The Plicator procedure for the treatment of gastroesophageal reflux disease: a registry study.

ABSTRACT

BACKGROUND: Endoscopic full-thickness plication of the gastric cardia using the Plicator is shown to be effective for the treatment of symptomatic gastroesophageal reflux disease (GERD) in both prospective and randomized controlled trials. This registry study aimed to evaluate Plicator procedure safety and efficacy among GERD patients treated in routine clinical practice at multiple academic and nonacademic centers. METHODS: An open-label, prospective multicenter trial was conducted at seven centers under institutional review board approval. Patients with symptomatic GERD completed a series of questionnaires at baseline to assess GERD symptoms, heartburn/regurgitation scores, antisecretory medication use, and treatment satisfaction. All the patients then underwent the Plicator procedure with placement of a single transmural pledgeted suture in the anterior gastric cardia. The patients were reevaluated at 12 months after plication. RESULTS: The 12-month follow-up assessment was completed by 81 patients. At 12 months, the mean GERD Health-Related Quality-of-Life score had improved significantly compared with the baseline score (12.0 vs 26.6; p < 0.001), with 66% of the subjects showing an GERD-HRQL score improved 50% or more. Statistically significant improvements also were observed in median heartburn and regurgitation symptom scores. At 12 months, the need for daily proton pump inhibitor (PPI) therapy was eliminated for 58% of the patients. At baseline, 18% of the subjects had been satisfied with their GERD symptom control while on antisecretory therapy. At 12 months, 75% of the patients were satisfied with their GERD symptom control after undergoing the Plicator procedure, and 86% would recommend the procedure to family or friends. There were no serious adverse events and no late onset of any adverse events. CONCLUSIONS: In this multicenter study, the Plicator procedure effectively improved GERD quality-of-life scores, reduced GERD symptoms and medication use, and yielded higher treatment satisfaction than with the use of chronic antisecretory therapy. These effects all were seen 12 months after plication, and no major adverse effects were observed.