Clinical feasibility of a new antireflux ablation therapy on gastroesophageal reflux disease (with video)

Backgrounds and Aims New mucosal resective and ablative endoscopic procedures based on gastric cardiac remodeling to prevent reflux have appeared. We aimed to evaluate the feasibility of a new ablative technique named antireflux ablation therapy (ARAT) for control of GERD in patients without hiatal hernia. Methods Patients with proton pump inhibitor (PPI)-refractory GERD without hiatal hernia underwent ARAT between January 2016 and October 2019. Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL), upper endoscopy, 24-hour pH monitoring, and PPI use were documented at 3, 6, 12, 24, and 36 months after ARAT. Results One hundred eight patients were included (61 men [56.5%]; median age, 36.5 years; range, 18-78 years). ARAT was performed on all patients. At the 36-month evaluation, 84 patients had completed the protocol. Median ARAT time was 35.5 minutes (range, 22-51 minutes), and median circumference ablation was 300° (range, 270°-320°). No major adverse events occurred, and 14 of 108 patients (12.9%) presented with stenosis that was responsive to balloon dilation (<5 sessions). At the 3-month evaluation, the acid exposure time (AET), DeMeester score, and GERD-HRQL score had decreased from 18.8% to 2.8% (P = .001), 42.5 to 9.1 (P = .001), and 36.5 to 10 (P = .02), respectively, and these values were maintained up to 36 months. Success (AET <4%) was achieved in 89% and 72.2% at 3 and 36 months, respectively. Related factors at 36 months were as follows: pre-ARAT Hill type II (odds ratio [OR], 3.212; 95% confidence interval [CI], 1.431-5.951; P = .033), post-ARAT 3-month Hill type I (OR, 4.101; 95% CI, 1.812-9.121; P = .042), and AET <4% at 3 months (OR, 5.512; 95% CI, 1.451-7.621; P = .021). Conclusions ARAT is a feasible, safe, and effective therapy for early and mid-term treatment of GERD in patients without a sliding hiatal hernia. However, longer follow-up evaluations and randomized comparative studies are needed to clarify its real role. (Clinical trial registration number: NCT03548298.) New mucosal resective and ablative endoscopic procedures based on gastric cardiac remodeling to prevent reflux have appeared. We aimed to evaluate the feasibility of a new ablative technique named antireflux ablation therapy (ARAT) for control of GERD in patients without hiatal hernia. Patients with proton pump inhibitor (PPI)-refractory GERD without hiatal hernia underwent ARAT between January 2016 and October 2019. Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL), upper endoscopy, 24-hour pH monitoring, and PPI use were documented at 3, 6, 12, 24, and 36 months after ARAT. One hundred eight patients were included (61 men [56.5%]; median age, 36.5 years; range, 18-78 years). ARAT was performed on all patients. At the 36-month evaluation, 84 patients had completed the protocol. Median ARAT time was 35.5 minutes (range, 22-51 minutes), and median circumference ablation was 300° (range, 270°-320°). No major adverse events occurred, and 14 of 108 patients (12.9%) presented with stenosis that was responsive to balloon dilation (<5 sessions). At the 3-month evaluation, the acid exposure time (AET), DeMeester score, and GERD-HRQL score had decreased from 18.8% to 2.8% (P = .001), 42.5 to 9.1 (P = .001), and 36.5 to 10 (P = .02), respectively, and these values were maintained up to 36 months. Success (AET <4%) was achieved in 89% and 72.2% at 3 and 36 months, respectively. Related factors at 36 months were as follows: pre-ARAT Hill type II (odds ratio [OR], 3.212; 95% confidence interval [CI], 1.431-5.951; P = .033), post-ARAT 3-month Hill type I (OR, 4.101; 95% CI, 1.812-9.121; P = .042), and AET <4% at 3 months (OR, 5.512; 95% CI, 1.451-7.621; P = .021). ARAT is a feasible, safe, and effective therapy for early and mid-term treatment of GERD in patients without a sliding hiatal hernia. However, longer follow-up evaluations and randomized comparative studies are needed to clarify its real role. (Clinical trial registration number: NCT03548298.)