2001 - STRETTA CLINICAL Initial experience with the Stretta procedure for the treatment of gastroesophageal reflux disease
Richards WO, Scholz S, Khaitan L, Sharp KW, Holzman MD.
J Laparoendosc Adv Surg Tech A. 2001 Oct;11(5):267-73.
BACKGROUND: The Stretta device (Curon Medical, Sunnyvale, CA) is a balloon-tipped four-needle catheter that delivers radiofrequency (RF) energy to the smooth muscle of the gastroesophageal junction. It can be used for the endoscopic treatment of gastroesophageal reflux disease (GERD). PATIENTS AND METHODS: Data prospectively collected on the first 25 consecutive patients undergoing the Stretta procedure at Vanderbilt University Medical Center between August 2000 and March 2001 are reported. Patient evaluation included esophageal manometry, ambulatory 24-hour pH testing, a standard GERD-specific quality-of-life survey (QOLRAD), a general quality-of-life survey (SF12), and endoscopy. Stretta surgery was performed following a standardized protocol. Thermocouple-controlled RF energy was delivered to the lower esophageal sphincter (LES) after endoscopic location of the z-line. Patients were followed up 3 months after endoscopic treatment. Results are presented as mean +/- SEM.
RESULTS: Prior to treatment, patients had a mean DeMeester score of 31.0+/-11.4, an LES pressure of 24+/-2 mm Hg, and normal esophageal peristalsis. Of the 25 outpatient procedures, 19 were done under conscious sedation and 6 under general anesthesia. There was a small learning curve (76+/-8 min for the first three procedures; 50+/-2 min for the subsequent 22). The mild to moderate pain during the first 24 postoperative hours was controlled with over-the-counter medication. Two complications were noted: one patient presented with ulcerative esophagitis and gastroparesis 10 days after the Stretta treatment, and one patient developed pancreatitis on postoperative day 27, which was probably unrelated to the Stretta procedure. Eight of the thirteen patients (62%) available for 3-month follow-up were off all antisecretory medication. The other five patients were still taking medications but had been able to reduce the amount considerably. The average daily dose of proton pump inhibitors was 43.0+/-5.0 mg/preoperatively and 6.4+/-2.2 mg/3 months postoperatively (P < 0.001). Other classes of GERD treatment such as metoclopramide had been completely abandoned. In all patients, QOLRAD scores improved (3.5+/-0.4 to 5.5+/-0.5; P < 0.001) as did SF12 physical (23.7+/-3.0 to 31.0+/-3.4; P < 0.008) and mental (40.5+/-2.9 to 47.7+/-3.2, P < 0.017) scores. All patients would undergo a Stretta procedure again except one 78-year-old man with progressive Alzheimer's disease.
CONCLUSION: The Stretta procedure is a promising new modality in the management of GERD. It can be safely performed in one short session with gastroesophageal endoscopy under conscious sedation in an outpatient setting. It improves GERD symptoms and quality-of-life scores in patients at 3 months and eliminates or significantly reduces the need for antisecretory drugs.