The Medtronic mosaic prosthesis: Clinical perfomance up to 16 years

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Objective: The MOSAIC bioprosthesis is a third generation stented porcine bioprosthesis, built upon the historical durability of the HANCOCK-II bioprosthesis. The MOSAIC Aortic and Mitral bioprostheses are preserved in buffered 0.2% glutaraldehyde in a zero pressure procedure and they are treated with the AOA (amino oleic acid) antimineralisation process, to improve hemodynamic performance and durability. Methods: The Mosaic post-approval long-term trial is prospective and non-randomized. Between 02/1994 and 10/1999 we enrolled 255 patients with AVR (mean age 67 years, range 23–82 years) and 47 patients with MVR (mean age 66.8 years, range 41–84 years). The cumulative follow-up was 2073 patient-years (pt-yrs) for AVR and 354 pt-yrs for MVR. Patients are followed yearly and have undergone serial echocardiographic assessment. Results: For AVR and MVR, late mortality including a valve-related/unexplained mortality was 3.5% and 4.7% per pt-yr. The mean gradient across all valve sizes remained stable over the years. Freedom from structural valve deterioration at 16 years was in the AVR group 86% and at 15 years in the MVR group 95% (one patient). Conclusions: Our midterm results demonstrate clinical safety and excellent performance of the MOSAIC bioprosthesis. Continued follow-up will determine, if this new design will provide increased durability.

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