Assessment of pericardium in cardiac bioprostheses. A review

Journal of Biomaterials Applications

Volumn 13, Issue 4, 1999, Pages 351-388

  García Páez, José María ^a   Jorge Herrero, Eduardo ^a  

^a HOSPITAL UNIVERSITARIO PUERTA DE HIERRO   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

BIOMATERIALS; BIOMECHANICS; CALCIFICATION (BIOCHEMISTRY); CARDIOVASCULAR SYSTEM; CHEMICAL OPERATIONS; DURABILITY; GRAFT VS. HOST REACTIONS; TISSUE;

CARDIAC BIOPROSTHESES; PERICARDIUM; TEARS;

PACEMAKERS;

BIOMATERIAL;

ANIMAL; HEART VALVE PROSTHESIS; PERICARDIUM; REVIEW;

ANIMALS; BIOCOMPATIBLE MATERIALS; HEART VALVE PROSTHESIS; PERICARDIUM;

EID: 0033112674     PISSN: 08853282     EISSN: None     Source Type: Journal    
DOI: 10.1177/088532829901300404     Document Type: Article

References (151)

1. Vongpatanasin, W., Hillis, L.D., and Lange, R.A., "Medical Progress: Prosthetic Heart Valves," N. Engl. J. Med., 335, 407-416 (1996).
2. Julien, M., Letouneau, D.R., Marois, Y., Cardou, A., King, M.W., Guidoin, R., Chachra, D., and Lee, J.M., "Shelf-life of Bioprosthetic Heart Valves: a Structural and Mechanical Study," Biomaterials, 18, 605-612 (1997).
3. Thubrikar, M., "Mechanical Stress in Aortic Valve and Replacement Cardiac Valves." In: Aortic Valve, Ed. M.A. Hayat. Boca Raton, FL: CRC Press, pp. 97-208 (1990).
4. Metzdorff, M.,T., Grunkemeier, G.L., Pinson, C.W., and Starr, A., "Thrombosis of Mechanical Cardiac Valves: a Qualitative Comparison of the Silastic Ball Valve and the Tilting Disc Valve," J. Am. Coll. Cardiol., 4, 50-53 (1984).
5. Edmunds, L.H., Jr., "Thromboembolic Complications of Current Cardiac Valvular Prostheses," Ann. Thorac. Surg., 34, 96-106 (1982).
6. Ryder, S.J., Bradley, H., Brannan, J.J., Turner, M.A., and Bain, WH., "Thrombotic Obstruction of the Björk-Shiley Valve: the Glasgow Experience," Thorax, 39, 487-492 (1984).
7. Cannegieter, S.C., Rosendaal, F.R., and Briet, E., "Thromboembolic and Bleeding Complications in Patients with Mechanical Heart Valve Prostheses," Circulation, 89, 635-641 (1994).
8. Turpie, A.G., Gunstensen, J., Hirsh, J, Nelson, H., and Gent, M., "Randomised Comparison of Two Intensities of Oral Anticoagulant Therapy after Tissue Heart Valve Replacement," Lancet, 1, 1242-1245 (1988).
9. Yacoub, M., Rasmi, N.R., and Sundt, T.M., "Fourteen-Year Experience with Homovital Homografts for Aortic Valve Replacement," J. Cardiovasc. Surg., 110, 186-194 (1995).
10. Bloomfield, P., Wheatley, D.J., Prescott, R.J., and Miller, H.C., "Twelve-Year Comparison of a Björk-Shiley Mechanical Heart Valve with Porcine Bioprotheses," N. Engl. J. Med., 324, 573-579 (1991).
11. Grunkemeier, G.L., Jamieson, W.R.E., Miller, B.C., and Starr, A., "Actuarial Versus Actual Risk of Porcine Structural Valve Deterioration," J. Thorac. Cardiovasc. Surg., 108, 709-718 (1994).
12. Carpentier, A., "From Valvular Xenograft to Valvular Bioprostheses (1965-1977)," Med. Instrum., 11, 98-101 (1977).
13. Ionescu, M., "Heart Valve Replacement with the Ionescu-Shiley Pericardial Xenograft," J. Thorac. Cardiovasc. Surg., 73, 31-36 (1977).
14. Cheung, D.T., and Nimni, M.E., "Mechanism of Crosslinking of Proteins by Glutaraldehyde. I: Reaction with Model Compounds," Connect. Tissue Res., 10, 187-199 (1982).
15. Cheung, D.T., and Nimni, M.E., "Mechanism of Crosslinking of Proteins by Glutaraldehyde. II: Reaction with Monomeric and Polymeric Collagen," Connect. Tissue Res., 10, 201-216 (1982).
16. Cheung, D.T., Perelman, N., Ko, E.C., and Nimni, M.E., "Mechanism of Crosslinking of Proteins by Glutaraldehyde III. Reaction with Collagen in Tissues," Connect. Tissue Res., 13, 109-115 (1985).
17. Olde Damink, L.H., Dijkstra, P.J., Van Luyn, M.J., Van Wachem, P., Nieuwenhius, E., and Feijen, J., "Glutaraldehyde as a Crosslinking Agent for Collagen Based Biomaterials," J. Mater. Sci.: Mater. in Med., 6, 460-472 (1995).
18. Nimni, M.E., Cheung, D., Strates, B., Kodama, M., and Sheikh, K., "Chemically Modified Collagen: a Natural Biomaterial for Tissue Replacement," J. Biomed. Mat. Res., 21, 741-771 (1987).
19. Saitanu, K., and Lund, E., "Inactivation of Enterovirus by Glutaraldehyde," Appl. Microbiol., 29, 571-576 (1975).
20. Angell, W.W., Angell, J.D., and Sywak, A., "Selection of Tissue for Prosthetic Valve: a Five Year Prospective Randomized Comparison," J. Thorac. Cardiovasc. Surg., 73, 43-53 (1977).
21. Ferrans, V.J., Spray, T.L., Billingham, M.E., and Roberts, W.C., "Structural Changes in Glutaraldehyde Treated Porcine Heterografts Used as Substitute Cardiac Valves," Am. J. Cardiol., 41, 1159-1184 (1978).
22. Hubert, S.L., Ferrans, V.J., McAllister, H.A., and Cooley, D.A., "Ionescu-Shiley Bovine Pericardial Bioprostheses. Histologic and Ultrastructural Studies," Am. J. Pathol, 140, 1195-1204 (1992).
23. Ishihara, T., Ferrans, V.J., Jones, M., Boyce, S.W., and Roberts, W.C., "Structure of Bovine Parietal Pericardium and of Unimplanted Ionescu-Shiley Pericardial Valvular Bioprostheses," J. Thorac. Cardiovasc. Surg., 81, 747-757 (1981).
24. Flomenbaum, M.A., and Schoen, F.J., "Effects of Fixation Back Pressure and Antimineralization Treatment on the Morphology of Porcine Aortic Bioprosthetic Valves," J. Thorac. Cardiovasc. Surg., 105, 154-164 (1993).
25. Duncan, A.C., Boughner, D., and Vesely I., "Dynamic Glutaraldehyde Fixation of Porcine Aortic Valve Xenograft," Biomaterials, 17, 1849-1856 (1996).
26. Vardaxis, N.F., Ruijgrok, J.M., Rietveld, D.C., Marres, E.M., and Boon, M.E., "Chemical and Physical Properties of Collagen Implants Influence Their Fate In Vivo as Evaluated by Light and Confocal Microscopy," J. Biomed. Mater. Res., 28, 1013-1025 (1994).
27. Lee, M., Pereira, C.A., Abdulla, D., Naimark, W.A., and Crawford, L, "A Multi-Sample Denaturation Temperature Tester for Collagenous Biomaterials," Med. Eng. Phys., 17, 115-121 (1995).
28. Grunkemeier, G.L., and Rahimtoola, S.H., "Artificial Heart Valves," Annu. Rev. Med., 41, 251-263 (1990).
29. O'Brien, M.F., Stafford, E.G., Gardner, M.A.H., Pohlner, P.G., Tesar, P.J., Cochrane, A.D., Mau, T.K., Gall, K.L., and Smith, S.E., "Allograft Aortic Valve Replacement: Long-Term Follow-Up," Ann. Thorac. Surg., 60 (2 suppl), S65-S70 (1995).
30. Gallo, I., Ruiz, B., Nistal, E, and Durán, C., "Degeneration in Porcine Bioprosthetic Cardiac Valves: Incidence of Primary Tissue Failure among 938 Bioprostheses at Risk," Am. J. Cardiol., 53, 1061-1065 (1984).
31. Jones, E.L., Weintraub, W.S., and Graver, J.M., "Ten Year Experience with the Porcine Bioprosthetic Valve: Interrelationship of Valve Survival and Patient Survival in 1050 Valve Replacements," Ann. Thorac. Surg., 49, 370-384 (1990).
32. Schoen, F.J., Tsao, J.W., and Levy, R.J., "Calcification of Bovine Pericardium Used in Cardiac Valve Bioprostheses. Implications for the Mechanism of Bioprosthetic Tissue Mineralization,"Am. J. Pathol., 123,134-145 (1986).
33. Schoen, F.J., Fernández, J., Gonzalez Lavin, L., and Cernaianu, A., "Causes of Failure and Pathologic Findings in Surgically Removed Ionescu-Shiley Standard Bovine Pericardial Heart Valve Bioprostheses: Emphasi 3 on Progressive Structural Deterioration," Circulation, 76, 618-627 (1987).
34. Paule, W.J., Bernick, S., Strates, B., and Nimni, M.E., "Calcification of Implanted Vascular Tissues Associated with Elastin in an Experimental Animal Model," J. Biomed. Mater. Res., 26, 1169-1177 (1992).
35. Courtman, D.W., Periera, C.A., Kashef, V, McComb, D., Lee, J.M., and Wilson, G.J., "Development of a Pericardial Acellular Matrix Biomaterial: Biochemical and Mechanical Effects of Cell Extraction," J. Biomed. Mater. Res., 28, 655-666 (1994).
36. Jorge-Herrero, E., Fernández, R, Gutiérrez, M., and Castillo-Olivares, J.L., "Study of the Calcification of Bovine Pericardium: Analysis of the Implication of Lipids and Proteoglycans," Biomaterials, 12, 683-689 (1991).
37. Vesely, I., Macris, N., Joy, R, Dunmore, D., and Boughner, D., "The Distribution and Morphology of Aortic Valve Cusp Lipids," J. Heart Value Dis., 3, 451-156 (1994).
38. Levy, R.J., Schoen, F.J., Sherman, F.S., Nichols, J., Hawley, M.A., and Lund, S.A., "Calcification of Subcutaneously Implanted Type I Collagen Sponges: Effects of Formaldehyde and Glutaraldehyde Pretreatments," Am. J. Pathol., 122, 71-82 (1986).
39. Levy, R.A., Zenker, J.A., and Lian, J.B., "Vitamin K Dependent Calcium Binding Protein in Aortic Valve Calcification," J. Clin. Invest., 65, 563-566 (1980).
40. Levy, R.J., Gundberg, C., and Scheinman, R., "The Identification of the Vitamin K-Dependent Bone Protein Osteocalcin as One of the Gamma-Carboxyglutamic Acid-Containing Proteins in Calcified Atherosclerotic Plaque and Mineralized Heart Valves," Atherosclerosis, 46, 49-56 (1983).
41. Levy, R.J., Schoen, F.J., and Howard, S.L., "Mechanism of Calcification of Porcine Bioprosthetic Aortic Valve Cusp: Role of T-Lymphocytes," Am. J. Cardiol., 52, 629-631 (1983).
42. Schoen, F.J., Levy, R.J., Hilbert, S.L., and Bianco, R.W., "Antimineralization Treatments for Bioprosthetic Heart Valves," J. Thorac. Cardiovasc. Surg., 104, 1285-1288 (1992).
43. Petite, H.J., Frei, V, Hue, A., and Herbage, D., "Use of Diphenylphosphorylazide for Crosslinking Collagen Based Biomaterials," J. Biomed. Mater. Res., 28, 159-165 (1994).
44. Petite, H., Duval, J.L., Frei, V, Malak, A., Sigot Luizard, M.F., and Herbage, D., "Cytocompatibility of Calf Pericardium Treated by Glutaraldehyde and by the Acyl Azide Methods in an Organotypic Culture Model," Biomaterials, 16, 1003-1008 (1995).
45. Anselme, K., Petite, H., and Herbage, D., "Inhibition of Calcification In Vivo by Acyl Azide Cross Linking of a Collagen Glycosaminoglycan Sponge," Matrix, 12, 264-273 (1992).
46. Naimark, W.A., Pereira, C.A., Tsang, K., and Lee, J.M., "HMDC Crosslinking of Bovine Pericardial Tissue: a Potential Role of the Solvent Environment in the Design of Bioprosthetic Materials," J. Mater. Sci.: Mater. in Med., 6, 235-241 (1995).
47. Olde Damink, L.H.H., Dijkstra, P.J., Van Luyn, M.J.A., Van Wachem, P.B., Nieuwenhuis, P., and Feijen, F., "Crosslinking of Dermal Sheep Collagen Using Hexamethylene Diisocyanate," J. Mater. Sci.: Mater. in Med., 6, 429-434 (1995).
48. Olde Damink, L.H.H., Dijkstra, P.J., Van Luyn, M.J.A., Van Wachem, P.B., Nieuwenhuis, P., and Feijen, F., "Crosslinking of Dermal Sheep Collagen Using a Water Soluble Carbodiimide," Biomaterials, 17, 765-773 (1996).
49. Eidbo, E.E., Hilbert, S.L., Ferrans, V.J., and Clark, R.E., "Anticalcification Treatments of Bioprosthetic Heart Valves: In Vivo Studies in Sheep," J. Card. Surg., 4, 69-73 (1989).
50. Hirsch, D., Drader, J., Thomas, T.J., Schoen, F.J., Levy, J.T, and Levy, R.J., "Inhibition of Calcification of Glutaraldehyde Pretreated Forcine Aortic Valve Cusp with Sodium Dodecyl Sulfate: Preincubation and Controlled Release Studies," J. Biomed. Mater. Res., 27, 1477-1484 (1993).
51. Gott, J.E, Pan, C., Dorsey, L.M., Jay, J.L., Jett, G.K., Schoen, F.J., Girardot, J.M., and Guyton, R.A., "Calcification of Porcine Valves: a Successful New Method of Antimineralization," Ann. Thorac. Surg., 53, 207-215 (1992).
52. Chen, W.L., Schoen, F.J., and Levy, R.J., "Mechanism of Efficacy of 2-Amino Oleic Acid for Inhibition of Calcification of Glutaraldehyde-Pretreated Porcine Bioprosthetic Heart Valves," Circulation, 90, 323-329 (1994).
53. Chen, W.L., Kim, J.D., Schoen, F.J., and Levy, R.J., "Effect of 2-Aminooleic Acid Exposure Conditions on the Inhibition of Calcification of Glutaraldehyde Cross-Linked Porcine Aortic Valves," J. Biomed. Mater. Res., 28, 1485-1495 (1994).
