The Medtronic Mosaic Prosthesis: Clinical performance up to 18 years

Objectives: 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 is 2062.9 patient-years (pt-yrs) for AVR and 361.4 pt-yrs for MVR. Patients are followed yearly and have undergone serial echocardiographic assessment.

Results: For AVR and MVR, late mortality was 3.1% and 3.6% per pt-yr, including a valve-related/unexplained mortality of 1.0% and 0.8% per pt-yr. The mean gradient across all valve sizes remained stable over the years. Freedom from structural valve deterioration at 18 years was in the AVR group 65.9 ± 27.2% and at 17 years in the MVR group it was 90.0 ± 28.5%.

Conclusions: Our long-term results demonstrate clinical safety and excellent performance of the MOSAIC bioprosthesis. Interestingly freedom from SVD was higher in the MVR group compared to the AVR group.