Careful follow up studies in patients receiving a Silzone (TM) -coated St.
Jude Medical valve (67 aortic valves, 36 mitral valves, nine double valves)
did not support the fear of a high risk of perivalvular leak and embolism
rate. Freedom from perivalvular risk at 12 and 24 months follow up was 98.5
+/- 1.5% and 100% for the aortic and mitral valves, respectively. Freedom
from any thromboembolic event was 96.6 +/- 2.4% at 12 and 24 months follow
up in the aortic group, and 97 +/- 3% at 12 and 24 months in the mitral gro
up. The risk of bleeding (92.2 +/- 3.8% at 12 and 24 months in the aortic g
roup; 85.5 +/- 6.0% in the mitral group) illustrated the risk of mechanical
valve implantation in an elderly population.