The Stretta procedure for the treatment of GERD: 6 and 12 month follow-up of the U.S. open label trial.
BACKGROUND
This multicenter prospective study investigated the longer-term (12 month) safety and efficacy of radiofrequency energy delivery for the treatment of GERD.


METHODS
A prospective study was conducted of 118 patients with chronic heartburn and/or regurgitation who required antisecretory medication daily and had demonstrated pathologic esophageal acid exposure, a sliding hiatal hernia (<or=2 cm), and esophagitis (<or= grade 2). RF energy was delivered with the Stretta catheter and thermocouple-controlled generator to create thermal lesions below the mucosa at the gastroesophageal junction. GERD symptom scores, quality of life (SF-36), and medication use were assessed at 0, 1, 4, 6, and 12 months; esophageal acid exposure, motility, and endoscopy were assessed at 0 and 6 months.


RESULTS
Seventy-two men and 46 women were treated. At 12 months, 94 patients were available for follow-up. There were improvements after 12 months in the median heartburn score (4 to 1, p = 0.0001), GERD score (27 to 9, p = 0.0001), satisfaction (1 to 4, p = 0.0001), mental SF-36 (46.3 to 55.4, p < 0.0001), and physical SF-36 (40.9 to 53.1, p = 0.0001); proton pump inhibitor requirement fell from 88.1% to 30% of patients. Esophageal acid exposure improved significantly (10.2% to 6.4%, p = 0.0001). There were 10 (8.6%) complications, none of which required therapeutic intervention.


CONCLUSIONS
The Stretta procedure significantly improves GERD symptoms, quality of life, and esophageal acid exposure and eliminates the need for antisecretory medication in the majority of patients at 12 months.
Triadafilopoulos
George
G
Gastroenterology and Otolaryngology-Head and Neck Surgery Sections, VA Palo Alto Health Care System, Palo Alto, CA 94304, USA.
DiBaise
John K
JK
Nostrant
Timothy T
TT
Stollman
Neil H
NH
Anderson
Paul K
PK
Wolfe
M Michael
MM
Rothstein
Richard I
RI
Wo
John M
JM
Corley
Douglas A
DA
Patti
Marco G
MG
Antignano
Louis V
LV
Goff
John S
JS
Edmundowicz
Steven A
SA
Castell
Donald O
DO
Rabine
John C
JC
Kim
Michael S
MS
Utley
David S
DS
D000328:Adult; D000368:Aged; D004942:Esophagitis, Peptic / Q000175:diagnosis / Q000628:therapy*; D004945:Esophagoscopy; D005260:Female; D005500:Follow-Up Studies; D005745:Gastric Acidity Determination; D005764:Gastroesophageal Reflux / Q000175:diagnosis / Q000628:therapy*; D006801:Humans; D006979:Hyperthermia, Induced / Q000295:instrumentation*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome