Early Experience with Customized, Meal-Triggered Gastric Electrical Stimulation in Obese Patients

Abstract

BackgroundWe report our initial gastric electrical stimulation experience using the abiliti® system for the treatment of obese patients followed for 1 year.MethodBetween March 2011 and June 2013, 27 obese patients (BMI 30 to 46 kg/m2) were enrolled in a prospective open label study and implanted with a gastric stimulator. The patients were provided with nutritional support, and sensor-based behavioral feedback.ResultsAt 12 months, percent excess weight loss (%EWL) obtained was 49.3 ± 19.2 % with no significant differences between gender or age sub-groups. The %EWL data were segmented into two groups according to BMI 30–40 kg/m2 patients (obesity grade I and II) and BMI >40 kg/m2, with the results of weight loss being significantly higher for the lower BMI group (59.1 ± 19.5 vs. 46.7 ± 13.4, respectively, p < 0.01). One subject requested to have his device explanted, and the minor postoperative adverse events were resolved without hospital admission. All patients experienced early satiety and reduced their intake.ConclusionsAfter 12 months of follow-up, gastric electrical stimulation treatment appears to be a safe and effective option for weight loss in obese subjects. Long-term follow-up and further studies are warranted.

Vagus nerve stimulation: state of the art of stimulation and recording strategies to address autonomic function neuromodulation

“…abiliti® device, IntraPace (Miras et al, 2015) Same as above 27 obese patients with BMI 30 to 46 kg/m² 49.3% excess weight loss at 12 months with no significant difference between age and gender. Using a subgroup analysis they showed that stimulation was more effective for patients with a lower BMI (30-40 kg/m²) than for those with a higher BMI.…”

“…Rapid and significant effect on glycemic control and blood pressure. abiliti® device, IntraPace (Ladabaum et al, 1998, Chen, 2004 (Greenway andZheng, 2007, Cha et al, 2014) Clinical studies (Horbach et al, 2015, Miras et al, 2015 GES 2 electrodes placed on the serosa of the proximal stomach. Food sensor, transgastric electrode, is placed through the stomach gastric wall: the stimulation is meal-activated The stimulation electrode is implanted on the anterior wall of the stomach.…”

Impact of the feedback provided by a gastric electrical stimulation system on eating behavior and physical activity levels

“…The CLGES system used in this study is designed to deliver intermittent gastric stimulation triggered by a transgastric sensor that senses the entry of food into the stomach. A particular feature of this device is that the intensity of the stimulation can be adjusted according to a personalized schedule, in order to obtain early satiety when the patient eats during the periods of the day when the ingestion of food is permitted and to produce gastric discomfort in case of off‐schedule food intakes . This particular mode of action was designed to reduce both portion sizes at meals and off‐schedule eating episodes, with a comprehensive reduction in unhealthy eating behaviors .…”

“…The CLGES system has the ability to collect objective electronic data on food intake and physical activity. These data can be stored, visualized, and used in a program of lifestyle modification . Encouraging preliminary results in patients treated with the CLGES system have been reported, with acceptable weight loss rates and very few complications and side effects .…”

Interventional treatment of obesity and diabetes: An interim report on gastric electrical stimulation

“…Patient and medical staff monitor the results and use the information to modify the patient’s behavior. Twelve month data in an open label study of 27 obese subjects (mean BMI 40.0 ± 5.7 kg/m 2 ) showed a mean percent excess weight loss (EWL) of 49.3 ± 19.2 [ 27 ]. It is not possible from the design of the study to determine the effect of the electrical signal versus the effect of food and exercise monitoring on behavioral modifications.…”