54. Jorge-Herrero, E., Fernández, P., Escudero, C., de la Torre, N., Zurita, M., García Páez, J.M., and Castillo-Olivares, J.L., "Influence of the Stress on Calcification of Delipidated Bovine Pericardial Tissue Employed in the Construction of Cardiac Valves," J. Biomed. Mater. Res., 30, 411-415 (1996).
55. Jorge-Herrero, E., Fernández, P., Escudero, C., de la Torre, N., García Páez, J.M., Buján, J., and Castillo-Olivares, J.L., "Inhibition of the Calcification of Porcine Valve Tissue by Selective Lipid Removal," Biomaterials, 15, 815-820 (1994).
56. Webb, C.L., Flowers, WE., Boyd, J., Rosenthal, E.L., Levy, F.J., and Levy, R.J., "A13+ Binding Studies and Metallic Cation Effects on Bioprosthetic Heart Valve Calcification in the Rat Subdermal Model," Am. Soc. Artif. Intern. Organs, 36, 56-59 (1990).
57. Pathak, V., Boyd, R., Levy, R.J., and Schoen, F.J., "Prevention of Calcification of Glutaraldehyde Pretreated Bovine Pericardium through Controlled Release Polymeric Implants: Studies of Fe3+, A13+, Protamine Sulphate and Levamisole," Biomaterials, 11, 718-723 (1990).
58. Webb, C.L., Schoen, F.J., and Levy, R.J., "A13+ Preincubation Inhibits Calcification of Bioprosthetic Heart Valve Tissue in the Rat Subdermal Model," Trans. Am. Soc. Artif. Intern. Organs, 34, 855-589 (1988).
59. Jorge-Herrero, E., Gutiérrez, M.R, and Castillo-Olivares, JL., "Calcification of Soft Tissue Employed in the Construction of Heart Valve Prostheses: Study of Different Chemical Treatments," Biomaterials, 12, 249-252 (1991).
60. Levy, R.J., Hawley, M.A., Schoen, F.J., Lund, S.A., and Piu, P.Y., "Inhibition by Diphosphonate Compounds of Calcification of Porcine Bioprosthetic Heart Valve Cusps Implanted Subcutaneously in Rats," Circulation, 71, 349-356 (1985).
61. Levy, R.J., Wolfrum, J., Schoen, FJ, Lund, S.A., and Langer, R., "Inhibition of Calcification of Bioprosthetic Heart Valves by Local Controlled Release Diphosphonate," Science, 228, 190-192 (1985).
62. Levy, R.J., Schoen, F.J., Lund, S.A., and Smith, M.S., "Prevention of Leaflet Calcification of Bioprosthetic Heart Valve Calcification with Diphosphonate Injection Therapy," J. Thorac. Cardiovasc. Surg., 94, 551-557 (1987).
63. Hirsch, D., "Effects of Metallic Ions and Diphosphonates on Inhibition of Pericardial Bioprosthetic Tissue Calcification and Associated Alkaline Phosphatase Activity," Biomaterials, 14, 371-377 (1993).
64. Lee, J.M., Pereira, C.A., and Kan, L.W.K., "Effect of Molecular Structure of Poly(Glycidyl Ether) Reagents on Crosslinking and Mechanical Properties of Bovine Pericardial Xenograft Materials," J. Biomed. Mater. Res., 28, 981-992 (1994).
65. Tu, R., Shen, S.H., Lin, D., Hata, C., Thyagarajan, K, Noishiki, Y., and Quijano, R. C., "Fixation of Bioprosthetic Tissues with Monofunctional and Multifunctional Polyepoxy Compounds," J. Biomed. Mater. Res., 28, 677-684 (1994).
66. Shen, S.H., Sung, H.W., Tu, R., Hata, C., Lin, D., Noishiki, Y., and Quijano, R.C., "Characterization of a Polyepoxy Compound Fixed Porcine Heart Valve Bioprosthesis," J. Appl. Biomater., 5, 159-162 (1994).
67. Ma, J., Tian, W., Lei, X., Long, S., and Xi, B., "Prevention of Tissue Calcification on Bioprosthetic Heart Valves by Using Epoxy Compounds: a Study of Calcification Tests In Vitro and In Vivo," J. Biomed. Mater. Res., 26, 1241-1251 (1992).
68. Dong Park, K., Lee, W.K., Yun, J.Y., Han, D.K., Kim, S.H., Kim, Y.H., and Kim, K.T., "Novel Anti-Calcification Treatment of Biological Tissues by Grafting of Sulphonated Poly(Ethylene Oxide)," Biomaterials, 18, 47-51 (1997).
69. Grimm, M., Grabenwoger, M., Eybl, E., Moritz, A., Bock, P., Muller, M.M., and Wolner, E., "Improved Biocompatibility of Bioprosthetic Heart Valves by L-Glutamic Acid Treatment," J. Card. Surg., 7, 58-64 (1992).
