Table 2. Safety outcomes.

Event	Early (≤30 days) (N=133) (total number of events observed/N)	Late (>30 days) (late patient-years =495.3, total number of events observed/late patient-years)
All-cause mortality	3 (2.3%)	16 (3.2%)
Valve-related mortality	1 (0.8%)	4 (0.8%)
Thromboembolism	3 (2.3%)	1 (0.2%)
Valve thrombosis	0 (0.0%)	1* (0.2%)
Endocarditis	0 (0.0%)	1** (0.2%)
Explant	0 (0.0%)	1** (0.2%)
Major bleeding requiring transfusion	9 (6.8%)	2 (0.4%)
Major paravalvular leak	1 (0.8%)	0 (0.0%)
Non-structural valve dysfunction	0 (0.0%)	1 (0.2%)
Structural valve deterioration	0 (0.0%)	0 (0.0%)

*, valve thrombosis was diagnosed post-mortem at autopsy; **, explant due to endocarditis occurred in one patient.