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Lower esophageal sphincter electrical stimulation eliminated PPI use for most
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SAN DIEGO — Patients treated with lower esophageal sphincter electrical stimulation therapy demonstrated sustained and significant improvement in esophageal acid exposure and GERD symptoms, a speaker said here.
“There was elimination of [proton pump inhibitor] use in almost 90% of patients, 86% success rate in control of GERD symptoms, improved quality-of-life scores and no device-related serious adverse events” at 6-month follow-up, Edy Soffer, MD, professor of clinical medicine, department of medicine/division of gastroenterology, University of Southern California, said during the American College of Gastroenterology Annual Scientific Meeting.
The ongoing, international, multicenter trial examined lower esophageal sphincter electrical stimulation therapy (LES-EST) in refractory GERD patients considered partially responsive to PPI. To date, 25 patients have been implanted; 20 have completed a 3-month evaluation, and 17 have completed a 6-month evaluation.
Median off-PPI GERD-HRQL score improved from 32 at baseline to 4 at 3 months (P<.001) and 5 at 6 months (P<.001), Soffer said. Significant improvement also was demonstrated in comparison to baseline on-PPI GERD-HRQL scores of 16.5 (P<.01).
Median esophageal pH improved from 11.8% at baseline to 3.6% (P<.001) at 3 months and 3.5% (P<.001) at 6 months, he said.
Fifteen of 17 of patients discontinued all PPI medication at 6 months.
Fifty adverse events have been reported in 17 patients. Serious adverse events included a trocar perforation during implantation and one case of AV nodal reentrant tachycardia that was not device- or procedure-related and was successfully ablated.
Of the 48 nonserious events, 26 are considered possible or probable device- or procedure-related and one is definite procedure related, Soffer said. Two instances of mild, transient dysphagia occurred in nine patients undergoing hiatus closure at implantation; both resolved within 4 weeks without intervention. No stimulation-related GI side effects or sensations were reported.
Continuing studies and future sham control studies are planned to clarify how this intervention may be used in treatment of GERD, Soffer said.
Disclosure: The study was supported by an industry grant from EndoStim BV.
For more information:
Siersema P. #2: Electrical Stimulation Therapy (EST) of the Lower Esophageal Sphincter (LES) – An Effective Therapy for Refractory GERD – Interim Results of an International Multicenter Trial. Presented at: the 2013 American College of Gastroenterology Annual Scientific Meeting; Oct. 11-16, San Diego.