Prosthetic valve complications: interpreting the literature YingXing Wu and

The American Association for Thoracic Surgery (AATS) and the Society of Thoracic Surgeons (STS) first proposed guidelines for reporting complications after cardiac valvular operations in 1988.1 The guidelines provide the definitions and recommendations to facilitate the analysis and reporting of results after cardiac valvular surgeries. The guidelines were updated in 1996.2 In 1994, the US Food and Drug Administration (FDA) issued a guidance document for pre-market evaluation of new heart valves.3 The guidance lists the objective performance criteria (OPC) as the target values for complication rates (Table 19.1).