abiliti® Closed-Loop Gastric Electrical Stimulation System for Treatment of Obesity: Clinical Results with a 27-Month Follow-Up

Abstract

BackgroundThe aim of the study was to evaluate the safety and effectiveness of a novel closed-loop gastric electric stimulation device (abiliti® system) featuring a transgastric sensor to detect food intake and an accelerometer to record physical activity to induce and maintain lifestyle changes to treat obesity.MethodsIn a prospective, multi-center study, 34 obese subjects (BMI of 42.1 ± 5.3 kg/m2) who passed an eligibility evaluation were implanted with the abiliti system. Safety evaluation included an endoscopic exam to assess the intragastric electrode healing. Efficacy evaluation at 1 year of therapy included weight loss, improvements in eating, and exercise behavior and quality of life.ResultsThe transgastric implant controlled by endoscopy was stable for all participants. At 12 months (12 M) the mean excess weight loss (EWL) was 28.7 % (95%CI, 34.5 to 22.5 %), and mean reduction in BMI was 4.8 ± 3.2 kg/m2. At 27 months (27 M), the EWL was 27.5 % (95 % CI, 21.3 % to 33.7 %). Eating behavior, evaluated by the “Three Factor Eating Questionnaire”, showed a significant increase in the cognition factor and decrease in the disinhibition and hunger factors at 12 M in comparison to baseline (p < 0.001). Participants significantly increased their weekly physical activity (p < 0.001). Quality of life was improved in 55.2 % of the patients.ConclusionsGastric electrical stimulation with abiliti system in obese participants is well tolerated and leads to significant 12 M weight loss, which was stable to 27 M. We suggest that weight loss is achieved due to the assessed alteration of eating behavior in particular the reduction in disinhibition and hunger, and the measured increase in physical activity.

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

“…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.…”

Clinical practice guidelines of the European Association for Endoscopic Surgery (EAES) on bariatric surgery: update 2020 endorsed by IFSO-EC, EASO and ESPCOP

“…Three cohort studies reported on the abiliti® device and 1-year follow-up [141][142][143]. EWL ranged from 28.7 to 49.3%.…”

Can Vestibular Stimulation be Used to Treat Obesity?

“…There are currently two neuromodulation devices available for the treatment of obesity. Namely, the Maestro, which targets the vagus nerve (a major parasympathetic nerve), and the Abiliti, which stimulates the nerves of the stomach wall . However, unlike GVS, both these devices require surgical implantation and, because of the risks this entails, they are restricted, in the jurisdictions where approved, to only the most obese patients.…”

“…Namely, the Maestro, which targets the vagus nerve (a major parasympathetic nerve), [76] and the Abiliti, which stimulates the nerves of the stomach wall. [77] However, unlike GVS, both these devices require surgical implantation and, because of the risks this entails, they are restricted, in the jurisdictions where approved, to only the most obese patients. There are also a variety of medications approved for the treatment of obesity, several of which, in a manner analogous to the proposed mechanism of action for GVS, target brain centers involved in energy homeostasis.…”