Alex Escalona, MD, Jelle P Ruurda, MD, Mark I Van Berge Henegouwen, MD, PhD, Philip Chiu, MD
Pontificia Universidad Catolica de Chile, University Medical Center, Academic Medical Center, The Chinese University of Hong Kong
INTRODUCTION: A previous trial showed that LES-EST significantly improves esophageal acid exposure and symptoms in GERD patients. (In Press Surg Endosc)
AIMS: The aim of this international multicenter trial was to evaluate the safety and efficacy of LES-EST in refractory GERD patients.
METHODS: We studied GERD patients partially responsive to PPI with off-PPI GERD HRQL >20, LES end-expiratory pressures of >5 mmHg, % 24 hour esophageal pH<4 for >5%, hiatal hernia < 3cm and esophagitis < LA Grade C. Bipolar stitch electrodes and a pulse generator (EndoStim BV, Hague, Netherland) were implanted laparoscopically. EST at 20 Hz, 220usec, 5-8mAmp in 6-12, 30 minutes sessions was initiated post-implant. Patients are evaluated using GERD-HRQL, symptom diaries, SF-12, esophageal pH and manometry at regular intervals. Stimulation sessions are optimized based on residual symptoms and esophageal pH.
RESULTS: Thirteen patients (mean age 51; men=9) have been enrolled and implanted with the LES stimulator. One patient suffered a trocar perforation of small bowel during the implant that was recognized post-op day 1. Patient underwent successful repair and the device was prophylactically explanted. The remaining twelve patients are continuing with the LES-EST; 11 patients have completed their 3 month and 7 their 6 month evaluation. The median (IQR) off-PPI GERD-HRQL scores at baseline were 30 (24-37), which improved to 6 (4-11) on EST at months 3, (p<0.001) and 9 (7-13) at month 6 (p<0.01). There was improvement compared to the on-PPI GERD-HRQL scores of 19 (8-22) at baseline. Patients median esophageal pH was 12.4% (8.8-15) at baseline and improved to 3.6% (2-10, p=0.07) at 3 months and 4.2% (2.7-6.7, p=0.01) at 6 months. Ninety-two% (11/12) patient had > 50% improvement in their off-PPI GERD-HRQL and were able to discontinue PPI use, 83% (10/12) patients had either normalized or >50% improvement in their esophageal acid exposure. Thirteen AEs including 1 SAE were reported in 4 patients. Nine were related to the device or procedure, 7 non-severe events were pain at the implant site and 1 post-op nausea.
CONCLUSION: Preliminary results show that LES-EST can be effective in treating PPI refractory GERD. There was a significant improvement in patient’s symptom, PPI usage and trend in improvement in their esophageal acid exposure. LES-EST was safe with no GI or cardiac side-effects. Long-term results in a larger group of patients are being collected to establish safety and efficacy of LES-EST in refractory GERD.
Session: Poster Presentation
Program Number: P256