Table 4.

Adverse events analysis after valve replacement with Bovine Pericardium Organic Valvular Bioprosthesis (BVP, Braile Biomédica®).

Adverse event	AVR (2 × OPC)(c)	AVR(a,b) (% per patient-year)	MVR (2 × OPC)(c)	MVR(a,b) (% per patient-year)
Thromboembolism	3.0	0.0	2.6	0.0
Valve thrombosis	0.08	0.22	0.06	0.0
Major hemorrhage	1.2	0.22	1.4	0.0
Major paravalvular leak	0.6	0.0	0.4	0.0
Endocarditis	1.0	0.68	0.8	0.72

AVR=aortic valve replacement; LPY=late patient-year; MVR=mitral valve replacement; OPC=objective performance criteria

^(a)Late linearized event rate calculated by the number of events/LPY expressed as a percentage

^(b)LPY is calculated from post-implant day 31 until the last day of contact

^(c)OPC for tissue valves, as described in Table J.1 of EN-International Organization for Standardization 5840-2:2015, Annex J^[7]