Endoscopic Full-Thickness Plication for the Treatment of GERD

Abstract

Purpose: The Plicator (NDO Surgical, Inc., Mansfield, MA) delivers a transmural suture through the gastric cardia under direct endoscopic visualization. The resulting serosal tissue apposition restructures the valvular mechanism of the gastroesophageal (GE) junction. Previously published studies have shown the Plicator procedure effective in reducing GERD symptoms and medication use at 1-year post-plication. Aim: To assess the long-term safety and efficacy of endoscopic full-thickness plication for the treatment of symptomatic GERD. Methods: Sixty-four patients with chronic heartburn requiring maintenance daily anti-secretory therapy received a single, endoscopically placed, full-thickness plication in the gastric cardia 1cm below the GE junction. Re-treatments were not permitted. Study exclusions included hiatal hernia >2 cm, Grades III and IV esophagitis, and Barrett's esophagus. Patients were evaluated for GERD symptoms and medication use at baseline, 12-months, and 36-months post-plication. Results: Twenty patients have completed the 36-month follow-up; additional data collection is in process. All procedure-related adverse events occurred acutely, as previously reported, and no new adverse events were observed during extended follow-up. At 3-years post-procedure, 63% (12/19) of PPI dependent patients remained off daily PPI. Treatment effect remained stable from the 12 to 36-month follow-up intervals, with only 4/20 patients showing an increase in medication requirements. At 3-years post-procedure, mean GERD-HRQL scores remained improved versus baseline off meds (20.8 vs. 11.9) and were comparable to baseline on-meds values (11.9 vs. 11.8). Conclusions: Endoscopic full-thickness plication can effectively reduce symptoms and medication use associated with GERD out to at least 3-years post-procedure.