1 Recipient Eligibility
The relative scarcity of donor organs means that transparent eligibility criteria are required to ensure a just and equitable system for deciding which patients will have access to organ transplantation as a therapy. Determining eligibility in an environment where need exceeds availability involves balancing the potentially conflicting ethical principles of equity and utility. Equity, in its purest form, requires that every potential recipient who might benefit from an organ transplant has an equal opportunity to receive one. Utility, on the other hand, requires that the community should derive the maximum possible benefit from the limited number of organs available for transplantation. The eligibility criteria and allocation processes outlined in this document attempt to balance these ethical principles in a practical and transparent manner. It should be noted, however, that because the allocation of organs is a complex process with a range of factors informing the decision to offer a particular organ to a particular recipient, wait-listed patients will wait for variable periods of time regardless of their relative medical need.
1.1 Referral
Patients are referred to transplant units by their treating specialist physician for assessment of their eligibility to be entered onto a transplant waiting list. Eligibility is determined on the basis of organ-specific criteria that have been developed by the relevant Advisory Committee or Working Group of the Transplantation Society of Australia and New Zealand.
Comprehensive, multidisciplinary assessment of potential candidates for transplantation is a complex and time-consuming process. It is important that referral is timely to enable suitable patients to be listed as early as is medically appropriate. In some cases—particularly in the case of kidney transplantation where the patient is not at immediate risk of death—it would usually be appropriate to optimise the patient’s medical, social and psychological situation prior to referral and evaluation for wait-listing.
1.2 Assessment for eligibility
1.2.1 General inclusion and exclusion criteria
The assessment process typically requires that patients undergo a standard set of consultations and investigations to evaluate their suitability for organ transplantation. Some patients will require further investigations depending on their specific circumstances. Clinical assessment should involve evaluation by a multidisciplinary transplant team that includes (as a minimum) both a suitably experienced transplant surgeon and a suitably experienced transplant physician (see Section 1.4).
The transplant team should regularly review wait-listed patients to ensure that they remain suitable for transplantation. Listed patients should be removed from the transplant waiting list if their condition changes (this could be either an improvement or a deterioration) to the point that they no longer meet the eligibility criteria outlined in this document.
While there are specific recipient inclusion and exclusion criteria for each organ, there are general conditions that apply across all organs. These are:
Age: with the increasing success of transplantation, the age range considered suitable for transplantation has steadily increased. Age is not by itself an exclusion criterion for most organs. However, the presence of multiple comorbidities in patients over 70 years of age is likely to exclude the majority of such patients from eligibility for transplantation.1,21 Mehra MR, Kobashigawa J, Starling R, et al. Listing criteria for heart transplantation: International Society for Heart and Lung Transplantation guidelines for the care of cardiac transplant candidates—2006. J Heart Lung Transplant, 2006;25(9):1024–42. 2 Macdonald P. Heart transplantation: who should be considered and when? Intern Med J, 2008;38(12): 911–17. ×
Comorbidities: exclusion criteria generally include conditions or combinations of conditions that would result in an unacceptably high risk of mortality or morbidity during or after transplantation (e.g. active malignancy, severe cardiac disease, or chronic infection).
Behavioural risk factors: the fact that an individual may require a transplant due to lifestyle choices they have made in the past is ethically irrelevant. However, ongoing substance abuse—including excessive alcohol consumption, cigarette smoking and illicit drug use—are generally considered contraindications to transplantation. These lifestyle factors increase the risk of poor transplant outcomes.3-73 Sung RS, Althoen M, Howell TA, et al. Excess risk of renal allograft loss associated with cigarette smoking. Transplantation, 2001;71(12):1752–57. 4 Kasiske BL & Klinger D. Cigarette smoking in renal transplant recipients. J Am Soc Nephrol, 2000;11(4):753–59. 5 Botha P, Peaston R, White K, et al. Smoking after cardiac transplantation. Am J Transplant, 2008;8(4):866-71. 6 Dew MA, DiMartini AF, Steel J, et al. Meta-analysis of risk for relapse to substance use after transplantation of the liver or other solid organs. Liver Transpl, 2008;14(2):159-72. 7 van der Heide F, Dijkstra G, Porte RJ, et al. Smoking behavior in liver transplant recipients. Liver Transplantation, 2009; 15(6):648-55. ×
Inability to adhere with complex medical therapy: for example chronic cognitive or neuropsychiatric deficits in the absence of a carer capable of facilitating adherence to therapy. 8-128 Chacko RC, Harper RG, Gotto J et al. Psychiatric interview and psychometric predictors of cardiac transplant survival. Am J Psychiatry, 1996;153(12):1607–12. 9 Dobbels F, Vanhaecke J, Desmyttere A et al. Prevalence and correlates of self-reported pretransplant non-adherence with medication in heart, liver and lung transplant candidates. Transplantation, 2005;79(11):1588-95. 10 Teeles-Cooeia D, Barbosa A, Mega I, et al. Adherence correlates in liver transplant candidates. Transplantation Proceedings, 2009;41(5):1731-34. 11 Barbour KA, Blumenthal JA, and Palmer SM. Psychosocial issues in the assessment and management of patients undergoing lung transplantation. Chest, 2006;129(5):1367-74. 12 Denhaerynck K, Desmyttere A, Dobbels F, et al. Nonadherence with immunosuppressive drugs: U.S. compared with European kidney transplant recipients. Prog Transplant, 2006;16(3):206-14 ×
All patients assessed for eligibility for transplantation have the right to know whether or not they have been placed on the transplant waiting list, and the reasons why they have not been listed if they are deemed ineligible.
