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Role of Device Retrieval and Analysis in the Evaluation of Substitute Heart Valves

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Clinical Evaluation of Medical Devices
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Abstract

Surgical replacement of diseased valves with functional substitutes is the dominant therapeutic modality in patients with symptomatic valvular heart disease, and improves the survival and enhances the quality of life of many individuals.1 Nevertheless, problems associated with prostheses remain a major impediment to the long-term success of this procedure. Despite considerable improvement in the technology of heart valve replacement devices since their first successful use approx 35 yr ago, both mechanical and tissue heart valve substitutes (see Fig. 1) remain imperfect, and prosthesis-associated complications have considerable impact on the long-term outlook for persons who have had valve replacement surgery.

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References

  1. Rahimtoola, S. H. 1989. Perspective on valvular heart disease: an update. J. Am. Coll. Cardiol. 14: 1–23.

    Article  CAS  Google Scholar 

  2. Schoen, F.J. 1986. Special considerations for pathological evaluation of explanted cardiovascular prostheses. In Handbook of Biomaterials Evaluation ( von Recum A. F. ed.). Macmillan, New York, pp. 412–435.

    Google Scholar 

  3. Schoen, F. J. 1989. Interventional and Surgical Cardiovascular Pathology: Clinical Correlations and Basic Principles. WB Saunders, Philadelphia, pp. 1–415.

    Google Scholar 

  4. Schoen, F. J., Anderson, J. M., Didisheim, P., Dobbins, J. J., Gristina, A. G., Harasaki, H., and Simmons, R. L. 1990. Ventricular Assist Device (VAD) pathology analyses: guidelines for clinical studies. J. Appl. Biomat. 1: 49–56.

    Article  CAS  Google Scholar 

  5. Anderson, J. M. 1993. Cardiovascular device retrieval and evaluation. Cardiovasc. Pathol. 2: 199S - 208S.

    Article  Google Scholar 

  6. Schoen, F. J. 1995. Approach to the analysis of cardiac valve prostheses as surgical pathology or autopsy specimens. Cardiovasc. Pathol. 4: 241–255.

    Article  Google Scholar 

  7. Schoen, F. J. 1996. Pathological evaluation of explanted cardiovascular prostheses. In Handbook of Biomaterials Evaluation (von Recum A. F. ed.). 2nd Ed. Taylor & Francis Washington, in press.

    Google Scholar 

  8. Savage, R. A. 1991. New law to require medical device injury report. CAP Today, July, p. 40.

    Google Scholar 

  9. Kahan, J. S. 1991. The Safe Medical Devices Act of 1990. Med. Dev. Diag. Ind. Jan, 67.

    Google Scholar 

  10. Akins, C. W. 1995. Results with mechanical cardiac valvular prostheses. Ann. Thorac. Surg. 60: 1836–1844.

    Article  CAS  Google Scholar 

  11. Turina, J., Hess, O. M., Turina, M., and Krayenbuehl, H. P. 1993. Cardiac bioprostheses in the 1990s. Circulation 88: 775–781.

    Article  CAS  Google Scholar 

  12. Bloomfield, P., Wheatley, D. J., Prescott, R. J., and Miller, H. C. 1991. Twelve-year comparison of a Björk-Shiley mechanical heart valve with porcine bioprostheses. N. Engl. J. Med. 324: 573–579.

    Article  CAS  Google Scholar 

  13. Hammermeister, K. E., Sethi, G. K., Henderson, W. G., Oprian, C., Kim, T., Rahimtoola, S. 1993. A comparison of outcomes in men 11 years after heart-valve replacement mechanical valve or bioprosthesis. N. Engl. J. Med. 328: 1289–1296.

    Article  CAS  Google Scholar 

  14. Schoen, F. J., Levy, R. J., and Piehler, H. R. 1992. Pathological considerations in replacement cardiac valves. Cardiovasc. Pathol.1:29–52.

    Google Scholar 

  15. Schoen, F. J. 1995. Pathological considerations in replacement heart valves and other cardiovascular prosthetic devices. In Cardiovascular Pathology: Clinicopathologic Correlations and Pathogenetic Mechanisms ( Schoen F. J. and Gimbrone M. A. eds.). Williams and Wilkins, Baltimore, pp. 194–222.

    Google Scholar 

  16. Palatianos, G. M., Dewanjee, M. K., Panoutsopoulos, G., Kapadvanjwala, M., Novak, S., and Sfakianakis, G. N. 1994. Comparative thrombogenicity of pacemaker leads. PACE Pacing Clin. Electrophysiol. 17: 141–145.

    Article  CAS  Google Scholar 

  17. Davis, P. F. and Bowyer, D. E. 1975. Scanning electron microscopy: arterial endothelial integrity after fixation at physiological pressure. Atherosclerosis 21: 463–469.

    Article  Google Scholar 

  18. Clowes, A. W., Gown, A. M., Hanson, S. R., and Reidy, M. A. 1985. Mechanisms of arterial graft failure. 1. Role of cellular proliferation in early healing of PTFE prostheses. Am. J. Pathol. 118: 43–54.

