Abstract
Our study aim was to evaluate the hemodynamic and clinical performance of the Mosaic bioprosthesis in aortic position. The stented porcine bioprosthesis combines zero pressure glutaraldehyde fixation and amino oleic acid antimineralization 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. 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 mm Hg (21), 14.5 mm Hg (23), 12.7 mm Hg (25) and 13.0 mm Hg (27) after one year; effective orifice areas 1.36 cm2 (21), 1.68 cm2 (23), 1.76 cm2 (25) and 2.57 cm2 (27). Clinical and hemodynamic performance of the Mosaic bioprosthesis was highly satisfactory during the first 8.5 years after clinical introduction.
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