Abstract
Background and AimsTo assess safety of the Exilis™ gastric electrical stimulation (GES) system and to investigate whether the settings can be adjusted for comfortable chronic use in subjects with morbid obesity. Gastric emptying and motility and meal intake were evaluated.MethodIn a multicenter, phase 1, open prospective cohort study, 20 morbidly obese subjects (17 female, mean BMI of 40.8 ± 0.7 kg/m2) were implanted with the Exilis™ system. Amplitude of the Exilis™ system was individually set during titration visits. Subjects underwent two blinded baseline test days (GES ON vs. OFF), after which long-term, monthly follow-up continued for up to 52 weeks.ResultsThe procedure was safe, and electrical stimulation was well tolerated and comfortable in all subjects. No significant differences in gastric emptying halftime (203 ± 16 vs. 212 ± 14 min, p > 0.05), food intake (713 ± 68 vs. 799 ± 69 kcal, p > 0.05), insulin AUC (2448 ± 347 vs. 2186 ± 204, p > 0.05), and glucose AUC (41 ± 2 vs.41 ± 2, p > 0.05) were found between GES ON and OFF. At week 4, 13, and 26, a significant (p < 0.01) reduction in weight loss was observed but not at week 52. At this time point, the mean excess weight loss (EWL) was 14.2 ± 4.5%.ConclusionGastric electrical stimulation with the Exilis™ system can be considered as safe. No significant effect on food intake, gastric emptying, or gastric motility was observed. The reduction in weight loss with Exilis™ GES was significant but short lasting. Further electrophysiological research is needed to gain more insight in optimal stimulation parameters and lead localization.
Highlights
Bariatric surgery is the only long-term effective treatment for morbid obesity
The technique aims to impair gastric motor function and to modulate afferent signaling from the stomach, leading to delayed gastric empting with prolonged gastric distension and enhanced satiety, resulting in decreased food intake and weight loss [6]
All patients were discharged after one night, and none of the patients had to be readmitted
Summary
Only a small percentage of potentially eligible subjects will ever undergo a bariatric procedure [1] Bariatric surgical procedures such as laparoscopic adjustable gastric banding (LAGB), laparoscopic sleeve gastrectomy (LSG), and Roux-en-Y gastric bypass (RYGB) [2, 3] modify gastrointestinal anatomy and physiology, require lifelong medical surveillance, and are associated with a considerable amount of complications and long-term adverse effects such as GERD, chronic vomiting, dumping syndrome, and nutritional deficiencies. Taking the abovementioned considerations into account, there is room for other, less invasive therapies for morbid obesity To assess safety of the ExilisTM gastric electrical stimulation (GES) system and to investigate whether the settings can be adjusted for comfortable chronic use in subjects with morbid obesity. Subjects underwent two blinded baseline test days (GES ON vs. OFF), after which long-term, monthly follow-up continued for up to 52 weeks
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