Clinical application of bioartificial liver support systems

Annals of Surgery

Volumn 240, Issue 2, 2004, Pages 216-230

  Van De Kerkhove, Maarten Paul ^a   Hoekstra, Ruurdtje ^a   Chamuleau, Robert A F M ^a   Van Gulik, Thomas M ^a,b  

^a UNIVERSITY OF AMSTERDAM   (Netherlands)

^b ACADEMIC MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ANTICOAGULANT AGENT; CITRIC ACID; HEPARIN;

ANIMAL CELL; ARTIFICIAL LIVER; ARTIFICIAL ORGAN; CELL TRANSPLANTATION; DIALYSIS; EXCHANGE BLOOD TRANSFUSION; HEMODIALYSIS; HEMOFILTRATION; HEMOPERFUSION; HUMAN; HUMAN CELL; LIVER CELL; LIVER DISEASE; LIVER FAILURE; MAJOR CLINICAL STUDY; NONHUMAN; PLASMAPHERESIS; PRIORITY JOURNAL; REVIEW; SURVIVAL RATE; ZOONOSIS;

CRITICAL ILLNESS; EXTRACORPOREAL CIRCULATION; FEMALE; FOLLOW-UP STUDIES; HUMANS; LIVER FAILURE; LIVER TRANSPLANTATION; LIVER, ARTIFICIAL; MALE; RISK ASSESSMENT; SURVIVAL ANALYSIS; TREATMENT OUTCOME; WAITING LISTS;

EID: 3242740190     PISSN: 00034932     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.sla.0000132986.75257.19     Document Type: Review

References (123)

1. Bemuau J, Rueff B, Benhamou JP. Fulminant and subfulminant liver failure: definitions and causes. Semin Liver Dis. 1986;6:97-106.
2. Adam R, Cailliez V, Majno P, et al. Normalised intrinsic mortality risk in liver transplantation: European Liver Transplant Registry study. Lancet. 2000;356:621-627.
3. Lidofsky SD, Bass NM, Prager MC, et al. Intracranial pressure monitoring and liver transplantation for fulminant hepatic failure. Hepatology. 1992;16:1-7.
4. de Rave S, Tilanus HW, van Der LJ, et al. The importance of orthotopic liver transplantation in acute hepatic failure. Transpl Int. 2002;15:29-33.
5. Wall WJ, Adams PC. Liver transplantation for fulminant hepatic failure: North American experience. Liver Transpl Surg. 1995;1:178-182.
6. Farmer DG, Anselmo DM, Ghobrial RM, et al. Liver transplantation for fulminant hepatic failure: experience with more than 200 patients over a 17-year period. Ann Surg. 2003;237:666-676.
7. United Network for Organ Sharing. Liver transplantation data 2002. Available at: www.unos.org.
8. Rahman TM, Hodgson HJ. Review article: liver support systems in acute hepatic failure. Aliment Pharmacol Ther. 1999;13:1255-1272.
9. Stockmann HB, Hiemstra CA, Marquet RL, et al. Extracorporeal perfusion for the treatment of acute liver failure. Ann Surg. 2000;231:460-470.
10. Davenport A. Artificial hepatic support. Where are we now? Blood Purif. 2001;19:1-3.
11. Mito M. Hepatic assist: present and future. Artif Organs. 1986;10:214-218.
12. Kjaergard LL, Liu J, Als-Nielsen B, et al. Artificial and bioartificial support systems for acute and acute-on-chronic liver failure: a systematic review. JAMA. 2003;289:217-222.
13. Kiley JE, Gundermann KJ, Lie TS. Ammonia intoxication treated by hemodialysis. N Engl J Med. 1958;25:1156-1161.
14. Opolon P, Rapin JR, Huguet C, et al. Hepatic failure coma (HFC) treated by polyacrylonitrile membrane (PAN) hemodialysis (HD). Trans Am Soc Artif Intern Organs. 1976;22:701-710.
15. Knell AJ, Dukes DC. Dialysis procedures in acute liver coma. Lancet. 1976;2:402-403.
16. Matsubara S, Okabe K, Ouchi K, et al. Continuous removal of middle molecules by hemofiltration in patients with acute liver failure. Crit Care Med. 1990;18:1331-1338.