    CAS  Google Scholar 

  19. Reidy, M. A., Chao, S. S., Kirkman, T. R., and Clowes, A. W. 1986. Endothelial regeneration. VI. Chronic nondenuding injury in baboon vascular grafts. Am. J. Pathol. 123: 432–439.

    CAS  Google Scholar 

  20. Levy, R. J., Schoen, F. J., Levy, J. T., Nelson, A. C., Howard, S. L., and Oshry, L. J. 1993. Biologic determinants of dystrophic calcification and osteocalcin deposition in glutaraldehyde-preserved porcine aortic valve leaflets implanted subcutaneously in rats. Am. J. Pathol. 113: 143–155.

    Google Scholar 

  21. Schoen, F. J., Hirsch, D., Bianco, R. W., and Levy, R. J. 1994. Onset and progression of calcification in porcine aortic bioprosthetic valves implanted as orthotopic mitral valve replacements in juvenile sheep. J. Thorac. Cardiovasc. Surg. 108: 880–887.

    CAS  Google Scholar 

  22. O’Rourke, R. A., Peterson, K. L., and Braunwald, N. S. 1973. Postoperative hemodynamic evaluation of a new fabric-covered ball-valve prosthesis. Circulation 47, 48: 74S - 79S.

    Google Scholar 

  23. Braunwald, N. S. and Bonchek, L. I. 1967. Prevention of thrombus on rigid prosthetic heart valves by the ingrowth of autogenous tissue. J. Thorac. Cardiovasc. Surg. 54: 630–638.

    CAS  Google Scholar 

  24. Braunwald, N. S. and Morrow, A. G. 1968. Tissue ingrowth and the rigid heart valve. J. Thorac. Cardiovasc. Surg. 56: 307–319.

    CAS  Google Scholar 

  25. Blackstone, E. H., Kirklin, J. W., Pluth, J. R., Turner, M. E., and Parr, G. V. 1977. The performance of the Braunwald-Cutter aortic prosthetic valve. Ann. Thorac. Surg. 23: 302–318.

    Article  CAS  Google Scholar 

  26. Schoen, F. J., Goodenough, S. H., Ionescu, M. I., and Braunwald, N. S. 1984. Implications of late morphology of Braunwald-Cutter mitral heart valve prostheses. J. Thorac. Cardiovasc. Surg. 88: 208–216.

    CAS  Google Scholar 

  27. Schreck, S., Inderbitzen, R., Chin, H., Wieting, D. W., Smilor, M., Breznock, E., and Pendray, D. 1995. Dynamics of Björk-Shiley convexoconcave mitral valve in sheep. J. Heart Valve Dis. 4: 21–24.

    Google Scholar 

  28. van der Meulen, J. H. P., Steyerberg, E. W., van der Graaf, Y., van Herwerden, L. A., Verbaan, C. J., DeFauw, J. J. A. M. T., and Habbema, J. D. F. 1993. Age threshold for prophylactic replacement of BjörkShiley convexo-concave heart valves-a clinical and economic evaluation. Circulation 88: 156–154.

    Article  Google Scholar 

  29. Orszulak, T. A., Schaff, H. V., DeSmet, J-M., Danielson, G. K., Pluth, J. R., and Puga, F. J. 1993. Late results of valve replacement with Björk-Shiley valve (1973–1982). J. Thorac. Cardiovasc. Surg. 105: 302–312.

    CAS  Google Scholar 

  30. Ericsson, A., Lindblom, D., Semb, G., Huysmans, H. A., Thulin, L. I., Scully, H. E., Bennett, J. G., Ostermeyer, J., and Grunkmeier, G. L. 1992. Strut fracture with Björk-Shiley 70° convexo-concave valve. An international multi-institutional follow-up study. Eur. J. CardioThorac. Surg. 6: 339–346.

    Article  CAS  Google Scholar 

  31. de Mol, B. A. J. M., Koornneef, F., and van Gaalen, G. L. 1995. What can be done to improve the safety of heart valves? Intl. J. Risk Safety Med. 6: 157–168.

    Google Scholar 

  32. O’Neill, W. W., Chandler, J. G., Gordon, R. E., Bakalyar, D. M., Abolfathi, A. H., Castellani, M. D., Hirsch, J. L., Wieting, D. W., Bassett, J. S., and Beatty, K. C. 1995. Radiographic detection of strut separations in Björk-Shiley convexo-concave mitral valves. N. Engl. J. Med. 333: 414–419.

    Article  Google Scholar 

  33. Plemons, T. D. and Hovenga, M. 1995. Acoustic classification of the state of artificial heart valves. J. Acoust. Soc. Am. 97: 2326–2333.

    Article  CAS  Google Scholar 

  34. Schoen, F. J. and Hobson, C. E. 1985. Anatomic analysis of removed prosthetic heart valves: causes of failure of 33 mechanical valves and 58 bioprostheses, 1980 to 1983. Hum. Pathol. 16: 549–559.

