The Endoscopic Plicator Procedure for GERD Using Two Full-Thickness Plications

Abstract

Purpose: The Plicator® (NDO Surgical, Mansfield MA) endoscopically delivers full-thickness pledgeted sutures to restructure the gastroesophageal junction and the anti-reflux barrier. To date, all Plicator studies have involved the placement of a single, full-thickness suture at the gastro-esophageal junction. The purpose of this pilot study was to evaluate the safety and effectiveness of placing two pledgeted sutures in the anterior gastric cardia. Methods: Patients with symptomatic GERD requiring maintenance proton pump inhibitor therapy were entered in an open-label, prospective, single-center pilot study. Patients with hiatal hernias > 3 cm, grade III and IV esophagitis, and Barrett's esophagus were excluded. All patients received two full-thickness Plicator sutures in the anterior gastric cardia, serially placed within 1 cm of the GEJ. The following were assessed at baseline and 18-months post-treatment: GERD-HRQL, VAS and medication use. The primary study endpoint was ≥50% improvement in GERD-HRQL score. Results: Thirty-seven patients underwent endoscopic full-thickness plication using two sutures. At 18-months post-treatment, the proportion of patients achieving ≥50% improvement in GERD-HRQL score was 57%. Median GERD-HRQL scores improved 61% compared to baseline off-meds scores (12.5 vs. 25.9, P < 0.001) and were superior when compared to patients' baseline on-meds GERD-HRQL scores (12.5 vs.15.6, P= 0.023). Heartburn symptoms measured by VAS showed a median improvement of 77% versus off-med baseline (P < 0.001). Complete PPI cessation was achieved in 35% of patients, with an additional 39% of patients able to reduce their PPI dose by at least half. All procedure-related adverse events occurred acutely, as previously reported, and no new adverse events were observed during extended follow-up. Conclusion: Endoscopic full-thickness plication using two sutures showed in 57% of patients an improvement in GERD-HRQL ≥50% at 18 months. Median GERD-HRQL scores improved 61% and heartburn symptoms showed a median improvement of 77%. Complete PPI cessation was achieved in 35% of patients. No new adverse events were observed during the 18 month follow-up.