Endoluminal Fundoplication (Esophyx®) in GERD Patients Refractory to PPI Therapy: Effect On Symptoms, PPI Use and Distensibility

Abstract

Proton pump inhibitor (PPI) therapy is the standard of care in gastroesophageal reflux disease (GERD) patients, while a surgical fundoplication is proposed for poor responders to PPI or those who desire not to be PPI-dependent. Endoscopic anti-reflux procedures, including the Endoluminal Fundoplication (EF), are being evaluated for their potential to relieve symptoms in GERD. Our aim was to evaluate EF in patients with persisting symptoms in spite of adequate PPI therapy. Methods: GERD patients with persisting typical or atypical reflux symptoms during PPI therapy, and a proven temporal association on impedance/pH monitoring, were recruited for this pilot trial. Exclusion criteria were age<18, high grade esophagitis including Barrett's and hiatal hernia>3 cm. Symptoms were evaluated off PPI before, 2 and 4 months after the EF. Assessments at baseline and after 2 months included 24 hour pH/impedance monitoring off PPI, esophageal manometry and measurement of the distensibility of the lower esophageal sphincter (LES). PPIs were stopped at 4 weeks, and started as prn after 2 months. All data (mean ± SD) were analyzed by Student's t test. Results: 10 patients (8 men, mean age 37.5 ± 10.4) were recruited. Under complete sedation a mean of 11.5 ± 2.9 fasteners were applied during a mean procedure time of 52 ± 6 min. Transient throat ache, retrosternal pain and minor bleeding were the only adverse events. EF significantly improved GERD symptoms off PPI at 2 months (13.5 ± 7.4 vs. 5.0 ± 4.8, p<0.01) and on PPI at 4 months (9.0 ± 4.9 vs. 2.0 ± 4.8; p<0.01), and was associated with decreased PPI need (14.0 ± 7.3 vs. 11.5 ± 5.1 units/2 months, p<0.05). LES pressure (14.0 ± 12.3 vs. 17.0 ± 7.8 mmHg, NS) and pH/impedance monitoring at 2 months were not significantly altered (%time pH<4: 9.2 ± 9.1 vs. 8.2 ± 6.1%, NS; no change in weakly acidic reflux events). There was a tendency towards decreased distensibility of the LES (8.8 ± 3.3 vs. 3.5 ± 1.4 ml/mmHg, p= 0.08). Conclusion: The present uncontrolled trial of EF in refractory GERD suggests symptomatic improvement. We found no differences in objective reflux or LES pressure, but distensibility of the gastroesophageal junction tended to be decreased. These findings need confirmation in a controlled study.