Decrease in Reported Rates of Catheter Ablation-Related Adverse Events
During the COVID-19 Pandemic
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.