Faculty Collaboration Database

EsophAguS Deviation During RadiofrequencY Ablation of Atrial Fibrillation: The EASY AF Trial. JACC Clin Electrophysiol 2024 Jan;10(1):68-78

Date

10/29/2023

Pubmed ID

37897465

DOI

10.1016/j.jacep.2023.09.004

Scopus ID

2-s2.0-85181813801 (requires institutional sign-in at Scopus site)   2 Citations

Abstract

BACKGROUND: Injury to the esophagus has been reported in a high percentage of patients undergoing ablation of atrial fibrillation (AF).

OBJECTIVES: This study assessed the incidence of esophageal injury in patients undergoing ablation of AF with and without an esophageal deviating device.

METHODS: This prospective, randomized, multicenter, double-blinded, controlled Food and Drug Administration investigational device exemption trial compared the incidence of ablation-related esophageal lesions, as assessed by endoscopy, in patients undergoing AF ablation assigned to a control group (luminal esophageal temperature [LET] monitoring alone) compared with patients randomized to a deviation group (esophagus deviation device + LET). This novel deviating device uses vacuum suction and mechanical deflection to deviate a segment of the esophagus, including the trailing edge.

RESULTS: The data safety and monitoring board recommended stopping the study early after randomizing 120 patients due to deviating device efficacy. The primary study endpoint, ablation injury to the esophageal mucosa, was significantly less in the deviation group (5.7%) in comparison to the control group (35.4%; P < 0.0001). Control patients had a significantly higher severity and greater number of ablation lesions per patient. There was no adverse event assigned to the device. By multivariable analysis, the only feature associated with reduced esophageal lesions was randomization to deviating device (OR: 0.13; 95% CI: 0.04-0.46; P = 0.001). Among control subjects, there was no difference in esophageal lesions with high power/short duration (31.8%) vs other radiofrequency techniques (37.2%; P = 0.79).

CONCLUSIONS: The use of an esophageal deviating device resulted in a significant reduction in ablation-related esophageal lesions without any adverse events.

Author List

Weiss R, Osorio J, Nair D, Aguinaga L, Arabia L, Alcivar D, Al-Ahmad A, Tomassoni G, Kahaly O, Mehta R, Ward C, Holmes B, Patel D, Killu AM, Munger T, Essandoh M, Houmsse M, Rajendra A, Morales G, Hummel JD, Balasubramanian G, Daoud EG

Author

Gokulakrishnan Balasubramanian MD Associate Professor in the Medicine department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Atrial Fibrillation
Catheter Ablation
Esophagus
Humans
Prospective Studies