Endoscopic Full-Thickness Plication for GERD: 12-Month Multi-Center Study Results Using a Multiple Plication Technique

Abstract

Background: The Plicator® (NDO Surgical, Mansfield MA) restructures the gastric cardia through endoscopic placement of a single transmural pledgeted suture at the gastroesophageal junction (GEJ). Although this procedure has been shown effective in the treatment of symptomatic GERD, the impact of placing multiple Plicator sutures in the gastric cardia has not previously been studied in a multi-center trial. In this study the safety and effectiveness of placing multiple full-thickness Plicator sutures in the gastric cardia in patients with symptomatic GERD was assessed. Patients & Methods: Patients with symptomatic GERD requiring maintenance proton pump inhibitor therapy were entered into an open-label, prospective, multi-center trial. Study exclusions were hiatal hernia >3 cm, grade III and IV esophagitis, and Barrett's esophagus. Patients received two or more full-thickness Plicator sutures placed serially in the anterior gastric cardia, within 1 cm of the GEJ. Patients were evaluated at baseline and at 12-months post-treatment for GERD-HRQL score, VAS, and medication use. Esophagitis scores at baseline and at 6-months post-treatment were also evaluated. Primary treatment success was ≥50% improvement in GERD-HRQL score. Results: Forty-one patients underwent endoscopic full-thickness plication using multiple sutures as previously reported. Of the 35 patients who completed the 12-month follow-up, 74% had achieved ≥50% improvement in GERD-HRQL score. The median percent change in GERD-HRQL score improved significantly compared to baseline off-meds (77%, p < 0.001). Heartburn symptoms measured by VAS showed a median improvement of 81% versus baseline (p < 0.001). At baseline, all patients required daily PPI therapy. At 12-months post-treatment, 69% (24/35) of patients had discontinued daily PPI use and 71% were reportedly satisfied with the Plicator treatment. Sixty-nine percent (69%) also reported adequate control of both heartburn and regurgitation symptoms. At 6-months, the median esophagitis score was significantly improved by 75% (p = 0.005) compared to baseline. All procedure-related adverse events occurred acutely as previously reported and no new device-related adverse events were observed during the extended follow-up period. Conclusions: Multi-center study results demonstrate that endoscopic full-thickness plication using multiple transmural sutures is safe and effective in significantly reducing GERD symptoms, esophagitis scores and medication use.