70. Wika, K.E., Utoh, J., Brown, J., and Harasaki, H., "Quantification of the Edge Effect in Calcified Bioprosthetic Tissues," J. Biomed. Mater. Res., 27, 1293-1299 (1993).
71. Hoffman, D., Gong, G., Liao, K., Macaluso, F., Mikolic, S.D., and Prater, R.W., "Spontaneous Host Endothelial Growth on Bioprostheses," Circulation, 86, 75-79 (1992).
72. Seifter, E., Gong, G., Yellin, E., and Frater, R., "Improved Biocompatibility of Bovine Pericardium Using a New Method of Cross Linking," ASAIO Transactions, 37, M175-M176 (1991).
73. Chanda, J., Rao, S.B., Mohanty, M., Lal, A.V., Muraleedharan, C.V., Bhuvaneshwar, G.S., and Valiathan, M.S., "Prevention of Calcification of Tissue Valves," Artif. Organs, 18, 752-757 (1994).
74. Grimm, M., Eybl, E., Leukauf, C., Muller, M.M., Plenck, H., Jr., and Bock, P., "Decreased Tissue Reaction to Bioprosthetic Heart Valve Material after L-Glutamic Acid Treatment. A Morphological Study," J. Biomed. Mater. Res., 26, 1231-1240 (1992).
75. Simionescu, A., Simionescu, D., and Deac, R., "Lysine-Enhanced Glutaraldehyde Crosslinking of Collagenous Biomaterials," J. Biomed. Mater. Res., 25, 1495-1505 (1991).
76. Jorge-Herrero, E., Fernández, P., Escudero, C., García Páez, J.M., and Castillo-Olivares, J.L., "Calcification of Pericardial Tissue Pretreated with Different Amino Acids," Biomaterials, 17, 571-575 (1996).
77. Trowbridge, E.A., Lawford, R.V., Crofts, E.G., and Keith, R.M., "Pericardial Heterografts: Why Do Valves Fail?" J. Cardiovasc. Surg., 95, 577-585 (1988).
78. Lee, M.J., and Boughner, D.R., "Tissue Mechanics of Canine Pericardium in Different Test Environments: Evidence for Time-Dependent Accommodation, Absence of Plasticity, and New Roles for Collagen and Elastin," Circ. Res., 49, 533-544 (1981).
79. Timoshenko, S., "Análisis de Fatigas y Deformaciones." In: Resistencia de Materiales, Vol. 1. Madrid: Espasa-Calpe (Spanish translation of "Strength of Materials"), 1-33 (1970).
80. Timoshenko, S., "Análisis de Fatigas y Deformaciones." In: Resistencia de Materiales, Vol. 1. Madrid: Espasa-Calpe (Spanish translation of "Strength of Materials"), 1-33 (1970).
81. García Páez, J.M., Carrera, A., Garcia Sestafe, J.V., Jorge-Herrero, E., Navidad, R., Cordon, A., Candela, I., and Castillo-Olivares, J.L., "Comparison of Elasticities of Components of Cardiac Bioprosthesis Leaflets," J. Biomed. Mater. Res., 30, 47-52 (1996).
82. Lee, R.T., and Kaamm, R.D., "Vascular Mechanics for Cardiologist," JAAC, 23, 1289-1295 (1994).
83. Haziza, F., Papouin, G., Barratt-Boyes, B., Christie, G., and Whitlock, R., "Tear in Bioprosthetic Heart Valve Leaflets without Calcific Degeneration," J. Heart Valve Dis., 5, 35-39 (1996).
84. Lee, J.M., and Wilson, G.J., "Anisotropic Tensile Viscoelastic Properties of Vascular Graft Materials Tested at Low Strain Rates," Biomaterials, 7, 423-431 (1986).
85. García Páez, J.M., Carrera, A., García Sestafe, J.V., Jorge-Herrero, E., Millan, I., and Candela, I., "The Relationship Between Stress and Relaxation in Calf Pericardium Used in Construction of Cardiac Bioprostheses," Biomaterials, 11, 186-190 (1990).
86. Gould, P.L., Cataloglu, A., Dhatt, P.S., Chattopadhyay, A., and Clirk, R., "Stress Analysis of the Human Aortic Valve." In: Computers and Structures. London: Pergamon Press, Vol. 3, pp. 377-384 (1973).
87. García Sestafe, J.V., García Páez, J.M., Carrera, A., Jorge-Herrero, E., Navidad, R., Candela, I., and Castillo-Olivares, J.L., "Description of the Mathematical Law that Defines the Relaxation of Bovine Pericardium Subjected to Stress," J. Biomed. Mater. Res., 28, 755-760 (1994).
88. Trowbridge, E.A., "Mechanical Characteristics of Pericardial Tissue and Their Relevance to Bioprosthetic Design," CRC Crit. Rev. Biocomp., 5, 105-172 (1989).
89. Cohn, L.H., and Collins, J.J., Jr., "The Glutaraldehyde Stabilized Porcine Aortic Valve." In: M.I. Ionescu, Ed., Tissue Heart Valves. Toronto: Butterworths, pp. 173-200 (1979).
