Radiofrequency Correction of GERD (Stretta) Results in Significant, Long Term 4-Year Improvement in Symptoms, Quality of Life and Medication Use in the Medically Refractory GERD Patient Mark D. Noar, Sahar Lotfi A single center, intent to treat, trial of long-term efficacy and safety of the Stretta procedure for treatment of medically refractory GERD despite multi-dose PPI medical therapy was conducted. Methods: Beginning August 2000, 109 subjects with documented GERD and/or regurgitation and inadequate symptom control despite minimum bid PPI had an outpatient Stretta procedure via conscious sedation by one doctor (MN), and were followed for 4C years. Patients with normal anatomy, or failed Nissen, large (O3 cm) hiatal hernia, erosive esophagitis, and Barrett’s metaplasia were included. Exclusion criteria were: ASAOIII, collagen vascular disease, stricture, or achalasia. Baseline on/off meds and follow-up 6, 12, 24, 36, 48 months GERD-HRQL scores (0-50), heartburn (0-5), satisfaction (0-5) and medication-use were collected. All statistics performed with SAS or JUMP Statistical Analysis Software. Results: 109 subjects entered study. 13/109 failed to respond. 96 responders followed thru year 4. GERD-HRQL, heartburn, satisfaction, and medication use significantly improved at all follow-up intervals 6, 12, 24, 36, 48 months, (p ! 0.001) and were superior to those achieved on baseline drug therapy. At year 4, patients were divided into 4 medication use categories: 1) No meds, 2) PRN antacids/OTC PPI, 3) Daily PPI QD, 4) PPI BID. 75% of patients showed significant improvement into categories 1 or 2 (p ! 0.05). In all parameters, no significant difference between patient scores at baseline on or off meds was noted. A comparative analysis between patients with (33) and without (76) erosive esophagitis showed significant improvement in both groups with no difference between groups, with durability of results maintained to 4 years without statistical difference between the two groups (p O.7). Anatomic differences did not alter success or response to treatment. No acute adverse events or pathological histological changes occurred. Conclusions: 1) The Stretta procedure has a significant positive and sustained effect on medication use, HRQL, satisfaction and GERD symptoms, with durability of response demonstrated at 4 years, 2) The observed improvement was superior to that achieved with escalated baseline antisecretory therapy, and 3) There was no difference in response in patients with variant anatomy such as Nissen fundoplication, hiatal hernia, erosive esophagitis or Barrett’s esophagus.