The Transplantation Society of Australia and New Zealand Clinical Guidelines for Organ Transplantation from Deceased Donors Version 1.5 – April 2021 Produced in partnership with Version 1.0 of the Clinical Guidelines for Organ Transplantation from Deceased Donors (the Clinical Guidelines) was released in April 2016. Updates were made in May 2017 (Version 1.1), December 2018 (Version 1.2), May 2019 (Version 1.3), and July 2020 (Version 1.4). The current document, Version 1.5 (April 2021), replaces these previous versions of the Clinical Guidelines. Version control Version # Changes made Approved by Date 1.5 Updated advice related COVID-19 (section 2.3.2.1). Australasian Transplant 28 April 2021 Addition of advice in the event of reactive screening antibody Coordinators Association results (section 2.3.2.9). (ATCA), Transplant Society of Australia and New Zealand Addition of section 2.5 on Risks related to other donor (TSANZ) and Organ and conditions. Tissue Authority (OTA). Updates relating to the Australian and New Zealand paired Kidney Exchange Program (ANZKX) (sections 5.2.5 and 5.4.4). 1.4 Chapter 11 (Paediatric Donors) was added to the Guidelines, Paediatric Donor Working 24 July 2020 providing organ-specific advice on acceptability and allocation Group. Australasian of organs from paediatric donors. Each of the organ- Transplant Coordinators specific chapters in Part B were updated to reflect the new Association (ATCA), recommendations for paediatric donors. Transplant Society of Australia and New Zealand Addition of advice on COVID-19 screening in deceased (TSANZ) and Organ and donors. Tissue Authority (OTA) 1.3 Broad revisions to section 2.3 (Donor assessment) and Australasian Transplant 31 May 2019 section 2.4 (Donor transmitted infectious disease). Coordinators Association (ATCA), Transplant Society of Addition of Appendix I: Summary of recommendations for Australia and New Zealand infectious disease screening in deceased donors (TSANZ) and Organ and Tissue Authority (OTA) References to donor and transplant registry statistics have been updated throughout to reflect the most up-to-date data. Changes to Chapter 4 (Heart): removal of the criterion of at least 10 years expected post-transplant survival (section 4.2); clarification of acceptable duration of warm ischaemia time (section 4.4.1); clarification of policy regarding HCV NAT- positive donors (section 4.7) Changes to Chapter 6 (Liver): updates to Section 6.4.1 ‘Use of HCV infected livers into HCV negative recipients’ 1.2 Changes to Chapter 5 (Kidney): Australasian Transplant 17 December Coordinators Association 2018 Rewording of the 80% five-year survival criterion for wait- (ATCA), Transplant Society of listing eligibility. This now states that “significant benefit” is Australia and New Zealand required from transplantation under section 5.1. (TSANZ) and Organ and Tissue Authority (OTA) An adjustment to the rules surrounding return of deceased donor waiting time in the event of a failed live donor transplant within 12 months under section 5.2. Removal of the 12-month waiting period for paediatric bonus score to be applied to section 5.2.4. 1.1 ’Use of HCV infected donor livers into HCV negative Australasian Transplant 17 May 2017 recipients’ has been added under section 6.4 on page 64. Coordinators Association Minor consequential amendments to Recipient Eligibility in (ATCA), Transplant Society of Section 1 and Organ Donor Eligibility in Section 2 have also Australia and New Zealand been made. (TSANZ) and Organ and Tissue Authority (OTA) April 2021 version 1.5 ii Disclaimer The information contained in this document is for general information only. It is designed to be educational, and is not intended to be—and is not—a complete or definitive statement on any area of medical practice or procedure. The Transplantation Society of Australia and New Zealand, its directors, and other officers make no express or implied warranties as to the suitability for a particular purpose or otherwise of the information included in this document. Rapid advances in medicine may cause information contained in this document to become out-dated or subject to debate. Readers of this document who are not medical practitioners qualified in the field should seek further professional advice before any action is taken in relation to the matters described or referred to in the document. April 2021 version 1.5 iii Table of contents Disclaimer iii Introduction vi Part A General issues related to recipient eligibility and donor assessment viii 1 Recipient Eligibility 1 1.1 Referral 1 1.2 Assessment for eligibility 1 1.3 Consent 2 1.4 Assessment and wait-listing 3 1.5 Appeals 3 1.6 Ongoing review 4 1.7 Retransplantation 4 2 Organ donor eligibility 6 2.1 The organ donation process 6 2.2 Deceased donor and organ assessment 7 2.3 Risk of donor transmitted infectious disease 12 2.4 Risk of donor transmitted malignancy 33 2.5 Risks related to other donor conditions 36 2.6 Organ distribution and allocation 38 2.7 Vigilance and Surveillance 39 3 Auditing