Primary endpoints | Secondary endpoints | |||||
---|---|---|---|---|---|---|
Mortality | Reoperations | Transvalvular gradient | Valvular function | Valvular characteristics | Histological commentary | Adverse events |
30-day | 30-day | Overall | Insufficiency | Diameter | Fibroproliferation | Infective endocarditis OR freedom from infective endocarditis |
1-year | 1-year | Â | Stenosis | Area | Recellularization | Valve thrombosis OR freedom from valve thrombosis |
Overall rate OR freedom from mortality | Overall rate OR freedom from reoperations | Â | Explantation rate OR freedom from explantation | Calcification | Antibody/humoral immune response | Â |
 | Time to reoperation |  | Rate of dysfunction OR freedom from dysfunction | Cusp mobility |  |  |
 |  |  | Failure rate OR freedom from failure | Cusp retraction |  |  |