Background: We report the mid-term results of a prospective trial of a new bioprosthetic valve. The Mosaic bioprosthesis consists of porcine aortic valve that has been cross linked ed in glutaraldehyde solution under zero-pressure fixation and treated with alpha amino oleic acid to reduce the potential for calcification.
Methods: Mosaic bioprosthetic valve replacement was performed in 67 consecutive patients between January 1995 and August 1998. There were 37 patients having aortic valve replacement (AVR) and 30 having mitral valve replacement (MVR) who entered this study. The patients age ranged 56 to 86 years (mean 74.9); 38 were female and 29 were male; 44 were in NYHA grade 3 and 21 were NYHA grade 4. All mitral valve replacements were performed with total preservation of subvalvular apparatus. Echocardiographic assessment of valve and LV function were performed on 7th day, 6 months 1,2 and 3 years.
Results: There was no hospital mortality. 3 year survival was 85.9+/-5.9% for AVR and 100% for MVR. Freedom from antithromboembolic related haemorrhage has been 96.7% for MVR and 91.9% for AVR. Freedom from the transient neurological event was 96.7+/-3.3% for MVR and 100% for AVR Freedom from structural valve failure, permanent thromboembolism, thrombosis or endocarditis has been 100% for both AVR and MVR. In AVR group left ventricle mass, left ventricle mass index significantly decreased, when cardiac index and effective orifice area increased significantly during study period. Transvalvular gradient did not change. In MVR group transvalvular gradient, effective orifice area and cardiac index did not change.
Conclusions: The valve was user friendly. The early results are very satisfactory. Echocardiography measurements after aortic valve replacement are showing very marked late postoperative remodelling of left ventricle. After mitral valve replacement there were exceptionally low transvalvular gradients, no left ventricle outflow tract obstruction.