The Mosaic Valve Clinical Performance at Seven Years: Results from a Multicenter Prospective Clinical Trial
Guy Fradet, Niels Bleese, Edward Busse, Eric Jamieson, Peter Raudkivi, Jacob Goldstein, Jacques Metras
Vancouver Hospital and Health Sciences Center, Vancouver, British Columbia, Canada
 

Background and aim of the study: The Mosaic valve is a third-generation stented porcine bioprosthesis built upon the historical durability of the Hancock II valve in an attempt to improve hemodynamic performance and durability.
Methods: This multicenter trial was prospective and non-randomized in design. Between February 1994 and October 1999, six centers following a common study protocol enrolled 797 patients (mean age 70 years: range: 21-88 years) who underwent aortic valve replacement (AVR), and 232 patients (mean age 68 years; range: 17-84 years) who underwent mitral valve replacement (MVR). The cumulative follow up was 3,442 patient-years (pt-yr) for AVR (mean 4.3 years; maximum 8 years), and 870 pt-yr for MVR (mean 3.7 years; maximum 7 years). Follow up was complete for 95% of AVR patients, and for 97% of MVR patients.

 Results: The mean gradient and calculated effective orifice area average across all valve sizes remained stable at one, four and six years. Freedom from valve-related adverse events (mean ± SE) at one, four and seven years after AVR were, respectively: Anti-thromboembolic-related hemorrhage (ARH) 97.0 ± 0.6, 95.6 ± 0.9, and 94.6 ± 5.1%; primary hemolysis 100, 100, and 100%; and structural valve deterioration (SVD) 100, 100 and 100%. Freedom at one, four and seven years after MVR were: ARH 96.9 ± 1.2, 95.6 ± 2.0, and 95.6 ± 7.6%; primary hemolysis 100, 100, and 100%; and SVD 100, 100, and 100%.
Conclusion: These mid-term results demonstrate the clinical safety and excellent performance of the Mosaic valve. Continued follow up will determine if this new-design, third-generation bioprosthesis will provide increased durability.
 
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