Endoscopic Full-Thickness Plication with Two Serially Placed Implants Improves Esophagitis, GERD Symptoms and Reduces PPI Use and Esophageal Acid Exposure

Abstract

Purpose: Recently, several endoluminal procedures for the treatment of GERD have been introduced. However, most of these techniques have been abandoned due to either lack of long-term efficacy or serious side effects. In a recently published prospective randomized, sham-controlled trial, the Plicator™ (NDO Surgical, Inc.) proved effective at controlling reflux symptoms and reducing medication use and esophageal acid exposure. Methods: In all studies to date, a single Plicator implant was placed to form a full thickness plication of the anterior gastric cardia. However, in several cases the narrowing of the GE-junction remained incomplete with this technique. Therefore, we evaluated the safety and effectiveness of placing two Plicator implants within 1 cm of the anterior GE-junction for the treatment of GERD. Results: 37 patients underwent endoscopic full-thickness plication using two serially placed Plicator implants. At 6 months post-treatment, the proportion of patients achieving >50% improvement in GERD-HRQL score was 68%. Complete PPI cessation was achieved in 59% of patients. In pH studies conducted at 6-months (N = 29), median percent time pH < 4 decreased 36%, with 28% of patients experiencing pH normalization. Erosive Reflux Disease (ERD) was diagnosed in 21 patients before endoscopic full-thickness plication. 16 patients had NERD before endoscopic full-thickness plication. Six months after endoscopic full-thickness plication the number of subjects with ERD was 15 and the number of subjects without esophagitis was 22. There were no serious adverse events observed. Minor adverse events included abdominal pain (73%), sore throat (54%), and chest pain (57%). All adverse events resolved spontaneously without intervention. Conclusion: In this study, endoscopic full-thickness plication using two serially placed Plicator implants was both safe and effective in reducing esophagitis, GERD symptoms, GERD medication use, and esophageal acid exposure. When compared to previous studies using a Plicator single implant technique, the Plicator multiple-implant technique demonstrates a similar safety profile and superior efficacy.