title: Effect of electrical stimulation of the lower esophageal sphincter using endoscopically implanted temporary stimulation leads in patients with reflux disease.
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.
authors.affiliation: Asian Institute of Gastroenterology, 6-3-661, Somajiguda, Hyderabad, 500 082, India, dr_rupa_banerjee@hotmail.com.
authors.forename: Rupa
authors.initials: R
authors.lastname: Banerjee
authors.forename: Nitesh
authors.initials: N
authors.lastname: Pratap
authors.forename: Rakesh
authors.initials: R
authors.lastname: Kalpala
authors.forename: D Nageshwar
authors.initials: DN
authors.lastname: Reddy
mesh_terms: D000328:Adult; D000818:Animals; D004599:Electric Stimulation Therapy / Q000295:instrumentation*; D004567:Electrodes, Implanted; D016099:Endoscopy, Gastrointestinal / Q000379:methods*; D004867:Equipment Design; D049630:Esophageal Sphincter, Lower / Q000503:physiopathology*; D005240:Feasibility Studies; D005500:Follow-Up Studies; D005764:Gastroesophageal Reflux / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D008297:Male; D051379:Mice; D013997:Time Factors; D016896:Treatment Outcome