Electrical stimulation therapy of the lower esophageal sphincter is successful in treating GERD: final results of open-label prospective trial

Abstract

BackgroundElectrical stimulation of the lower esophageal sphincter (LES) improves LES pressure without interfering with LES relaxation. The aim of this open-label pilot trial was to evaluate the safety and efficacy of long-term LES stimulation using a permanently implanted LES stimulator in patients with gastroesophageal reflux disease (GERD).MethodsGERD patients who were at least partially responsive to proton pump inhibitors (PPI) with abnormal esophageal pH, hiatal hernia ≤3 cm, and esophagitis ≤LA grade C were included. Bipolar stitch electrodes were placed in the LES and an IPG was placed in a subcutaneous pocket. Electrical stimulation was delivered at 20 Hz, 215 μs, 3–8 mA in 30 min sessions. The number and timing of sessions was tailored to each patient’s GERD profile. Patients were evaluated using GERD-HRQL, daily symptom and medication diaries, SF-12, esophageal pH, and high-resolution manometry.Results24 patients (mean age = 53 years, SD = 12 years; 14 men) were implanted; 23 completed their 6-month evaluation. Median GERD-HRQL scores at 6 months was 2.0 (IQR = 0–5.5) and was significantly better than both baseline on-PPI [9.0 (range = 6.0–10.0); p < 0.001] and off-PPI [23 (21–25); p < 0.001] GERD-HRQL. Median% 24-h esophageal pH < 4.0 at baseline was 10.1 and improved to 5.1 at 6 months (p < 0.001). At their 6-month follow-up, 91 % (21/23) of the patients were off PPI and had significantly better median GERD-HRQL on LES stimulation compared to their on-PPI GERD-HRQL at baseline (9.0 vs. 2.0; p < 0.001). There were no unanticipated implantation- or stimulation-related adverse events or untoward sensation due to stimulation. There were no reports of treatment-related dysphagia, and manometric swallow was also unaffected.ConclusionsElectrical stimulation of the LES is safe and effective for treating GERD. There is a significant and sustained improvement in GERD symptoms, esophageal pH, and reduction in PPI usage without any side effects with the therapy. Furthermore, the therapy can be optimized to address an individual patient’s disease.

Strategies to improve outcomes in esophageal adenocarcinoma

“…Importantly, LES stimulation is not associated with any sensation or side effects and the stimulation can be tailored to the patient's symptoms. In an open-label study, median percentage of 24-h esophageal pH <4.0 was reduced from 10.1 (7.8-13.0) to 3.3 (1.8-6.9); p < 0.001 [35,36]. Good quality randomized trials with appropriate follow-up are now required to determine the efficacy of these devices for GERD treatment, before considering neoplasia prevention.…”

Electrical Stimulation Therapy for Gastroesophageal Reflux Disease

“…11 In short, after trocar placement, dissection of fat tissue is performed to expose the muscle wall of the distal esophagus. In the presence of a small hiatal hernia, repair by caudal retraction of the esophagus and tightening of the hiatus by standard surgical procedure is indicated.…”

“…[11][12][13] In the first open-label, single center trial performed in Chile, 25 GERD patients (14 men, mean age 52 years) with chronic (> 6 months) GERD symptoms, such as heartburn, regurgitation or retrosternal pain were included. GERD was well documented by 24-hour pH-monitoring and upper GI endoscopy, showing pathologic acid exposure time (pH < 4.0 during > 5.0% of time) and/or esophagitis.…”

New Options for the Management of GERD

“…The device is tested intraoperatively and turned on 12 h after the procedure. Electrical stimulation parameters reported in prior studies were 20 Hz, 215 ms and 3-8 mA in 30-min sessions [22]. Patients are typically discharged home on postoperative day 1; it is unclear from these series whether they were on PPIs or diet restricted.…”

“…The EndoStim device is placed laparoscopically as described by Rodriquez et al [22]. The GEJ is dissected with care to preserve the phrenoesophageal ligament and vagus nerve branches.…”