Prosthetic heart valves are commonly used in the treatment of valvular heart disease. Mechanical valves are more durable than the bioprosthetic valves; however, the need for long-term anticoagulant therapy renders them unsuitable for some patient groups. In this paper we discuss the different types and models of bioprosthesis, and in particular, pericardial bioprosthesis. We also discuss the preimplantation preparation processes, as well as their postimplantation changes and modes of failure. 1. Introduction Prosthetic heart valves, used for the definitive treatment of diseased and dysfunctional native heart valves, have been in use since the mid 1960s. They are broadly divided into mechanical heart valves (MHVs) and bioprosthetic heart valves (BHVs). MHVs are made of synthetic material (e.g., polymers, metal, and carbon), where as BHVs are made of biologic tissues which are mounted on a fabric covered plastic frame, called a stent. MHVs are more durable, but their thrombogenicity and need for long-term anticoagulant therapy make them unsuitable for patients in some age groups especially older age groups. In contrast, BHVs are safe to implant, functionally similar to the native aortic valve, do not require long-term anticoagulant therapy, and are hence associated with reduced risk of hemorrhage. Since their introduction in the mid 1960s, BHVs have gone through many modifications, in their handling from time of harvesting to availability for implantation. Many tissues and different animal species aortic valves have been tried with varying results. Today, the most commonly used BHVs are those from porcine aortic valves and from calf pericardium. While the use of either one may be guided by patient age and other considerations, the trend in the United States and Europe has been towards greater use of tissue rather than mechanical valves [1]. This paper discusses bioprostheses, and in particular, pericardial bioprostheses. We also review the post-implantation changes in their biomaterial components and their modes of failure. 2. Classification of Bioprosthetic Valves Bioprosthetic replacement heart valves are derived from human (homograft) or animal (xenograft) tissues. 2.1. Homograft These are derived from cadaveric (human) aortic valves. They are cryopreserved and are implanted into the aortic root without a stent. Autograft. Patient’s own valve was taken from one site (pulmonary) and implanted at another site, for example, pulmonary valve grafted into the aortic site. This predominately occurs in children with diseased native aortic valves [2]. 2.2.
References
[1]
A. Vahanian, H. Baumgartner, J. Bax et al., “Guidelines on the management of valvular heart disease: the task force on the management of valvular heart disease of the European society of cardiology,” European Heart Journal, vol. 28, no. 2, pp. 230–268, 2007.
[2]
R. F. Siddiqui, J. R. Abraham, and J. Butany, “Bioprosthetic heart valves: modes of failure,” Histopathology, vol. 55, no. 2, pp. 135–144, 2009.
[3]
L. H. Edmunds, R. E. Clark, L. H. Cohn, G. L. Grunkemeier, D. C. Miller, and R. D. Weisel, “Guidelines for reporting morbidity and mortality after cardiac valvular operations,” Annals of Thoracic Surgery, vol. 62, no. 3, pp. 932–935, 1996.
[4]
X. Y. Jin, K. Dhital, K. Bhattacharya, R. Pieris, N. Amarasena, and R. Pillai, “Fifth-year hemodynamic performance of the Prima stentless aortic valve,” Annals of Thoracic Surgery, vol. 66, no. 3, pp. 805–809, 1998.
[5]
J. P. Gott, M. N. Girardot, J. M. D. Girardot et al., “Refinement of the alpha aminooleic acid bioprosthetic valve anticalcification technique,” Annals of Thoracic Surgery, vol. 64, no. 1, pp. 50–58, 1997.
[6]
P. Pibarot and J. G. Dumesnil, “Prosthetic heart valves: selection of the optimal prosthesis and long-term management,” Circulation, vol. 119, no. 7, pp. 1034–1048, 2009.
[7]
C. M. Cunanan, C. M. Cabiling, T. T. Dinh et al., “Tissue characterization and calcification potential of commercial bioprosthetic heart valves,” Annals of Thoracic Surgery, vol. 71, no. 5, pp. S417–S421, 2001.
[8]
N. D. Broom and F. J. Thomson, “Influence of fixation conditions on the performance of glutaraldehyde-treated porcine aortic valves: towards a more scientific basis,” Thorax, vol. 34, no. 2, pp. 166–176, 1979.
