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Mosaic valve international clinical trial: early performance results
G J Fradet1, N Bleese, J Burgess
1University of British Columbia, Vancouver, Canada. gfradet@interchange.ubc.ca
Background:
A new third generation porcine bioprosthesis was developed in an attempt to improve on hemodynamic performance and durability of current prostheses.
Methods:
One thousand, two hundred, sixty patients underwent aortic valve replacement and 366 patients underwent mitral valve replacement between February 1994 and September 2000. The cumulative follow-up was 3,696.3 patient-years for aortic valve replacement and 880.1 patient-years for mitral valve replacement. Follow-up was complete for 95.5% of aortic valve replacement patients and 97.5% of mitral valve replacement patients.
Results:
For aortic valve replacement, freedom from valve-related adverse events at 1 year was 96.5%+/-0.5% for antithromboembolic-related hemorrhage and 100% for structural valve deterioration. Freedom from valve-related adverse events at 5 years was 93.8%+/-2.6% for antithromboembolic-related hemorrhage and 99.3%+/-0.9% for structural valve deterioration. For mitral valve replacement, freedom from valve-related adverse events at 1 year was 96.0%+/-1.1% for antithromboembolic-related hemorrhage and 100% for structural valve deterioration. Freedom from valve-related adverse events at 4 years was 92.1%+/-3.7% for antithromboembolic-related hemorrhage and 100% for structural valve deterioration.
Conclusions:
These results support the claim that the Mosaic bioprosthetic valve is efficacious and safe, but continued follow-up is mandatory to determine mid- and long-term performance.