Background: Gastric electrical stimulation to treat morbid obesity, using the Transcend Implantable Gastric Stimulator (IGS), is being evaluated. We present our preliminary results from the French segment of the worldwide study to evaluate this therapy.
Methods: Institutionally-approved informed consent was obtained from all patients. The IGS is placed laparoscopically. The system has two implantable components: 1) a lead with two electrodes that is implanted in a gastric lesser curvature muscle tunnel; 2) the lead is connected to an electrical pulse generator positioned subcutaneously on the abdominal wall. Two electrode positions were used; half (6/12, 50%) were "low" near the pes anserinus, and the other 50% "high" nearer the esophagogastric junction. Intraoperative gastroscopy is used to diagnose inadvertent gastric perforation. 12 patients (5 M, 7 F) had the IGS implanted between July 2000 and February 2001. Mean age was 40.6 years (31-51). Mean weight was 122.2 kg (93-146), mean BMI was 42.7 kg/m2 (39.1-48.6), and mean excess weight was 60 kg (42-74). Electrical stimulation commenced 1 month after implantation.
Results: All devices were successfully placed laparoscopically. There were no deaths or major operative complications. Postoperative course was uneventful in all cases. In 25% (3/12), postoperative lead dislodgement occurred; 2 of the 3 had their leads replaced. By 9 months, mean excess BMI lost was 30 +/- 24% or 16 +/- 12 kg.
Conclusion: Implanting the IGS to treat morbid obesity is technically feasible and safe. Lead dislodgement has been simply and satisfactorily corrected. Satisfactory short-term weight loss has been achieved in a subset of patients. Long-term efficacy must now be determined.