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Decrease in Reported Rates of Catheter Ablation-Related Adverse Events During the COVID-19 Pandemic
  • Sujata K. Bhatia,
  • Sungjoon Kang
Sujata K. Bhatia
Harvard University Faculty of Arts and Sciences

Corresponding Author:[email protected]

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Sungjoon Kang
Harvard University Faculty of Arts and Sciences
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Abstract

Because the coronavirus disease 10 (COVID-19) pandemic has significantly altered cardiovascular care, we sought to investigate whether the number of reports of adverse events attributed to percutaneous catheter ablation devices changed over the course of the pandemic, specifically examining three medical device classes: cardiac ablation percutaneous catheters; cardiac ablation percutaneous catheters for treatment of atrial fibrillation; and cardiac ablation percutaneous catheters for treatment of atrial flutter. Using data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, we compared weekly reported rates of adverse events for each device during the year immediately preceding the pandemic (March 2019-March 2020) to those during the first year of the pandemic (March 2020-March 2021).  We report a 19% decrease in reported malfunctions related to cardiac ablation percutaneous catheters during the pandemic compared to pre-pandemic. We further report a 23% decrease in reported malfunctions related to cardiac ablation percutaneous catheters for atrial fibrillation during the pandemic compared to pre-pandemic. Finally, we report a 25% decrease in reported injuries related to cardiac ablation percutaneous catheters for atrial flutter during the pandemic compared to pre-pandemic.