90. Angell, W.W., Angell, J.D., and Kosek, J.C., "Clinical and Experimental Comparisons Establishing the Glutaraldehyde Treated Xenografts as the Standard for Tissue Heart Valve Replacement." In: M.I. Ionescu, Ed., Tissue Heart Valves. Toronto: Butterworths, pp. 89-126 (1979).
91. Cohn, L.H., Gilbert, H.M., Prater, E., and Collin, J.J., Jr., "Five to Eight Year Follow-Up of Patients Undergoing Porcine Heart-Valve Replacement," N. Engl. J. Med., 304, 258-262 (1981).
92. Duncan, A.C., Boughner, D., and Vesely, L., "Viscoelasticity of Dynamically Fixed Bioprosthetic Valves. II. Effect of Glutaraldehyde Concentration," J. Thorac. Cardiovasc. Surg., 113, 302-310 (1997).
93. Fung, Y.C.B., "Stress-Strain, History Relation of Soft Tissues in Simple Elongation." In: Y.C. Yung, N. Perrone, and M. Alinker, Eds., Biomechanics, 1st Foundation and Objectives. Englewood Cliffs, NJ: Prentice-Hall, p. 181 (1972).
94. Rabkin, S., Berghause, D.R., and Bauer, H.F., "Mechanical Properties of the Isolated Canine Pericardium," J. Appl. Physiol, 36, 69-73 (1974).
95. Lee, J.M., Courtman, D.W., and Boughner, D.R., "The Glutaraldehyde Stabilized Porcine Aortic Valve Xenografts. I. Tensile Viscoelastic Properties of the Fresh Leaflet Material," J. Biomed. Mater. Res., 18, 61-79 (1984).
96. Trowbridge, E.A., Black, M.M., and Daniel, C.L., "The Mechanical Response of Glutaraldehyde-Fixed Bovine Pericardium to Uniaxial Load," J. Mater. Sci., 20, 114-140 (1985).
97. Trowbridge, E.A., and Crofts, C.E., "The Extension Rate Independence of the Hysteresis in Glutaraldehyde Fixed Bovine Pericardium," Biomaterials, 8, 201-206 (1987).
98. Lee, J.M., and Boughner, D.R., "Mechanical Properties of Human Pericardium. Differences in Viscoelastic Response When Compared with Canine Pericardium," Circ. Res., 57, 475 (1985).
99. Zioupos, P., Barbenel, J.C., and Fisher, J., "Mechanical and Optical Anisotropy of Bovine Pericardium," Med. Biol. Eng. Comput., 30, 78-82 (1992).
100. Clark, R.E., "Stress-Strain Characteristics of Fresh and Frozen Human Aortic and Mitral Leaflets and Chordae Tendinae," J. Thorac. Cardiovasc. Surg., 66, 202-208 (1973).
101. Zioupos, E., and Barbenel, J.C., "Mechanics of Native Bovine Pericardium. I. The Multiangular Behaviour of Strength and Stiffness of the Tissue," Biomaterials, 15, 366-373 (1994).
102. Zioupos, P., and Barbenel, J.C., "Mechanics of Native Bovine Pericardium. II. A Structure Based Model for the Anisotropic Mechanical Behaviour of Tissue," Biomaterials, 15, 374-382 (1994).
103. Zioupos, P., Barbenel, J.C., and Fisher, J., "Anisotropy Elasticity and Strength of Glutaraldehyde Fixed Bovine Pericardium for Use in Pericardial Bioprosthetic Valves," J. Biomed. Mater. Res., 28, 49-57 (1994).
104. Cohn, D., Younes, H., and Uretzky, G., "Mechanical Behaviour of Isolated Pericardium: Species, Isotropy, Strain Rate and Collagenase Effect Pericardial Tissue," Clin. Mater., 2, 115 (1987).
105. Holt, J.R., "The Normal Pericardium," Am. J. Cardiol, 26,455-465 (1970).
106. Christie, G.W., "Anatomy of Aortic Heart Valve Leaflets: the Influence of Glutaraldehyde Fixation on Function," Eur. J. Cardio-Thorac. Surg., 6 (Suppl 1), 525-533 (1992).
107. Carrera, A., García Páez, J.M., García Sestafe, J.V, Jorge-Herrero, E., Navidad, R., Cordon, A., and Castillo-Olivares, J.L., "Analysis of Shearing Stress in the Limited Durability of Bovine Pericardium Used as a Biomaterial," J. Mater. Sci.: Mater. Med., 9, 77-81 (1998).
108. García Páez, J.M., Carrera, A., García Sestafe, J.V., Millan, I., Jorge-Herrero, E., Candela, I., and Castillo-Olivares, J.L., "Is Cutting Stress Responsible for the Limited Durability of Heart Valve Bioprostheses?" J. Thorac. Cardiovasc. Surg., 100, 580-586 (1990).
109. García Páez, J.M., Carrera, A., García Sestafe, J.V., Jorge-Herrero, E., Millan, L., Navidad, R., Cordon, A., and Castillo-Olivares, J.L., "Resistance and Elasticity of Suture Threads Employed in Cardiac Bioprostheses," Biomaterials, 15, 981-984 (1994).
