: summary of results of the European multi-center study.
BACKGROUND
The Implantable Gastric Stimulator (IGS(R)), a pacemaker-like device, has been found to be safe and effective to induce and maintain weight loss. The LOSS (Laparoscopic Obesity Stimulation Survey) is a prospective non-randomized trial which enrolled 69 patients involving 11 investigator centers in 5 European Countries. In 19 patients, ghrelin was analyzed.


METHODS
Between January 2002 and December 2003, 69 patients (F/M 49/20), mean age 41 years (18-65) underwent IGS implantation. Mean BMI was 41 (35-57), mean weight 115.0 kg (65-160) and mean excess weight (EW) 52 kg (13-89). The IGS was actived 30 days after implantation. In a subset of 19 patients studied further, 0, 6, and 12 months appetite and satiety score were evaluated and 0 and 6 months ghrelin profile was analyzed.


RESULTS
The mean +/- standard error %EWL was: 8.6+/-1.8 at 1 month, 15.8+/-2.3 at 3 months, 17.8+/-2.6 at 6 months, 21.0+/-3.5 at 10 months, and 21.0+/-5.0 at 15 months. There were no intraoperative surgical or long-term complications. 7 intra-operative gastric penetrations occurred, observed by gastroscopy, without sequelae. 1 patient required a reoperation to remove a retained lead needle. In the subset of 19 patients, appetite was reduced and post-prandial and inter-prandial satiety was increased after IGS implantation. In the 19 patients, despite weight reduction, ghrelin did not increase.


CONCLUSIONS
IGS can be implanted laparoscopically with minimal perioperative complications. Appetite is reduced and satiety is increased after the implantation. Ghrelin levels could be one of the mechanisms explaining weight loss and weight maintenance in IGS patients. If weight loss is maintained, IGS could be considered a good option for selected patients.
Department of Surgery, Regional Hospital of Vicenza, Italy. nnwdel@tin.it
Maurizio
M
De Luca
Gianni
G
Segato
Luca
L
Busetto
Franco
F
Favretti
Franz
F
Aigner
Helmut
H
Weiss
Charles
C
de Gheldere
Giorgio
G
Gaggiotti
Jacques
J
Himpens
Jorge
J
Limao
Matthias
M
Scheyer
Mauro
M
Toppino
Ernst L
EL
Zurmeyer
Giorgio
G
Bottani
Heinrich
H
Penthaler
D000293:Adolescent; D000328:Adult; D000368:Aged; D001066:Appetite; D004599:Electric Stimulation Therapy / Q000379:methods*; D004567:Electrodes, Implanted; D005060:Europe; D005260:Female; D054439:Ghrelin; D006801:Humans; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D009767:Obesity, Morbid / Q000097:blood / Q000601:surgery*; D036361:Peptide Hormones / Q000097:blood*; D011446:Prospective Studies; D012528:Satiety Response; D013270:Stomach / Q000601:surgery; D016896:Treatment Outcome; D015431:Weight Loss
D054439:Ghrelin; D036361:Peptide Hormones