Risk assessment of immunosuppressive therapy in facial transplantation

Plastic and Reconstructive Surgery

Volumn 120, Issue 3, 2007, Pages 657-668

  Vasilic, Dalibor ^b   Alloway, Rita R ^b   Barker, John H ^a   Furr, Allen ^b   Ashcroft, Rachael ^b   Banis, Joseph C ^b   Kon, Moshe ^b   Woodle, E Steve ^b  

^a University of Louisville School of Medicine   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ALEMTUZUMAB; CORTICOSTEROID; CYCLOSPORIN; IMMUNOSUPPRESSIVE AGENT; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; PROTON PUMP INHIBITOR; RAPAMYCIN; TACROLIMUS; THYMOCYTE ANTIBODY;

ABDOMINAL PAIN; ACUTE GRAFT REJECTION; ANTIGENICITY; ASPERGILLOSIS; BACTERIAL INFECTION; CANDIDIASIS; CHRONIC GRAFT REJECTION; CLINICAL TRIAL; CORTICOSTEROID THERAPY; CYTOMEGALOVIRUS INFECTION; DERMATOMYCOSIS; DIABETES MELLITUS; DIGESTIVE SYSTEM ULCER; DRUG EFFECT; DRUG MEGADOSE; FACE SURGERY; GASTROINTESTINAL HEMORRHAGE; GASTROINTESTINAL SYMPTOM; HERPES SIMPLEX; HUMAN; HYPERLIPIDEMIA; HYPERTENSION; IMMUNOSUPPRESSIVE TREATMENT; INFECTION PREVENTION; INSULIN RESISTANCE; INTESTINE PERFORATION; KIDNEY FAILURE; KIDNEY TRANSPLANTATION; LYMPHOPROLIFERATIVE DISEASE; MYCOSIS; NAUSEA; NEPHROTOXICITY; OSTEOPENIA; OSTEOPOROSIS; OUTCOME ASSESSMENT; PATIENT SELECTION; PNEUMOCYSTIS PNEUMONIA; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; SKIN CANCER; SKIN CARCINOMA; VIRUS INFECTION; VOMITING;

FACE; GRAFT REJECTION; HUMANS; IMMUNOSUPPRESSION; ORGAN TRANSPLANTATION; RISK ASSESSMENT;

EID: 34547854739     PISSN: 00321052     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.prs.0000270316.33293.ec     Document Type: Review

References (97)

