Calcification is the most frequent cause of the failure of bioprosthetic heart valves fabricated from glutaraldehyde pretreated porcine aortic valves or bovine pericardium. Formulation and evaluation of controlled-release drug delivery system to inhibit bioprosthetic heart valve calcification is reviewed.
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References
1.
Carpentier, A., G. Lemaigre, L. Robert and C. DuBost. "Biological Factors Affecting Long-Term Results of Valvular Heterografts;' J. Thorac. Cardiovasc. Surg., 58:467 (1969).
2.
Carpentier, A., C. DuBost, E. Lane, A. Nashef, A. Carpentier, J. Relland, A. Deloche, J.N. Fabiani, S. Chauvand, P. Perrier and S. Maxwell. "Continuing Improvements in Valvular Bioprostheses" J. Thorac. Cardiovasc. Surg., 83:27 ( 1982).
3.
Carpentier, A., A. Deloche and J. Relland. "Six Year Follow-Up of Gluteraldehyde Preserved Heterografts: with Particular Reference to the Treatment of Congenital Valve Malformation" J. Thorac. Cardiovasc. Surg., 68: 771 (1974).
4.
lonescu, M.I. , D. R. Smith, S. S. Hasen, A. P. Chidambraram, A. P. Tan. dom. "Clinical Durability of the Pericardial Xenograft Valve; Ten Years' Experience with Mitral Replacement," Ann. Thorac. Surg., 34:265 (1982).
5.
Ishihara, T. , V.J. Ferrans and M. Jones. "Calcific Deposits Developing in a Bovine Pericardial Bioprosthetic Valve 3 Days After Implantation," Circulation, 63:718 (1981).
6.
Brais, M.P., J.P. Bedard and W. Goldstein. "Ionescu-Shiley Pericardial Xenografts: Follow-Up of Up to 6 Years," Ann. Thorac. Surg., 39:105 (1985).
7.
Reul, G.J., A.D. Cooley, J.M. Duncan and O.H. Frazier. "Valve Failure with the Ionescu-Shiley Bovine Pericardial Bioprosthesis: Analysis of 2680 Patients" J. Thorac Cardiovasc. Surg., 2:192 (1985).
8.
Schoen, F.J. and R.J. Levy. "Bioprosthetic Heart Valve Failure; Pathology and Pathogenesis," Cardiol. Clin., 2:717 (1984).
9.
Schoen, F.J. , J.J. Collins and L.H. Cohn. "Long-Term Failure Rate and Morphologic Correlations in Porcine Bioprosthetic Heart Valves," Am. J. Cardiol., 51:957 (1983).
10.
Schoen, F.J. and C.E. Hobson. "Anatomic Analysis of Removed Prosthetic Heart Valves: Causes of Failure of 33 Mechanical and 58 Bioprostheses, 1980-1983; ' Human Pathol., 16:549m (1985).
11.
Schoen, F.J. , J.L. Titus and G.M. Lawrie. "Autopsy Determined Causes of Death After Cardiac Valve Replacement," JAMA, 249:899 (1983).
12.
Roberts, W.C. "Factors Determining Outcome of Cardiac Valve Replacement," Ann. Thorac. Surg., 27:101 (1979).
13.
Gallo, I., F. Nistal, J.M. Revuelta, E. Gracia-Satue, E. Artinano and C.G. Duran. "Incidence of Primary Tissue Valve Failure with the Ionescu-Shiley Pericardial Valve" J. Thorac. Cardiovasc. Surg., 90:278 (1985).
14.
Fishbein, M.C. , S.A. Gissen, J.J. Collins, E.M. Barsamian and L.H. Cohn. "Pathologic Findings After Cardiac Valve Replacement with Glutaraldehyde-Fixed Porcine Valves," Am. J. Cardiol., 40:331 (1977).
15.
Ferrans, V.J. , T.L. Spray, M.E. Billingham and W.C. Roberts. "Structural Changes in Gluteraldehyde-Treated Porcine Heterografts Used as Substitute Cardiac Valves: Transmission and Scanning Electron Microscopic Observations in 12 Patients;' Am. J. Cardiol., 41:1159 (1973).
16.
Valente, M., U. Bortolotti and G. Thiene. "Ultrastructural Substrates of Dystrophic Calcification in Porcine Bioprosthetic Valve Failure," Am. J. Pathol., 119:12 (1985).
17.
Schoen, F.J. , R.J. Levy, A.C. Nelson, W.F. Bernard, A. Nashef and M. Hawley. "Onset and Progression of Experimental Bioprosthetic Heart Valve Calcification" Lab. Invest., 52:523 (1985).
18.
Fishbein, M. , R.J. Levy, A. Nashef, V.J. Ferrans, L.C. Dearden, A.P. Goodman and A. Carpentier. "Calcification of Cardiac Valve Bioprostheses: Histological, Ultrastructural and Biochemical Studies in a Subcutaneous Implantation Model System" J. Thorac. Cordiovasc. Surg., 83:602 (1982).
19.
Levy, R.J., F.J. Schoen, J.T. Levy, A.C. Nelson, S.L. Howard and L.J. Oshry. "Biologic Determinants of Dystrophic Calcification and Osteocalcin Deposition in Gluteraldehyde Preserved Porcine Aortic Valve Leaflets Im. planted Subcutaneously in Rats" Am. J. Pathol., 113:144 (1983).
20.
