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Axel Rahmel

Axel Rahmel. Organ Donation and Transplantation in the European Union Challenges and opportunities of international cooperation in organ allocation. Technical Assistance for Alignment in Organ Donation 1 st International Symposium Istanbul – May 29-31, 2014. 135. Eurotransplant. 62.9.

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Axel Rahmel

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  1. Axel Rahmel Organ Donation and Transplantation in the European UnionChallenges and opportunities of international cooperation in organ allocation Technical Assistance for Alignment in Organ Donation 1st International Symposium Istanbul – May 29-31, 2014

  2. 135 Eurotransplant 62.9 UKTransplant 61.5 ABM France 56.9 CNT Italy 43.2 ONT Spain Poltransplant 38.2 Scandiatransplant 24.2 21 NTA Romenia 11 Hellas NTO Czech Transplant 10.3 OPT Portugal 10 SwissTransplant 7.2 7.1 Baltransplant European Organ Exchange Organizations(million pop.)

  3. Distribution of tasks in organ transplantation Transplantat Law National Competent Authorities Transplantation Allocation Organ donation Organ Procurement Organization Transplant- center

  4. WHO GUIDING PRINCIPLES ON HUMAN CELL, TISSUE AND ORGAN TRANSPLANTATIONGuiding Principle 9 • Where donation rates do not meet clinical demand, allocation criteria should be defined at national or subregional level by a committee that includes experts in the relevant medical specialties, bioethics and public health…

  5. WHO GUIDING PRINCIPLES ON HUMAN CELL, TISSUE AND ORGAN TRANSPLANTATIONGuiding Principle 9 • The allocation of organs, cells and tissues should be guided by clinical criteria and ethical norms, not financial or other considerations. • Allocation rules, defined by appropriately constituted committees, should be equitable, externally justified, and transparent.

  6. Aims of organ allocation • Finding a suitable donor organ for all patients on the waiting list (including special patient groups) …in time • Optimizing the match between donor and recipient to improve long term outcome of transplantation • Preventing organ loss

  7. Requirements for an organ allocation system • Objectivity • Allocation is independent of subjective factors (procurement and allocation organization, transplant center) • Reliability • With same donor information and same waiting list information an identical matchlist is generated • Transparency and accountability • Every step in the allocation process is documented and can be explained • Validity of allocation criteria • Ethically acceptable, medically based ET office ET AC

  8. Requirements for an organ allocation system • Objectivity • Allocation is independent of subjective factors (procurement and allocation organization, transplant center) • Reliability • With same donor information and same waiting list information an identical matchlist is generated • Transparency and accountability • Every step in the allocation process is documented and can be explained • Validity of allocation criteria • Ethically acceptable, medically based ET office ET AC

  9. The allocationcenter

  10. Match Donor data Recipient data Match

  11. Matchlist  Allocation

  12. Requirements for an organ allocation system • Objectivity • Allocation is independent of subjective factors (procurement and allocation organization, transplant center) • Reliability • With same donor information and same waiting list information an identical matchlist is generated • Transparency and accountability • Every step in the allocation process is documented and can be explained • Validity of allocation criteria • Ethically acceptable, medically based ET office ET AC

  13. Allocation – The key steps • Step 1 - Selection: • Identifying those patients that are suitable at all for a specific organ among all patients on the waiting list. • Step 2 - Ranking: • Determining the allocation sequence among all suitable recipients.

  14. Selection of suitable recipients • Selection criteria • Blood group • Age (specific programs) • Organ specific matching factors • Size, weight, total lung capacity (TLC) • Recipient and center profile • Donor age • Donor risk factors • Virology (Hep B, C (maybe in the future HIV) • History of malignancy • Drug abuse • Sepsis • Meningitis

  15. Selecting: recipientand center profile

  16. Determination ofthe MatchlistSelectionandRanking X B D C X A X E Waiting list Day 1 F G X H X X J I Donor A 65 yrs, 50kg Matchlist 1 Pat. „C“ isnumber2 on thematchlist

  17. Determination ofthe MatchlistSelectionand Ranking B D D C A E Waiting list Day 2 F G H K J I

  18. Determination ofthe MatchlistSelectionand Ranking B D C A E F Waiting list H K X X J I Donor B 40 yrs, 75kg Matchlist 2 Pat. „C“ isnumber5 on thematchlist

  19. Balancing urgency and outcome Urgency Outcome

  20. Examples of the consequences of allocation trade-offs *Median survivalforthisspecific patientgroup (US data)

  21. Examples of the consequences of allocation trade-offs Allocationtothemost urgent patient (maximizewaitinglistsurvival) *Median survivalforthisspecific patientgroup (US data)

  22. Examples of the consequences of allocation trade-offs Allocation to the patient with best outcome (maximize post transplant survival) *Median survivalforthisspecific patientgroup (US data)

  23. Examples of the consequences of allocation trade-offs Allocation to the patient largest benefit (maximize incremental survival) *Median survival for this specific patient group (US data)

  24. The benefitsof international cooperation

  25. Benefits of international cooperation in organ transplantation • Preventing organ loss • Addressing the needs of special patient groups • Improving the outcome of organ transplantation • International harmonization of activitiesin organ donation and transplantation

