Anti-reflux mucosal ablation (ARMA) as a new treatment for gastroesophageal reflux refractory to proton pump inhibitors: a pilot study

Abstract

Background The incidence of proton pump inhibitor (PPI)-refractory gastroesophageal reflux disease (GERD) has been increasing. While surgical intervention with Laparoscopic Nissen Fundoplication remains the gold standard, less invasive anti-reflux interventions are desired. We have developed a minimally invasive anti-reflux mucosal ablation (ARMA) treatment. Herein, we report its technical details and describe its feasibility, safety, and efficacy in PPI-refractory GERD. Methods We conducted a prospective single-center single-arm interventional trial evaluating the outcome of ARMA in 12 patients with PPI-refractory GERD. GERD-Health Related Quality of Life Questionnaire (GERD-HRQL) evaluation, Frequency Scale for the Symptoms of GERD (FSSG) assessment, and impedance-pH monitoring were performed at baseline and at 2 months post-ARMA. Results A total of 12 patients underwent ARMA with a median follow-up duration of 9 months (range: 6 - 14 months). Median GERD-HRQL score significantly improved from 30.5 to 12 ( P = 0.002); median FSSG score significantly improved from 25 to 10.5 ( P = 0.002), and median DeMeester score decreased from 33.5 to 2.8 ( P = 0.049) at 2 months follow-up. No immediate complications were observed. Conclusion Our pilot study has shown that ARMA, a new endoscopic treatment for PPI-refractory GERD, is simple, safe, and improves GERD-related symptoms and objective acid reflux parameters.

Conflict of interest statement

Competing interests Dr. Inoue is an advisor for Olympus Corporation and Top Corporation. He has also received educational grants from Olympus Corp. and Takeda Pharmaceutical Co.

Figures

Fig. 1

The first case of anti-reflux mucosal ablation (ARMA).aPre-anti-reflux mucosectomy (ARMS). Endoscopy in retroflexion demonstrated significant valve opening/impairment (Flap valve grade III).bPost-ARMS. cImmediately post-ARMA.dAppearance at 1 month post-ARMA. Mucosal flap valve was re-shaped (Flap valve grade I).

Fig. 2

Endoscopic follow-up of anti-reflux mucosal ablation (ARMA).aPre-ARMA. Endoscopy in retroflexion demonstrated significant hernia (Flap valve grade III) but no sliding component.bImmediately post-ARMA. Endoscopy in retroflexion showed butterfly-shaped artificial ulcer.cAppearance at 1 month post-ARMA. Mucosal flap valve was re-shaped (Flap valve grade I).dBefore ARMA. Los Angeles grade A esophagitis is seen.eAfter ARMA. Erosive esophagitis resolved.

Fig. 3

Symptom scores pre- and post-ARMA (n = 12).aGERD-health-related quality of life score (GERD-HRQL) pre- and 2 months post-ARMA.bFrequency scale for the symptoms of gastroesophageal reflux disease (FSSG) pre- and 2 months post-ARMA. *Wilcoxon matched-pairs signed-ranks test.

Fig. 4

MII-pH monitoring data pre- and post-ARMA (n = 8).aMedian DeMeester score pre- and post-ARMA significantly improved from 33.5 to 2.8 (P = 0.049).bMedian Acid Exposure Time (pH < 4) decreased from 9.0 % to 0.5 % (P = 0.068). *Wilcoxon matched-pairs signed-ranks test.