Table 3

Kaplan–Meier event-free estimates: mitral or double valve replacement

Standard valve event-free (%)Silzone valve event-free (%)Standard − Silzone (% and 95% CI)
3 m1 y3 y3 m1 y3 y3 m1 y3 y
*Significant difference between the groups.
†There was one definite and one probable case of endocarditis in the Silzone group, as assessed by the Duke criteria.
CI, confidence interval; m, months; y, year.
All thromboembolism93888065656528 (0 to 56)23 (−8 to 54)15 (−18 to 48)
Major thromboembolism1001009565656535 (8 to 62)*35 (5 to 65)*30 (0 to 60)
Major bleed10010092100100930 (0 to 0)0 (0 to 0)−1 (−17 to 15)
Endocarditis†1001001009488886 (−5 to 17)12 (−4 to 28)12 (−4 to 28)
Reoperation1001001009488886 (−5 to 17)12 (−4 to 28)12 (−4 to 28)
Death9191878979742 (−15 to 19)12 (−10 to 34)13 (−12 to 38)