Effect of electrical stimulation of the lower esophageal sphincter using endoscopically implanted temporary stimulation leads in patients with reflux disease

Surg Endosc. 2014 Mar;28(3):1003-9. doi: 10.1007/s00464-013-3271-2. Epub 2013 Oct 30.

Abstract

Background: Electrical stimulation therapy (EST) has been shown to increase lower esophageal sphincter (LES) pressure in animals; however, data on the effect of EST on LES pressure in patients with gastroesophageal reflux disease (GERD) are lacking.

Objective: The aim of our study was to investigate the effect of EST on LES pressure and esophageal function in patients with GERD.

Methods: Patients with a diagnosis of GERD responsive to proton pump inhibitors (PPIs), increased esophageal acid on 24-h pH monitoring off GERD medications, basal LES pressure >5 mmHg, hernia <2 cm and esophagitis <LA grade B were included. A temporary pacemaker lead was placed endoscopically in the LES by creating a 3 cm submucosal tunnel, secured to the esophagus using endoscopic clips along the body of the lead and exteriorized nasally. EST was delivered 6-12 h post-implant per protocol using (i) short-pulse 200 μs, 20 Hz, and (ii) intermediate-pulse 3 ms, 20 Hz, each for 20 min at varying amplitudes. High-resolution manometry was performed pre-, during and post-EST. Symptoms of heartburn, chest or abdominal pain and dysphagia pre-, during and post-stimulation and 7 days post-procedure were recorded. Continuous cardiac monitoring was performed during and after the EST to evaluate any effect of EST on cardiac rhythm.

Results: Six male patients (mean age 34.6 years) underwent successful endoscopic lead implantation; the first patient had premature lead dislodgement and did not undergo EST. The remaining five patients underwent successful EST. All patients had a significant increase in LES pressure with all sessions of EST. There was no effect on swallow-induced LES relaxation, And there were no EST-related adverse symptoms or any cardiac rhythm abnormalities.

Conclusions: In patients with GERD, short-term EST delivered using electrodes endoscopically implanted in the LES results in a significant increase in LES pressure without affecting patients' swallow function or causing any adverse symptoms or cardiac rhythm disturbances. EST may offer a novel therapy to patients with GERD.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Animals
  • Electric Stimulation Therapy / instrumentation*
  • Electrodes, Implanted*
  • Endoscopy, Gastrointestinal / methods*
  • Equipment Design
  • Esophageal Sphincter, Lower / physiopathology*
  • Feasibility Studies
  • Follow-Up Studies
  • Gastroesophageal Reflux / physiopathology
  • Gastroesophageal Reflux / therapy*
  • Humans
  • Male
  • Mice
  • Time Factors
  • Treatment Outcome