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

Abstract

Summary 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.