    Article  CAS  Google Scholar 

  35. Schoen, F. J., Kujovich, J. L., Webb, C. L., and Levy, R. J. 1987. Chemically determined mineral content of explanted porcine aortic valve bioprostheses: correlation with radiographic assessment of calcification and clinical data. Circulation 76: 1061–1066.

    Article  CAS  Google Scholar 

  36. Tomazic, B. B., Edwards, W. D., and Schoen, F. J. 1995. Physicochemical characterization of natural and bioprosthetic heart valve calcific deposits: implications for prevention. Ann. Thorac. Surg. 60: 322S - 327S.

    Article  Google Scholar 

  37. Schoen, F. J., Levy, R. J., Nelson, A. C., Bernhard, W. F., Nashef, A., and Hawley, M. A. 1985. Onset and progression of experimental bioprosthetic heart valve calcification. Lab. Invest. 52: 523–532.

    CAS  Google Scholar 

  38. Schoen, F. J., Tsao, W., and Levy, R. J. 1986. Calcification of bovine pericardium used in cardiac valve bioprostheses: implications for the mechanisms of bioprosthetic tissue mineralization. Am. J. Pathol. 123: 134–145.

    CAS  Google Scholar 

  39. Schoen, F. J., Kujovich, J. L., Levy, R. J., and St. John Sutton, M. 1988. Bioprosthetic heart valve pathology: clinicopathologic features of valve failure and pathobiology of calcification. Cardiovasc. Clin. 18: 289–317.

    CAS  Google Scholar 

  40. Levy, R. J., Schoen, F. J., Flowers, W. B., and Staelin, S. T. 1991. Initiation of mineralization in bioprosthetic heart valves: studies of alkaline phosphatase activity and its inhibition by AlCi3 or FeCl3 preincubations. J. Biomed. Mater. Res. 25: 905–935.

    Google Scholar 

  41. Schoen, F. J., Levy, R. J., Hilbert, S. L., and Bianco, R. W. 1992. Anti-mineralization treatments for bioprosthetic heart valves: assessment of efficacy and safety. J. Thorac. Cardiovasc. Surg. 104: 1285–1288.

    CAS  Google Scholar 

  42. Flomenbaum, M. A. and Schoen, F. J. 1993. Effects of fixation back-pressure and antimineralization treatment on the morphology of porcine aortic bioprosthetic valves. J. Thorac. Cardiovasc. Surg. 105: 154–164.

    CAS  Google Scholar 

  43. Robinson, M. J., Hildner, F. J., and Greenberg, J. J. 1971. Disc variance of Beall mitral valve. Ann. Thor. Surg. 11: 11–17.

    Article  CAS  Google Scholar 

  44. Silver, M. D. and Wilson, G. J. 1977. The pathology of wear in the Beall Model 104 heart valve prosthesis. Circulation 56: 617–622.

    Article  CAS  Google Scholar 

  45. Schoen, F. J., Titus, J. L., and Lawrie, G. M. 1982. Durability of pyrolytic carbon-containing heart valve prostheses. J. Biomed. Mater. Res. 16: 559–570.

    Article  CAS  Google Scholar 

  46. Haubold, A. D. 1994. On the durability of pyrolytic carbon in-vivo. Med. Prog. Tech. 20: 201–208.

    CAS  Google Scholar 

  47. Kirklin, J. K., Smith, D., Novick, W., Naftel, D. C., Kirklin, J. W., Pacifico, A. D., Nanda, N. C., Helmcke, F. R., and Bourge, R. C. 1993. Long-term function of cryopreserved aortic homografts. A ten-year study. J. Thorac. Cardiovasc. Surg. 106: 154–165.

    CAS  Google Scholar 

  48. Cleveland, D. C., Williams, W. G., Razzouk, A. J., Trusler; G. A., Rebeyka, I. M., Duffy, L., Kan, Z., Coles, J. G., and Freedom, R. M. 1992. Failure of cryopreserved homograft valved conduits in the pulmonary circulation. Circulation 86:II-150S–153S.

    Google Scholar 

  49. Grunkemeier, G. L. and Bodnar, E. 1994. Comparison of structural valve failure among different “models” of homograft valves. J. Heart Valve Dis. 3: 556–560.

    CAS  Google Scholar 

  50. Schoen, F. J., Mitchell, R. N., and Jonas, R. A. 1995. Pathological considerations in cryopreserved allograft heart valves. J. Heart Valve Dis. 4: 72–75.

    Google Scholar 

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Schoen, F.J. (1998). Role of Device Retrieval and Analysis in the Evaluation of Substitute Heart Valves. In: Witkin, K.B. (eds) Clinical Evaluation of Medical Devices. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-4757-2756-2_11

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  • DOI: https://doi.org/10.1007/978-1-4757-2756-2_11

  • Publisher Name: Humana Press, Totowa, NJ

  • Print ISBN: 978-1-61737-040-3

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