Prosthesis-related complications: first-year annual rates.

The rates of valve-related complications determine the clinical performance of biological and mechanical heart valve prostheses by valve position. The crude rates of valve-related complications within the first year after implantation have not been previously reported. The Food and Drug Administration (FDA) of the United States guidance document for the performance of new heart valve prostheses uses objective performance criteria (OPC) as target values for valve-related complications.