1. Devauchelle, B., Badet, L., Lengele, B., et al. First human face allograft: Early report. Lancet 368: 203, 2006.
2. China's 1st face transplant successful. Available at: http://news.xinhuanet.com/english/2006-04/14/content_4425653. htm. Accessed April 15, 2006.
3. Wiggins, O. P., Barker, J. H., Martinez, S., et al. On the ethics of facial transplantation research. Am. J. Bioeth. 4: 1, 2004.
4. Agich, G. J., and Siemionow, M. Facing the ethical questions in facial transplantation. Am. J. Bioeth. 4: 25, 2004.
5. Ankeny, R. A., and Kerridge, I. On not taking objective risk assessments at face value. Am. J. Bioeth. 4: 35, 2004.
6. Banis, J. C., Barker, J. H., Cunningham, M., et al. Response to selected commentaries on the AJOB target article "On the ethics of facial transplantation research." Am. J. Bioeth. 4: W23, 2004.
7. Baylis, F. A face is not just like a hand: Pace Barker. Am. J. Bioeth. 4: 30, 2004.
8. Butler, P. E., Clarke, A., and Ashcroft, R. E. Face transplantation: When and for whom? Am. J. Bioeth. 4: 16, 2004.
9. Caplan, A. Facing ourselves. Am. J. Bioeth. 4: 18, 2004.
10. Chambers, T. How to do things with AJOB: The case of facial transplantation. Am. J. Bioeth. 4: 20, 2004.
11. Maschke, K. J., and Trump, E. Facial transplantation research: a need for additional deliberation. Am. J. Bioeth. 4: 33, 2004.
12. Miles, S. H. Medical ethicists, human curiosities, and the new media midway. Am. J. Bioeth. 4: 39, 2004.
13. Morreim, E. H. About face: Downplaying the role of the press in facial transplantation research. Am. J. Bioeth. 4: 27, 2004.
14. Petit, F., Paraskevas, A., and Lantieri, L. A surgeons' perspective on the ethics of face transplantation. Am. J. Bioeth. 4: 14, 2004.
15. Robertson, J. A.. Face transplants: Enriching the debate. Am. J. Bioeth. 4: 32, 2004.
16. Rumsey, N. Psychological aspects of face transplantation: Read the small print carefully. Am. J. Bioeth. 4: 22, 2004.
17. Strong, C. Should we be putting a good face on facial transplantation? Am. J. Bioeth. 4: 13, 2004.
18. Trachtman, H. Facing the truth: A response to "On the ethics of facial transplantation research" by Wiggins. Am. J. Bioeth. 4: W33, 2004.
19. Clark, P. A. Face transplantation: Part II. An ethical perspective. Med. Sci. Monit. 11: RA41, 2005.
20. Powell, T. Face transplant: Real and imagined ethical challenges. J. Law Med. Ethics 34: 111, 2006.
21. Morris, P. J., Bradley, J. A., Doyal, L., et al. Facial transplantation: A working party report from the Royal College of Surgeons of England. Transplantation 77: 330, 2004.
22. Rohrich, R. J., Longaker, M. T., and Cunningham, B. On the ethics of composite tissue allotransplantation (facial transplantation). Plast. Reconstr. Surg. 117: 2071, 2006.
23. The American Society for Reconstructive Microsurgery (ASRM) and the American Society of Plastic Surgeons (ASPS). Facial Transplantation: ASRM/ASPS Guiding Principles. Available at: http://www.microsurg.org/ftGuidelines.pdf. Accessed June 20, 2006.
24. Brown, C. S., Gander, B., and Cunningham, M. Ethical considerations in face transplantation. Int. J. Surg. (Epub 2006 Sept. 5).
25. Gander, B., Brown, C. S., and Vasilic, D. Hand and face transplantation: A new frontier. Transplant. Int. 19: 868, 2006.
26. Comit'e Consultatif National d'Ethique pour les sciences de la vie et de la sant'e., L'allotransplantation de tissu composite (ATC) au niveau de la face (Greffe totale ou partielle d'un visage). Available at: http://www.ccne_ethique. fr/english/avis/a_082.htm. Opinion 82: 1, 2004.
27. Hettiaratchy, S., Randolph, M. A., Petit, F., et al. Composite tissue allotransplantation: A new era in plastic surgery? Br. J. Plast. Surg. 57: 381, 2004.
28. Lanzetta, M., Petruzzo, P., Margreiter, R., et al. The International Registry on Hand and Composite Tissue Transplantation. Transplantation 79: 1210, 2005.
29. Pirsch, J. D., Miller, J., Deierhoi, M. H., et al. A comparison of tacrolimus (FK506) and cyclosporine for immunosuppression after cadaveric renal transplantation: FK506 Kidney Transplant Study Group. Transplantation 63: 977, 1997.
30. Sollinger, H. W. Mycophenolate mofetil for the prevention of acute rejection in primary cadaveric renal allograft recipients: U.S. Renal Transplant Mycophenolate Mofetil Study Group. Transplantation 60: 225, 1995.
