2.1. Background Medical History
The donor’s medical history must be known and recorded in the hospital records. Specific attention must be paid to:
2.2. Current Medical History
Current medical history must include the diagnosis of the cause of brain death and knowledge of the hospital course, together with the current clinical status. The standardised ATCA medical history questionnaire will be completed for all donors. Specific attention must be paid to:
2.3. Absolute contra-indications or organ donation
These include the following:
2.4. Investigations
The following investigations are necessary:
Mandatory
Recommended
2.5. Guidelines on Hepatitis B testing and use of HBV core antibody donors
2.5.1 Background
Hepatitis B is a highly infectious agent which causes potentially serious disease and may be identified in infected individuals in a number of ways. Recent data has led to re-examination of the appropriate guidelines for the testing of donors’ organs and tissues for transplantation. Guidelines of the TSANZ Expert Advisory Panel, August 1997, recognised that the tests for Hepatitis B are subject to a degree of false positives and false negatives and that the precise details of the tests employed vary from manufacturer to manufacturer and with development over time.
2.5.2. Hepatitis B Testing
| Persistent Infection | Past Infection | Vaccinated | Uncertain | |
| Hepatitis B Surface Antigen | + | - | - | - |
| Hepatitis B Surface Antibody | - | + or - | + | - |
| Hepatitis C Core Antibody (IgG) | + | + or - | - | + |
A positive result for Hepatitis B core Antibody alone may indicate:
2.5.3. Transplantation from the HBsAg -, Hepatitis B core Ab + donor
2.5.3a. Liver Transplantation
It is clear that Hepatitis B is frequently transmitted by donation from donors with this status.
Wachs et al. Transplantion. 1995; 59:230-234. 3 of the 6 recipients infected
Uemoto et al. Unpublished. Liver related donors. 15 of 16 recipients infected
Dickson et al. Gastroenterology. 1997; 113: 1668. 18 of 23 recipients infected
Lowell et al. Lancet. 1995; 345: 1084-1085. 1 of 1 recipient infected
Radomski et al. Liver Transplant Surg. 1996: 130-131. 1 of 1 recipient infected
Preiksaitis JK, et al. Transplantation. 1999;68S: 97
Lee SK et al. Transplantation. 1999; 67S: 638
Recent data suggests that transmission of infection can be prevented by use of Lamivudine therapy in the recipient.
Nery J, Nery-Avilla C, and Reddy KR. Use of liver grafts from donors positive for anti-Hepatitis B core Ab in the era of prophylaxis with Lamivudine and HBIG transplantation. 2003;75:1179-1186.
deVilla VH, Chen YS, and Chen CL. Hepatitis B core Ab+ donors recipients risks. Transplantation. 2003;75(supp13)549-553.
2.5.3b. Other Solid Organ Transplantation
There is much less data on transmission of infection by Hepatitis B core antibody positive donors after transplantation of other solid organs or tissue. Inquiry in Australia has revealed no known case of transmission of Hepatitis B by renal transplantation. The only published data to the knowledge of the Expert Advisory Panel comes from:
Wachs et al. Transplantation. 1995; 59:230-234. 1 of 42 recipients infected
Delmonico et al. Transplantation 1998; 65: 603-610 – review article.
2.5.3c. Tissue Transplantation
There is data available on the use of heart valves from Hepatitis B surface antigen positive donors in both immune and non-immune patient.
Morris et al. Ann. Thoracic Surg. 1990; 49: 802-805. 0 of 7 heart recipients infected
2.5.4. Recommendations
2.5.4a. All potential liver donors must be tested for Hepatitis B surface antigen and Hepatitis B core antibody. Donors positive for Hepatitis B surface antigen represent the highest risk for transmission. All donors positive for HBsAg should be excluded as donors for Hepatitis B negative recipients, other than in exceptional circumstances. Hepatitis B core antibody positive donors should be considered for Hepatitis B surface antigen positive recipients in units with protocols that use Lamivudine and Hepatitis B Immunoglobulin cover for transplantation. HB core antibody+ donors may be considered for HBsAg– recipients provided informed consent is obtained and anti-HBV anti-viral therapy is used in the recipient.
2.5.4b. All potential ldonors of hearts, lung, kidneys, pancreas or other vascularised organs except the liver, must be tested for Hepatitis B surface antigen and organs from Hepatitis B surface antigen positive donors must not be used for Hepatitis B surface antigen negative recipients. There is no current evidence of transmission of Hepatitis B by Hepatitis B surface antigen negative donors in Australia. There is a single case report of 1 out of 42 kidney recipients of Hepatitis B core antigen antibody positive Hepatitis B surface antigen negative kidneys becoming infected with Hepatitis B. There is insufficient information at this time to change current practice of Hepatitis B surface antigen testing only.
