Radiofrequency energy delivery to the gastroesophageal junction for the treatment of GERD.
BACKGROUND
In this multi-center study, the feasibility, safety, and efficacy of radiofrequency (RF) energy delivery to the gastroesophageal junction (GEJ) for the treatment of gastroesophageal reflux disease (GERD) were investigated.


METHODS
Forty-seven patients with classic symptoms of GERD (heartburn and/or regurgitation), a daily anti-secretory medication requirement, and at least partial symptom response to drugs were enrolled. All patients had pathologic esophageal acid exposure by 24-hour pH study, a 2 cm or smaller hiatal hernia, grade 2 or less esophagitis, and no significant dysmotility or dysphagia. RF energy was delivered with a catheter and thermocouple-controlled 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 with the short-form health survey (SF-36). Anti-secretory medications were withdrawn 7 days before each assessment of symptoms and pH/motility study. Medication 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 < or = 0.0001), GERD score (26 to 7, p < or = 0.0001), satisfaction (1 to 4, p < or = 0.0001), mental SF-36 (46.2 to 55.5, p = 0.01), physical SF-36 (41.1 to 51.9, p < or = 0.0001), and esophageal acid exposure (11.7% to 4.8%, p < or = 0.0001). Esophagitis was present in 25 patients before treatment (15 grade 1 and 10 grade 2) and 8 had esophagitis at 6 months (4 grade 1 and 4 grade 2, p = 0.005). At 6 months, 87% no longer required proton pump inhibitor medication. There was no significant change in median lower esophageal sphincter pressure (14.0 to 12.0 mm Hg, p = 0.19), peristaltic amplitude (64 to 66 mm Hg, p = 0.71), or lower esophageal sphincter length (3.0 to 3.0, p = 0.28). There were 3 self-limited complications (fever for 24 hours, odynophagia lasting for 5 days, and a linear mucosal injury that was healed after 3 weeks).


CONCLUSIONS
RF energy delivery significantly improved GERD symptoms, quality of life, and esophageal acid exposure while eliminating the need for anti-secretory medication in the majority of patients with a heterogeneous spectrum of clinical disease severity but with minimal active esophagitis or hiatal hernia.
Gastroenterology and Otolaryngology-Head and Neck Surgery Sections, VA Palo Alto Health Care System, California 94304, USA.
G
G
Triadafilopoulos
J K
JK
Dibaise
T T
TT
Nostrant
N H
NH
Stollman
P K
PK
Anderson
S A
SA
Edmundowicz
D O
DO
Castell
M S
MS
Kim
J C
JC
Rabine
D S
DS
Utley
D000328:Adult; D000368:Aged; D002404:Catheterization; D004735:Energy Transfer; D004943:Esophagogastric Junction / Q000737:chemistry; D005260:Female; D005764:Gastroesophageal Reflux / Q000517:prevention & control / Q000628:therapy*; D006356:Heartburn / Q000175:diagnosis; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011846:Radio Waves / Q000009:adverse effects; D000078702:Radiofrequency Therapy