Radiofrequency energy delivered to the gastroesophageal junction for the treatment of GERD

Background: In this multi-center study, the feasibility, safety, and effici ency of radiofrequency (RF) energy delivery to the gastroesophageal junctio n (GEJ) for the treatment of gastroesophageal reflux disease (GERD) were in vestigated. Methods: Forty-seven patients with classic symptoms of GERD (heartburn and/ or regurgitation), a daily anti-secretory medication requirement, and at le ast partial symptom response to drugs were enrolled. All patients had patho logic esophageal acid exposure by 24-hour pH study, a 2 cm or smaller hiata l hernia, grade 2 or less esophagitis, and no significant dysmotility of dy sphagia. RF energy was delivered with a catheter and thermocouple-controlle d generator to create submucosal thermal lesions in the muscle of the GEJ. GERD symptoms and quality of life were assessed at 0, 1, 4, and 6 months wi th short-form health survey (SF-36). Anti-secretory medications were withdr awn 7 days before each assessment of symptoms and pH/motility study. Medica tion use, endoscopic findings, esophageal acid exposure, and motility were assessed at 0 and 6 months. Results: Thirty-two men and 15 women underwent treatment. At 6 months there were improvements in the median heartburn score (4 to 1, p less than or eq ual to 0.0001), GERD score (26 to 7, p less than or equal to 0.0001), satis faction (1 to 4, p less than or equal to 0.0001), mental SF-36 (46.2 to 55. 5, p less than or equal to 0.01), physical SF-36 (41.1 to 51.9, p less than or equal to 0.0001), and esophageal acid exposure (11.7% to 4.8%, p less t han or equal to 0.0001). Esophagitis was present in 25 patients before trea tment (15 grade 1 and 10 grade 2) and 8 had esophagitis at 6 months (4 grad e 1 and 4 grade 2, p less than or equal to 0.005). At 6 months, 87% no long er required proton pump inhibitor medication. There was no significant chan ge in median lower esophageal sphincter pressure (14.0 to 12.0 mm Hg, p = 0 .19), peristaltic amplitude (64 to 666 mm Hg, p = 0.71), or lower esophagea l sphincter length (3.0 to 3.0, p = 0.28). There were 3 self-limited compli cations (fever for 24 hours, odynophagia lasting for 5 days, and a linear m ucosal injury that was healed after 3 weeks). Conclusion: RF energy delivery significantly improved GERD symptoms, qualit y of life, and esophageal acid exposure while eliminating the need for anti -secretory medication in the majority of patients of patients with a hetero genous spectrum of clinical disease severity but with minimal active esopha gitis or hiatal hernia.