Endoscopic Full-Thickness Plication for GERD: Durability at 12-Months

Abstract

Background: The Plicator procedure has been designed to inhibit gastroesophageal (GE) reflux by fixating the full-thickness of the cardia wall under direct endoscopic visualization. The resulting serosa-to-serosa tissue union may help to accentuate and restore the valvular mechanism of the GE junction. Aim: To assess safety, efficacy, and 12-month durability of endoscopic full-thickness plication in patients with symptomatic GERD. Methods: Patients with chronic heartburn requiring maintenance anti-secretory therapy were recruited. Exclusions were hiatal hernia (>2cm), Grades III and IV esophagitis, and Barrett's. The following were assessed at baseline (on and off-meds) and 12 month post-plication: GERD-HRQL, GSRS, SF-36 questionnaires, and medication use. Additionally, 24-hr pH-metry and manometry were measured at baseline, three-months (pH/manometry) and six-months (pH only) post-plication. All patients received a single, full-thickness plication in the gastric cardia 1-2cm below the GE junction. Results: Sixty-four patients (mean age 46.3, range 23-71) underwent endoscopic full-thickness plication. No re-treatments were performed. 12 months post-procedure, proton pump inhibitor (PPI) therapy remained completely discontinued in 68% (36/53) of PPI dependent patients and median GERD-HRQL scores (n=57) were improved when compared to baseline off-med (19.0 vs. 5.0) and on-med (13.0 vs. 5.0). In 24-hour pH-metry performed at six-months post-procedure (n = 46), 80% of patients demonstrated an improvement in distal esophageal acid exposure. Median % time pH < 4 decreased 39% with 30% of patients experiencing a normalization of pH at 6-months. No significant change in esophageal manometry was noted. All procedure related adverse events occurred acutely, including one gastric perforation which was managed conservatively without sequelae. Common adverse events included sore throat (41%) and abdominal pain (20%), resolving spontaneously within several days post-procedure. Conclusions: In this study, a single full-thickness plication placed at the GE junction reduced symptoms, medication use and esophageal acid exposure associated with GERD. Sustained reduction in PPI use at 1-year follow-up suggests durability of full-thickness tissue apposition.