Endoscopically Implanted, Self-Powered, Vagal Nerve Stimulation Device: Experimental Feasibility Study.

Abstract

Background: The prevalence of metabolic disorders and obesity is increasing worldwide. The underlying pathogenetic mechanisms include an imbalance of the autonomic nervous system secondary to a relative decrease of the parasympathetic vagal tone or increase of the sympathetic tone. Previous clinical experience with a surgically implanted gastric pacemaker for morbid obesity showed that augmenting the vagal tone effects satiety and weight control. The aim of this study was to assess the feasibility of endoscopic implantation of a brain-neuromodulator (BNM) within the proximal gastric wall. Methods: Experimental study testing the prototype of an original, self-powered BNM implanted in pigs through upper gastrointestinal endoscopy. The miniaturized electronic device, designed to deploy depolarization signals through the afferent fibers of the vagus nerve, was placed submucosally at the level of the proximal lesser gastric curve. The feasibility, biocompatibility, and biosafety of the procedure were evaluated radiologically, endoscopically, and at the time of the explant. Heart rate variability (HRV) was assessed at baseline and during and after the procedure to measure changes in the vagal tone. Results: The procedure was uncomplicated, and the BNM remained in a stable position at the level of the lesser gastric curve without notable side effects or device displacement as assessed radiologically and endoscopically. Compared to baseline measurements, post-procedural HRV consistently increased, confirming that signaling through the afferent vagal pathway has the potential to increase parasympathetic tone. Autopsy showed that the device was in the original position, embedded in the gastric wall and without any sign of transmural ulceration. Conclusions: This feasibility study shows that a miniaturized battery-free and catheter-free BNM can be placed endoscopically in the submucosal layer of the lesser gastric curve. The device was well-tolerated, biocompatible, and safe. Rigorous validation of the physiological endpoints and optimization of the stimulation parameters are necessary for future clinical application of BNM.