Leading Practices for the Allocation of Organs for Combined Transplantation
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Leading Practices for the Allocation of Organs for Combined Transplantation March 22-23, 2012 Toronto, ON Forum Report Leading Practices for the Allocation of Organs for Combined Transplantation March 22-23, 2012 Forum Report Copyright 2014 by Canadian Blood Services All rights reserved. No part of this document may be reproduced without permission in writing from Canadian Blood Services. For reprints, please contact: Canadian Blood Services 1800 Alta Vista Drive Ottawa, Ontario K1G 4J5 Canada 613-739-2300 Email: [email protected] Canadian Blood Services assumes no responsibility or liability for any consequences, losses or injuries, foreseen or unforeseen, whatsoever or howsoever occurring, which might result from the implementation, use or misuse of any information or recommendations in the report, Leading Practices for the Allocation of Organs for Combined Transplantation. This report contains recommendations that must be assessed in the context of a full review of applicable medical, legal and ethical requirements in any individual case. The views expressed herein do not necessarily represent the views of Canadian Blood Services and/or the Government of Canada. Production of this report has been made possible through a financial contribution from Health Canada. Page 2 of 113 Leading Practices for the Allocation of Organs for Combined Transplantation March 22-23, 2012 Forum Report TABLE OF CONTENTS EXECUTIVE SUMMARY............................................................................................................ 4 FORUM STEERING COMMITTEE MEMBERS .......................................................................... 5 THE FORUM PROCESS ........................................................................................................... 6 FORUM CHALLENGE QUESTIONS ......................................................................................... 9 FORUM RECOMMENDATIONS .............................................................................................. 12 A. Eligibility ............................................................................................................................ 13 A1. Investigate the Etiology and Severity of Kidney Dysfunction .............................................. 13 A2. Duration and Level of Dysfunction .................................................................................. 14 A3. Documenting the Degree of Non-reversible Kidney Injury ................................................. 14 A4. Staged Combined Transplants ........................................................................................ 16 A5. Recommendations against Eligibility ............................................................................... 17 A6. Early Eligibility for a Non-Kidney Organ Transplant in the Face of End-Stage Renal Disease ... 18 B. Allocation ............................................................................................................................. 20 B7. Priority Ranking ............................................................................................................ 20 B8. Kidney/Non-Kidney priority allocation ............................................................................ 20 B9. Priority of Simultaneous Combined Transplant in the Non-Kidney Priority Allocation System 21 B10. Kidney Availability for Simultaneous Combined Transplants .............................................. 22 B11. High Status Inter-Provincial Kidney Sharing ..................................................................... 22 B12. Inter-Provincial Organ Sharing ....................................................................................... 23 B13. Priority for Kidney after Non-Renal Transplant ................................................................. 23 B14. Priority for Kidney in Staged Combined Transplant ........................................................... 24 B 15. Priority for Kidney after Post-Operative Irreversible Renal Failure ...................................... 25 B16. Priority for Prior Non-Kidney Transplant Recipients .......................................................... 25 APPENDICES .......................................................................................................................... 28 APPENDIX A: LITERATURE REVIEW ..................................................................................... 29 APPENDIX B: US DATA REVIEW ........................................................................................... 53 APPENDIX C: PARTICIPANT BIOGRAPHIES ......................................................................... 99 Page 3 of 113 Leading Practices for the Allocation of Organs for Combined Transplantation March 22-23, 2012 Forum Report EXECUTIVE SUMMARY In Canada in 2011, more than 4500 patients were awaiting an organ transplant. As organs are a scarce resource, there must be processes in place to ensure equitable and transparent allocation. Currently, there are inequities and inconsistent practices with regard to allocation, as well as, unequal access to services in various regions. As such, policies must be developed which are supported as much as possible by evidence-based information. From this basis, consensus-built recommendations can be developed that will subsequently inform the development of registries and a national system design. In addition the demand for transplantable organs is complicated by the additional needs of some patients who require more than one organ transplant such as those with end-stage heart, lung or liver disease who experience advanced chronic kidney disease. In some of these cases there is no clear consensus about the best strategy regarding the indication of heart, lung or liver transplant alone, or combined (either simultaneous or staged) heart, lung or liver and kidney transplant In collaboration with the Canadian Society of Transplantation, the Canadian Blood Services conducted a consensus forum in order to evaluate the current evidence and practise, and to make recommendations on listing and allocation for combined transplant candidates, where they are not currently part of organ- specific allocation models. The purpose of this initiative was to develop eligibility (including listing) criteria and a decision-making model which could be applied to the allocation of organs for combined transplants that is acceptable, useful and adaptable within unique regions across the country. The consensus forum was the first step of a consultative process which is intended to aid programs with their task standardizing policies for combined transplant and interprovincial sharing. In in this report, the term “combined transplants” is defined as kidney/non-kidney combined transplant pairs and excluding kidney/pancreas as well as all other pairs. Forum Objectives: 1. To understand, review and communicate current practice with regard to the needs of communities for organ allocation for combined transplants and the impact of combined transplants on single organ wait lists. 2. To develop Canadian eligibility criteria for combined transplants. 3. To develop leading practice recommendations that will support the integration of algorithms for eligibility (including listing) for combined and single organ allocation. 4. To initiate a discussion between the Canadian Blood Services and Canadian Society of Transplantation on balancing and the evidence these two groups require in order to collaborate on the development of recommendations for interprovincial sharing. 5. To initiate a discussion with stakeholders in order to facilitate data gathering in support of on-going policy development. 6. To enhance transparency for the organ donation and transplantation system and to thereby contribute to the public confidence of Canadians. Page 4 of 113 Leading Practices for the Allocation of Organs for Combined Transplantation March 22-23, 2012 Forum Report FORUM STEERING COMMITTEE MEMBERS Dr. Tom D. Blydt-Hansen (Co-chair) Dr. Dale Lien Associate Professor, Pediatrics, Director, Lung Transplant Program and, University of British Columbia Co-director, Pulmonary Hypertension Program, Director, Multi Organ Transplant Program University of Alberta Hospital Edmonton, BC Children’s Hospital Alberta, Canada Vancouver, British Columbia, Canada Dr. Jeffrey Schiff Dr. Marcelo Cantarovich (Co-chair) Medical Director, Kidney/Pancreas Program, Professor of Medicine McGill University, and Associate Director of the Multi-Organ Transplant Toronto General Hospital, Program University Health Network Royal Victoria Hospital, Toronto, Ontario, Canada McGill University Health Centre Montréal, Québec, Canada Dr. Debra Isaac Medical Director, Dr. Peter Nickerson (Co-chair) Heart Transplant Program, Executive Medical Director - Transplantation Foothills Medical Centre, Canadian Blood Services, Alberta Health Services, Winnipeg, Manitoba, Canada Calgary, Alberta, Canada Dr. Ian Alwayn Dr. Anne Dipchand Director, Kidney Transplant Program and, Section Head, Heart Transplant Program, Surgical Lead-Multi-Organ Transplant Program, Hospital for Sick Kids, Queen Elisabeth II Health Sciences Centre Toronto, Ontario, Canada. Halifax, Nova Scotia, Canada Dr. Vince Bain Mr. Sean Delaney Medical Director, Liver Transplant Program, Director, Organ Registries, University of Alberta Hospital, Canadian Blood Services, Edmonton, Alberta, Canada Edmonton, Alberta, Canada Ms. Dorothy Strachan Dr. John Gill Process Consultant, Nephrologist, Strachan-Tomlinson Inc., St. Paul’s