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Risk of atrioesophageal fistula with cryoballoon ablation of atrial fibrillation.

Publication ,  Journal Article
Piccini, JP; Braegelmann, KM; Simma, S; Koneru, JN; Ellenbogen, KA
Published in: Heart Rhythm O2
August 2020

BACKGROUND: Although there are considerable data on the safety of cryoablation, data on the rare but severe complication of atrioesophageal fistula (AEF) following cryoballoon ablation are limited. OBJECTIVE: To report the global, user-reported incidence of AEF associated with cryoballoon ablation for the treatment of atrial fibrillation using Medtronic's complaint database. METHODS: User-reported cryoballoon ablation complications occurring between July 1, 2009, and March 31, 2019, were reviewed to identify cases of AEF. A global event rate of AEF was calculated by dividing the event count by total catheter utilization over the same period. Data on symptoms and patient sequalae were reported as available. RESULTS: More than 500,000 Arctic Front cryoballoon catheters (Arctic Front, Arctic Front Advance, Arctic Front Advance ST, and Arctic Front Advance Pro; Medtronic, Inc) were distributed globally during the 9.75-year study period. During this time, 18 confirmed AEF, 1 suspected AEF, and 1 pericardial esophageal fistula were identified; therefore, global incidence of AEF associated with the Arctic Front family of ablation catheters was 0.00396%. Patients most commonly presented with fever (88.2%), and initial symptoms were reported a median of 21 (interquartile range: 4-30) days after the ablation. Although rare, the development of an AEF resulted in death in 68.8% (11/16) of patients with known outcomes. CONCLUSIONS: AEF is a possible but rare complication of cryoballoon ablation with a reported frequency of 1 in every 25,000 patients treated. Awareness of the prevalence and manifestation of AEF associated with cryoballoon ablation is critical for early identification and treatment of this complication.

Duke Scholars

Published In

Heart Rhythm O2

DOI

EISSN

2666-5018

Publication Date

August 2020

Volume

1

Issue

3

Start / End Page

173 / 179

Location

United States
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Piccini, J. P., Braegelmann, K. M., Simma, S., Koneru, J. N., & Ellenbogen, K. A. (2020). Risk of atrioesophageal fistula with cryoballoon ablation of atrial fibrillation. Heart Rhythm O2, 1(3), 173–179. https://doi.org/10.1016/j.hroo.2020.05.007
Piccini, Jonathan P., Kendra M. Braegelmann, Sara Simma, Jayanthi N. Koneru, and Kenneth A. Ellenbogen. “Risk of atrioesophageal fistula with cryoballoon ablation of atrial fibrillation.Heart Rhythm O2 1, no. 3 (August 2020): 173–79. https://doi.org/10.1016/j.hroo.2020.05.007.
Piccini JP, Braegelmann KM, Simma S, Koneru JN, Ellenbogen KA. Risk of atrioesophageal fistula with cryoballoon ablation of atrial fibrillation. Heart Rhythm O2. 2020 Aug;1(3):173–9.
Piccini, Jonathan P., et al. “Risk of atrioesophageal fistula with cryoballoon ablation of atrial fibrillation.Heart Rhythm O2, vol. 1, no. 3, Aug. 2020, pp. 173–79. Pubmed, doi:10.1016/j.hroo.2020.05.007.
Piccini JP, Braegelmann KM, Simma S, Koneru JN, Ellenbogen KA. Risk of atrioesophageal fistula with cryoballoon ablation of atrial fibrillation. Heart Rhythm O2. 2020 Aug;1(3):173–179.

Published In

Heart Rhythm O2

DOI

EISSN

2666-5018

Publication Date

August 2020

Volume

1

Issue

3

Start / End Page

173 / 179

Location

United States