Increase in Reported Deaths, Injuries, and Malfunctions for Transcatheter Aortic Valve Prostheses During the COVID-19 Pandemic

Abstract

Shifts in care delivery during the COVID-19 pandemic, particularly from surgical aortic valve replacement to percutaneous aortic valve replacement, may have had adverse outcomes for patients. We analyzed data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, to determine trends in reported malfunctions, injuries, and deaths for transcatheter aortic valve prostheses during the decade 2012 to 2021. We find that reported deaths attributed to transcatheter aortic valve prostheses more than doubled from the pre-pandemic year of 2019 to the pandemic year of 2020. Monthly reported deaths attributed to transcatheter aortic valve prostheses increased by 124%, from 25.0 monthly deaths in 2019 to 55.9 monthly deaths in 2020 (p<0.003). The increased level of deaths persisted in 2021, with 58.3 monthly reported deaths in 2021; the overall increase in deaths from 2019 to 2021 was 133%. We find that reported injuries attributed to transcatheter aortic valve prostheses increased by 25%, from 297.8 monthly injuries in 2019 to 371.4 monthly injuries in 2020 (p<0.03). Finally we find that reported malfunctions attributed to transcatheter aortic valve prostheses increased by 39%, from 40.1 monthly malfunctions in 2019 to 55.7 monthly malfunctions in 2020 (p<0.007). These results suggest an overall increase in adverse events following transcatheter aortic valve prostheses during the pandemic, and indicate a pressing need for further research into short-term and long-term patient outcomes following transcatheter aortic valve prostheses.