110. Hubert, S.L., Barrick, M.K., and Ferrans, V.J., "Porcine Aortic Valve Bioprostheses: a Morphologic Comparison of the Effects of Fixation Pressure," J. Biomed. Mater. Res., 24, 773-787 (1990).
111. Broom, N.D., and Thomson, F.J., "Influence of Fixation Conditions on the Performance of Glutaraldehyde-Treated Porcine Aortic Valves: Toward a More Scientific Basis," Thorax, 34, 166-176 (1979).
112. Vesley, I., and Noseworthy, R., "Micromechanics of the Fibrosa and Ventricularis of Aortic Valve Leaflets," J. Biomech., 25, 101-113 (1992).
113. Vesely, I., and Lozon, A., "Natural Preload of Aortic Valve Leaflet Components during Glutaraldehyde Fixation: Effects on Tissue Mechanics," J. Biomech., 26, 121-131 (1993).
114. Han, H.C., and Fun, Y.C., "Residual Strain in Porcine and Canine Trachea," J. Biomech., 24, 307-315 (1991).
115. Vesely, I., Lozon, A., and Talman, E., "Is Zero-Pressure Fixation of Bioprosthetic Valves Truly Stress Free?" J. Thorac. Cardiovasc. Surg., 106, 288-298 (1993).
116. Gross, L., and Kungel, M.A., "Topographic Anatomy and Histology of the Valves in the Human Heart," Am. J. Pathol., 1, 445-456 (1931).
117. Nawy, E.G., "Prestressed Concrete," 2nd Ed., A Fundamental Approach. New York: Prentice Hall (1995).
118. Walley, V.M., and Keon, W.J., "Patterns of Failure in Ionescu-Shiley Bovine Pericardial Bioprosthetic Valves," J. Thorac. Cardiovasc. Surg., 93, 925-933 (1987).
119. Carrera, A., García Páez, J.M., García Sestafe, J.V., Jorge-Herrero, E., Salvador, J., R., Cordon, A., and Castillo-Olivares, J.L., "Selection and Interaction of Biomaterials Used in the Construction of Cardiac Bioprostheises," J. Biomed. Mater. Res., 39, 568-574 (1998).
120. Metz, S.A., von Fraunhofer, J.A., and Masterson, B.J., "Stress Relaxation of Organic Suture Materials,"Biomaterials, 11, 197-199 (1990).
121. Hermann, J.B., "Tensile Strength and Known Security of Surgical Suture Materials," Am. Surg., 37, 209-217 (1971).
122. von Fraunhofer, J.A., Storey, R.J., Slone, I.K., and Masterson, B.J., "Tensile Strength of Suture Materials," J. Biomed. Mater. Res., 19, 595-600 (1985).
123. von Fraunhofer, J.A., Storey, R.J., and Masterson, B.J., "Tensile Properties of Suture Materials," Biomaterials, 9, 324-327 (1988).
124. von Fraunhofer, J.A., and Sichina, W.J., "Characterization of Surgiccil Suture Materials Using Dynamic Mechanical Analysis," Biomaterials, 13, 715-720 (1992).
125. García Páez, J.M., Carrera, A., García Sestafe, J.V, Jorge-Herrero, E., Navidad, R., Cordon, A., and Castillo-Olivares, J.L., "Elastic Behaviour of Sutured Calf Pericardium: Influence of the Suture Threads," Biomaterials, 17, 1677-1683 (1996).
126. Purinya, B., Kasynov, J., Volkolakov, J., Latsis, R., and Tetere, G., "Biomechanical and Structural Properties of the Explanted Biopros thetic Valve Leaflets," J. Biomechan., 27, 1-11 (1974).
127. Talman, E.A., and Boughner, D.R., "Internal Shear Properties of Fresh Porcine Aortic Valve Cusps: Implications for Normal Valve Function," J. Heart Valve Dis., 5, 152-159 (1996).
128. Carrera, A., García Páez, J.M., Jorge-Herrero, E., Millan, I., Navidad, R., García Sestafe, J.V., Candela, I., and Castillo-Olivares, J.L., "Behaviour of the Bovine Pericardium Used in Cardiac Bioprostheses When Subjected to a Real Fatigue Assay," Biomaterials, 14, 76-79 (1993).
129. García Páez, J.M., Carrera, A., Jorge-Herrero, E., Millan, I., Navidad, R., Candela, I., García Sestafe, J.V., and Castillo-Olivares, J.L., "Effect of Suture on the Durability of Bovine Pericardium Used in Cardiac Bioprostheses," Biomaterials, 5, 172-176 (1994).
130. Tomita, N., Tamai, S., Ikeuchi, K., and Ikada, Y., "Effect of Cross-Sectional Stress-Relaxation on Handling Characteristics of Suture Materials." In: Bio-Medical Materials and Engineering, Vol. 4. New York: Pergamon, pp. 47-59 (1994).
131. Song, T., Vesely, I., and Boughner, D., "Effects of Dynamic Fixation on Shear Behaviour of Porcine Xenograft Valves," Biomaterials, 11, 191-196 (1990).
