Long-Term Outcomes of the Mosaic Bioprosthesis

Abstract

Background: The Mosaic bioprosthesis is a third-generation stented porcine bioprosthesis. This study was performed to evaluate long-term survival and durability associated with this device.

Methods: A total of 1,029 patients (797 aortic valve replacements, 232 mitral valve replacements) previously enrolled at 6 centers as part of the original regulatory study were included. We evaluated freedom from death, valve-related reoperation, and explant due to structural valve deterioration (SVD), and compared these outcomes by age (<60 and ≥60 years) at the time of implant.

Results: Cumulative follow-up was 7021.2 patient-years in the aortic cohort and 1969.5 patient-years in the mitral cohort. Mean age was 69.5 ± 8.6 and 67.9 ± 10.5 years; 66% and 48% were male, respectively. In the aortic cohort at 17 years, freedom from death was 54.0% in patients younger than 60 years and 24.0% in patients aged 60 years and older (p < 0.01); freedom from reoperation was 36.4% and 81.2%, respectively (p < 0.01); and freedom from explant due to SVD was 47.5% and 89.1% (p < 0.01). At 16 years in the mitral cohort, freedom from death was 67.6% and 20.6% (p < 0.01); freedom from reoperation was 51.3% versus 77.9% (p = 0.04); and freedom from explant due to SVD was 65.2% versus 83.8% (p = 0.23).

Conclusions: This study demonstrates acceptable long-term rates of death, reoperation, and explant due to SVD with the Mosaic bioprosthesis implanted in either the aortic or mitral position. Freedom from explant due to SVD was lower in patients younger than 60 years in the aortic cohort at 17 years, but it was not significantly different between patients younger than 60 years or 60 years and older in the mitral cohort at 16 years.