Gastric Pacing for the Treatment of Morbidly Obese Patients

by V. Cigaina, A. Saggioro, L. Gracco, L. Pivotto, G. Tamburrano

Background: A novel method to treat morbid obesity is presented – gastric electrical pacing. Follow-ing animal research, human investigation in a total of 24 patients in three cohorts began in 1995.

Methods : Morbidly obese subjects (BMI 40) received electrical stimulation devices in 1995/6 (n=4), 1998 (n=10) and 2000 (n=10). Electrodes were positioned intramuscularly on the anterior gastric wall at the lesser curvature. BMI = body mass index; %EBL = % excess BMI (>25) lost.

Results: Patients reported satiety for food with less food.The 2 patients from the first study followed for >5 years have 38 and 67 %EBL. In the second study, every patient lost weight.At 36 months followup, the mean %EBL was 24±10 SD (n=10).

Conclusions: Implantable gastric pacing is a safe procedure and causes changes in eating habits in morbidly obese humans,resulting in decreased food intake and weight loss.


Implantable Gastric Stimulation for the Treatment of Morbid Obesity

by Valerio Cigaina, MD

Background: The implantable gastric stimulator (IGS), a pacemaker-like device, has been found to be safe and effective to induce and maintain weight loss.We present our experience with 20 morbidly obese patients.

Methods: Between September 20 and November 22, 2002, 20 patients (F/M 12/8), mean age 40.3 years (23-62) underwent IGS implantation. Mean BMI was 40.9(33.9-48.2), mean weight 115.0 kg (87.0-137.0) and mean excess weight (EW) 51.3 kg (35.6-70.1). Co-morbitidies were: 3 cases of hypertension, 1 diabetes, 1 dislipidemia and 1 depression. Mean operative time was 58.5 min (37-85). The IGS was actived 30 days after implantation. Patients were advised to follow a low calorie diet and behavior modification (to avoid fat and to ingest more liquids during meals, to chew slowly, to eat vegetables before main meals, and to perform exercise daily).

Results: Mean ± standard error percent excess weight loss (%EWL) was: 10.6±1.8 at 1 month; 15.0±2.3 at 2 months; 16.6±2.6 at 3 months; 18.1±3.5 at 4 months; 15.5±3.5 at 6 months; 18.9±3.5 at 8 months; and 23.8±5.0 at 10 months. There were no intra-operative surgical or long-term complications. There were 3 intra-operative gastric penetrations, observed by gastroscopy, without sequelae. One patient with hypertension ceased his medical therapy at the 4th month.

Conclusion: IGS can be implanted laparoscopicall y with minimal perioperative complications. The observed weight loss is comparable to other noninvasive procedures. If weight loss is maintained, IGS could be considered as a first choice therapy in the treatment of morbid obesity in selected patients.


Long-Term Follow-Up of Gastric Stimulation for Obesity: The Mestre 8-Year Experience

by Valerio Cigaina, MD

Background: 10 years experience with gastric stimulation demonstrates promise, in particular because weight loss is achieved and maintained without drugs or side-effects.We report on a total of 65 patients who have received an Implantable Gastric Stimulator (IGS®) since 1995.

Methods: 65 patients have received an IGS and were monitored for weight loss as well as co-morbidities. Gastroesophageal Reflux Disease (GERD) was assessed by endoscopy and symptoms were evaluated. An acute Holter study was performed on 4 patients pre-implant, post-implant, and post-activation of the IGS. Oral glucose tolerance test (OGTT) using a 76-g bolus of oral dextrose was done before device implantation and after-activation. Gastric emptying was tested on 19 of the patients using Tc99, both pre-implant and 6 months post-implant. Resting Energy Expenditure (REE) was studied in 15 patients using indirect calorimetry at 3 different points in time: pre-activation, 6 months post-implant, and 12 months post-implant. Blood pressure was measured using an electronic wrist device to overcome potential artifacts due to arm fat.