132. Vesely, I., and Boughner, D., "Analysis of the Bending Behaviour of Porcine Xenograft Leaflets and of Natural Aortic Valve Material: Bending Stiffness, Neutral Axis and Shear Measurements," J. Biomech., 22, 655-671 (1989).
133. Gabbay, S., Bortolotti, U., Wasserman, R., Tindel, N., Factor, S.M., and Prater, R.W., "Long Term Follow-Up of Ionescu-Shiley Mitral Pericardial Xenograft," J. Thorac. Cardiovasc. Surg., 88, 758-763 (1984).
134. Ionescu, M.I., "The Pericardial Xenograft Valve: Mode of Failure and Possible Remedial Developments." In: E. Bodnar and M. Yacoub, Eds., Biologic and Bioprosthetic Valves. New York: York Medical Books, pp. 245-251 (1986).
135. Ius, P., Thiene, G., Minarini, M., Valente, M., and Bortolotti, U., "Low-Profile Porcine Bioprosthesis (Liotta): Pathologic Findings and Mode of Failure in the Long Term," J. Heart Valve Dis., 5, 323-327 (1996).
136. Hamid, M.S., Sabbah, H.N., andStein, P.D., "Influence of Stent Height upon Stresses on the Cusp of Closed Bioprosthetic Valves," J. Biomech., 19, 759-769 (1986).
137. Gabbay, S., Bortolotti, U., Wasserman, F., Factor, S., and Prater, R.W., "Fatigue Induced Failure of the Ionescu-Shiley Pericardial Xenograft in Mitral Position. In Vivo and In Vitro Correlation and a Proposed Classification," J. Thorac. Cardiovasc. Surg., 87, 836-844 (1984).
138. Bustamante, J., Santamaria, J., Infante, O., Flores, P, and Juarez, A., "Evaluatión Dinámica y Cinemática de la Función de Bioprótesis en Positión Aórtica," Arch. Inst. Cardiol. Méx., 66, 229-243 (1996).
139. Vesely, I., Boughner, D., and Song, T., "Tissue Buckling as a Mechanism of Bioprosthetic Valve Failure," Ann. Thorac. Surg., 46, 302-308 (1988).
140. Lopez, C.L., Ibarra, F., Carreras, L., Guiterrez, F., Martinez, F., and Alonso, F., "Rotura Temprana de la Bioprótesis de Xenafic. Neustra Experiencia en 26 Implantaciones," Rev. Esp. Cardiol., 36, 306-312 (1983).
141. Wheatley, D.J., Fisher, J., Reece, I.J., Spyt, T., and Breze, R., "PrimaryTissue Failure in Pericardial Heart Valves," J. Thorac. Cardiovasc. Surg., 94, 367-374 (1987).
142. Trowbridge, E.A., Lawford, P.V., and Crofts, C.E., "Pericardial Heterografts: a Comparative Study of Suture Pull-Out and Tissue Strength," J. Biomed. Eng., 11, 311-314 (1989).
143. Bortolotti, U., Milano, A., Thiene, G., Guerra, F., Mazzuco, A., Valente, M., Talenti, E., and Galluci, V., "Early Mechanical Failure of the Hancock Pericardial Xenograft," J. Thorac. Cardiovasc. Surg., 94, 200-207 (1987).
144. Hiester, E.D., and Sacks, M.S., "Optimal Bovine Pericardial Tissue Selection Sites. I. Fiber Architecture and Tissue Thickness Measurements," J. Biomed. Mater. Res., 39, 207-214 (1998).
145. Hiester, E.D., and Sacks, M.S., "Optimal Bovine Pericardial Tissue Selection Sites. II. Cartographic Analysis," J. Biomed. Mater. Res., 39, 215-221 (1998).
146. Braue, D.M., Soares, M.J., Souza, D.R., Ramirez, D.A., Suzigan, S., and Godoy, M.F., "Mapping of Bovine Pericardium: Physical and Histopathologic Tests," J. Heart Valve Dis., 7, 202-206 (1998).
147. Smith, D.B., Sacks, M.S., Pattany, P.M., and Schroeder, R., "High-Resolution Magnetic Resonance Imaging to Characterize the Geometry of Fatigued Porcine Bioprosthetic Heart Valves," J. Heart Valve Dis., 6, 424-432 (1997).
148. Kunzelman, K., Cochran, R.P., and Verrier, E., "Finite Element of Mitral Valve Pathology," J. Long-Term Effects Med. Impl., 3, 161-179 (1993).
149. Thubrikar, M., Skinner, J.R., Aouad, J., Finkelmeier, B.A., and Nolan, S.P., "Analysis of the Design and Dynamics of Aortic Bioprostheses In Vivo," J. Thorac. Cardiovasc. Surg., 84, 282-290 (1982).
150. Lehner, G., Fischlein, T., Baretton, G., Murphy, J.G., and Reichart, B., "Endothelialized Biological Heart Valve Prostheses in the Non-Hum an Primate Model," Eur. J. Cardiothorac. Surg., 11, 498-504 (1997).
151. Helmus, M.N., and Hubbell, J.A., "Materials Selection," Cardiovasc. Pathol., 2 (suppl.), 53S-71S (1993).