[9]
I. Vesely, “The evolution of bioprosthetic heart valve design and its impact on durability,” Cardiovascular Pathology, vol. 12, no. 5, pp. 277–286, 2003.
[10]
T. E. David, C. M. Feindel, H. E. Scully, J. Bos, and H. Rakowski, “Aortic valve replacement with stentless porcine aortic valves: a ten-year experience,” Journal of Heart Valve Disease, vol. 7, no. 3, pp. 250–254, 1998.
[11]
A. Milano, C. Guglielmi, M. De Carlo et al., “Valve-related complications in elderly patients with biological and mechanical aortic valves,” Annals of Thoracic Surgery, vol. 66, no. 6, pp. S82–S87, 1998.
[12]
D. J. Wheatly, J. Fisher, and I. J. Reece, “Primary tissue failure in pericardial heart valves,” Journal of Thoracic and Cardiovascular Surgery, vol. 94, no. 3, pp. 367–374, 1987.
[13]
F. J. Schoen and R. J. Levy, “Calcification of tissue heart valve substitutes: progress toward understanding and prevention,” Annals of Thoracic Surgery, vol. 79, no. 3, pp. 1072–1080, 2005.
[14]
J. Butany, T. Zhou, S. W. Leong et al., “Inflammation and infection in nine surgically explanted Medtronic Freestyle stentless aortic valves,” Cardiovascular Pathology, vol. 16, no. 5, pp. 258–267, 2007.
[15]
K. Z. Konakci, B. Bohle, R. Blumer et al., “Alpha-Gal on bioprostheses: xenograft immune response in cardiac surgery,” European Journal of Clinical Investigation, vol. 35, no. 1, pp. 17–23, 2005.
[16]
J. Butany and R. Leask, “The failure modes of biological prosthetic heart valves,” Journal of Long-Term Effects of Medical Implants, vol. 11, no. 3-4, pp. 115–135, 2001.
[17]
M. Ruel, A. Kulik, F. D. Rubens et al., “Late incidence and determinants of reoperation in patients with prosthetic heart valves,” European Journal of Cardio-thoracic Surgery, vol. 25, no. 3, pp. 364–370, 2004.
[18]
R. V. Freeman and C. M. Otto, “Spectrum of calcific aortic valve disease: pathogenesis, disease progression, and treatment strategies,” Circulation, vol. 111, no. 24, pp. 3316–3326, 2005.
[19]
S. C. Cannegieter, F. R. Rosendaal, and E. Briet, “Thromboembolic and bleeding complications in patients with mechanical heart valve prostheses,” Circulation, vol. 89, no. 2, pp. 635–641, 1994.
[20]
J. A. Dearani, T. A. Orszulak, H. V. Schaff, R. C. Daly, B. J. Anderson, and G. K. Danielson, “Results of allograft aortic valve replacement for complex endocarditis,” Journal of Thoracic and Cardiovascular Surgery, vol. 113, no. 2, pp. 285–291, 1997.
[21]
M. T. Metzdorff, G. L. Grunkemeier, C. W. Pinson, and A. Starr, “Thrombosis of mechanical cardiac valves: a qualitative comparison of the Silastic ball valve and the tilting disc valve,” Journal of the American College of Cardiology, vol. 4, no. 1, pp. 50–53, 1984.
[22]
F. Schoen and R. Levy, “Tissue heart valves: current challenges and future research perspectives,” Journal of Biomedical Materials Research, vol. 47, pp. 439–465, 1999.
[23]
Y. A. Goffin and M. A. Bartik, “Porcine aortic versus bovine pericardial valves: a comparative study of unimplanted and from patient explanted bioprostheses,” Life Support Systems, vol. 5, no. 2, pp. 127–143, 1987.
[24]
E. A. Trowbridge, K. M. Roberts, C. E. Crofts, and P. V. Lawford, “Pericardial heterografts. Toward quality control of the mechanical properties of glutaraldehyde-fixed leaflets,” Journal of Thoracic and Cardiovascular Surgery, vol. 92, no. 1, pp. 21–28, 1986.
[25]
V. M. Walley, C. A. Keon, M. Khalili, D. Moher, M. Campagna, and W. J. Keon, “Ionescu-Shiley valve failure I: experience with 125 standard-profile explants,” Annals of Thoracic Surgery, vol. 54, no. 1, pp. 111–116, 1992.
