First year experience of patients undergoing the Stretta procedure

Background: The Stretta procedure is a new, totally endoscopic treatment for GERD, where radiofrequency energy is delivered to the smooth muscle of the gastroesophageal junction. Methods: Forty-one patients undergoing the Stretta procedure between August 2000 and August 2001 were prospectively evaluated. Under an IRB-approved protocol, patients were studied preoperatively and postoperatively with esophageal manometry, 24-h pH testing, SF12 surveys, and GERD-specific questionnaires (QOLRAD). Results: Results are reported as mean +/- SEM. All procedures were performed on an outpatient basis; 33 were under conscious sedation and 8 were under general anesthesia. Prior to treatment, patients had a mean LES pressure of 25 +/- 2.4 mmHg, Johnson-Demeester score of 32.8 +/- 4.6 mmHg, and % time reflux 8.4 +/- 0.9%. The quality-of-life scores were significantly improved at 6 months: QOLRAD score increased from 3.7 +/- 0.2 to 5.1 +/- 0.2 (p = 0.002), SF12 mental score increased from 44.3 +/- 2.0 to 51.8 +/- 1.7 (p = 0.001), and SF12 physical score increased from 26.2 +/- 2.4 to 33.1 +/- 3.8 (p = 0.001). Eighteen patients returned for esophageal manometry and 24-h pH testing at a mean of 6.8 +/- 0.5 months. There was a significant decrease in esophageal acid exposure time (8.4 0.9% to 4.4 +/- 1.3%, p = 0.03) and Johnson-Demeester score (32.8 4.6 to 22.9 +/- 5.3, p = 0.04). There was no significant change in mean LES pressure (25.3 +/- 2.4 mmHg to 26.8 +/- 2.6 mmHg, p = 0.63). Twenty of 31 patients (65%) available for 6 months follow-up were completely off proton pump inhibitors. The only complication related to Stretta was a case of gastroparesis 10 days post-operatively that resolved completely. Conclusions: The Stretta procedure is a promising new endoscopic treatment for GERD. It significantly improves GERD symptoms and quality of life while eliminating the need for proton pump inhibitors in the majority of patients.