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Ann Thorac Surg. 2001 May;71(5 Suppl):S273-7.

Mosaic valve international clinical trial: early performance results.

Author information

1
University of British Columbia, Vancouver, Canada. gfradet@interchange.ubc.ca

Abstract

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.

PMID:
11388203
DOI:
10.1016/s0003-4975(01)02539-5
[Indexed for MEDLINE]

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