Device to move esophagus may make catheter ablation for AF safer
Key takeaways:
- A device that moves the esophagus was linked with less esophageal injury after radiofrequency catheter ablation for atrial fibrillation.
- There were no adverse events associated with the device.
A device to move the esophagus away from the catheter tip during ablation for atrial fibrillation reduced esophageal injury during procedures, according to the results of the EASY AF study presented at Heart Rhythm 2023.
“As an electrophysiologist who performs many ablation procedures for AF, I was concerned about safety of the procedure and felt that a technology could be developed to protect the esophagus from ablation injury. A serious ablation lesion to the esophagus can result in a hole in the esophagus that leads to a life-threatening emergency,” Emile Daoud, MD, section chief of the cardiac electrophysiology program and professor of internal medicine at the Ohio State University Wexner Medical Center College of Medicine, the inventor of the device (Esolution, S4 Medical), who was not an author of the study, told Healio.
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For the prospective, randomized, double-blind, controlled EASY AF trial, the researchers performed radiofrequency catheter ablation on 120 patients with AF, of whom 56 had a procedure with the device plus luminal esophageal temperature monitoring (deviation group) and 64 had a procedure with luminal esophageal temperature monitoring alone (control group).
The device “uses low-force vacuum suction coupled with low-force mechanical deflecting force to move the esophagus safely and only a short distance of about 1 inch, but that is a far distance for ablation energy,” Daoud told Healio. “This makes the device appealing since the distance of moving the esophagus is small, and thus, there is a low risk of adverse effects of moving the esophagus, but is quite effective to reduce ablation lesions.”
The deviation group had greater distance between the radiofrequency catheter tip and the esophagus (28.5 mm vs. 9.4 mm; P < .001), the researchers found. In addition, the deviation group had more patients with more than 20 mm distance between tip and esophagus (85% vs. 19%; P < .001), and among the control group, the distance was less than 5 mm in 54%.
Peak change in luminal esophageal temperature was higher in the control group (1.8° vs. 0.7°; P < .001).
The study was stopped early on the recommendation of the data safety monitoring board due to efficacy in the deviation group. The primary outcome of ablation injury to esophageal mucosa occurred in 5.7% of the deviation group compared with 35.4% of the control group (P < .001), according to the researchers.
There were no adverse events in the deviation group.
“There are three major messages,” Daoud told Healio. “No. 1, the occurrence of ablation injury of the esophagus is high — about one out of every three patients. No. 2, with use of the deviating technology that moves the esophagus, there is a dramatic reduction (about 85%) in the occurrence of lesions in the esophagus. No. 3, there were no adverse side effects with use of the deviating device.”
The device is not yet approved for commercial use in the United States, but an application has been filed for FDA approval based on the results of EASY AF, Daoud told Healio, noting that a new generation of the device is in development.
“This device has been proven to reduce ablation lesions to the esophagus, and so this device makes the procedure safer and reduced complications for patients, and it likely will enhance the procedure for the physician,” Daoud told Healio.
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Osorio J, et al. Abstract AB-452654-2. Presented at: Heart Rhythm 2023; May 19-21, 2023; New Orleans (hybrid meeting).
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