17. Jones RC, Strader LD, Berry WC. Peritonela dialysis in liver coma. US Armed Forces Med J. 1959;10:977-982.
18. Agarwal R, Farber MO. Is continuous veno-venous hemofiltration for acetaminophen-induced acute liver and renal failure worthwhile? Clin Nephrol. 2002;57:167-170.
19. Bellomo R, Ronco C. Continuous hemofiltration in the intensive care unit. Crit Care. 2000;4:339-345.
20. Sadamori H, Yagi T, Inagaki M, et al. High-flow-rate haemodiafiltration as a brain-support therapy proceeding to liver transplantation for hyperacute fulminant hepatic failure. Eur J Gastroenterol Hepatol. 2002;14:435-439.
21. Mori T, Eguchi Y, Shimizu T, et al. A case of acute hepatic insufficiency treated with novel plasmapheresis plasma diafiltration for bridge use until liver transplantation. Ther Apher. 2002;6:463-466.
22. Schlechter DC, Nealon TF, Gibbon JH. A simple extracorporeal device for reducing elevated blood ammonia levels. Surgery. 1958;44:892-897.
23. Rozenbaum JL, Kramer MS, Raja R, et al. Resin hemoperfusion: a new treatment for acute drug intoxication. N Engl J Med. 1971;284:874-883.
24. Juggi JS. Extracorporeal cation-exchange circuits in the treatment of hyperammonaemia of hepatic failure. Med J Aust. 1973;1:926-930.
25. O'Grady JG, Gimson AE, O'Brien CJ, et al. Controlled trials of charcoal hemoperfusion and prognostic factors in fulminant hepatic failure. Gastroenterology. 1988;94:1186-1192.
26. Ash SR. Hemodiabsorption in treatment of acute hepatic failure and chronic cirrhosis with ascites. Artif Organs. 1994;18:355-362.
27. Yarmush ML, Dunn JC, Tompkins RG. Assessment of artificial liver support technology. Cell Transplant. 1992;1:323-341.
28. Flendrig LM. Development of a novel bioarticial liver [thesis]. Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands; 1998.
29. Steiner C, Mitzner S. Experiences with MARS liver support therapy in liver failure: analysis of 176 patients of the International MARS Registry. Liver. 2002;22(suppl 2):20-25.
30. Schmidt LE, Sorensen VR, Svendsen LB, et al. Hemodynamic changes during a single treatment with the molecular adsorbents recirculating system in patients with acute-on-chronic liver failure. Liver Transpl. 2001;7:1034-1039.
31. Mitzner SR, Stange J, Klammt S, et al R. Improvement of hepatorenal syndrome with extracorporeal albumin dialysis MARS: results of a prospective, randomized, controlled clinical trial. Liver Transpl. 2000;6:277-286.
32. Stange J, Hassanein TI, Mehta R, et al. The molecular adsorbents recycling system as a liver support system based on albumin dialysis: a summary of preclinical investigations, prospective, randomized, controlled clinical trial, and clinical experience from 19 centers. Artif Organs. 2002;26:103-110.
33. Seige M, Kreymann B, Jeschke B, et al. Long-term treatment of patients with acute exacerbation of chronic liver failure by albumin dialysis. Transplant Proc. 1999;31:1371-1375.
34. Lanjuan L, Qian Y, Jianrong H, et al. Severe hepatitis treated with an artificial liver support system. Int J Artif Organs. 2001;24:297-303.
35. Ash SR. Extracorporeal blood detoxification by sorbents in treatment of hepatic encephalopathy. Adv Ren Replace Ther. 2002;9:3-18.
36. Sorrentino F. Prime ricerche per la realizzazione di un fegato artificiale. Chir Patol Sperim. 1956;4:1401-1404.
37. Kimoto S. The artificial liver: experiments and clinical application. Trans Am Soc Artif Intern Organs. 1959;5:102-112.
