Mid-Term Hemodynamic and Clinical Results of the Stented Porcine Medtronic Mosaic Valve in Aortic Position[*]

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.

Aortic valve replacement - heart valve bioprosthesis - AOA - zero pressure - structural valve deterioration

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.