2001 - STRETTA CLINICAL Community practice evaluation of the effectiveness on the STRETTA procedure for the treatment of GERD
Donald E Mansell, Gastroenterology, Feather River Hospital, Paradise, California, United States.
Am Journal Gastro, September, Suppl., 2001
PURPOSE: This is a single center, community practice evaluation of the effectiveness of endoluminal radiofrequency (RF) energy delivery, the STRETTA procedure, for the treatment of gastroesophageal reflux disease (GERD) regarding GERD symptoms, quality of life (QOL), and medication use.
METHODS: Data was collected on 29 patients with a diagnosis of chronic GERD, daily symptoms of heartburn and/or regurgitation, daily anti-secretory medication use, and pathologic esophageal acid exposure by 24-hr pH study or endoscopic biopsy. Pretreatment esophageal motility was performed to exclude patients with achalasia. After conscious sedation and standard endoscopy, we delivered RF energy with the STRETTA catheter and thermocouple-controlled generator to create thermal lesions in the muscle of the gastroesophageal junction. Mucosal integrity was preserved via cooling with constant irrigation through the device. GERD symptom scores (0–50), heartburn (0–5), quality of life (SF-36), and medication use were assessed at baseline and post-treatment. Results were stratified according to presence or absence of hiatal hernia.
RESULTS: Twenty-two women and 7 men were treated (age 63.1 + 14 years, mean + SD). At follow-up (136 + 78 days), there were significant improvements in the median heartburn score (4 to 1, p < 0.001), GERD score (32 to 9 p < 0.001), satisfaction (1 to 5, p < 0.001), mental SF-36 (52.5 to 59.4, p < 0.001), physical SF-36 (31.3 to 39.2, p < 0.001). Subgroup analysis demonstrated that presence of a hiatal hernia had no impact on the observed improvements in GERD, heartburn, QOL, or medication use (p < 0.05). Medication use improved from baseline (79% 2 X PPI, 17% 1 X PPI, and 4% H2RA) to post-treatment (17% 2 X PPI, 7% 1 X PPI, 7% H2RA, and 69% no drug or prn medication only). There were no adverse effects requiring therapeutic or diagnostic intervention. One patient had fundoplication for incomplete symptom control.
CONCLUSIONS: The STRETTA procedure significantly improves GERD symptoms, patient quality of life, and medication use in this predominantly elderly, female study population both with and without hiatal hernia.