Esophagus Deviation During AF Ablation: EASY AF Trial

Quick Takes

  • In this prospective, randomized study of 120 patients undergoing AF ablation, the use of a novel deviating device with vacuum suction and mechanical deflection resulted in less frequent and less severe esophageal lesions than in the control group.

Study Questions:

What is the incidence of esophageal injury in patients undergoing ablation of atrial fibrillation (AF) with and without an esophageal deviating device?

Methods:

This was a prospective, randomized, multicenter, double-blind, controlled Food and Drug Administration investigational device exemption trial. The incidence of ablation-related esophageal lesions was assessed in patients undergoing AF ablation by endoscopy, who were assigned to a control group (luminal esophageal temperature [LET] monitoring alone) versus a deviation group (esophagus deviation device + LET).

Results:

A total of 120 patients were randomized to control and deviation groups. The data safety and monitoring board terminated the study early. Ablation injury to the esophageal mucosa was significantly less frequent in the deviation group (5.7%) compared to the control group (35.4%, p < 0.0001). Control patients had a significantly higher severity and greater number of esophageal 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 (odds ratio, 0.13; p = 0.001). Among control subjects, there was no difference in esophageal lesions with high power/short duration versus other radiofrequency techniques.

Conclusions:

The authors concluded that the use of the esophageal deviating device resulted in a significant reduction in ablation-related esophageal lesions without any adverse events.

Perspective:

Esophageal injury during AF ablation is common in virtually all types of ablation energy sources, save for the emerging pulse field ablation, although the instances of life-threatening atrio-esophageal fistula is indeed very low. Esophageal temperature monitoring during ablation, shortened duration of power, and perioperative proton pump inhibitor use have emerged as the main measures aimed at the reduction of esophageal injury. Prior reports of esophageal retractors have shown the feasibility of the approach, but the retractors were limited by the inability of the device to move the training edge of the esophagus. The present report shows that the new study device using deflection and suction can effectively move both the leading and the trailing edge of the esophagus with less esophageal injury observed on endoscopy 1-day post-ablation in those patients in whom it was used. Of note, the study was terminated early after only 120 patients had been enrolled. The electrophysiology proceduralist was not blinded to the randomization and may have altered the ablation strategy to avoid esophageal injury.

Clinical Topics: Arrhythmias and Clinical EP, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Atrial Fibrillation, Esophagus, Radiofrequency Ablation


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