Three-Year Experience with the Ultracor Valve Prosthesis

Abstract

From February 1992 to October 1995, 504 patients aged 3 to 69 years (median, 36 years) received 663 Ultracor prostheses (103 aortic, 259 mitral, 12 tricuspid, and 130 multiple). Early mortality was 2.77% with a rate of 3.88% for aortic valve replacement, 3.47% for mitral, 0% for tricuspid, and 0.99% for double valve replacement. Follow-up was 100% (719.5 patient-years) and the overall mortality (early and late deaths) was 3.76% with a rate of 4.85% after aortic valve replacement, 3.85% after mitral valve replacement, 8.33% after tricuspid valve replacement, and 2.97% after double valve replacement. There were no deaths among 29 patients who had triple valve replacement. All patients including 33 children (3.5 to 18 years of age) received sodium warfarin. The linearized risk per patient-year for all embolic events (major and minor) was 0.69%, 1.11%, and 0.69% for aortic, mitral, and multiple valve replacement respectively. When only major events were considered, the linearized risks were 0.27%, 0.13%, and 0% per patient-year respectively. Freedom from major systemic embolism was 99% ± 0.07% after aortic valve replacement, 99% ± 0.07% after mitral valve replacement, and 99% ± 0.06% after multiple valve replacement. Five patients suffered valve thrombosis, 4 of whom definitely received inadequate anticoagulation therapy. Sixteen patients had 25 episodes of anticoagulant-related hemorrhage. No structural failure was recorded and no significant hemolysis was found in the absence of periprosthetic leak. This experience encourages us to continue using the Ultracor prosthesis.