EsophAguS Deviation During RadiofrequencY Ablation of Atrial Fibrillation: EASY AF.
atrial fibrillation
atrioesophageal fistula
catheter ablation
deviation
esophagus
radiofrequency
Journal
JACC. Clinical electrophysiology
ISSN: 2405-5018
Titre abrégé: JACC Clin Electrophysiol
Pays: United States
ID NLM: 101656995
Informations de publication
Date de publication:
12 Oct 2023
12 Oct 2023
Historique:
received:
05
07
2023
revised:
21
08
2023
accepted:
14
09
2023
medline:
29
10
2023
pubmed:
29
10
2023
entrez:
28
10
2023
Statut:
aheadofprint
Résumé
Injury to the esophagus has been reported in a high percentage of patients undergoing ablation of atrial fibrillation (AF). This study assessed the incidence of esophageal injury in patients undergoing ablation of AF with and without an esophageal deviating device. 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. 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). The use of an esophageal deviating device resulted in a significant reduction in ablation-related esophageal lesions without any adverse events.
Sections du résumé
BACKGROUND
BACKGROUND
Injury to the esophagus has been reported in a high percentage of patients undergoing ablation of atrial fibrillation (AF).
OBJECTIVES
OBJECTIVE
This study assessed the incidence of esophageal injury in patients undergoing ablation of AF with and without an esophageal deviating device.
METHODS
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
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
CONCLUSIONS
The use of an esophageal deviating device resulted in a significant reduction in ablation-related esophageal lesions without any adverse events.
Identifiants
pubmed: 37897465
pii: S2405-500X(23)00724-7
doi: 10.1016/j.jacep.2023.09.004
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Funding Support and Author Disclosures This study was funded by S4 Medical Corp. Dr Daoud and The Ohio State University have equity ownership in S4 Medical. Dr. Daoud is chief medical officer for S4 Medical and receives a consultant fee. Drs Weiss, Essandoh, and Hummel are paid consultants as members of the S4 Medical advisory board. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.