Introduction
Various minimally invasive endoscopic procedures have aimed at filling the gap between medical therapy and surgical intervention. Anti-reflux mucosal ablation (ARMA) is a novel endoscopic treatment in which mucosal ablation of the gastric cardiac mucosa with either a thermal probe or with an argon plasma catheter is performed to induce scar formation to enhance the gastroesophageal junction flap valve.
Aims & Methods
We aimed to assess the feasibility, effectiveness, and safety of ARMA. All patients who underwent ARMA between May 2018 and December 2022 were retrospectively analyzed using a prospectively collected database at two referral centers. We offered ARMA to patients if they met the following criteria:
1) Patients with chronic (> six months) GERD symptoms, including heartburn, regurgitation, and/or extraesophageal symptoms;
2) Objective GERD diagnosis based on the Lyon consensus, either on an acid exposure time in the distal esophagus > 6% (definitive GERD) or on the existence of hypersensitive esophagus;
3) No significant sliding hernia (< 3cm);
4) Symptoms refractory to Proton pump inhibitors (PPI) or potassium competitive acid blockers (PCAB) or PPI/PCAB-sensitive GERD patients unwilling to maintain long-term acid suppression drugs.
GERD questionnaires, upper endoscopy, and 24-hour pH monitoring were documented at 2-6 months and 12 months after ARMA. Clinical success was defined as a > 50% reduction in validated GERD questionnaires.
Results
A total of 80 ARMA procedures in 68 patients were analyzed. Definitive GERD was diagnosed in 44 (64.7%) patients and 24 (35.3%) with reflux hypersensitivity. The ARMA procedure had technical success in all cases, and mucosal ablation of the planned area was completed. The median procedural time was 32 (range 16-100) minutes. Clinical success at 2-6 months and one year of a first ARMA procedure was 60% (39/65, 95% CI 48%-71%) and 70% (21/30, 95% CI 52%-83%), respectively. The median GERD-HRQL score at 2-6 months improved significantly from 26 (range, 5 – 51) to 11 (range, 0-50) (p < 0.001). Fifty-one patients (71.8%) were evaluated by 24-hour pH monitoring at 2-6 months post-ARMA. The median AET significantly decreased from 5.3% to 0.7% (p=0.003). In addition, the rate of esophagitis decreased (p< 0.001). Eight patients underwent a second ARMA, and the second ARMA had a clinical success rate of 50% (4/8). All cases had no immediate adverse events, but ten (12.1%) patients with transient stenosis required balloon dilatation. Six patients (7.5%) experienced delayed bleeding after a median of 10 days (range 1-21), which was controlled with conservative treatment (n = 1) or repeated endoscopy (n = 5). No patient required a blood transfusion. Multivariate analysis performed to identify predictors of the short-term success of a first ARMA did not find any factor associated with the primary outcome.
Conclusion
Our data shows that ARMA in patients without significant sliding hernia is technically feasible, reproducible, safe, and improves GERD symptoms in approximately two out of three patients in the short term. Patients with reflux hypersensitivity and proven GERD may be the appropriate candidates regardless of their response to PPI/PCAB.
References
1. Rodríguez de Santiago E, Sanchez-Vegazo CT, Peñas B, et al. Anti-reflux mucosectomy (ARMS) and anti-reflux mucosal ablation (ARMA) for gastroesophageal reflux disease: a systematic review and meta-analysis. Endosc Int Open 2021;9:E1740-e1751.
2. Inoue H, Tanabe M, de Santiago ER, et al. Anti-reflux mucosal ablation (ARMA) as a new treatment for gastroesophageal reflux refractory to proton pump inhibitors: a pilot study. Endosc Int Open 2020;8:E133-e138.
3. Gyawali CP, Kahrilas PJ, Savarino E, et al. Modern diagnosis of GERD: the Lyon Consensus. Gut 2018;67:1351-1362.
Disclosure
Enrique Rodríguez de Santiago declares Olympus (speaker fee, advisory, proctorship, and educational activities), Norgine (educational activities), and Casen (educational activities). Carlos Teruel declares Norgine (educational activities). Haruhiro Inoue declares Olympus (advisory, educational activities), Top Corporation (advisory), and Takeda Pharmaceutical Company (educational activities)