31. Johnson, C., Ahsan, N., Gonwa, T., et al. Randomized trial of tacrolimus (Prograf) in combination with azathioprine or mycophenolate mofetil versus cyclosporine (Neoral) with mycophenolate mofetil after cadaveric kidney transplantation. Transplantation 69: 834, 2000.
32. Ahsan, N., Johnson, C., Gonwa, T., et al. Randomized trial of tacrolimus plus mycophenolate mofetil or azathioprine versus cyclosporine oral solution (modified) plus mycophenolate mofetil after cadaveric kidney transplantation: Results at 2 years. Transplantation 72: 245, 2001.
33. Gonwa, T., Johnson, C., Ahsan, N., et al. Randomized trial of tacrolimus + mycophenolate mofetil or azathioprine versus cyclosporine + mycophenolate mofetil after cadaveric kidney transplantation: Results at three years. Transplantation 75: 2048, 2003.
34. Miller, J., Mendez, R., Pirsch, J. D., et al. Safety and efficacy of tacrolimus in combination with mycophenolate mofetil (MMF) in cadaveric renal transplant recipients: FK506/MMF Dose-Ranging Kidney Transplant Study Group. Transplantation 69: 875, 2000.
35. Woodle, E. S. A randomized double blinded, placebo controlled trial of early corticosteroid cessation versus chronic corticosteroids maintenance therapy (Abstract 1511). Am. J. Transplant. 5: 540, 2005.
36. Gonwa, T., Mendez, R., Yang, H. C., et al. Randomized trial of tacrolimus in combination with sirolimus or mycophenolate mofetil in kidney transplantation: Results at 6 months. Transplantation 75: 1213, 2003.
37. Mendez, R., Gonwa, T., Yang, H. C., et al. A prospective, randomized trial of tacrolimus in combination with sirolimus or mycophenolate mofetil in kidney transplantation: Results at 1 year. Transplantation 80: 303, 2005.
38. Ciancio, G., Burke, G. W., Suzart, K., et al. Daclizumab induction, tacrolimus, mycophenolate mofetil and steroids as an immunosuppression regimen for primary kidney transplant recipients. Transplantation 73: 1100, 2002.
39. Ciancio, G., Burke, G. W., Gaynor, J. J., et al. A randomized long-term trial of tacrolimus/sirolimus versus tacrolimus/mycophenolate mofetil versus cyclosporine (NEORAL)/sirolimus in renal transplantation: II. Survival, function, and protocol compliance at 1 year. Transplantation 77: 252, 2004.
40. Vanrenterghem, Y., van Hooff, J. P., Squifflet, J. P., et al. Minimization of immunosuppressive therapy after renal transplantation: Results of a randomized controlled trial. Am. J. Transplant. 5: 87, 2005.
41. Rostaing, L., Cantarovich, D., Mourad, G., et al. Corticosteroid-free immunosuppression with tacrolimus, mycophenolate mofetil, and daclizumab induction in renal transplantation. Transplantation 79: 807, 2005.
42. Ciancio, G., Burke, G. W., Gaynor, J. J., et al. A randomized trial of three renal transplant induction antibodies: Early comparison of tacrolimus, mycophenolate mofetil, and steroid dosing, and newer immune-monitoring. Transplantation 80: 457, 2005.
43. Ciancio, G., Burke, G. W., Suzart, K., et al. Efficacy and safety of daclizumab induction for primary kidney transplant recipients in combination with tacrolimus, mycophenolate mofetil, and steroids as maintenance immunosuppression. Transplant. Proc. 35: 873, 2003.
44. Schneeberger, S., Kreczy, A., Brandacher, G., et al. Steroid- and ATG-resistant rejection after double forearm transplantation responds to Campath-1H. Am. J. Transplant. 4: 1372, 2004.
45. Kanitakis, J., Jullien, D., Petruzzo, P., et al. Clinicopathologic features of graft rejection of the first human hand allograft. Transplantation 76: 688, 2003.
46. Kanitakis, J., Petruzzo, P., Jullien, D., et al. Pathological score for the evaluation of allograft rejection in human hand (composite tissue) allotransplantation. Eur. J. Dermatol. 15: 235, 2005.
47. Lanzetta, M., Ayrout, C., Gal, A., et al. Experimental limb transplantation, part II: excellent return of function and indefinite survival after withdrawal of immunosuppression. Transplant. Proc. 36: 675, 2004.
48. Lee, W. P., Yaremchuk, M. J., Pan, Y. C., et al. Relative antigenicity of components of a vascularized limb allograft. Plast. Reconstr. Surg. 87: 401, 1991.
49. Kanitakis, J., Jullien, D., Nicolas, J. F., et al. Sequential histological and immunohistochemical study of the skin of the first human hand allograft. Transplantation 69: 1380, 2000.
