2002 - STRETTA CLINICAL The Stretta procedure for the treatment of GERD: a registry of 558 patients
Wolfsen HC, Richards WO.
J Laparoendosc Adv Surg Tech A. 2002 Dec;12(6):395-402
PURPOSE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.