Results: IGS patients lost significant weight with no side-effects and experienced significant and rapid improvements in blood pressure. Almost all of the GERD patients reported symptomatic relief during gastric pacing. OGTT demonstrated improved response to insulin at 7 months post-stimulation. The gastric emptying and REE tests were less conclusive, to a great extent because of the small sub-population of patients.

Conclusion: While the exact mechanisms of gastric stimulation remain incompletely understood, it appears that the implantation of an IGS is associated with weight loss, an improvement (decrease) in blood pressure in hypertensive patients, and a reduction or elimination of symptoms in those who had GERD. This promising weight loss therapy warrants further study, in particular because of its intriguing results with co-morbidities.


Gastric Pacing for Morbid Obesity: Plasma Levels of Gastrointestinal Peptides and Leptin

by Valerio Cigaina and Angelica L. Hirschberg

Gastric pacing for morbid obesity: plasma levels of gastrointestinal peptides and leptin. Obes Res. 2003;11: 1456–1462. Objective: A gastric pacemaker has been developed to treat morbid obesity. Patients experience increased satiety, the ability to reduce food intake, and a resultant weight loss. However, the mechanism behind the changed eating behavior in paced patients is still under investigation.

Research Methods and Procedures: This study was performed on 11 morbidly obese patients (mean BMI, 46.0 kg/m2 ) treated with gastric pacing. The peripheral blood levels of satiety signals of cholecystokinin (CCK), somatostatin, glucagon-like peptide-1 (GLP-1), and leptin were studied 1 month before gastric pacer implantation, 1 month after implantation, and 6 months after activation of electrical stimulation. Blood samples were drawn 12 hours after fasting and in response to a hypocaloric meal (270 kcal). Patients were followed monthly for vital signs and weight level.

Results: Gastric pacing resulted in a significant weight loss of a mean of 10.4 kg (4.4 BMI units). No negative side effects or complications were observed during the treatment. After activation of the pacemaker, meal-related response of CCK and somatostatin and basal levels of GLP-1 and leptin were significantly reduced (p  0.05) compared with the tests before gastric pacing. The weight loss correlated significantly with a decrease of leptin levels (R 0.79, p  0.01).

Discussion: Gastric pacing is a novel and promising therapy for morbid obesity. Activation of the gastric pacer was associated with a decrease in plasma levels of CCK, somatostatin, GLP-1, and leptin. More studies are necessary to elucidate the correlations between satiety, weight loss, and digestive neuro-hormone changes.


Pacing the Stomach: Our Experience on Two Obese Patient Populations

by V. Cigaina, A. Saggioro


Treatment of Obesity with the Transcend® Implantable Gastric Stimulator: MULTI-CENTER STUDY

by V. Cigaina, J. Dargent, M. Belachew, L. Melissas, K. Miller, F. Favretti, F. Horber

Abstract

Laparoscopic gastric pacing (LGP) is a minimally invasive technique that is performed for the treatment of obesity. LGP was first developed in the early 1990s for gastroparesis, and was also found to be effective in the treatment of obesity. The application of electrical current to the stomach alters gastric myoelectrical activity, without any changes in the gastrointestinal anatomy. The exact mechanism of LGP remains to be elucidated. However, potential mechanisms to assess the success of LGP might include an increased feeling of satiety as the result of reduced gastric emptying, or changes in neuropeptide levels.

LGP is a minimally invasive technique that is potentially safe and effective for treating obesity; nevertheless, the selection of patients for gastric stimulation therapy appears to be an important determinant of the outcome of this treatment.

This article reviews the current status, potential mechanisms of action, operating techniques, complications, postoperative management and outcomes, and possible future applications of gastric stimulation in obesity management.


Gastric Pacing and Morbid Obesity: The Role of the Autonomic Nervous System (ANS)

by V. Cigaina, R. Bacci


MedAutonomic Brain NeuroModulator: A Brief Summary of the Fundamental Science and Research

by Valerio Cigaina MD, Dr. Paolo Fabris, John Gonzales PhD