[26]
F. J. Schoen, J. Fernandez, L. Gonzalez-Lavin, and A. Cernaianu, “Causes of failure and pathologic findings in surgically removed Ionescu-Shiley standard bovine pericardial heart valve bioprostheses: emphasis on progressive structural deterioration,” Circulation, vol. 76, no. 3, pp. 618–627, 1987.
[27]
D. J. Wheatley, F. A. Crawford, P. H. Kay et al., “A ten-year study of the Ionescu-Shiley low-profile bioprosthetic heart valve,” European Journal of Cardio-Thoracic Surgery, vol. 8, no. 10, pp. 541–548, 1994.
[28]
J. Butany, K. Vanlerberghe, and M. D. Silver, “Morphologic findings and causes of failure in 24 explanted Ionescu-Shiley low-profile pericardial heart valves,” Human Pathology, vol. 23, no. 11, pp. 1224–1233, 1992.
[29]
V. M. Walley, P. Bedard, M. Brais, and W. J. Keon, “Valve failure caused by cusp tears in low-profile Ionescu-Shiley bovine pericardial bioprosthetic valves,” Journal of Thoracic and Cardiovascular Surgery, vol. 93, no. 4, pp. 583–586, 1987.
[30]
V. M. Walley and W. J. Keon, “Patterns of failure in Ionescu-Shiley bovine pericardial bioprosthetic valves,” Journal of Thoracic and Cardiovascular Surgery, vol. 93, no. 6, pp. 925–933, 1987.
[31]
D. A. Cooley, G. J. Reul, J. M. Duncan, et al., “Ionescu-Shiley bovine pericardial bioprostheses. Clinical results in 2701 patients,” in Proceedings of the 3rd International Symposium on Biological and Bioprosthetic Valvesin, E. Bodnar and M. Yacoub, Eds., pp. 177–184, Yorke Medical Books, New York NY, USA, 1986.
[32]
G. J. Reul, D. A. Cooley, and J. M. Duncan, “Valve failure with the Ionescu-Shiley bovine pericardial bioprosthesis: analysis of 2680 patients,” Journal of Vascular Surgery, vol. 2, no. 1, pp. 192–204, 1985.
[33]
S. Gabbay, U. Bortolotti, and F. Wasserman, “Long-term follow-up of the Ionescu-Shiley mitral pericardial xenograft,” Journal of Thoracic and Cardiovascular Surgery, vol. 88, no. 5, pp. 758–763, 1984.
[34]
J. W. Butany, R. Kesarwani, T. M. Yau et al., “The role of pannus in the longevity of an Ionescu-Shiley pericardial bioprosthesis,” Journal of Cardiac Surgery, vol. 21, no. 5, pp. 505–507, 2006.
[35]
U. Bortolotti, A. Milano, and G. Thiene, “Early mechanical failures of the Hancock pericardial xenograft,” Journal of Thoracic and Cardiovascular Surgery, vol. 94, no. 2, pp. 200–207, 1987.
[36]
R. G. Masters, A. L. Pipe, J. P. Bedard et al., “Long-term clinical results with the Ionescu-Shiley pericardial xenograft,” Journal of Thoracic and Cardiovascular Surgery, vol. 101, no. 1, pp. 81–89, 1991.
[37]
F. J. Schoen, J. J. Collins, and L. H. Cohn, “Long-term failure rate and morphologic correlations in porcine bioprosthetic heart valves,” American Journal of Cardiology, vol. 51, no. 6, p. 957, 1983.
[38]
F. J. Schoen and C. E. Hobson, “Anatomic analysis of removed prosthetic heart valves: causes of failure of 33 mechanical valves and 58 bioprostheses, 1980 to 1983,” Human Pathology, vol. 16, no. 6, pp. 549–559, 1985.
[39]
F. J. Schoen, “Cardiac valve prostheses: pathological and bioengineering considerations,” Journal of Cardiac Surgery, vol. 2, no. 1, pp. 65–108, 1987.
[40]
V. M. Walley, F. D. Rubens, M. Campagna, A. L. Pipe, and W. J. Keon, “Patterns of failure in Hancock pericardial bioprostheses,” Journal of Thoracic and Cardiovascular Surgery, vol. 102, no. 2, pp. 187–194, 1991.
