Endocinch Device Safe, Effective in GERD

Laurie Barclay, MD

January 06, 2003

Jan. 6, 2003 — The Endocinch device is safe and effective for the treatment of gastroesophageal reflux disease (GERD), according to a one-year, prospective, follow-up trial reported in the January issue of Gut.

"GERD is, in the main, treated with either proton pump inhibitor (PPI) drugs or a Nissen fundoplication operation," write Z. Mahmood and colleagues from St James's Hospital in Dublin, Ireland. "Recently, BARD [Endoscopic Technologies (Billerica, Massachusetts)] developed Endocinch, a device used to place sutures just below the esophagogastric junction to treat GERD."

Of 26 patients with symptoms of GERD who had the Endocinch procedure, four were lost to follow-up. Mean age of all the subjects was 39 years (range, 22-62 years). Complaints after the procedure resolved within 72 hours. At three months after the procedure, pH DeMeester acid score decreased from 44.1 ± 4.3 to 33.32 ± 4.73 (P = .028).

At 12-month follow-up, mean heartburn symptom score decreased from 19.22 at baseline to 7.5 (P < .0001), and regurgitation score decreased from 2.27 to 0.86 (P < .001). Use of PPIs decreased by 64%, and upright acid exposure and number of reflux episodes also decreased significantly. There was significant improvement in all quality of life assessments (P = .01).

"The Endocinch procedure is an effective and safe outpatient procedure that offers GERD patients significant improvement in symptomatology, quality of life, and reduced requirements for PPIs over at least a one year period," the authors write. "Whether or not these improvements will be maintained, only time will tell.... This procedure may fill a gap between medical and surgical treatment of GERD. At this stage prospective randomized studies are needed to compare it with both medical and surgical antireflux therapies."

Gut. 2003;52:34-39

Reviewed by Gary D. Vogin, MD