Elsa S Zhou, Sujata K. Bhatia

Abstract: The COVID-19 pandemic forced cardiologists to adapt to unprecedented circumstances. We chose to investigate the pandemic’s effect on heart valve replacements, in particular focussing on device failure in mitral valve replacements and percutaneous aortic valve prostheses. In order to measure this effect, we examined adverse event reports of these two devices in the Food and Drug Administration (FDA)’s Manufacturer and User Facility Device Experience (MAUDE) database. We compared weekly numbers of adverse event reports during the pandemic (March 2020-March 2021) to those of the year before (March 2019-March 2020). We find that reports of deaths, injuries, and malfunctions attributed to mitral valve repair devices all showed no significant changes during the pandemic, compared to the year preceding. However, we have also found that during the pandemic, there was a 107.4% increase in deaths reported to the FDA that were attributed to percutaneous aortic valve prostheses, and a 45.1% increase in reports of malfunctions as well compared to the year preceding the pandemic. These results suggest that the pandemic may have induced an increase in transcatheter aortic valve replacements vs. surgical aortic valve replacements, leading to an increase in adverse event reports associated with percutaneous aortic valve prostheses. In contrast, transcatheter mitral valve repair is not commonly performed, and the pandemic is unlikely to have changed treatment protocols for mitral valve repair.

Keywords: Adverse events, devices, heart valves

Date Published: October 11, 2022
DOI: 10.11159/jbeb.2022.004

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