EsophAguS Deviation During RadiofrequencY Ablation of Atrial Fibrillation

BACKGROUND Injury to the esophagus has been reported ina 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 thorn 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. (J Am Coll Cardiol EP 2024;10:68-78) (c) 2024 by the American College of Cardiology Foundation.