Electrical neuromodulation of the lower esophageal sphincter for the treatment of gastroesophageal reflux disease

Alejandro Nieponice, Mauricio Ramirez, Adolfo Badaloni, Pedro Renda, Romina Lovera, Jelle P. Ruurda, Mark I. van Berge Henegouwen


Gastroesophageal reflux disease (GERD) is a difficult to treat medical condition. Inadequate symptom control has been cited as one of the main reasons to drive to surgical therapies for GERD. This unmet medical need has led to new attempts at developing less-invasive therapies for the treatment of GERD. Lower esophageal sphincter (LES) electrical neuromodulation has been shown to improve outcomes in GERD, and may represent and alternative of treatment for special subgroups of patients, such as esophageal dysmotility patients, sleeve gastrectomy and lung transplant patients. A concise review of literature was performed through PubMed. We searched to identify published studies reporting on subjective and objective GERD after LES-electrical neuromodulation therapy (ENT). Data evaluated included GERD-health-related quality of life (HRQL), extra esophageal symptoms, PPI discontinuation and patient satisfaction rates, pH-study metrics, severe adverse effects (AEs), and treatment failures. The aim of the review is to summarize the safety and efficacy of LES-ENT in GERD patients reported up to date, including original data from the authors. Two clinical trials have shown safety and efficacy of LES-ENT with both short and long-term follow-up up to 3 years. Results were comparable in a prospective multi-center registry of LES-ENT for GERD with 223 patients from 16 sites in Europe and Latin America with an extended 5-year-follow up. LES-ENT has shown adequate efficacy in symptom control, medication use, acid exposure control, a solid safety profile and may represent an alternative treatment for patients that are not satisfied with PPI therapy, unable to receive a fundoplication or reluctant to undergo reported side effects. LES-ENT allows correction of hiatal hernia when needed, enhancing the effects of neuromodulation that can also be optimized after surgery. This can lead to an expanded indication of surgical therapies for those patients with unmet needs for GERD.