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Background and Objectives <p>Anti-reflux mucosal ablation (ARMA) is a minimally invasive therapy for patients with proton pump inhibitor (PPI) controlled gastro-esophageal reflux disease (GERD). This study evaluated the safety and efficacy of ARMA over 12&#xa0;months.</p> Methods <p>This single-center prospective study included PPI-dependent GERD patients (acid exposure time [AET] &gt; 6% or AET &gt; 4.2% with reflux episodes &gt; 80 on 24-h-pH-impedance monitoring). ARMA was performed in a standardized fashion using hybrid technique (sub-mucosal lift followed by ablation). Patients were evaluated using the GERD health-related quality of life questionnaire (HRQL) at baseline, three&#xa0;months and 12&#xa0;months, with 24-h-pH-impedance monitoring at baseline and 12&#xa0;months.</p> Results <p>Total 216 patients (67.1% males, mean age = 38.7&#xa0;years) underwent ARMA. At baseline, 123 (56.9%) patients had Hill’s grade I and 93 (43.1%) had Hill’s grade II on endoscopy. Ninety (41.7%) patients had Los Angeles (LA)&#xa0;grade A and 2 (0.93%) had LA grade B. There was a significant improvement in GERD-HRQL score from 43.8 (12.6) at baseline to 20.6 (13.8) at three&#xa0;months and to 8.3 (12.3) at 12&#xa0;months (<i>p</i> = 0.001). The mean (SD) heartburn and regurgitation scores improved from 22.9 (10.8) and 20.6 (9.4) at baseline to 11.1 (8.7) and 9.5 (8.7) at three&#xa0;months and 3.9 (6.9) and 3.9 (6.9) at 12&#xa0;months, respectively (<i>p</i> = 0.001). The AET (median [IQR]) decreased from 11.9 (15.9) to 7.6 (10.8) (<i>n</i> = 125, <i>p</i> = 0.009) at 12&#xa0;months and the median DeMeester score reduced from 42.4 (47.1) to 26.2 (32.3) (<i>p</i> = 0.001). There was also a&#xa0;significant decrease in number of patients with AET 4%&#xa0;to&#xa0;6%&#xa0;and &gt; 6% and reflux episodes 40–80 and &gt; 80&#xa0;and DeMeester score &gt; 14.72, as well as an&#xa0;increase in&#xa0;patients with AET &lt; 4% and reflux episodes &lt; 40. There was a&#xa0;significant improvement in Hill’s grading and endoscopic esophagitis at one&#xa0;year. No major adverse events were observed.</p> Conclusion <p>In PPI-dependent GERD patients, ARMA resulted in sustained symptom reduction and improved quality of life at 12&#xa0;months. This procedure is relatively simple, widely accessible and has a good safety profile.</p> Clinical trial registration <p>ClinicalTrials.gov (NCT04243668).</p> Graphical Abstract <p></p>

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Efficacy and safety of anti-reflux mucosal ablation therapy at 12 months

  • 期刊论文

  • 发表日期：

    2025年6月11日

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  • Krithi Krishna Koduri,
  • Neeraj Singla,
  • Rajesh Goud Maragoni,
  • Nitin Jagtap,
  • Aniruddha Pratap Singh,
  • Rakesh Kalapala,
  • D. Nageshwar Reddy

摘要

Background and Objectives

Anti-reflux mucosal ablation (ARMA) is a minimally invasive therapy for patients with proton pump inhibitor (PPI) controlled gastro-esophageal reflux disease (GERD). This study evaluated the safety and efficacy of ARMA over 12 months.

Methods

This single-center prospective study included PPI-dependent GERD patients (acid exposure time [AET] > 6% or AET > 4.2% with reflux episodes > 80 on 24-h-pH-impedance monitoring). ARMA was performed in a standardized fashion using hybrid technique (sub-mucosal lift followed by ablation). Patients were evaluated using the GERD health-related quality of life questionnaire (HRQL) at baseline, three months and 12 months, with 24-h-pH-impedance monitoring at baseline and 12 months.

Results

Total 216 patients (67.1% males, mean age = 38.7 years) underwent ARMA. At baseline, 123 (56.9%) patients had Hill’s grade I and 93 (43.1%) had Hill’s grade II on endoscopy. Ninety (41.7%) patients had Los Angeles (LA) grade A and 2 (0.93%) had LA grade B. There was a significant improvement in GERD-HRQL score from 43.8 (12.6) at baseline to 20.6 (13.8) at three months and to 8.3 (12.3) at 12 months (p = 0.001). The mean (SD) heartburn and regurgitation scores improved from 22.9 (10.8) and 20.6 (9.4) at baseline to 11.1 (8.7) and 9.5 (8.7) at three months and 3.9 (6.9) and 3.9 (6.9) at 12 months, respectively (p = 0.001). The AET (median [IQR]) decreased from 11.9 (15.9) to 7.6 (10.8) (n = 125, p = 0.009) at 12 months and the median DeMeester score reduced from 42.4 (47.1) to 26.2 (32.3) (p = 0.001). There was also a significant decrease in number of patients with AET 4% to 6% and > 6% and reflux episodes 40–80 and > 80 and DeMeester score > 14.72, as well as an increase in patients with AET < 4% and reflux episodes < 40. There was a significant improvement in Hill’s grading and endoscopic esophagitis at one year. No major adverse events were observed.

Conclusion

In PPI-dependent GERD patients, ARMA resulted in sustained symptom reduction and improved quality of life at 12 months. This procedure is relatively simple, widely accessible and has a good safety profile.

Clinical trial registration

ClinicalTrials.gov (NCT04243668).

Graphical Abstract