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DOI: 10.1055/s-2004-817800
© Georg Thieme Verlag Stuttgart · New York
Mid-Term Hemodynamic and Clinical Results of the Stented Porcine Medtronic Mosaic Valve in Aortic Position[*]
Publication History
Received February 27, 2003
Publication Date:
04 March 2004 (online)
Abstract
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 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. 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 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). Conclusions: Clinical and hemodynamic performance of the Mosaic bioprosthesis was highly satisfactory during the first 8.5 years after clinical introduction.
Key words
Aortic valve replacement - heart valve bioprosthesis - AOA - zero pressure - structural valve deterioration
1 Presented at the 32nd Annual Meeting of the German Society for Thoracic and Cardiovascular Surgery in Leipzig/Germany in February 2003.
References
- 1 Grunkemeier G L, Bodnar E. Comparative assessment of bioprosthesis durability in the aortic position. J Heart Valve Dis. 1995; 4 49-55
- 2 Burdon T A, Miller D C, Oyer P E. et al . Durability of porcine valves at fifteen years in a representative North American patient population. J Thorac Cardiovasc Surg. 1992; 103 238-252
- 3 Fann J L, Miller D C, Moore K A. et al . Twenty-year clinical experience with porcine bioprostheses. Ann Thorac Surg. 1996; 62 1301-1312
- 4 Vesley I. Analysis of the Medtronic Intact bioprosthesis valve. Effects of “zero-pressure” fixation. J Thorac Cardiovasc Surg. 1991; 101 90-99
- 5 Levy R J. Glutaraldehyde and the calcification mechanism of bioprosthetic heart valves. J Heart Valve Dis. 1994; 3 101-104
- 6 Chen W, Schoen F J, Levy R J. Mechanism of efficacy of 2-amino oleic acid for inhibition of calcification of glutaraldehyde-pretreated porcine bioprosthetic heart valves. Circulation. 1994; 90 323-329
- 7 Duarte I G, MacDonald M J, Cooper W A. et al . In vivo hemodynamic, histologic and antimineralization characteristics of the Mosaic bioprosthesis. Ann Thorac Surg. 2001; 71 92-99
- 8 Edmunds L H, Clark R E, Cohn L H, Grunkemeier G L, Miller C M, Weisel R D. Guidelines for reporting morbidity and mortality after cardiac valvular operations. Ann Thorac Surg. 1996; 62 932-935
- 9 Banbury M K, Cosgrove D M, Thomas J D. et al . Hemodynamic stability during 17 years of the Carpentier-Edwards aortic pericardial bioprosthesis. Ann Thorac Surg. 2002; 73 1460-1465
- 10 Aupart M R, Sirinelli A L, Diemont F F, Meurisse Y A, Dreyfus X B, Marchand M A. The last generation of pericardial valves in the aortic position: ten-year follow-up in 589 patients. Ann Thorac Surg. 1996; 61 615-620
- 11 Dellgren G, David T E, Raanani E, Armstrong S, Ivanov J, Rakowski H. Late hemodynamic and clinical outcomes of aortic valve replacement with the Carpentier-Edwards Perimount pericardial bioprosthesis. J Thorac Cardiovasc Surg. 2002; 124 146-54
- 12 Jamieson W RE, Janusz M T, MacNab J, Henderson C. Hemodynamic comparison of second- and third-generation stented bioprostheses in aortic valve replacement. Ann Thorac Surg. 2001; 71 282-284
- 13 Eichinger W B, Schütz A, Simmerl D. et al . The Mosaic bioprosthesis in the aortic position: Hemodynamic performance after 2 years. Ann Thorac Surg. 1998; 66 126-129
- 14 Thomson D J, Jamieson W RE, Dumesnil J G. et al . Medtronic Mosaic porcine bioprosthesis: midterm investigational trial results. Ann Thorac Surg. 2001; 71 S269-272
- 15 Pibarot P, Dumesnil J G. Hemodynamic and clinical impact of prosthesis-patient mismatch in the aortic valve position and its prevention. J Am Coll Cardiol. 2000; 36 1131-1141
- 16 Hanayama N, Christakis G T, Mallidi H R. et al . Patient prosthesis mismatch is rare after aortic valve replacement: Valve size may be irrelevant. Ann Thorac Surg. 2002; 73 1822-1829
- 17 Jamieson W RE, Tyers G F, Miyagishima R T, Germann E, Janusz M T, Ling H. Carpentier-Edwards porcine bioprosthesis. Comparison of standard and supra-annular prosthesis at 7 years. Circulation. 1991; 84 (Suppl 3) 145-152
- 18 Jamieson W RE, Lemieux M D, Sullivan J A, Munro A I, Metras J, Cartier P C. Medtronic Intact porcine bioprosthesis experience to twelve years. Ann Thorac Surg. 2001; 71 278-281
- 19 David T E, Ivanov J, Armstrong S, Feindel C M, Cohen G. Late results of heart valve replacement with the Hancock II bioprosthesis. J Thorac Cardiovasc. 2001; 121 268-278
- 20 Mecozzi G, Milano A D, De Carlo M. et al . Intravascular hemolysis in patients with new-generation prosthetic heart valves: a prospective study. J Thorac Cardiovasc Surg. 2002; 123 550-556
1 Presented at the 32nd Annual Meeting of the German Society for Thoracic and Cardiovascular Surgery in Leipzig/Germany in February 2003.
M. D. Brigitte Gansera
Krankenhaus München-Bogenhausen, Department of Cardiovascular Surgery
Englschalkinger Straße 77
81925 Munich
Germany
Phone: + 498992702630
Fax: + 49 89 92 70 26 05