50. Rush, D., Nickerson, P., Gough, J., et al. Beneficial effects of treatment of early subclinical rejection: A randomized study. J. Am. Soc. Nephrol. 9: 2129, 1998.
51. Rush, D. N., Jeffery, J. R., and Gough, J. Sequential protocol biopsies in renal transplant patients: Clinico-pathological correlations using the Banff schema. Transplantation 59: 511, 1995.
52. Shishido, S., Asanuma, H., Nakai, H., et al. The impact of repeated subclinical acute rejection on the progression of chronic allograft nephropathy. J. Am. Soc. Nephrol. 14: 1046, 2003.
53. Waaga, A. M., Gasser, M., Laskowski, I., et al. Mechanisms of chronic rejection. Curr. Opin. Immunol. 12: 517, 2000.
54. Jones, T. R., Humphrey, P. A., and Brennan, D. C. Transplantation of vascularized allogeneic skeletal muscle for scalp reconstruction in a renal transplant patient. Transplantation 65: 1605, 1998.
55. Wendt, J. R., Ulich, T., and Rao, P. N. Long-term survival of human skin allografts in patients with immunosuppression. Plast. Reconstr. Surg. 113: 1347, 2004.
56. Kanitakis, J., Jullien, D., Petruzzo, P., et al. Immunohistologic studies of the skin of human hand allografts: Our experience with two patients. Transplant. Proc. 33: 1722, 2001.
57. Rubin, R. H.. Infection in the organ transplant recipient. In R. H. Rubin and L. S. Young (Eds.), Clinical Approach to Infection in the Compromised Host, 4th Ed. New York: Kluwer Academic/Plenum Publishers, 2002.
58. Paya, C., Humar, A., Dominguez, E., et al. Efficacy and safety of valganciclovir vs. oral ganciclovir for prevention of cytomegalovirus disease in solid organ transplant recipients. Am. J. Transplant. 4: 611, 2004.
59. Fishman, J. A., and Rubin, R. H. Infection in organ-transplant recipients. N. Engl. J. Med. 338: 1741, 1998.
60. Reinke, P., Prosch, S., Kern, F., et al. Mechanisms of human cytomegalovirus (HCMV) (re)activation and its impact on organ transplant patients. Transpl. Infect. Dis. 1: 157, 1999.
61. Schneeberger, S., Lucchina, S., Lanzetta, M., et al. Cytomegalovirus- related complications in human hand transplantation. Transplantation 80: 441, 2005.
62. Nalesnik, M. A. Clinicopathologic features of posttransplant lymphoproliferative disorders. Ann. Transplant. 2: 33, 1997.
63. Penn, I. Post-transplant malignancy: The role of immunosuppression. Drug Saf. 23: 101, 2000.
64. Didlake, R. H., Dreyfus, K., Kerman, R. H., et al. Patient noncompliance: A major cause of late graft failure in cyclosporinetreated renal transplants. Transplant. Proc. 20: 63, 1988.
65. Preiksaitis, J. K., and Keay, S. Diagnosis and management of posttransplant lymphoproliferative disorder in solid-organ transplant recipients. Clin. Infect. Dis. 33 (Suppl. 1): S38, 2001.
66. Shroff, R., and Rees, L. The post-transplant lymphoproliferative disorder: A literature review. Pediatr. Nephrol. 19: 369, 2004.
67. Paya, C. V., Fung, J. J., Nalesnik, M. A., et al. Epstein-Barr virus-induced posttransplant lymphoproliferative disorders: ASTS/ASTP EBV-PTLD Task Force and The Mayo Clinic Organized International Consensus Development Meeting. Transplantation 68: 1517, 1999.
68. Kotton, C. N., and Fishman, J. A. Viral infection in the renal transplant recipient. J. Am. Soc. Nephrol. 16: 1758, 2005.
69. Opelz, G., and Henderson, R. Incidence of non-Hodgkin lymphoma in kidney and heart transplant recipients. Lancet 342: 1514, 1993.
70. A randomized comparative trial of Prograf (tacrolimus, FK506) in combination with azathioprine or mycophenolate mofetil (MMF) vs. Neoral (cyclosporine) with mycophenolate mofetil after cadaveric kidney transplantation: Three Year Report; Study Report on File; Data obtained with permission of Astellas Pharma US, Inc., 2000.
71. Andreoni, M., Goletti, D., Pezzotti, P., et al. Prevalence, incidence and correlates of HHV-8/KSHV infection and Kaposi's sarcoma in renal and liver transplant recipients. J. Infect. 43: 195, 2001.
72. Woodle, E. S., Hanaway, M., Buell, J., et al. Kaposi sarcoma: An analysis of the US and international experiences from the Israel Penn International Transplant Tumor Registry. Transplant. Proc. 33: 3660, 2001.
73. Kasiske, B. L., Snyder, J. J., Gilbertson, D. T., et al. Cancer after kidney transplantation in the United States. Am. J. Transplant. 4: 905, 2004.
74. Ramsay, H. M., Fryer, A. A., Hawley, C. M., et al. Non-melanoma skin cancer risk in the Queensland renal transplant population. Br. J. Dermatol. 147: 950, 2002.