Recognised transplant units in Australia and New Zealand are listed in Appendix H.
1.2.2 Eligibility for publicly funded access to deceased donor organs (or living non-directed donor organs) allocated by the national algorithms
TSANZ supports the Declaration of Istanbul on organ trafficking and transplant tourism.13,14 and is committed to the principles of fairness and transparency in the processes of assessment and listing for organ transplantation.13 The Declaration of Istanbul on Organ Trafficking and Transplant Tourism (2018 Edition). Transplantation: February 2019 ,103 (2):218-219. 14 Martin DE, Van Assche K, Domínguez-Gil B et al. A new edition of the Declaration of Istanbul: updated guidance to combat organ trafficking and transplant tourism worldwide. Kidney international. 2019 Apr 1;95(4):757-9. ×
TSANZ considers that all patients who reside* in Australia (AU) or New Zealand (NZ) and who are eligible for publicly funded treatment for end stage organ failure within AU/NZ are eligible for assessment, waitlisting and transplantation. Further organ specific information pertaining to transplant recipient inclusion and exclusion criteria can be found in chapters 4-10 of these Clinical Guidelines.
In view of the existing gap between the need for organs and their availability, TSANZ considers it inappropriate for patients who are not eligible for publicly funded healthcare to be assessed for transplantation except under exceptional circumstances. An exceptional circumstance may include a non-eligible patient who develops acute life threatening, non-reversible organ failure that would normally warrant consideration for transplantation and is too unwell to return to their home country to access care there. In this situation it needs to be established that the patient will return to a jurisdiction where there is access to safe and effective long-term care of the transplanted patient.
In addition to ensuring the relevant jurisdictional health oversight, we recommend that the appropriate TSANZ organ advisory committee be notified of such candidates. An annual audit of international patient waitlisting will be conducted by the TSANZ organ advisory committees.
*Further information on required residency status and eligibility for publicly funded healthcare can be found here: About Medicare | Australian Government Department of Health and Aged Care (AU) and Getting publicly funded health services | New Zealand Government (www.govt.nz) (NZ).
1.3 Consent
Consent is defined in the Ethical Guidelines as a person’s or a group’s agreement, based on adequate knowledge and understanding of relevant material.15 As for all medical procedures, consent should be given before transplantation can proceed. If the individual does not have the capacity to give consent or is a minor, a representative should be involved in ongoing discussions and decision-making. Sufficient information about the procedure must be made available, including the risks, the benefits, and what will happen if the procedure does not go ahead.15 Ethical Guidelines for Organ Transplantation from Deceased Donors. Australian Government National Health and Medical Research Council, Canberra, 2016. ×
The acceptability of donor organs that may pose an element of risk to the recipient should be discussed with both the potential recipient and their carer at the time of wait-listing (rather than at the time of the organ offer). With the introduction of new and safe antiviral therapy for Hepatitis C virus (HCV) infection this should include the possible use of an organ from a HCV infected donor into a recipient without HCV infection. The provision of adequate counselling and education is critical to the potential recipient’s ability to consider their options and ultimately provide informed consent if they choose to proceed with transplantation in these circumstances.
It is imperative that the potential recipient receives comprehensive education regarding the transplant procedure and its potential short- and long-term outcomes. All patients are not equal in terms of their capacity to understand this information, and it is the clinician’s role to ensure that information is provided at a level that is comprehensible to the patient. This should be done before surgery—ideally during the assessment phase—and over a series of meetings including consultations with clinicians and patient education sessions, with provision of supplementary reading material and/or electronic media.
Provision of written consent specific to the planned transplant must be sought. Provision of written consent should be preceded by discussion(s) of immunological and surgical risks, plus explicit discussion of any case-specific risks related to donor quality or risk of donor-derived disease (e.g. in the case of a tumorectomised kidney and cancer risk, or a hepatitis B core antibody positive donor or, more recently, the use of HCV positive organs in HCV negative transplant recipients – see Chapter 2) without compromising donor anonymity. In the case of children, both the patient and their carers should be educated and provide consent. For those deemed not legally competent, the appointed guardian should be educated and asked to provide consent.
1.4 Assessment and wait-listing
The referral of individuals with organ failure to a transplant unit for assessment of transplant eligibility should be initiated and completed in a timely manner to maximise the chances of successful transplantation. The transplant eligibility assessment should include:
Patient education regarding treatment options: treatment options include transplantation versus no transplantation, or living donor versus deceased donor transplantation for those with kidney failure (and for some patients with liver failure). Patients should be educated regarding likely risks, estimated benefits, and expected outcomes of transplantation. Patients should also be educated about the range of donor characteristics and the potential risks and benefits of accepting a higher-risk organ.
