Endoscopic Full-Thickness Plication for the Treatment of GERD: Five Year Multi-Center Results

Abstract

Background: The Plicator® (NDO Surgical, Inc., Mansfield, MA) procedure, which is an endoscopic procedure that delivers a full-thickness plication, was previously reported to be effective at reducing GERD symptoms and medication use for up to 3-years post-plication with no long-term procedural adverse events. The purpose of this study was to assess the long-term safety and treatment durability of the Plicator up to 5-years post-plication. Methods: Patients with chronic heartburn who had originally participated in the open-label study and received a single plication in the gastric cardia 1 cm below the gastroesophageal junction were eligible. Subjects were evaluated at baseline for GERD symptoms and medication use. Long-term subject follow-up was completed to evaluate safety and long-term treatment durability. Results: Thirty-three subjects completed the long-term follow-up (mean follow-up interval: 5 years (59 months), range: 50-65 months). All procedure-related adverse events occurred acutely, as previously reported, and no new adverse events were observed during extended follow-up. At 5-years post-procedure, 67% of baseline PPI dependent patients remained off daily PPI therapy. Treatment effect remained stable from the 3 to 5-year follow-up interval, with 11/28 patients requiring daily PPI at 3-years compared to 12/30 patients at 5-years. Median GERD-HRQL scores remained significantly improved at 5-years versus baseline off-meds scores (10 vs. 19, p < 0.001). In addition, the proportion of patients achieving ≥ 50% improvement in GERD-HRQL score was consistent from 3-years (55%) to 5-years (50%). Conclusions: Endoscopic full-thickness plication can effectively reduce GERD symptoms and medication use for at least 5-years post-procedure. Treatment effect is stable for 5-years and there are no long-term procedural adverse effects.