ABSTRACT
BACKGROUND: The Mosaic bioprosthesis is a third-generation stented porcine bioprosthesis combining physiologic fixation and α-amino oleic acid antimineralization treatment to improve durability and hemodynamic function. This single-center study reports on the performance of the Mosaic bioprosthesis in patients 65 years of age or less and patients older than 65 years at implantation. METHODS: Between 1994 and 1999, 88 younger patients (mean age, 58 years) and 167 older patients (mean age, 72 years) were enrolled in this prospective nonrandomized clinical trial. Follow-up visits were performed after 30 days, 6 months, and annually. Cumulative follow-up was 751 patient-years in the younger group and 1223 patient-years in the older group. RESULTS: Mean systolic gradient increased significantly to 17.0 and 14.7 mm Hg in younger and older patients, respectively, at their latest follow-up (P < .001). Effective orifice area values decreased significantly to 1.8 and 1.6 cm(2) (P < .001). Overall, effective orifice area values were significantly higher in younger patients (P < .001). Transvalvular regurgitation increased over time (P < .001) but remained mild or less in more than 95% of the patients. Freedom from adverse events at latest follow-up in younger and older patients, respectively, were as follows: structural valve deterioration, 85.7% and 86.2% (P < .05); endocarditis, 87.5% and 98.5% (P < .01); valvular thrombosis, 98.8% and 97.1% (not significant); and explantation, 68.9% and 77.9% (P < .01). CONCLUSIONS: Hemodynamic performance is similar in both groups. In the younger patients the incidence of structural valve disease, endocarditis, valve-related reoperation, and explantation is higher. The incidence in structural valve deterioration in the younger patients tends to be similar or lower compared with that seen in the literature.
