Adjustable totally implantable intragastric prosthesis (ATIIP)-Endogast for treatment of morbid obesity: one-year follow-up of a multicenter prospective clinical survey.

BACKGROUND: The Adjustable Totally Implantable Intragastric Prosthesis (ATIIP)-Endogas is a new mini-invasive technique for the treatment of morbid obesity. The ATIIP is conducted using a surgical and endoscopic procedure. The permanent presence of an air-inflated prosthesis inside the gastric corpus-fundus area and the fixation of the stomach to the abdominal wall are the two main principles in the technique. The prosthesis is connected to a subcutaneous totally implantable system. The aim of the ATIIP is to induce early satiety and reduction of meal intake. This study presents the preliminary results of 1-year follow-up of a multicenter prospective clinical survey. METHODS: From November 2004 to March 2007, 57 patients underwent ATIIP: 28 males (49%) and 29 females (51%), with mean age 43.6 years (18-69) and mean BMI 48.9 (33.7-81.2). Follow-up was 1-28 months. RESULTS: Feasibility was 100%, reproducibility 100%, and acceptability found no vomitting. Mean volume of the prosthesis was 210 ml of air (first 3 months, 40 patients). Mean %EWL was 22.3% (3 mos, 40 pts), 28.7% (6 mos, 38 pts), and 39.2% (12 mos, 20 pts). Early postoperative complication was local subcutaneous infection in 7 pts (12.2%). In 16 pts who had a subcutaneous drain and empirical antibiotic therapy until the 4th postoperative day, local infection occurred in 1 patient (6.2%). Late postoperative complications occurred in 3 pts (5.2%) who developed port erosion. CONCLUSIONS: Preliminary results indicate that the ATIIP is feasible, reproducible, safe with low risk of complications and has encouraging results in weight loss. Morbidly obese patients >60 years old and the super-obese (BMI>50) are specific indications.

[Bariatric pacing. A new frontier for the treatment of severe obesity]. / Pacing gastrico. Una nuova frontiera nel trattamento dell'obesità grave.

A new bariatric procedure, gastric myo-electrical stimulation, has been developed. The Implantable Gastric Stimulator (IGS) induces satiety while avoiding the morbidity and mortality of the common restrictive malabsorptive or combination restrictive or malabsorptive procedure. The procedure does not alter normal anatomy. Advantages of IGS therapy are simplicity, a more rapid procedure, a safer procedure and the absence of nutritional side effects associated with some bariatric operations. The devices consists of a stimulation lead implanted in the gastric wall, connected to an electronic pulse generator (Transcend IGS, Transneuronix Inc, Mt. Arlington, NJ, SA) implanted subcutaneously into the abdominal wall. The lead is implanted by laparoscopy into the muscular layer of the lesser curvature of the stomach at the end of the pes anserinus area. The generator is connected (proper connection, was confirmed via radio frequency programming), and implanted subcutaneously. The mechanism of action of the IGS therapy requires a concomitant program of diet and lifestyle modifications in order to optimise the results.

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. CONCLUSION: 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.