Leonardo Rodriguez1, Patricia Rodriguez1, Beatriz Gomez1, Juan Ayala2, Daniel Oxenberg2, Alberto Perez-Castilla2, Manoel Netto3, Edy Soffer4, Michael Crowell5. 1Surgery, CCO Obesidad Y Diabetes, Santiago, Chile, 2Gastroenterology, Clinic Indisa, Santiago, Chile, 3Surgery, Gastro Obeso Center, Sao Paulo, Brazil, 4University of Southern California, Los Angeles, CA, 5Mayo Clinic in Arizona, Scottsdale, AZ .
BACKGROUND: We have previously reported that LES-EST significantly improves esophageal acid exposure and symptoms in GERD patients, and the effect is sustained through 2 years of follow-up. (UEG Journal 2013; 1:A111)
AIM: To study the cohort of patients who completed the above open-label trial of 2 years of LES-EST over a 5-year follow-up period, as part of a registry study. We report the results of this cohort at 3 year follow-up.
METHODS: Patients consenting to join the 5-year registry study were evaluated with GERD-HRQL, symptom diaries, and esophageal pH testing for their 3 year follow-up. Patients in this study were at least partially responsive to proton pump inhibitors (PPI) at baseline with off-PPI GERD-HRQL >20 and score improvement of ≥10 points when on PPI, %24-hour esophageal pH <4.0 for >5%, hiatal hernia <3cm and esophagitis
RESULTS: Twenty-five patients were implanted as part of the pilot trial, 21 completed their 24-month follow-up. 18 completed their 3-year evaluation, of which 15 were receiving continuous stimulation with parameters of 20 Hz, 215usec, 5mAmp, in 30-minute sessions, 12 times per day, prior to the 3-year follow-up. Three patients were not receiving EST prior to their 3-year follow-up visit and were not included in this analysis
Patients’ median (IQR) GERD-HRQL scores significantly improved from baseline on-PPI of 9 (6-10) and baseline off-PPI of 22 (21-24) to 1 (0-2) at 3 year follow-up (p<0.001 vs. BL on and off-PPI). 100% of patients demonstrated clinically meaningful reduction in GERD-HRQL (GERD-HRQL score at 3 years at least 50% improved from baseline off-PPI), and 100% of patients reported lower (better) GERD-HRQL at 3 years compared to their baseline PPI therapy.
Patients’ median (IQR) distal esophageal acid exposure measured by 24-hour pH-metry significantly improved from 10.3 (7.5-11.6) % at baseline to 3.0 (1.9-5.6) % at 3-year follow-up (p<0.001). All patients demonstrated an improvement in their distal esophageal acid exposure with 73% normalized (pH <4.0 for ≤4%; 10/15; 67%) or improved at least 50% (1/15; 6%). The remaining 4 patients demonstrated improvements of 20-47% from baseline.
All but one patient (14/15; 93%) reported cessation of regular PPI use (>50% of days with PPI use); 3 (20%) patients reported occasional PPI use (<50% of days with PPI use).
There were no unanticipated device or stimulation-related adverse events or untoward sensation reported between the 2 and 3-year follow-up period. There were no complaints of dysphagia.
CONCLUSION: LES-EST is safe and effective for treating GERD over a 3-year period. There was a significant and sustained improvement in esophageal acid exposure, GERD symptoms and medication use. There were no therapy related adverse events reported.