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. The FDA requirement for each valve-related complication is that the rate cannot be greater than twice the OPC. This report provides the first-year rates of valve-related complications from a university database of over 7,000 implants, followed longitudinally between 1982 and 1999, of currently marketed biological and mechanical heart valve prostheses. The aim of this report was to provide an additional method for consideration by regulatory authorities in determination of the standards of performance for pre-market approval of new prosthetic valves for heart valve replacement surgery.