Adverse Events in Cryoballoon Ablation for Pulmonary Vein Isolation: Insight from the Food and Drug Administration Manufacturer and User Facility Device Experience
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 Ar...
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fttourocollege:oai:touroscholar.touro.edu:nymc_res_pubs-1196 2024-05-19T07:35:22+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 2023-10-01T07:00:00Z https://touroscholar.touro.edu/nymc_res_pubs/310 https://doi.org/10.1002/joa3.12898 https://onlinelibrary.wiley.com/doi/10.1002/joa3.12898 unknown Touro Scholar https://touroscholar.touro.edu/nymc_res_pubs/310 doi:10.1002/joa3.12898 https://onlinelibrary.wiley.com/doi/10.1002/joa3.12898 NYMC Residents/Fellows Publications Resident/Fellow Medicine and Health Sciences article 2023 fttourocollege https://doi.org/10.1002/joa3.12898 2024-04-21T23:42:33Z 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 Touro College & University System: Touro Scholar Journal of Arrhythmia 39 5 784 789 |
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Touro College & University System: Touro Scholar |
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fttourocollege |
language |
unknown |
topic |
Resident/Fellow Medicine and Health Sciences |
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Resident/Fellow Medicine and Health Sciences 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 |
topic_facet |
Resident/Fellow Medicine and Health Sciences |
description |
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 |
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 |
Touro Scholar |
publishDate |
2023 |
url |
https://touroscholar.touro.edu/nymc_res_pubs/310 https://doi.org/10.1002/joa3.12898 https://onlinelibrary.wiley.com/doi/10.1002/joa3.12898 |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
NYMC Residents/Fellows Publications |
op_relation |
https://touroscholar.touro.edu/nymc_res_pubs/310 doi:10.1002/joa3.12898 https://onlinelibrary.wiley.com/doi/10.1002/joa3.12898 |
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 |
_version_ |
1799474011040645120 |