38. Mikami J, Moto M, Nishimuro A, et al. Surgical treatment of acute liver failure. II: an experimental study of extracorporeal metabolism in the artificial liver using slices of canine liver. Jpn J Gastroenterol. 1959;56:1022.
39. Nose Y, Mikami J, Kasai N, et al. An experimental artificial liver utilizing extracorporeal metabolism with sliced or granulated canine liver. ASAIO Trans. 1963;9:358.
40. Abouna GM, Ganguly PK, Hamdy HM, et al. Extracorporeal liver perfusion system for successful hepatic support pending liver regeneration or liver transplantation: a pre-clinical controlled trial. Transplantation. 1999;67:1576-1583.
41. Horslen SP, Hammel JM, Fristoe LW, et al. Extracorporeal liver perfusion using human and pig livers for acute liver failure. Transplantation. 2000;70:1472-1478.
42. Eiseman B, Liem DS, Raffucci F. Heterologous liver perfusion in treatment of hepatic failure. Ann Surg. 1965;162:329-345.
43. Burnell JM, Dawborn JK, Epstein RB, et al. Acute hepatic coma treated by cross-circulation or exchange perfusion. N Engl J Med. 1967;276:935-943.
44. Ymazaki K, Kamai F, Ieszuki Y, et al. Extracorporeal methods of liver failure treatment. Biomater Artif Cells Artif Organs. 1987;15:667-675.
45. Kondrup J, Almdal T, Vilstrup H, et al. High volume plasma exchange in fulminant hepatic failure. Int J Artif Organs. 1992;15:669-676.
46. Clemmesen JO, Kondrup J, Nielsen LB, et al. Effects of high-volume plasmapheresis on ammonia, urea, and amino acids in patients with acute liver failure. Am J Gastroenterol. 2001;96:1217-1223.
47. Brunner G, Losgen H. Benefits and dangers of plasma with fulminant hepatic failure. In: Oda T, Shiokawa Y, Inoue N, eds. Therapeutic Plasmapheresis V. Cleveland, OH: ISAO Press; 1987:187-191.
48. Strom S, Fisher R. Hepatocyte transplantation: new possibilities for therapy. Gastroenterology. 2003;124:568-571.
49. Nagata H, Ito M, Cai J, et al. Treatment of cirrhosis and liver failure in rats by hepatocyte xenotransplantation. Gastroenterology. 2003;124:422-431.
50. Demetriou AA, Reisner A, Sanchez J, et al. Transplantation of microcarrier-attached hepatocytes into 90% partially hepatectomized rats. Hepatology. 1988;8:1006-1009.
51. Vogels BA, Maas MA, Bosma A, et al. Significant improvement of survival by intrasplenic hepatocyte transplantation in totally hepatectomized rats. Cell Transplant. 1996;5:369-378.
52. Braun KM, Degen JL, Sandgren EP. Hepatocyte transplantation in a model of toxin-induced liver disease: variable therapeutic effect during replacement of damaged parenchyma by donor cells. Nat Med. 2000;6:320-326.
53. McLaughlin BE, Tosone CM, Custer LM, et al. Overview of extracorporeal liver support systems and clinical results. Ann N Y Acad Sci. 1999;875:310-325.
54. Suh KS, Lilja H, Kamohara Y, et al. Bioartificial liver treatment in rats with fulminant hepatic failure: effect on DNA-binding activity of liver-enriched and growth-associated transcription factors. J Surg Res. 1999;85:243-250.
55. Gerlach JC, Botsch M, Kardassis D, et al. Experimental evaluation of a cell module for hybrid liver support. Int J Artif Organs. 2001;24:793-798.
56. Berry MN, Phillips JW. The isolated hepatocyte preparation: 30 years on. Biochem Soc Trans. 2000;28:131-135.
57. Flendrig LM, Calise F, Di Florio E, et al. Significantly improved survival time in pigs with complete liver ischemia treated with a novel bioartificial liver. Int J Artif Organs. 1999;22:701-709.
58. Sosef MN, Abrahamse LS, van de Kerkhove MP, et al. Assessment of the AMC-bioartificial liver in the anhepatic pig. Transplantation. 2002;73:204-209.