  26. Benefits of international cooperation in organ transplantation • Preventing organ loss • Addressing the needs of special patient groups • Improving the outcome of organ transplantation • International harmonization of activitiesin organ donation and transplantation

  27. Transplanted organs per donor in countries with less than 15 Mill inhabitantsET vs. countries without multinational collaboration Newsletter transplant, September 2010

  28. Estimating the increase in donor organs with better use of available donor organs • If the use of donor organs in EU countries with a population of < 15 Mill (currently without established international collaboration) would be similar to that of the small ET countries, the number of available donor organs would increase by: • 88 kidneys • 265 livers • 89 hearts • 222 lungs • 68 pancreata • This is a total increase of 732 organs or 2 organs per day without any increase in the number of utilized donors / donation rates pmp

  29. Benefits of international cooperation in organ transplantation • Preventing organ loss • Addressing the needs of special patient groups • Improving the outcome of organ transplantation • International harmonization of activitiesin organ donation and transplantation

  30. International HU (Accepted) Combined Organs National HU National HU National HU National HU Elective Elective Elective Elective Elective General organ allocationsequenceEurotransplant Eurotransplant Other Organ Exchange Organizations

  31. International HU (Accepted) Combined Organs National HU National HU National HU National HU Elective Elective Elective Elective Elective General organ allocationsequenceEurotransplant Eurotransplant Other Organ Exchange Organizations

  32. Waiting time HU Liver-transplantFirst HU Liver-Tx [n=1254] Pediatric (<16 yrs) Adult (16+ yrs) n=201 (16%) n=1053 (84%) Median waiting time: 2 d (both groups)

  33. Highly Immunized - Acceptable Mismatch (AM) – ABO compatible Organ allocation - Kidney ESP/ESDP ABO identical 0 HLA Mismatches (“full house”) ABO identical Pediatric donor (< 16yrs) recipients with status pediatric ABO identical ETKAS Point Score System including HU : ABO Identical A B/L D H HR NL SLO

  34. Highly Immunized - Acceptable Mismatch (AM) – ABO compatible Organ allocation - Kidney ESP/ESDP ABO identical 0 HLA Mismatches (“full house”) ABO identical Pediatric donor (< 16yrs) recipients with status pediatric ABO identical ETKAS Point Score System including HU : ABO Identical A B/L D H HR NL SLO

  35. Procedure AM Program • HLA typing of every potential donor is introduced in ENIS. • Recipient is selected on the basis of compatibility of the donor with the patient’s HLA-A,-B and -DR antigens in combination with acceptable mismatches. • In case of a compatible donor: mandatory shipment of the kidney to recipient center.

  36. Claas et al. Transplantation, 2004

  37. Benefits of international cooperation in organ transplantation • Preventing organ loss • Addressing the needs of special patient groups • Improving the outcome of organ transplantation • International harmonization of activitiesin organ donation and transplantation

  38. Probability of dying on the liver waiting list or removal due to clinical deterioration Elective liver-tx candidates, ET Jan 2002 – Jun 2009

  39. Highly Immunized - Acceptable Mismatch (AM) – ABO compatible Organ allocation - Kidney ESP/ESDP ABO identical 0 HLA Mismatches (“full house”) ABO identical Pediatric donor (< 16yrs) recipients with status pediatric ABO identical ETKAS Point Score System including HU : ABO Identical A B/L D H HR NL SLO

  40. Role of HLA-matching for graft survival after kidney transplantationCTS Newsletter 2004:1 6.2 yrs. difference

  41. HLA-matching in kidney transplantationEurotransplant 2000-2004, non-ESP patients No. of mismatches No. of transplantations Percentage 2176 21,6 % 0 1 832 8,3 % 2 2679 26,6 % 3 3043 30,2% 4 1055 10,5 % 5 244 2,4 % 6 44 0,4% total 10073 100%

  42. Impact ofkidney organ exchangeon selectedpatientgroupsEurotransplant 01.01.2002 -31.12.2006

  43. Impact ofkidney organ exchange on selectedpatientgroupsBelgium, 01.01.2001 - 31.12.2005

  44. The challengesof international cooperation

  45. Challenges of international cooperation in organ transplantation • International harmonization of allocation rules • Logistical challenges including limitation of ischemic time • Balancing of organ exchange

  46. Challenges of international cooperation in organ transplantation • International harmonization of allocation rules • Logistical challenges including limitation of ischemic time • Balancing of organ exchange

  47. Examples of the consequences of allocation trade-offs Allocation to the patient largest benefit (maximize incremental survival) *Median survival for this specific patient group (US data)

  48. ELIAC EThAC ETKAC EPAC ET-Board EC ISWG TTC Allocation development – role of ET National Competent Authorities „Guidelines“ for implementaion ET Council Control „Recommendations“ for approval „Policies“ ET-Office Allocation Allocation-Development OPC FC Support Data collection and -analysis etc.

  49. International HU (Accepted) Combined Organs National HU National HU National HU National HU Elective Elective Elective Elective Elective General organ allocationsequenceEurotransplant Eurotransplant Other Organ Exchange Organizations

  50. Eurotransplant liver allocation policyCountries with central MELD-based allocation as of 16.12.2006 Leiden Patient-oriented, central MELD-based allocation Center-oriented, local allocation

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