[41]
G. Thiene, U. Bortolotti, M. Valente et al., “Mode of failure of the Hancock pericardial valve xenograft,” American Journal of Cardiology, vol. 63, no. 1, pp. 129–133, 1989.
[42]
V. J. Ferrans, Y. Tomita, and S. L. Hilbert, “Pathology of bioprosthetic cardiac valves,” Human Pathology, vol. 18, no. 6, pp. 586–595, 1987.
[43]
B. Goldman, H. Scully, C. Tong et al., “Clinical results of pericardial xenograft valves: the Ionescu-Shiley and Hancock valves,” The Canadian Journal of Cardiology, vol. 4, no. 6, pp. 328–332, 1988.
[44]
J. Butany, C. Fayet, M. S. Ahluwalia et al., “Biological replacement heart valves: identification and evaluation,” Cardiovascular Pathology, vol. 12, no. 3, pp. 119–139, 2003.
[45]
Edwards Life Sciences, 2002, http://www.edwards.com/.
[46]
R. W. M. Frater, N. W. Salomon, W. G. Rainer, D. M. Cosgrove, and E. Wickham, “The Carpentier-Edwards pericardial aortic valve: intermediate results,” Annals of Thoracic Surgery, vol. 53, no. 5, pp. 764–771, 1992.
[47]
J. Butany, V. Nair, S. W. Leong, G. S. Soor, and C. Feindel, “Carpentier-Edwards Perimount valves—morphological findings in surgical explants,” Journal of Cardiac Surgery, vol. 22, no. 1, pp. 7–12, 2007.
[48]
H. Machida, H. Ishibashi-Ueda, K. Nakano et al., “A morphologic study of Carpentier-Edwards pericardial xenografts in the mitral position exhibiting primary tissue failure in adults in comparison with Ionescu-Shiley pericardial xenografts,” Journal of Thoracic and Cardiovascular Surgery, vol. 122, no. 4, pp. 649–655, 2001.
[49]
M. K. Banbury, D. M. Cosgrove, J. A. White, E. H. Blackstone, R. W. M. Frater, and J. E. Okies, “Age and valve size effect on the long-term durability of the Carpentier-Edwards aortic pericardial bioprosthesis,” Annals of Thoracic Surgery, vol. 72, no. 3, pp. 753–757, 2001.
[50]
W. R. E. Jamieson, M. A. Marchand, C. L. Pelletier et al., “Structural valve deterioration in mitral replacement surgery: comparison of Carpentier-Edwards supra-annular porcine and Perimount pericardial bioprostheses,” Journal of Thoracic and Cardiovascular Surgery, vol. 118, no. 2, pp. 297–305, 1999.
[51]
J. Butany, W. Yu, M. D. Silver, and T. E. David, “Morphologic findings in explanted Hancock II porcine bioprostheses,” Journal of Heart Valve Disease, vol. 8, no. 1, pp. 4–15, 1999.
[52]
K. McGonagle-Wolff and F. J. Schoen, “Morphologic findings in explanted mitroflow pericardial bioprosthetic valves,” American Journal of Cardiology, vol. 70, no. 2, pp. 263–264, 1992.
[53]
J. Butany, T. Feng, A. Luk, K. Law, R. Suri, and V. Nair, “Modes of failure in explanted mitroflow pericardial valves,” The Annals of Thoracic Surgery, vol. 92, pp. 1621–1628, 2011.
[54]
J. R. Gonzalez-Juanatey, J. M. Garcia Acuna, A. Amaro et al., “Doppler echocardiographic comparison of small (19 mm) bileaflet and pericardial heart valve prostheses in aortic position,” Scandinavian Journal of Thoracic and Cardiovascular Surgery, vol. 29, no. 1, pp. 29–35, 1995.
[55]
L. C. Pelletier and M. Carrier, in Textbook of Acquired Heart Valve Disease, Vol II, J. Acar and E. Bodnar, Eds., pp. 513–521, ICR Publishers, London, UK, 1995.
[56]
K. Minami, A. Zittermann, S. Schulte-Eistrup, H. Koertke, and R. K？rfer, “Mitroflow synergy prostheses for aortic valve replacement: 19 years experience with 1,516 patients,” Annals of Thoracic Surgery, vol. 80, no. 5, pp. 1699–1705, 2005.
