The Plicator Procedure for the Treatment of GERD: 12-Month Multicenter Results

Abstract

Background: The Plicator (NDO Surgical Inc., Mansfield, MA) is a unique endoscopic suturing device which delivers a transmural suture. The ability to achieve serosal tissue apposition allows for restructuring of the cardia and reshaping of the valvular mechanism at the gastro-esophageal junction (GEJ). Aim: To assess the safety and 12-month efficacy of endoscopic full-thickness suturing using a second generation, reduced diameter Plicator. Methods: Thirty-six patients with chronic heartburn requiring maintenance anti-secretory therapy received a single, endoscopically placed, full-thickness plication in the gastric cardia 1 cm below the GEJ. Study exclusions included hiatal hernia >2 cm, Grades III and IV esophagitis, and Barrett's esophagus. At baseline and 12-months post-plication, patients were evaluated for GERD symptoms and medication use. Ambulatory 24-hr pH studies were conducted at baseline and repeated between 6 and 12-months post-plication. Results: Thirty-six patients underwent endoscopic full-thickness plication with two patients lost to follow-up. There were no serious adverse events. Common side effects included sore throat (23%) and epigastric pain (21%) which resolved spontaneously. Two patients were admitted overnight for observation. One year post-plication, 68% (23/34) of PPI dependent patients remained off daily PPI therapy; with an additional 12% (4/34) able to reduce their PPI dose by at least 50%. Median GERD-HRQL scores were significantly improved versus baseline off-meds (16.0 vs. 7.0) and were comparable to baseline on-meds values (7.0 vs. 5.0). Twenty-six subjects underwent post-procedure ambulatory pH studies (mean follow-up 9.5 months). Of these, 73% demonstrated an improvement in distal esophageal acid exposure. Median % time pH<4 decreased 29% (9.9 to 8.1) with 23% of patients experiencing pH normalization. Conclusions: Endoscopic full-thickness suturing with the reduced diameter Plicator was found to be a safe procedure that can effectively reduce symptoms, medication use and esophageal acid exposure associated with GERD. Background: The Plicator (NDO Surgical Inc., Mansfield, MA) is a unique endoscopic suturing device which delivers a transmural suture. The ability to achieve serosal tissue apposition allows for restructuring of the cardia and reshaping of the valvular mechanism at the gastro-esophageal junction (GEJ). Aim: To assess the safety and 12-month efficacy of endoscopic full-thickness suturing using a second generation, reduced diameter Plicator. Methods: Thirty-six patients with chronic heartburn requiring maintenance anti-secretory therapy received a single, endoscopically placed, full-thickness plication in the gastric cardia 1 cm below the GEJ. Study exclusions included hiatal hernia >2 cm, Grades III and IV esophagitis, and Barrett's esophagus. At baseline and 12-months post-plication, patients were evaluated for GERD symptoms and medication use. Ambulatory 24-hr pH studies were conducted at baseline and repeated between 6 and 12-months post-plication. Results: Thirty-six patients underwent endoscopic full-thickness plication with two patients lost to follow-up. There were no serious adverse events. Common side effects included sore throat (23%) and epigastric pain (21%) which resolved spontaneously. Two patients were admitted overnight for observation. One year post-plication, 68% (23/34) of PPI dependent patients remained off daily PPI therapy; with an additional 12% (4/34) able to reduce their PPI dose by at least 50%. Median GERD-HRQL scores were significantly improved versus baseline off-meds (16.0 vs. 7.0) and were comparable to baseline on-meds values (7.0 vs. 5.0). Twenty-six subjects underwent post-procedure ambulatory pH studies (mean follow-up 9.5 months). Of these, 73% demonstrated an improvement in distal esophageal acid exposure. Median % time pH<4 decreased 29% (9.9 to 8.1) with 23% of patients experiencing pH normalization. Conclusions: Endoscopic full-thickness suturing with the reduced diameter Plicator was found to be a safe procedure that can effectively reduce symptoms, medication use and esophageal acid exposure associated with GERD.