Effect of electrical stimulation therapy of the lower esophageal sphincter in GERD patients with ineffective esophageal motility

Abstract

Background Electrical stimulation therapy (EST) of the lower esophageal sphincter (LES) is a novel technique in antireflux surgery. Due to the minimal alteration at the LES during surgery, LES-EST is meant to be ideal for patients with gastroesophageal reflux disease (GERD) and ineffective esophageal motility (IEM). The aim of this prospective trial (NCT03476265) is to evaluate health-related quality of life and esophageal acid exposure after LES-EST in patients with GERD and IEM. Methods This is a prospective non-randomized open-label study. Patients with GERD and IEM undergoing LES-EST were included. Follow-up (FUP) at 12 months after surgery included health-related quality of life (HRQL) assessment with standardized questionnaires (GERD-HRQL) and esophageal functional testing. Results According to the study protocol, 17 patients fulfilled eligibility criteria. HRQL score for heartburn and regurgitation improved from 21 (interquartile range (IQR) 15–27) to 7.5 (1.25–19), p = 0.001 and from 17 (11–23.5) to 4 (0–12), p = 0.003, respectively. There was neither significant improvement of esophageal acid exposure nor reduction of number of reflux events in pH impedance measurement. Distal contractile integral improved from 64 (11.5–301) to 115 (IQR 10–363) mmHg s cm, p = 0.249. None of the patients showed any sign of dysphagia after LES-EST. One patient needed re-do surgery and re-implantation of the LES-EST due to breaking of the lead after one year. Conclusion Although patient satisfaction improved significantly after surgery, this study fails to demonstrate normalization or significant improvement of acid exposure in the distal esophagus after LES-EST.

Neuromodulation for functional upper gastrointestinal diseases

“…It resulted in a reduction of acid reflux from 10% to 4% and normalization of acid reflux in 71% of the patients after 24-month treatment. [63] However, another open-label study in 17 patients with GERD and ineffective esophageal motility, the same method of electrical stimulation at LES failed to demonstrate normalization or significant improvement of acid exposure in the distal esophagus although patients satisfaction was improved. [64] It remains to be determined whether this novel LES electrical stimulation method will gain regulatory approval for treating GERD.…”

Advanced Endoscopic Imaging and Interventions in GERD: An Update and Future Directions

“…It obtained the CE mark in 2012. Currently, most of the studies involve the placement of this device laparoscopically ( 56 , 57 ). Banerjee et al conducted a study with a device placed endoscopically.…”