1. Implanted Closed-Loop Gastric Electrical Stimulation (CLGES) System with Sensor-Based Feedback Safely Limits Weight Regain at 24 Months.
- Author
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Morales-Conde, S., Alarcón del Agua, I., Socas-Macias, M., Barranco-Moreno, A., Busetto, L., Favretti, F., Anselmino, M., Rovera, G. M., Province-Azalde, R., and Torres, A. J.
- Subjects
ELECTRIC stimulation ,WEIGHT gain prevention ,ARTIFICIAL implants ,CLOSED loop systems ,STOMACH ,WEIGHT loss ,PATIENT safety ,CARDIOVASCULAR diseases risk factors ,EQUIPMENT & supplies - Abstract
Background: Weight regain following bariatric surgery is not uncommon. Safe, effective weight loss treatment up to 1 year has been reported with the closed-loop gastric electrical stimulation (CLGES) system. Continuous recording of eating and activity behavior by onboard sensors is one of the novel features of this closed-loop electrical stimulation therapy, and may provide improved long-term weight maintenance by enhancing aftercare.Methods: Four centers participating in a 12-month prospective multicenter randomized study monitored all implanted participants (n = 47) up to 24 months after laparoscopic implantation of a CLGES system. Weight loss, safety, quality of life (QOL), and cardiac risk factors were analyzed.Results: Weight regain was limited in the 35 (74%) participants remaining enrolled at 24 months. Mean percent total body weight loss (%TBWL) changed by only 1.5% between 12 and 24 months, reported at 14.8% (95% CI 12.3 to 17.3) and 13.3% (95% CI 10.7 to 15.8), respectively. The only serious device-/procedure-related adverse events were two elective system replacements due to lead failure in the first 12 months, while improvements in QOL and cardiovascular risk factors were stable thru 24 months.Conclusion: During the 24 month follow-up, CLGES was shown to limit weight regain with strong safety outcomes, including no serious adverse events in the second year. We hypothesize that CLGES and objective sensor-based behavior data combined to produce behavior change. The study supports CLGES as a safe obesity treatment with potential for long-term health benefits.Trial registration:
ClinicalTrials.gov identifier: NCT01448785 [ABSTRACT FROM AUTHOR] more...- Published
- 2018
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