Background: The full-thickness Plicator allows transmural suturing at the gastroesophageal (GE) junction to restructure the antireflux barrier. Studies of the Plicator procedure to date have been limited to placement of a single transmural suture to create the endoscopic gastroplication.
Objective: The purpose of this study was to evaluate the safety and efficacy of placing multiple transmural sutures for the treatment of GERD.
Design: Open-label, prospective, multicenter study.
Setting: Four tertiary-referral centers.
Patients: Subjects with symptomatic GERD who require daily maintenance proton pump inhibitor (PPI) therapy. Study exclusions were hiatal hernia >3 cm, grades III and IV esophagitis, Barrett's epithelium, and esophageal dysmotility.
Interventions: Forty-one patients received two or more transmural sutures placed linearly in the anterior gastric cardia approximately 1 cm below the GE junction.
Main outcome measurements: Six months after the procedure, median GERD-health-related quality of life (HRQL) improved 76% compared with off-medication baseline (6.0 vs 25.0, P < .001), with 75% of patients (32/40) achieving >50% improvement in their baseline GERD-HRQL score. Six months after the procedure, daily PPI therapy was eliminated in 70% of patients (28/40). Heartburn symptoms improved 80% compared with off-medication baseline (16.0 vs 84.0, P < .001). Median esophagitis grade improved 75% compared with baseline (0.0 vs 1.0, P = .005). Esophageal pH assessed as median distal esophageal-acid exposure (percentage time pH < 4.0) improved 38% compared with baseline (9.0 vs 11.0, P < .020; nominal P value for a single statistical test: significance removed upon the Bonferroni adjustment for multiple testing of data) and manometric outcomes were also improved compared with baseline (median lower esophageal sphincter resting pressure improved 25% [10.0 vs 6.0, P < .017; nominal P value for a single statistical test: significance removed upon the Bonferroni adjustment for multiple testing of data]) and median amplitude of contraction improved 11% (70.0 vs 62.0, P < .037; nominal P value for a single statistical test: significance removed upon the Bonferroni adjustment for multiple testing of data).
Limitations: Small sample size. No randomized comparison with a single implant group.
Conclusions: Endoscopic full-thickness plication with multiple serially placed implants was safe and effective in reducing GERD symptoms, medication use, esophageal-acid exposure, and esophagitis.