Introduction
The pandemic brought about unprecedented challenges for healthcare,
particularly for cardiovascular surgery. As public health professionals
implemented measures to limit the spread of infectious disease,
minimally invasive surgeries were favored over open surgeries, both to
shorten hospital stays and preserve healthcare resources. These shifts
in care delivery may have had adverse effects on patient outcomes,
particularly for aortic valve prostheses. We have previously reported
that the COVID-19 pandemic had divergent effects on valve replacement
procedures, with an increase in adverse events for percutaneous aortic
valve prostheses and a decrease in adverse events for non-allograft
tissue valves (1). In the present study, we aimed to determine long-term
patterns in adverse events for percutaneous aortic valve prostheses, and
characterize pandemic-related shifts in the context of longer-term
trends. 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.