Endoscopic full-thickness plication for the treatment of GERD by application of multiple Plicator implants: a multicenter study (with video).

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.