Adverse events in cryoballoon ablation for pulmonary vein isolation: Insight from the Food and Drug Administration Manufacturer and User Facility Device Experience
Abstract Background Real‐world clinical data on the adverse events related to the use of cryoballoon catheter for pulmonary vein isolation remains limited. Objective To report and describe the adverse events related to the use of Artic Front cryoballoon catheters (Arctic Front, Arctic Front Advance,...
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crwiley:10.1002/joa3.12898 2024-09-09T19:21:55+00:00 Adverse events in cryoballoon ablation for pulmonary vein isolation: Insight from the Food and Drug Administration Manufacturer and User Facility Device Experience Tan, Min Choon Tan, Jian Liang Lee, Wei Jun Srivathsan, Komandoor Sorajja, Dan El Masry, Hicham Scott, Luis R. Lee, Justin Z. 2023 http://dx.doi.org/10.1002/joa3.12898 https://onlinelibrary.wiley.com/doi/pdf/10.1002/joa3.12898 en eng Wiley http://creativecommons.org/licenses/by-nc/4.0/ Journal of Arrhythmia volume 39, issue 5, page 784-789 ISSN 1880-4276 1883-2148 journal-article 2023 crwiley https://doi.org/10.1002/joa3.12898 2024-08-09T04:28:06Z Abstract Background Real‐world clinical data on the adverse events related to the use of cryoballoon catheter for pulmonary vein isolation remains limited. Objective To report and describe the adverse events related to the use of Artic Front cryoballoon catheters (Arctic Front, Arctic Front Advance, and Arctic Front Advance Pro) reported in the Food and Drug Administration's (FDA) Manufacturers and User Defined Experience (MAUDE) database. Methods We reviewed all the adverse events reported to the FDA MAUDE database over a 10.7‐year study period from January 01, 2011 to September 31, 2021. All events were independently reviewed by two physicians. Results During the study period, a total of 320 procedural‐related adverse events reported in the MAUDE database were identified. The most common adverse event was transient or persistent phrenic nerve palsy (PNP), accounting for 48% of all events. This was followed by cardiac perforation (15%), pulmonary vein stenosis (8%), transient ischemic attack or stroke (6%), vascular injury (4%), transient or persistent ST‐elevation myocardial infarction (3%), hemoptysis (2%), pericarditis (2%), and esophageal ulcer or fistula (1%). There were six reported intra‐procedural death events as a result of cardiac perforation. Conclusion The two most common procedural adverse events associated with cryoballoon ablation were PNP and cardiac perforation. All cases of procedural mortality were due to cardiac perforation. Article in Journal/Newspaper Arctic Wiley Online Library Arctic Maude ENVELOPE(168.417,168.417,-83.150,-83.150) Journal of Arrhythmia 39 5 784 789 |
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Wiley Online Library |
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English |
description |
Abstract Background Real‐world clinical data on the adverse events related to the use of cryoballoon catheter for pulmonary vein isolation remains limited. Objective To report and describe the adverse events related to the use of Artic Front cryoballoon catheters (Arctic Front, Arctic Front Advance, and Arctic Front Advance Pro) reported in the Food and Drug Administration's (FDA) Manufacturers and User Defined Experience (MAUDE) database. Methods We reviewed all the adverse events reported to the FDA MAUDE database over a 10.7‐year study period from January 01, 2011 to September 31, 2021. All events were independently reviewed by two physicians. Results During the study period, a total of 320 procedural‐related adverse events reported in the MAUDE database were identified. The most common adverse event was transient or persistent phrenic nerve palsy (PNP), accounting for 48% of all events. This was followed by cardiac perforation (15%), pulmonary vein stenosis (8%), transient ischemic attack or stroke (6%), vascular injury (4%), transient or persistent ST‐elevation myocardial infarction (3%), hemoptysis (2%), pericarditis (2%), and esophageal ulcer or fistula (1%). There were six reported intra‐procedural death events as a result of cardiac perforation. Conclusion The two most common procedural adverse events associated with cryoballoon ablation were PNP and cardiac perforation. All cases of procedural mortality were due to cardiac perforation. |
format |
Article in Journal/Newspaper |
author |
Tan, Min Choon Tan, Jian Liang Lee, Wei Jun Srivathsan, Komandoor Sorajja, Dan El Masry, Hicham Scott, Luis R. Lee, Justin Z. |
spellingShingle |
Tan, Min Choon Tan, Jian Liang Lee, Wei Jun Srivathsan, Komandoor Sorajja, Dan El Masry, Hicham Scott, Luis R. Lee, Justin Z. Adverse events in cryoballoon ablation for pulmonary vein isolation: Insight from the Food and Drug Administration Manufacturer and User Facility Device Experience |
author_facet |
Tan, Min Choon Tan, Jian Liang Lee, Wei Jun Srivathsan, Komandoor Sorajja, Dan El Masry, Hicham Scott, Luis R. Lee, Justin Z. |
author_sort |
Tan, Min Choon |
title |
Adverse events in cryoballoon ablation for pulmonary vein isolation: Insight from the Food and Drug Administration Manufacturer and User Facility Device Experience |
title_short |
Adverse events in cryoballoon ablation for pulmonary vein isolation: Insight from the Food and Drug Administration Manufacturer and User Facility Device Experience |
title_full |
Adverse events in cryoballoon ablation for pulmonary vein isolation: Insight from the Food and Drug Administration Manufacturer and User Facility Device Experience |
title_fullStr |
Adverse events in cryoballoon ablation for pulmonary vein isolation: Insight from the Food and Drug Administration Manufacturer and User Facility Device Experience |
title_full_unstemmed |
Adverse events in cryoballoon ablation for pulmonary vein isolation: Insight from the Food and Drug Administration Manufacturer and User Facility Device Experience |
title_sort |
adverse events in cryoballoon ablation for pulmonary vein isolation: insight from the food and drug administration manufacturer and user facility device experience |
publisher |
Wiley |
publishDate |
2023 |
url |
http://dx.doi.org/10.1002/joa3.12898 https://onlinelibrary.wiley.com/doi/pdf/10.1002/joa3.12898 |
long_lat |
ENVELOPE(168.417,168.417,-83.150,-83.150) |
geographic |
Arctic Maude |
geographic_facet |
Arctic Maude |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Journal of Arrhythmia volume 39, issue 5, page 784-789 ISSN 1880-4276 1883-2148 |
op_rights |
http://creativecommons.org/licenses/by-nc/4.0/ |
op_doi |
https://doi.org/10.1002/joa3.12898 |
container_title |
Journal of Arrhythmia |
container_volume |
39 |
container_issue |
5 |
container_start_page |
784 |
op_container_end_page |
789 |
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1809762199756865536 |