Medical assessment: both physical and psychological assessment is required to identify possible issues or contraindications to transplantation, and to enable an estimation of the risks and benefits of transplantation for each individual. This assessment should include clinical review by members of the transplanting team, including (at a minimum) a suitably experienced transplant surgeon and a suitably experienced transplant physician, plus any other clinicians deemed necessary. Assessment will include screening tests designed to ensure medical suitability for transplantation, as directed by the transplant team. The time required to complete medical assessment is variable, determined largely by case complexity.
Listing for deceased donor organ transplantation: this should be done by the transplant team following completion of the assessment to their satisfaction. Criteria for listing vary from organ to organ, and are detailed in each organ-specific chapter within this document. If the transplant team believe transplantation is either contraindicated or that the patient does not meet the criteria for listing—either due to the absence of an indication for transplantation or an unfavourable projected risk-benefit scenario if transplantation were to be attempted—then the patient and their referring clinician should be informed and advised as to the reasoning behind this decision. In some cases, where additional information is required, a listing decision may be deferred until such information becomes available. Every reasonable effort should be made to obtain the necessary information within a reasonable timeframe, and the referring clinician should be kept adequately informed regarding information requirements and timelines.
1.5 Appeals
Patients in Australia who are either (i) not referred for transplant assessment, or (ii) assessed by a transplant unit and deemed unsuitable for listing, have a right to appeal such decisions (see the NHMRC Ethical Guidelines15). The appropriate pathway for patients in scenario (i) who disagree with their assessment is to seek a second opinion from a specialist within the field. Potential outcomes of seeking a second opinion are: (a) the specialist from whom the second opinion is sought believes that referral for transplant is not indicated, in which case this should be explained to the patient, or (b) the second opinion is that referral is indicated, and that specialist refers the patient to a transplant service for assessment. In the case of scenario (ii), where the decision not to list a patient is appealed, the local unit will first review the clinical information to determine whether there are any factors that might lead to a change in the original decision. If the unit uphold their decision that the patient is not eligible for listing, however the patient, their family or other advocates still disagree with this assessment, then the appropriate pathway is to seek—via the patient’s specialist, and with the impartial assistance of the local unit—referral to a second transplant unit within the patient’s jurisdiction; an inter-state opinion may, if required, be sought by negotiation between the units and with the patient’s consent. In the case of heart transplantation, given the logistical challenges and costs related to patient transport, the second unit should first conduct a data review, followed by a face-to-face review only if warranted. In all cases, the local unit should assist patients and families in pursuing a second opinion by providing clinical data to the second unit so that the patient does not have to undergo repeat investigations. Potential outcomes of referral to a second transplant unit are: (a) the second transplant unit agrees that the patient is not suitable for transplant listing, and this is explained to the patient; or (b) the second unit believes that the patient should be waitlisted, which should then be performed at either the primary or the secondary unit following discussion involving all parties.15 Ethical Guidelines for Organ Transplantation from Deceased Donors. Australian Government National Health and Medical Research Council, Canberra, 2016. ×
In the case of intestinal transplantation and vascularised composite allotransplantation, for which only single transplant units currently exist, there is not the option of referral to a second unit within Australia or New Zealand if a patient appeals the decision of the transplant unit not to list. For intestinal transplantation, an understanding exists with the United Kingdom to refer cases for second opinion to the UK National Adult Intestinal Transplant forum, which convenes every two months.
New Zealand has a formalised process for appeals to the National Renal Transplant Leadership Team.
1.6 Ongoing review
Factors affecting patient suitability for transplantation may change over time. For this reason, patients wait-listed for organ transplantation should be monitored by their local physician. In addition, patients should be reviewed by the transplant unit (i) regularly, at an interval determined by the transplant unit based on patient comorbidity profile and stability (typically annually), AND (ii) ad-hoc, when the transplant unit is alerted to a potential change in suitability by the patient’s usual treating physician or other medical staff. For example, unscheduled hospitalisations, intercurrent events such as myocardial infarction, or concerns with respect to non-adherence to therapy may warrant ad-hoc review by the transplant unit. If, upon review, the patient is determined to be no longer suitable for transplantation, they should be (i) delisted, if the change in status is deemed likely to be permanent, or (ii) temporarily moved to the inactive list, if the problem identified is felt to be remediable—in this case a plan for reassessment with a view to reinstatement to the active list should be made. The patient and their referring physician should be kept informed of any changes in listing status and, subsequently, of the steps involved in determining suitability for reinstatement to the active list.
1.7 Retransplantation
Organ transplant recipients who develop failure of the transplanted organ (e.g. a kidney transplant recipient who develops failure of the transplanted kidney) or another organ (e.g. a patient with a functioning liver transplant who develops kidney failure) are entitled to be assessed and listed for transplantation of a subsequent organ. The assessment should determine medical eligibility and the likelihood of successful transplantation in the same way as those seeking transplantation of a first organ. The presence or absence of a previous transplant should not affect access to transplantation, except where this impacts upon medical suitability.1515 Ethical Guidelines for Organ Transplantation from Deceased Donors. Australian Government National Health and Medical Research Council, Canberra, 2016. ×