Leonardo Rodriguez, MD, Patricia Rodriguez, RN, Juan C Ayala, MD, Daniel Oxenberg, Alberto Perez-Castilla, MD, Manoel G Netto
Surgery, CCO Obesidad Y Diabetes, Clinic Indisa, Gastro Obeso Center
BACKGROUND: Short-term LES-EST has shown improvement in LES pressure in animals and patients with GERD.
AIM: The aim of this open-label human pilot extension trial was to study the safety and efficacy during chronic LES-EST in GERD patients over longer 1-year follow-up.
METHODS We studied GERD patients at least partially responsive to proton pump inhibitors (PPI) and had off-PPI GERD HRQL>20, % 24 hour esophageal pH<4.0 for >5%, hiatal hernia < 3cm and esophagitis < LA Grade C. Bipolar stitch electrodes and an implantable pulse generator (EndoStim BV, the Hague, Netherlands) was implanted using laparoscopy. EST at 20 Hz, 220usec, 3-8mAmp in 30 minutes, 6-12 sessions was delivered starting on day 1 post-implant. Patients are being evaluated using GERD-HRQL, symptom diaries and SF-12, and esophageal pH testing at regular intervals. Stimulation sessions are optimized based on residual symptoms, pH data when available and lead impedance at follow-up.
RESULTS: Twenty-five patients (mean age= 53+12 years; men=14) were successfully implanted, 23 agreed to participate in the 2 year extension trial and have completed their 12 month evaluation. At 12 months there was a significant improvement in their median GERD-HRQL on LES-EST compared to both their on-PPI (9 vs. 2, p=0.002) and off-PPI (23.5 vs 2, p<0.001) median GERD-HRQL and their median 24-hour distal esophageal acid exposure (10.1 vs 3.1, p<0.001). 77% patients reported either normalization or at least 50% reduction in their distal esophageal acid exposure. All but one patient reported cessation of regular PPI use (>50% of days with PPI use). There were no implantation- or stimulation-related unanticipated adverse events, or untoward sensation due to stimulation. There was no dysphagia and swallowing function assessed by manometry was also unaffected.
CONCLUSION: LES-EST is safe and effective for treating patients with GERD over long-term 1 year duration. There was a significant and sustained improvement in symptoms, esophageal acid exposure and reduction in PPI use. Further, LES-EST is not associated with any GI side-effects or adverse events and can be optimized to individual patient needs.
Session: Poster Presentation
Program Number: P257