59. Matsumura KN, Guevara GR, Huston H, et al. Hybrid bioartificial liver in hepatic failure: preliminary clinical report. Surgery. 1987;101:99-103.
60. Margulis MS, Erukhimov EA, Andreiman LA, et al. Temporary organ substitution by hemoperfusion through suspension of active donor hepatocytes in a total complex of intensive therapy in patients with acute hepatic insufficiency. Resuscitation. 1989;18:85-94.
61. Ellis AJ, Hughes RD, Wendon JA, et al. Pilot-controlled trial of the extracorporeal liver assist device in acute liver failure. Hepatology. 1996;24:1446-1451.
62. Sussman NL, Gislason GT, Conlin CA, et al. The Hepatix extracorporeal liver assist device: initial clinical experience. Artif Organs. 1994;18:390-396.
63. Sussman NL, Gislason GT, Kelly JH. Extracorporeal liver support. Application to fulminant hepatic failure. J Clin Gastroenterol. 1994;18:320-324.
64. Gislason GT, Lobdell DD, Kelly JH, et al. A treatment system for implementing an extracorporeal liver assist device. Artif Organs. 1994;18:385-389.
65. Sussman NL, Kelly JH. Improved liver function following treatment with an extracorporeal liver assist device. Artif Organs. 1993;17:27-30.
66. Millis JM, Cronin DC, Johnson R, et al. Initial experience with the modified extracorporeal liver-assist device for patients with fulminant hepatic failure: system modifications and clinical impact. Transplantation. 2002;74:1735-1746.
67. Demetriou AA, Rozga J, Podesta L, et al. Early clinical experience with a hybrid bioartificial liver. Scand J Gastroenterol Suppl. 1995;208:111-117.
68. Rozga J, Holzman MD, Ro MS, et al. Development of a hybrid bioartificial liver. Ann Surg. 1993;217:502-509.
69. Samuel D, Ichai P, Feray C, et al. Neurological improvement during bioartificial liver sessions in patients with acute liver failure awaiting transplantation. Transplantation. 2002;73:257-264.
70. Hui T, Rozga J, Demetriou AA. Bioartificial liver support. J Hepatobiliary Pancreat Surg. 2001;8:1-15.
71. Watanabe FD, Mullon CJ, Hewitt WR, et al. Clinical experience with a bioartificial liver in the treatment of severe liver failure. A phase I clinical trial. Ann Surg. 1997;225:484-491.
72. Chen SC, Hewitt WR, Watanabe FD, et al. Clinical experience with a porcine hepatocyte-based liver support system. Int J Artif Organs. 1996;19:664-669.
73. Demetriou AA, Watanabe F, Rozga J. Artificial hepatic support systems. Prog Liver Dis. 1995;13:331-348.
74. Arkadopoulos N, Detry O, Rozga J, et al. Liver assist systems: state of the art. Int J Artif Organs. 1998;21:781-787.
75. Neuzil DF, Rozga J, Moscioni AD, et al. Use of a novel bioartificial liver in a patient with acute liver insufficiency. Surgery. 1993;113:340-343.
76. Rozga J, Podesta L, Lepage E, et al. A bioartificial liver to treat severe acute liver failure. Ann Surg. 1994;219:538-544.
77. Stevens C, Demetriou AA. An interim analysis of a phase II/III prospective randomized, multicenter, controlled trial of the HepatAssist bioartificial liver support system for the treatment of fulminant hepatic failure. Hepatology. 2001;34:299a.
78. Xue YL, Zhao SF, Luo Y, et al. TECA hybrid artificial liver support system in treatment of acute liver failure. World J Gastroenterol. 2001;7:826-829.
79. Chen XP, Xue YL, Li XJ, et al. Experimental research on TECA-I bioartificial liver support system to treat canines with acute liver failure. World J Gastroenterol. 2001;7:706-709.
80. Patzer JF, Mazariegos GV, Lopez R, et al. Novel bioartificial liver support system: preclinical evaluation. Ann N Y Acad Sci. 1999;875:340-352.
81. Mazariegos GV, Kramer DJ, Lopez RC, et al. Safety observations in phase I clinical evaluation of the Excorp Medical Bioartificial Liver Support System after the first four patients. ASAIO J. 2001;47:471-475.
