2004 - STRETTA CLINICAL Delivery of radiofrequency energy to the lower esophageal sphincter improves symptoms of gastroesophageal reflux
Go MR, Dundon JM, Karlowicz DJ, Domingo CB, Muscarella P, Melvin WS
Surgery. 2004 Oct;136(4):786-94
BACKGROUND: The Stretta procedure has been proposed as a novel therapeutic alternative to antireflux surgery for gastroesophageal reflux disease (GERD). Early reports indicated improvement in GERD symptoms overall, but improvement in patients who have poor outcome after surgery remains unclear. METHODS: Patients with reflux who did not have a hiatal hernia were offered the procedure. All were administered a GERD Health Related Quality of Life survey at preprocedure and at greater than 3 months postprocedure. Differences in pre- and postprocedure responses were deemed significant with the use of the Wilcoxon rank sum test with P <.05.
RESULTS: Fifty patients underwent the Stretta procedure. There were no complications. All were evaluated postprocedure, with 74% completing a postprocedure survey. Overall heartburn score improved from 3.19 (scale, 0-5) preprocedure to 1.74 postprocedure (P=.0012). Overall symptoms satisfaction score improved from 3.92 to 1.63 (P=.0001). Symptoms satisfaction score of patients who failed antireflux surgery improved from 3.5 to 1.75 (P=.0166), and, in those with a body mass index >30, it improved from 4.11 to 1.56 (P=.0024). Four patients went on to have antireflux surgery after having the Stretta procedure.
CONCLUSIONS: Stretta improves heartburn symptoms both overall and in patients with poor outcome after antireflux surgery, with a low procedural risk. It may have a role in the treatment of patients with primary reflux and in those who have failed antireflux surgery or who are a high risk for surgery.