Mid-term hemodynamic and clinical results of the stented porcine Medtronic Mosaic valve in aortic position

Background: Our study aim was to evaluate the hemodynamic and clinical performance of the Mosaic bioprosthesis in aortic position. Methods: The stented porcine bioprosthesis combines zero pressure glutaraldehyde fixation and amino oleic acid anti-mineralization treatment for improved hemodynamics and durability. Between 2/1994 and 5/1999, 100 patients underwent aortic valve replacement. Mean age at implant was 73.4 years. Patients were followed up within thirty days after intervention, after six months and then annually. Mean follow-up was 4.8 years (range 0.1 -8.8 years), totaling 483.4 patient-years. Results: Mortality within 30 days was 3.0%; late mortality was 4.6%/patient-year, including 0.4%/patient-year prosthesis-related mortality. Freedom from event rates at 8.5 years were 96.8% for thromboembolism, 97.7% for thrombosed bioprosthesis, 97.4% for structural deterioration, 98.7% for nonstructural dysfunction, 95.9% for hemorrhage, 98.9% for endocarditis and 95.1% for reoperation and explant. Mean pressure gradients were 15.2 mmHg (21), 14.5 mmHg (23), 12.7 mmHg (25) and 13.0 mmHg (27) after one year; effective orifice areas 1.36 cm(2) (21),1.68 cm(2) (23),1.76 cm(2) (25) and 2.57 cm(2) (27). Conclusions: Clinical and hemodynamic performance of the Mosaic bioprosthesis was highly satisfactory during the first 8.5 years after clinical introduction.