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Title: The mosaic valve clinical performance at seven years: results from a multicenter prospective clinical trial. Author: Fradet G, Bleese N, Busse E, Jamieson E, Raudkivi P, Goldstein J, Metras J. Journal: J Heart Valve Dis; 2004 Mar; 13(2):239-46; discussion 246-7. PubMed ID: 15086263. Abstract: 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: Antithromboembolic-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.[Abstract] [Full Text] [Related] [New Search]