Risk of atrioesophageal fistula with cryoballoon ablation of atrial fibrillation
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 f...
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ftdoajarticles:oai:doaj.org/article:2227eb19556842b78b8d940c565068fe 2023-05-15T14:43:18+02:00 Risk of atrioesophageal fistula with cryoballoon ablation of atrial fibrillation Jonathan P. Piccini, MD, MHS, FHRS Kendra M. Braegelmann, PhD Sara Simma, MS Jayanthi N. Koneru, MBBS, CCDS Kenneth A. Ellenbogen, MD, FHRS 2020-08-01T00:00:00Z https://doi.org/10.1016/j.hroo.2020.05.007 https://doaj.org/article/2227eb19556842b78b8d940c565068fe EN eng Elsevier http://www.sciencedirect.com/science/article/pii/S2666501820300465 https://doaj.org/toc/2666-5018 2666-5018 doi:10.1016/j.hroo.2020.05.007 https://doaj.org/article/2227eb19556842b78b8d940c565068fe Heart Rhythm O2, Vol 1, Iss 3, Pp 173-179 (2020) Cryoballoon Ablation Atrial fibrillation Safety Atrioesophageal fistula AEF Diseases of the circulatory (Cardiovascular) system RC666-701 article 2020 ftdoajarticles https://doi.org/10.1016/j.hroo.2020.05.007 2022-12-31T06:39:24Z 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. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Heart Rhythm O2 1 3 173 179 |
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Open Polar |
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Directory of Open Access Journals: DOAJ Articles |
op_collection_id |
ftdoajarticles |
language |
English |
topic |
Cryoballoon Ablation Atrial fibrillation Safety Atrioesophageal fistula AEF Diseases of the circulatory (Cardiovascular) system RC666-701 |
spellingShingle |
Cryoballoon Ablation Atrial fibrillation Safety Atrioesophageal fistula AEF Diseases of the circulatory (Cardiovascular) system RC666-701 Jonathan P. Piccini, MD, MHS, FHRS Kendra M. Braegelmann, PhD Sara Simma, MS Jayanthi N. Koneru, MBBS, CCDS Kenneth A. Ellenbogen, MD, FHRS Risk of atrioesophageal fistula with cryoballoon ablation of atrial fibrillation |
topic_facet |
Cryoballoon Ablation Atrial fibrillation Safety Atrioesophageal fistula AEF Diseases of the circulatory (Cardiovascular) system RC666-701 |
description |
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. |
format |
Article in Journal/Newspaper |
author |
Jonathan P. Piccini, MD, MHS, FHRS Kendra M. Braegelmann, PhD Sara Simma, MS Jayanthi N. Koneru, MBBS, CCDS Kenneth A. Ellenbogen, MD, FHRS |
author_facet |
Jonathan P. Piccini, MD, MHS, FHRS Kendra M. Braegelmann, PhD Sara Simma, MS Jayanthi N. Koneru, MBBS, CCDS Kenneth A. Ellenbogen, MD, FHRS |
author_sort |
Jonathan P. Piccini, MD, MHS, FHRS |
title |
Risk of atrioesophageal fistula with cryoballoon ablation of atrial fibrillation |
title_short |
Risk of atrioesophageal fistula with cryoballoon ablation of atrial fibrillation |
title_full |
Risk of atrioesophageal fistula with cryoballoon ablation of atrial fibrillation |
title_fullStr |
Risk of atrioesophageal fistula with cryoballoon ablation of atrial fibrillation |
title_full_unstemmed |
Risk of atrioesophageal fistula with cryoballoon ablation of atrial fibrillation |
title_sort |
risk of atrioesophageal fistula with cryoballoon ablation of atrial fibrillation |
publisher |
Elsevier |
publishDate |
2020 |
url |
https://doi.org/10.1016/j.hroo.2020.05.007 https://doaj.org/article/2227eb19556842b78b8d940c565068fe |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Heart Rhythm O2, Vol 1, Iss 3, Pp 173-179 (2020) |
op_relation |
http://www.sciencedirect.com/science/article/pii/S2666501820300465 https://doaj.org/toc/2666-5018 2666-5018 doi:10.1016/j.hroo.2020.05.007 https://doaj.org/article/2227eb19556842b78b8d940c565068fe |
op_doi |
https://doi.org/10.1016/j.hroo.2020.05.007 |
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Heart Rhythm O2 |
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3 |
container_start_page |
173 |
op_container_end_page |
179 |
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