82. Morsiani E, Brogli M, Galavotti D, et al. Long-term expression of highly differentiated functions by isolated porcine hepatocytes perfused in a radial-flow bioreactor. Artif Organs. 2001;25:740-748.
83. Morsiani E, Pazzi P, Puviani AC, et al. Early experiences with a porcine hepatocyte-based bioartificial liver in acute hepatic failure patients. Int J Artif Organs. 2002;25:192-202.
84. Gerlach JC. Development of a hybrid liver support system: a review. Int J Artif Organs. 1996;19:645-654.
85. Sauer IM, Obermeyer N, Kardassis D, et al. Development of a hybrid liver support system. Ann N Y Acad Sci. 2001;944:308-319.
86. Mundt A, Puhl G, Muller A, et al. A method to assess biochemical activity of liver cells during clinical application of extracorporeal hybrid liver support. Int J Artif Organs. 2002;25:542-548.
87. Sauer IM, Zeilinger K, Obermayer N, et al. Primary human liver cells as source for modular extracorporeal liver support-a preliminary report. Int J Artif Organs. 2002;25:1001-1005.
88. Gerlach JC, Zeilinger K, Sauer IM, et al. Extracorporeal liver support: porcine or human cell based systems? Int J Artif Organs. 2002;25:1013-1018.
89. Flendrig LM, te Velde AA, Chamuleau PA. Semipermeable hollow fiber membranes in hepatocyte bioreactors: a prerequisite for a successful bioartificial liver? Artif Organs. 1997;21:1177-1181.
90. Flendrig LM, la Soe JW, Jorning GG, et al. In vitro evaluation of a novel bioreactor based on an integral oxygenator and a spirally wound nonwoven polyester matrix for hepatocyte culture as small aggregates. J Hepatol. 1997;26:1379-1392.
91. Flendrig LM, Sommeijer D, Ladiges NC, et al. Commercially available media for flushing extracorporeal bioartificial liver systems prior to connection to the patient's circulation: an in vitro comparative study in two and three dimensional porcine hepatocyte cultures. Int J Artif Organs. 1998;21:467-472.
92. Flendrig LM, Maas MA, Daalhuisen J, et al. Does the extend of the culture time of primary hepatocytes in a bioreactor affect the treatment efficacy of a bioartificial liver? Int J Artif Organs. 1998;21:542-547.
93. Flendrig LM, Chamuleau RA, Maas MA, et al. Evaluation of a novel bioartificial liver in rats with complete liver ischemia: treatment efficacy and species-specific alpha-GST detection to monitor hepatocyte viability. J Hepatol. 1999;30:311-320.
94. Sosef MN, van de Kerkhove MP, Abrahamse LS, et al. Blood Coagulation in Anhepatic, Pigs: Effects of Treatment with the AMC Bioartificial Liver. J Thromb Haemost. 2003;1:511-515.
95. van de Kerkhove MP, Di Florio E, Scuderi V, et al. Phase I clinical trial with the AMC-bioartificial liver. Academic Medical Center. Int J Artif Organs. 2002;25:950-959.
96. Abrahamse SL, van de Kerkhove MP, Sosef MN, et al. Treatment of acute liver failure in pigs reduces hepatocyte function in a bioartificial liver support system. Int J Artif Organs. 2002;25:966-974.
97. Crepaldi G, Demetriou AA, Muraca M. Experience in design of controlled clinical trials in acute liver failure. In: Riordan SM, Williams R, eds. Bioartificial Liver Support Systems. Rome: CIC Edizioni Internazionali; 1997:104-115.
98. O'Grady JG, Alexander GJ, Hayllar KM, et al. Early indicators of prognosis in fulminant hepatic failure. Gastroenterology. 1989;97:439-445.
99. Bernuau J, Goudeau A, Poynard T, et al. Multivariate analysis of prognostic factors in fulminant hepatitis B. Hepatology. 1986;6:648-651.
100. Donini A, Baccarani U, Risaliti A, et al. Temporary neurological improvement in a patient with acute or chronic liver failure treated with a bioartificial liver device. Am J Gastroenterol. 2000;95:1102-1104.
