Electrical stimulation therapy of the lower esophageal sphincter in GERD patients—a prospective single-center study

Abstract

Background: Electrical stimulation therapy (EST) of the lower esophageal sphincter (LES) for gastro esophageal reflux disease (GERD) treatment increases LES pressure through chronic stimulation, with a low risk for gastrointestinal side effects and preservation of hiatal anatomy. The aim of this study was to evaluate the efficacy and safety of this novel technique in a high-output specialized reflux center. Methods: This is a prospective single-center study including GERD patients indicated for anti-reflux therapy who consented to undergo LES-EST. Patients underwent prospective scheduled follow-up visits including interrogation of the stimulation device, clinical examination, and assessment of health-related quality of life (HRQL). Results: Within a 4-year period, 37 LES-EST implantations were performed. The majority of patients were male (54.1%), mean BMI was 25.8 (SD 4.4), and mean age was 54.0 (SD 15.8). The median GERD HRQL composite score was 41 (IQR 21–49). Median total % of pH <4 was 10.1 (IQR 4.4–17.3). Six (16.2%) individuals underwent explantation of the entire system (IPG and leads) due to technical defect (n = 4) or failure of therapy (n = 2). HRQL score improved from 41 (IQR 21–49) to 8.50 (IQR 4.25–20.5, p < 0.001) and 9 (23.7%) patients were on at least occasional PPI treatment. Conclusion: Due to the low rate of GI side effects and its minimal invasive character preserving the hiatal anatomy, this novel technique might find its place in anti-reflux surgery. However, the considerably high rate of device dysfunction needs further investigation.