Electrical Stimulation of the LES – An Emerging Therapy for GERD Patients With Failed Esophageal Persitalsis

Alejandro Nieponice, MD, PhD, Juan M Riganti, MD, Franco F Ciotola, MD, Claudio Bilder, MD, Andres DiTaranto, MD, Fabio Nachman, MD, Adolfo E Badaloni, MD. Fundacion Favaloro

Introduction: Antireflux surgery for GERD associated with failed peristalsis can be a challenge . Traditional antireflux surgery such as Nissen fundoplication is associated with high rates of dysphagia and Roux-en-y reconstruction is a significantly more invasive procedure. Partial fundoplications are traditionally employed but are not as effective in controlling reflux. Electrical stimulation of the LES (LES-EST) has emerged as a new alternative for the treatment of GERD. Briefly, the technology involves a laparoscopically implantable neurostimulator with two electrodes implanted at the LES that provide programmed electrical stimuli to improve LES function. Open-label trials report successful control of symptoms, near elimination of dependence on acid suppression medications and significant improvement of esophageal acid exposure up to three-year follow-up. Manometric studies reveal no negative effect on LES relaxation, making it an attractive treatment option for GERD patients with failed peristalsis. We report the outcome of LES-EST in 3 such patients.

Methods: Three patients (mean age = 58;men = 2) diagnosed with severe GERD and failed peristalsis (aperistalsis -2; failed peristalsis – 1); were found eligible for LES-EST and agreed to undergo the procedure. Peristalsis was assessed with high resolution manometry and reflux disease was diagnosed with Multichannel Intraluminal Impedance-pH testing (MII-pH). The LES Stimulation system (EndoStim, BV, The Hague, The Netherlands) was implanted using standard technique (Surg Endosc. 2013;27:1083-92)and stimulation was delivered in 12, 30 minute sessions of 5mA, 215usec, at 20Hz. Postop follow-up endpoints included clinical symptoms, PPI intake, HRM, MII-pH and Barium Swallow. Mean follow-up was 6 months (2-10)
Results: Surgical implant was completed successfully LES-EST was initiated in all cases. At their last follow-up ( 8, 6 and 2 months after implantation), all patients were free of GERD symptoms and medication use with no dysphagia associated with LES-EST. First patients with aperistalsis showed normalization of his MII-pH reflux events, a 50% improvement in his LES pressure (LES-EEP 7mmHg at baseline to 10.5mm Hg at 6 month) and improvement in esophageal body function with 40% peristaltic contractions at follow-up (0% baseline). The patient with frequent failed peristalsis showed normal barium swallow with no emptying delay and no spontaneous reflux. The third patient with aperistalsis was free of GERD symptoms and off-PPI medications at her 2 month follow-up and awaits 6 month esophageal function evaluation.

Conclusions: Our small case-series represents the first report of successful use of LES-EST in patients with GERD associated with severe esophageal dysmotility..Early results confirm that LES-EST is a safe and effective treatment modality in such patients without any associated dysphagia in this particular patient population. The lack of dysphagia is particularly encouraging. Further experience is required to fully assess the role of LES-EST in this difficult group of patients