SAFETY AND EFFICACY OF ANTIREFLUX ABLATION THERAPY (ARAT) AT THE ESOPHAGOGASTRIC JUNCTION (EGJ) IN PATIENTS WITH GASTROESOPHAGEAL REFLUX DISEASE (GERD) WITHOUT HIATAL HERNIA

Aims GERD is a high-prevalent condition with potential severe complications. Medical and surgical treatments are the cornerstone; however, adverse events or complications limit their use. We hypothesize that an esophagogastric-junction(EGJ) controlled stenosis generated with a mucosal ablation(Antireflux ablation therapy[ARAT]), could decrease esophageal exposure to gastric contents. Therefore, our aim was to evaluate the safety and efficacy of ARAT in GERD treatment at early and mid-term.

Methods This prospective study(NCT03548298) was performed in a tertiary-care center in Mexico,from January 2016 to September 2019. GERD positive patients were included (acid exposure time[AET] > 6%, esophagitis ³B and a positive GERD-HRQL questionnaire). ARAT technique was performed with a hybrid-APC catheter. First,EGJ was marked in retroflexion, then, submucosal bleb creation and finally mucosal ablation (300-330degrees) including z-line and 4cms below EGJ. Patients with hiatal hernia were excluded. Post-ARAT evaluation included endoscopy, pHmetry, and GERD-HRQL at 3,6,12,24 and 36 m. Success was considered when AET < 4%, no esophagitis and GERD-HRQL < 12points. Comparisons between pre and post-ARAT procedure were performed, considering a p < 0.05 as statistically significant.

Results 95 patients were included. Follow-up has been completed in 95/95(100%),93/95(97%), 88/95(92%),80/95(84%) and 76/95(80%) at 3,6,12,24 and 36 m. 62/95(65%) were male and mean age was 46 ± 5.5yo. ARAT time was 33.1 ± 8.8 min,without procedural adverse events. 17/95(18%) had mild dysphagia, of whom 5 required endoscopic dilatation (1–2 sessions). GERD was totally(PPI withdraw), partially(decrease PPI dose) and no controlled in 78/95(82.1%);14/95(14.7%) and 3(3.2%), respectively at 36 m follow-up. A second ARAT in partially controlled patients obtained total control in 11/14 (78.5%), and 3 didn’t improve. Clinical, endoscopic and AET improved from 26.8 ± 5.3 to 8.9 ± 3.5(p = 0.002); esophagitis³B from 11.5% to 2.1%(p > 0.001) and 10.4 ± 2.2 to 3.8 ± 1.5(p = 0.01), between baseline and 36 m follow-up.

Conclusions ARAT is a novel promising minimally-invasive treatment with high rates of GERD control at early and mid-term evaluations. However, longer follow-up is needed to define its real role in this disease.