Electrical stimulation therapy of the lower esophageal sphincter is successful in treating GERD: long-term 3-year results.
Electrical stimulation of the lower esophageal sphincter (LES) has been shown to improve outcomes in patients with gastroesophageal reflux disease (GERD) at 2 years. The aim of the study was to evaluate the safety and efficacy of LES stimulation in the same cohort at 3 years.



GERD patients with partial response to PPI, with % 24-h esophageal pH < 4.0 for >5 %, with hiatal hernia <3 cm and with esophagitis ≤LA grade C were treated with LES stimulation in an open-label 2-year trial. All patients were on fixed stimulation parameter of 20 Hz, 220 μs, 5 mA delivered in twelve, 30-min sessions. After completing the 2-year open-label study, they were offered enrollment into a multicenter registry trial and were evaluated using GERD-HRQL, symptom diaries and pH testing at their 3-year follow-up.



Fifteen patients completed their 3-year evaluation [mean (SD) age = 56.1 (9.7) years; men = 8] on LES stimulation. At 3 years, there was a significant improvement in their median (IQR) GERD-HRQL on electrical stimulation compared to both their on PPI [9 (6-10) vs. 1 (0-2), p = 0.001] and off PPI [22 (21-24) vs. 1 (0-2), p < 0.001]. Median 24-h distal esophageal acid exposure was significantly reduced from [10.3 (7.5-11.6) % at baseline vs. 3 (1.9-4.5) %, p < 0.001] at 3 years. Seventy-three % (11/15) patients had normalized their distal esophageal acid exposure at 3 years. Remaining four patients had improved their distal esophageal acid exposure by 39-48 % from baseline. All but four patients reported cessation of regular PPI use (>50 % of days with PPI use); three had normal esophageal pH at 3 years. There were no unanticipated device- or stimulation-related adverse events or untoward sensation reported during the 2- to 3-year follow-up.



LES-EST is safe and effective for treating patients with GERD over long-term, 3-year duration. There was a significant and sustained improvement in esophageal acid exposure and reduction in GERD symptoms and PPI use. Further, no new GI side effects or adverse events were reported.
Centro Clinico de Obesidad Diabetes y Reflujo, Santiago, Chile.
Leonardo
L
Rodríguez
Centro Clinico de Obesidad Diabetes y Reflujo, Santiago, Chile.
Patricia A
PA
Rodriguez
Centro Clinico de Obesidad Diabetes y Reflujo, Santiago, Chile.
Beatrice
B
Gómez
Department of Surgery, Gastro Obeso Center, Sao Paulo, Brazil.
Manoel Galvao
MG
Netto
Department of Gastroenterology, Mayo Clinic, Scottsdale, AZ, USA.
Michael D
MD
Crowell
Department of Medicine, Keck School of Medicine at the University of Southern California, Los Angeles, CA, USA. esoffer@usc.edu.
Edy
E
Soffer
D002677:Chile; D004599:Electric Stimulation Therapy; D049630:Esophageal Sphincter, Lower / Q000503:physiopathology*; D004941:Esophagitis / Q000628:therapy; D005260:Female; D005764:Gastroesophageal Reflux / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D011788:Quality of Life; D012042:Registries
D054328:Proton Pump Inhibitors
Electrical stimulation; Esophageal acid; GERD; Lower esophageal sphincter; Outcomes; Treatment