75. Moloney, F. J., Kelly, P. O., Kay, E. W., et al. Maintenance versus reduction of immunosuppression in renal transplant recipients with aggressive squamous cell carcinoma. Dermatol. Surg. 30: 674, 2004.
76. Kasiske, B. L., Chakkera, H. A., and Roel, J. Explained and unexplained ischemic heart disease risk after renal transplantation. J. Am. Soc. Nephrol. 11: 1735, 2000.
77. Radermacher, J., Meiners, M., Bramlage, C., et al. Pronounced renal vasoconstriction and systemic hypertension in renal transplant patients treated with cyclosporin A versus FK 506. Transpl. Int. 11: 3, 1998.
78. Pagano, G., Bruno, A., Cavallo-Perin, P., et al. Glucose intolerance after short-term administration of corticosteroids in healthy subjects: Prednisone, deflazacort, and betamethasone. Arch. Intern. Med. 149: 1098, 1989.
79. Diamant, S., and Shafrir, E. Modulation of the activity of insulin-dependent enzymes of lipogenesis by glucocorticoids. Eur. J. Biochem. 53: 541, 1975.
80. Ligtenberg, G., Hene, R. J., Blankestijn, P. J., et al. Cardiovascular risk factors in renal transplant patients: Cyclosporin A versus tacrolimus. J. Am. Soc. Nephrol. 12: 368, 2001.
81. Klein, I. H., Abrahams, A., van Ede, T., et al. Different effects of tacrolimus and cyclosporine on renal hemodynamics and blood pressure in healthy subjects. Transplantation 73: 732, 2002.
82. Morales, J. M., Andres, A., Rengel, M., et al. Influence of cyclosporin, tacrolimus and rapamycin on renal function and arterial hypertension after renal transplantation. Nephrol. Dial. Transplant. 16 (Suppl. 1): 121, 2001.
83. Kasiske, B. L., Snyder, J. J., Gilbertson, D., et al. Diabetes mellitus after kidney transplantation in the United States. Am. J. Transplant. 3: 178, 2003.
84. Duijnhoven, E. M., Boots, J. M., Christiaans, M. H., et al. Influence of tacrolimus on glucose metabolism before and after renal transplantation: A prospective study. J. Am. Soc. Nephrol. 12: 583, 2001.
85. Francois, C. G., Breidenbach, W. C., Maldonado, C., et al. Hand transplantation: Comparisons and observations of the first four clinical cases. Microsurgery 20: 360, 2000.
86. Yocum, D. E., Furst, D. E., Bensen, W. G., et al. Safety of tacrolimus in patients with rheumatoid arthritis: Long-term experience. Rheumatology (Oxford) 43: 992, 2004.
87. Squifflet, J. P., Backman, L., Claesson, K., et al. Dose optimization of mycophenolate mofetil when administered with a low dose of tacrolimus in cadaveric renal transplant recipients. Transplantation 72: 63, 2001.
88. Casez, J. P., Lippuner, K., Horber, F. F., et al. Changes in bone mineral density over 18 months following kidney transplantation: The respective roles of prednisone and parathyroid hormone. Nephrol. Dial. Transplant. 17: 1318, 2002.
89. Canalis, E. Mechanisms of glucocorticoid-induced osteoporosis. Curr. Opin. Rheumatol. 15: 454, 2003.
90. van den Ham, E. C., Kooman, J. P., Christiaans, M. L., et al. The influence of early steroid withdrawal on body composition and bone mineral density in renal transplantation patients. Transpl. Int. 16: 82, 2003.
91. Epstein, S. Post-transplantation bone disease: The role of immunosuppressive agents and the skeleton. J. Bone Miner. Res. 11: 1, 1996.
92. Frazier, P. A., Davis-Ali, S. H., and Dahl, K. E. Correlates of noncompliance among renal transplant recipients. Clin. Transplant. 8: 550, 1994.
93. Sketris, I., Waite, N., Grobler, K., et al. Factors affecting compliance with cyclosporine in adult renal transplant patients. Transplant. Proc. 26: 2538, 1994.
94. Kiley, D. J., Lam, C. S., and Pollak, R. A study of treatment compliance following kidney transplantation. Transplantation 55: 51, 1993.
95. Thorp, M., DeMattos, A., Bennett, W., et al. The effect of conversion from cyclosporine to tacrolimus on gingival hyperplasia, hirsutism and cholesterol. Transplantation 69: 1218, 2000.
96. Face transplant patient uses new lips to smoke: Doctors fear habit will interfere with healing, raise risk of tissue rejection. Available at: http://www.msnbc.msn.com/id/10912182. Accessed cited January 18, 2006.
97. Furr, A., Wiggins, O., Vasilic, D., et al. A discussion of the psychosocial implications of disfigurement and the future of human face transplantation. Plast. Reconstr. Surg. (in press).