Schoen, F.J. , J.W. Tsao and R.J. Levy. "Calcification of Porcine Valves and Bovine Pericardium are Equivalent," Trans. Soc. Biomater., 8:13 ( 1985).
21.
Levy, R.J., F.J. Schoen, F.S. Sherman, J. Nichols, M.A. Hawley and S.A. Lund. "Calcification of Subcutaneously Implanted Type I Collagen Sponges: Effects of Formaldehyde and Gluteraldehyde Pretreatments" Am. J. Pathol., 122:71 (1986).
22.
Golomb, G., F.J. Schoen, M. Smith, J. Linden, M. Dixon and R.J. Levy. "The Role of Gluteraldehyde-Induced Crosslinks in Calcification of Bovine Pericardium Used in Cardiac Valve Bioprostheses," Am. J. Pathol., 127:122 (1987).
23.
Lentz, J., E.M. Pollock, D.B. Olsen and E.J. Andrews. "Prevention of Intrinsic Calcification in Porcine and Bovine Xenograft Materials," Trans. Am. Soc. Artif. Intern. Organs , 28:494 (1982).
24.
Levy, R.J., M.A. Haley, F.J. Schoen, S.A. Lund and P.Y. Liu. "Inhibition by Diphosphonate Compounds of Calcification of Porcine Bioprosthetic Heart Valve Cusps Implanted Subcutaneously in Rats " Circulation, 21: 349 (1985).
25.
Levy, R.J., J. Wolfrum, F.J. Schoen, M.A. Hawley, S.A. Lund and R. Langer. "Inhibition of Calcification of Bioprosthetic Heart Valves by Local Controlled-Release Diphosphonate" Science, 228:190 (1985).
26.
Golomb, G., R. Langer, F.J. Schoen, M. Smith, Y. Choi and R.J. Levy. "Controlled-Release of Diphosphonate to Inhibit Bioprosthetic Heart Valve Calcification: Dose-Response and Mechanistic Studies" J. Cont. Rel., 4:181 (1986).
27.
Golomb, G., M. Dixon, M. Smith, F.J. Schoen and R.J. Levy. "Controlled-Release Drug Delivery of Diphosphonates to Inhibit Bioprosthetic Heart Valve Calcification: Release Rate Modulation with Silicone Matrices Via Drug Solubility and Membrane Coating," J. Pharm. Sci., 76:271 (1987).
28.
Levy, R.J., G. Golomb, J. Wolfrum, S.A. Lund, F.J. Schoen and R. Langer. "Local Controlled-Release of Diphosphonates from Ethylenevinylacetate Matrices Prevents Bioprosthetic Valve Calcification," Trans. Am. Soc. Intern. Organs, 31:459 (1985).
29.
Golomb, G., M. Dixon, M. Smith, F.J. Schoen and R.J. Levy. "Inhibition of Bioprosthetic Heart Valve Calcification by Sustained Local Delivery of Ca and Na Diphosphonate Via Controlled-Release Matrices," Trans. Am. Sac. Artif. Intern Organs, 32:587 (1986).
30.
Thubrikar, M.J., S.P. Nolan, J.D. Deck, J. Aouad and L.C. Levitt. "Intrinsic Calcification of T6-Processed and Control Porcine and Bovine Bioprosthesis in Calves, Trans. Am. Soc. Artif. Intern. Organs, 29:245 (1983).
31.
Arbustini, E., M. Jones, R.D. Moses, E.E. Eidbo, R.J. Carroll and V.J. Ferrans. "Modification by Hancock T6 Process of Calcification of Bioprosthetic Cardiac Valves Implanted in Sheep," Am. J. Cardiol., 53:1388 (1984).
32.
Langer, R., H. Brem and D. Tapper."Biocompatibiltiy of Polymeric Delivery Systems for Macromolecules," J. Biomed. Mater. Res., 15:267 (1981).
33.
Nash, H.A. "Controlled-Release Systems for Contraception," in Medical Applications of Controlled Release, Vol. 2. R. Langer and D. Wise, eds. Boca Raton:CRC Press, pp. 35-64 (1984).
34.
Conn, H. and R. Langer. "Ocular Applications of Controlled-Release," in Medical Applications of Controlled Release, Vol. 2. R. Langer and D. Wise, eds. Boca Raton:CRC Press, pp. 65-76 (1984).
35.
Szycher, M.Biocompatible Polymers, Metals and Composites. Lancaster : Technomic Publishing Co. Inc. ( 1983).
36.
Langer, R., L. Brown and E. Edelman. "Controlled-Release and Magnetically Modulated Release Systems for Macromolecules," in Methods in Enzymology, Vol. 112. J. Widder and R. G. Green, eds. New York Academic Press, pp. 399-422 (1985).
37.
Siegel, R.A. and R. Langer. "Controlled-Release of Polypeptides and Other Macromolecules," Pharm. Res., 1:2 (1984).
38.
Levy, R.J., G. Golomb and R. Langer. "Prevention of Cardiovascular Calcification with Controlled.Release Diphosphonate," in Artificial Organs: The W J. Kolff Festschrift . FL:VCH Publ. Inc. (1986).
39.
Levy, R.J., F.J. Schoen and G. Golomb. "Bioprosthetic Heart Valve Calcifi. cation: Clinical Features, Pathobiology and Prospects for Prevention," CRC Critical Reviews in Biocompatibility, 2(2):147 (1986).