101. Ding YT, Qiu YD, Chen Z, et al. The development of a new bioartificial liver and its application in 12 acute liver failure patients. World J Gastroenterol. 2003;9:829-832.
102. Hughes RD. Review of methods to remove protein-bound substances in liver failure. Int J Artif Organs. 2002;25:911-917.
103. Hughes RD, Cochrane AM, Thomson AD, et al. The cytotoxicity of plasma from patients with acute hepatic failure to isolated rabbit hepatocytes. Br J Exp Pathol. 1976;57:348-353.
104. DeMatteo RP, Fong Y, Blumgart LH. Surgical treatment of malignant liver tumours. Baillieres Best Pract Res Clin Gastroenterol. 1999;13:557-574.
105. McCarter MD, Fong Y. Metastatic liver tumors. Semin Surg Oncol. 2000;19:177-188.
106. van de Kerkhove MP, De Jong KP, Rijken AM, et al. MARS treatment in posthepatectomy liver failure. Liver Int. 2003;23(suppl 3):44-51.
107. Allen JW, Hassanein T, Bhatia SN. Advances in bioartificial liver devices. Hepatology. 2001;34:447-455.
108. Mitry RR, Hughes RD, Aw MM, et al. Human hepatocyte isolation and relationship of cell viability to early graft function. Cell Transplant. 2003;12:69-74.
109. Lawley TJ, Bielory L, Gascon P, et al. A prospective clinical and immunologic analysis of patients with serum sickness. N Engl J Med. 1984;311:1407-1413.
110. te Velde AA, Flendrig LM, Ladiges NC, et al. Immunological consequences of the use of xenogeneic hepatocytes in a bioartificial liver for acute liver failure. Int J Artif Organs. 1997;20:229-233.
111. Koebe HG, Dahnhardt C, Muller-Hocker J, et al. Cryopreservation of porcine hepatocyte cultures. Cryobiology. 1996;33:127-141.
112. Morsiani E, Brogli M, Galavotti D, et al. Biologic liver support: optimal cell source and mass. Int J Artif Organs. 2002;25:985-993.
113. Darr TB, Hubel A. Postthaw viability of precultured hepatocytes. Cryobiology. 2001;42:11-20.
114. Hubel A, Conroy M, Darr TB. Influence of preculture on the prefreeze and postthaw characteristics of hepatocytes. Biotechnol Bioeng. 2000;71:173-183.
115. Chen Z, Ding Y, Zhang H. Cryopreservation of suckling pig hepatocytes. Ann Clin Lab Sci. 2001;31:391-398.
116. Demetriou AA, Whiting J, Levenson SM, et al. New method of hepatocyte transplantation and extracorporeal liver support. Ann Surg. 1986;204:259-271.
117. Morsiani E, Rozga J, Scott HC, et al. Automated liver cell processing facilitates large scale isolation and purification of porcine hepatocytes. ASAIO J. 1995;41:155-161.
118. Calise F, Mancini A, Amoroso P, et al. Functional evaluation of the AMC-BAL to be employed in a multicentric clinical trial for acute liver failure. Transplant Proc. 2001;33:647-649.
119. Hoekstra R, Chamuleau RA. Recent developments on human cell lines for the bioartificial liver. Int J Artif Organs. 2002;25:182-191.
120. Kelly JH, Koussayer T, He D, et al. Assessment of an extracorporeal liver assist device in anhepatic dogs. Artif Organs. 1992;16:418-422.
121. Hughes RD, Williams R. Evaluation of extracorporeal bioartificial liver devices. Liver Transpl Surg. 1995;1:200-206.
122. Colletti LM, Johnson KJ, Kunkel RG, et al. Mechanisms of hyperacute rejection in porcine liver transplantation. Antibody-mediated endothelial injury. Transplantation. 1994;57:1357-1363.
123. Stoves J, Goode NP, Visvanathan R, et al. The bradykinin response and early hypotension at the introduction of continuous renal replacement therapy in the intensive care unit. Artif Organs. 2001;25:1009-1013.