The Stretta procedure for the treatment of GERD: a registry of 558 patients.

Abstract

To evaluate gastroesophageal reflux disease (GERD) symptoms, patient satisfaction, and antisecretory drug use in a large group of GERD patients treated with the Stretta procedure (endoluminal temperature-controlled radiofrequency energy for the treatment of GERD) at multiple centers since February 1999. All subjects provided informed consent. A health care provider from each institution administered a standardized GERD survey to patients who had undergone Stretta. Subjects provided (at baseline and follow-up) (1) GERD severity (none, mild, moderate, severe), (2) percentage of GERD symptom control, (3) satisfaction, and (4) antisecretory medication use. Outcomes were compared with the McNemar test, paired t test, and Wilcoxon signed rank test. Surveys of 558 patients were evaluated (33 institutions, mean follow-up of 8 months). Most patients (76%) were dissatisfied with baseline antisecretory therapy for GERD. After treatment, onset of GERD relief was less than 2 months (68.7%) or 2 to 6 months (14.6%). The median drug requirement improved from proton pump inhibitors twice daily to antacids as needed (P < .0001). The percentage of patients with satisfactory GERD control (absent or mild) improved from 26.3% at baseline (on drugs) to 77.0% after Stretta (P < .0001). Median baseline symptom control on drugs was 50%, compared with 90% at follow-up (P < .0001). Baseline patient satisfaction on drugs was 23.2%, compared with 86.5% at follow-up (P < .0001). Subgroup analysis (<1 year vs. >1 year of follow-up) showed a superior effect on symptom control and drug use in those patients beyond 1 year of follow-up, supporting procedure durability. The Stretta procedure results in significant GERD symptom control and patient satisfaction, superior to that derived from drug therapy in this study group. The treatment effect is durable beyond 1 year, and most patients were off all antisecretory drugs at follow-up. These results support the use of the Stretta procedure for patients with GERD, particularly those with inadequate control of symptoms on medical therapy.