Non-liver organ recipients of organs from donors known to be Hepatitis B surface antigen negative but Hepatitis B core antibody positive should ideally be immune and/or vaccinated to Hepatitis B and must be transplanted only after specific informed consent has obtained.
2.5.4c. All donors of banked and non-vascularised tissue, including cornea, bone and heart must be tested for Hepatitis B surface antigen and should be tested for Hepatitis B core antibody. The non-urgent and non-life threatening nature of the indications for tissue transplantation require that all donors positive for Hepatitis B surface antigen represent a potential risk for transmission of Hepatitis B and their tissues must not be used. Donors negative for Hepatitis B surface antigen but positive for Hepatitis core antibody represent an unknown risk for the transmission of Hepatitis B and their tissues should not be used other than in exceptional circumstances. If tissues from positive donors are considered then prophylactic treatment of the recipient should be considered and informed consent must be obtained.
2.6. Guidelines on Hepatitis C testing and use of HCV Ab+ donors
2.6.1 Prevalence of organ donor anti-HCV Ab positive and transmission risk from organ donors
Organ donors in the USA have a mean prevalence of approximately 5%. Anti-HCV Ab positivity in Australia or New Zealand donors is similar. These figures are significantly greater than random blood donors (0.3%). Not all anti-HCV Ab positive subject are currently HCV infected. It has been estimated that approximately 50% of HCV donor organs are HCV PCR positive (1, 2). This figure may be an overestimation depending on number of false positives anti-HCV Ab results in the organ donor cohort. It is only HCV PCR positive donors who have been documented to transmit infection (3) and up to 100% of HCV PCR positive donors transmit infection to recipients (1). There is no demographic data to distinguish anti-HCV Ab+ PCR+ vs anti-HCV Ab- PCR- subjects (1).
2.6.2. Natural history of HCV infection in non-liver allograft recipients
There is evidence that HCV infected kidneys and cardiac allograft patients have a significantly worse long term outcome following transplantation that HCV non-infected subjects (4). There are however some short term studies that do not show this and only preliminary data is available on cardiac transplants (5). There is no data yet on lung transplants. In general it is difficult to dissect out from the literature HCV positive subjects who were HCV Ab+ pre transplant from those who acquired the infection post transplant.
2.6.3. Natural history of HCV infection post liver transplant
There is data that HCV infection in this setting may result in significant liver disease. However, 5 year survival rates do not as yet show significant differences between HCV Ab+ and HCV Ab- recipients (6). There is no emerging data suggesting subjects with higher pre transplant and post transplant viral loads do worse (7) and earlier data indicated that patients who require liver transplant with genotype 1b also do worse (6) but this has not been supported in all studies.
2.6.4. Use of HCV positive liver allografts
There is data that suggests that recipients of such grafts do not have a worse outcome (8-10). Indeed when HCV positive grafts are transplanted into HCV positive recipients with different genocytes, the recipients who develop the donor genotype have a better outcome (8).
2.6.5. Conclusions arising from the current data
2.6.5a. Organs from HCV Ab+ donors should not be used for HCV negative allograft recipients
The combination of a significant transmission risk combined with increasing data on poorer long-term outcome, if transmission does occur, leads to this conclusion.
2.6.5b. HCV Ab+ organs may be used for non-liver HCV Ab+ allograft recipients who are PCR positive
Hence the PCR status of recipients should be known. The use of HCV Ab+ donors for HCV Ab+ PCR+ should not be dismissed. The theoretical risks involve aspects such as different HCV genotypes and viral loads between recipient and donor that may influence outcomes. More data is required but it is not unreasonable to use such donors in certain circumstances and with the specific informed consent of the recipient including clear information on the potential risks.
2.6.5c. HCV Ab+ donors may be used for HCV PCR+ liver allograft recipient
The waiting list for liver allograft recipients in Australia in increasing and HCV related cirrhosis is the main indication for liver transplantation (approximately 30% of all adult recipients). The evidence that discarding HCV Ab+ donors, 50% of whom may be PCR-, will affect outcomes is not available. The theoretical risks of different viral loads and genotypes should be studied. However, recent data suggests that this does not alter outcomes (changing to donor genotype may even be beneficial). Specific informed consent of the recipient would be required with provision of clear information of the potential risks.
2.6.6. Recommendations
2.6.7. References
Date of protocol: August 2002
Updated: November 2004