Introduction
A substantial part of patients with gastroesophageal reflux disease (GERD) responds insufficiently to pharmacological therapy. Therefore, a novel anti-reflux endoscopic procedure - anti-reflux mucosectomy (ARMS) - has been developed. Previous studies suggest that ARMS is effective in reducing reflux symptoms and total acid exposure, although the mechanisms through which reflux is reduced has not yet been investigated.
Aims & Methods
GERD patients with a pathological acid exposure and insufficient symptom control despite twice daily PPI underwent a piecemeal multiband mucosectomy of 50% of the circumference of the esophago-gastric-junction (EGJ), extending 2cm into the cardia. Prior and 3 months following the procedure patients underwent (ambulatory and postprandial stationary) manometry and pH-impedance study, endoscopy and impedance planimetry (Endoflip). PPI treatment was temporarily stopped prior to these investigations. The main study parameter was the total number of reflux episodes assessed during ambulatory 24-h pH-impedance studies. Secondary endpoints were: total 24-h acid exposure time, number of reflux episodes and acid exposure time during prolonged postprandial stationary measurement, prevalence of transient lower esophageal sphincter relaxations (TLESRs), EGJ morphology and distensibility, grade of reflux esophagitis, symptoms and quality of life and occurrence of complications.
Results
11 patients were treated, of which follow-up is complete in 9 patients (6 men, median age 37 (36-61) years, mean BMI 28.7 (±3.1) kg/m2).
ARMS reduced the total number of reflux episodes from 71 (59.5-82.5) to 39 (28-67)(p=0.018), resulting in a reduction of both acidic (63 (50-73) vs 36 (23-55), p=0.012) and weakly acidic reflux episodes (8 (4-17) vs 4 (4-5), p=0.093). The total acid exposure was reduced from 9% (6.5-13.8) to 5.3% (4.0-6.4) (p=0.036).
The 90-minute post-prandial measurement showed an acid exposure time of 16.6% (3.1-30.2) after treatment compared to 11.2% (4.6-33) at baseline (p=0.767). Number of acidic reflux episodes (6 (3-10) vs 8 (1.5-13), p=0.953) and weakly acidic reflux episodes (0 (0-1) vs 0 (0-0.5), p=0.680) were not significantly reduced. Treatment reduced the number of TLESRs after treatment (from 4 (1-7.5) to 2 (0.5-4.5), p=0.048).
Reflux symptoms were reduced substantially (RDQ from 3.8 (3.1-4.0) to 1.4 (0.6-2.8), p=0.008) and GERD-health related quality of life improved substantially as well (28 (21-32) to 15 (6-24), p=0.012). There was no effect of treatment on dysphagia symptoms (Brief Esophageal Dysphagia Questionnaire (BEDQ) of 8.9 (±7.4) vs 9.2 (±6.5) (p=0.880).
Endoscopy showed reflux esophagitis in 89% (8/9) (3 grade A; 5 grade B) prior to treatment, this was 56% (5/9) (1 grade A; 4 grade B) after treatment (p=0.250).
Impedance planimetry showed no changes in distensibility after treatment (3.6 (±1.2) mm2/mmHg vs 4.4 (±1.2) mm2/mmHg), p=0.375). One delayed post-procedural bleeding (11%, (1/9)) occurred requiring repeat endoscopy.
Conclusion
Preliminary results show that ARMS is a successful treatment option in PPI refractory GERD patients reducing both reflux episodes and symptoms. While the mechanism could not be explained by a difference in distensibility, a reduction in TSLERs might play a role.
Disclosure
RP consultancy for Medtronic BV and Micro-Tech Endoscopy. AB received research funding from Nutricia, Norgine, SST, Thelial, Sanofi, Dr Falk Pharma and Bayer and received speaker and/or consulting fees from Laborie, Medtronic, Dr. Falk Pharma, Calypso Biotech, Alimentiv, Regeneron/Sanofi, AstraZeneca. All other authors declare no competing interests