and Monitoring 46 3.1 TSANZ Advisory Committee Audits 46 3.2 ATCA/TSANZ National Organ Allocation, Organ Rotation, Urgent Listing, Auditing Process 46 3.3 Data collection 46 3.4 Governance 47 Part B Organ-specific guidelines 48 4 Heart 49 4.1 Preamble 49 4.2 Recipient eligibility criteria 49 4.3 Waiting list management 53 4.4 Donor assessment 54 4.5 Allocation 56 4.6 Multi-organ transplantation 57 4.7 Emerging Issues 58 5 Kidney 61 5.1 Recipient eligibility criteria 61 5.2 Waiting list management 63 5.3 Donor assessment 65 5.4 Allocation: Australia 67 5.5 Allocation: New Zealand 71 5.6 Multi-organ transplantation 72 5.7 Emerging Issues 72 6 Liver 75 6.1 Preamble 75 6.2 Recipient eligibility criteria 76 6.3 Waiting list management 80 6.4 Donor assessment 82 6.5 Allocation 85 6.6 Multi organ transplantation 87 6.7 Emerging issues 88 April 2021 version 1.5 iv 7 Lung 90 7.1 Preamble 90 7.2 Recipient eligibility criteria 90 7.3 Waiting list management 92 7.4 Donor assessment 92 7.5 Allocation 93 7.6 Multi-organ transplantation 95 8 Pancreas and Islet 97 8.1 Preamble 97 8.2 Recipient eligibility criteria 97 8.3 Waiting list management 100 8.4 Donor assessment 101 8.5 Allocation 102 9 Intestine 105 9.1 Preamble 105 9.2 Parenteral Nutrition 106 9.3 Intestinal transplantation in Australia 106 9.4 Recipient eligibility 107 9.5 Donor assessment 110 9.6 Allocation 111 9.7 Multi-visceral intestinal allocation versus liver-pancreas allocation 111 10 Vascularised composite allotransplantation 113 10.1 Preamble 113 10.2 Recipient eligibility criteria: hand transplantation 113 10.3 Recipient eligibility criteria: face transplantation 115 10.4 Donor Assessment 116 10.5 Allocation of VCA organs 116 10.6 Multi-organ transplantation 117 10.7 Emerging Issues 117 Part C Special donor groups 119 11 Paediatric donors 120 11.1 Paediatric donor eligibility 120 11.2 Paediatric kidney donation and allocation 120 11.3 Paediatric liver and intestinal donation and allocation 121 11.4 Paediatric lung donation and allocation 121 11.5 Paediatric heart donation and allocation 122 11.6 Paediatric pancreas donation and allocation 122 Appendices 123 Appendix A 124 Appendix B 125 Appendix C 128 Appendix D 131 Appendix E 132 Appendix F 134 Appendix G 135 Appendix H 136 Appendix I 139 April 2021 version 1.5 v Introduction Organ transplantation is a highly effective treatment for advanced organ failure that relies on the donation of organs from living or deceased persons. The focus of this document is on the transplantation of solid organs donated from deceased persons. Currently, the number of patients who might potentially benefit from transplantation is far greater than the number of organs donated. For this reason, organ transplantation is offered primarily to patients who have end-stage organ disease and—with the exception of kidney transplantation—who have exhausted all alternative treatment options. Furthermore, transplantation is offered only to patients who have a reasonable prospect of achieving an acceptably good quality and duration of life after transplantation. Decision-making regarding the allocation and transplantation of donated organs seeks to balance the needs of individual patients against the need to maximise the overall benefit to the community from this scarce and valuable resource. The Transplantation Society of Australia and New Zealand (TSANZ) is the body responsible for developing eligibility criteria for organ transplantation and protocols for the allocation of deceased donor organs to wait-listed patients. Specifically, TSANZ is funded by the Australian Government’s Organ and Tissue Authority to maintain: 1. Current, nationally uniform eligibility criteria to ensure that there are equitable and transparent criteria by which patients are listed for organ transplantation, and 2. Current, nationally uniform allocation protocols to ensure consistency in the criteria by which donated organs are allocated. The TSANZ document Organ Transplantation from Deceased Donors: Consensus Statement on Eligibility Criteria and Allocation Protocols was released in version 1.1 in June 2011, version 1.2 in May 2012, and version 1.3 in January 2014; version 1.4 was released in April 2015. The current document (Clinical Guidelines for Organ Transplantation from Deceased Donors) replaces the previous Consensus Statement, and was developed by the TSANZ Advisory Committees with written feedback sought through a targeted consultation process (see Appendix B). Version 1.0 of the Clinical Guidelines was released in April 2016, with updates released in May 2017 (version 1.1), and December 2018 (version 1.2). The current document, Version 1.3, updates and replaces all prior versions of the Clinical Guidelines. Central to the eligibility criteria and allocation protocols described in this document are the following ethical principles, which are embodied in the National Health and Medical Research Council (NHMRC) publication Ethical Guidelines for Organ Transplantation from Deceased Donors (the Ethical Guidelines):1 1.