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 1st International SymposiumIstanbul – May 29-31, 2014

European Organ Exchange Organizations(million pop.)

7.17.21010.311

2124.2

38.243.2

56.961.562.9

Baltransplant

SwissTransplant

OPT Portugal

Czech Transplant

Hellas NTO

NTA Romenia

Scandiatransplant

Poltransplant

ONT Spain

CNT Italy

ABM France

UKTransplant

Eurotransplant

Organ Procurement

OrganizationTransplant-

center

National Competent Authorities

Transplantat Law

Organ donation Allocation Transplantatio

Distribution of tasks in organ transplantation

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…

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.

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

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

The allocation center

Donor data Recipient data

Matchlist Allocation

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.

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

Selecting: recipient and center profile

Determination of the MatchlistSelection and Ranking

DF GCB

Waiting listDay 1

Donor A65 yrs, 50kg

X XX X

Matchlist 1Pat. „C“ is number 2 on the matchlist

Waiting listDay 2 KG

Waiting list

Donor B40 yrs, 75kg

Matchlist 2Pat. „C“ is number 5 on the matchlist

Urgency Outcome

Balancing urgency and outcome

Examples of the consequences of allocation trade-offs

Recipient60 years

with Diabetes

20 years withoutDiabetes

20 years with

DiabetesLifespanwithout transplant*

4 years 16 years 9 years

Lifespanwith transplant* 9 years 22 years 16 years

Incremantal survival 5 years 6 years 7 years

*Median survival for this specific patient group (US data)

Recipient60 years

with Diabetes

20 years with

Allocation to the most urgent patient(maximize waiting list survival)

Recipient60 years

with Diabetes

20 years with

Allocation to the patient with best outcome(maximize post transplant survival)

Recipient60 years

with Diabetes

20 years with

Allocation to the patient largest benefit (maximize incremental survival)

The benefits of international cooperation

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 activities

in organ donation and transplantation

Transplanted organs per donor in countries with less than 15 Mill inhabitantsET vs. countries without multinational collaboration

ET countries < 15 Mill population

EU countries < 15 Mill populationnot multinational

Deceased donors 813 (19,3 pmp) 1061 (15,6 pmp)Multi-organ donors 78,7% 57,3%Tx kidney p.d. 1,74 1,67Tx liver p.d. 0,76 0,51Tx heart p.d. 0,27 0,20Tx lung p.d. 0,28 0,07Tx pancreas p.d. 0,13 0,07

Newsletter transplant, September 2010

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

• Preventing organ loss• Addressing the needs of special

patient groups• Improving the outcome of organ

General organ allocation sequenceEurotransplant

International HU(Accepted) Combined Organs

Elective

Other Organ Exchange Organizations

National HU National HU National HU National HU

Elective

n=201 (16%) n=1053 (84%)

Waiting time HU Liver-transplantFirst HU Liver-Tx [n=1254]

Pediatric (<16 yrs) Adult (16+ yrs)

Median waiting time: 2 d (both groups)

0-2 d 3-4 d

5-8 d 9-16 d

0-2 d 3-4 d 5-8 d

9-16 d 16+ d

Organ allocation - KidneyHighly Immunized -

Acceptable Mismatch (AM) – ABO compatible

ETKAS Point Score System including HU : ABO Identical

A D HB/L

Pediatric donor (< 16yrs) recipients with status pediatricABO identical

NL SLO

0 HLA Mismatches (“full house”)

ESP/ESDP ABO identical

ABO identical

A D HB/L

NL SLO

ABO identical

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.

Claas et al. Transplantation, 2004

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

0 1 2 3 4 5 6 7 8 9 10 11 120

20Pts registered Jan 2002 - Jun 2005 (PreMELD) [N=6367]

Pts registered Jan 2007 -Dec 2007 (First year MELD)[N=1991]

Pts on WL 15.12.06 [N=1990]

Months after registration

A D HB/L

NL SLO

ABO identical

Role of HLA-matching for graft survival after kidney transplantationCTS Newsletter 2004:1

6.2 yrs.difference

100%10073total0,4%4462,4 %2445

10,5 %1055430,2%3043326,6 %26792

832121760

PercentageNo. of transplantations

No. of mismatches

21,6 %8,3 %

HLA-matching in kidney transplantationEurotransplant 2000-2004, non-ESP patients

Impact of kidney organ exchange on selected patient groupsEurotransplant 01.01.2002 -31.12.2006

Outside ET 0 1 0 0 44Other ET country 121 1022 141 87 1422Recipient country 60 1420 336 271 9106

Highly immunized

000- HLA MM Paediatric High

Urgency Other

Impact of kidney organ exchange on selected patient groupsBelgium, 01.01.2001 - 31.12.2005

outside ET 0 1 0 0 5other ET country 11 129 5 37 418own country 3 64 3 22 1176

Highly Immunized

000- HLA MM

High Urgency Children other

The challengesof international cooperation

Challenges of international cooperation in organ transplantation

• International harmonization of allocation rules

• Logistical challenges including limitation of ischemic time

• Balancing of organ exchange

Recipient60 years

with Diabetes

20 years with

Allocation to the patient largest benefit (maximize incremental survival)

National Competent Authorities

Allocation development – role of ET

ET-BoardEC ISWG

ELIAC EThAC

FC TTC

ET Council

ET-Office

„Recommendations“

for approval

„Guid

for im

plemen

„Policies“

SupportData collection and -analysis etc.

Allocation Allocation-Development

Elective

Leiden

Eurotransplant liver allocation policyCountries with central MELD-based allocation as of 16.12.2006

Patient-oriented, centralMELD-basedallocation

Center-oriented, local allocation

Local/regionalNationalInternationalNon-ET donor

Ischemic time kidney transplantationLocal/regional vs. national vs. international allocation

12,4 h

15,8 h18,1 h

19,5 h

Ischemic time kidney transplantationLocal/regional vs national vs international allocationGermany

12,4 h

15,8 h18,1 h

19,5 h

Ischemic time kidney transplantation Local/regional vs national vs international allocation

Austria

Belgium

German

Netherl

Sloven

Organ donation – Eurotransplant 2012

ET A B D HR H NL L SLO0

13.215.1

3,2% +0

The concept of self-sufficency and organ balancing • Self-sufficiency in organ transplantation means

the adequate provision of transplantation services and supply of human organs from within a given population, to satisfy the organ transplantation needs of that population

• In practice, populations pursuing self-sufficiency are likely to correspond to the citizens or residents of nation states.

• In the context of multinational organ exchange organizations like Eurotransplant the concept of self-sufficiency therefore typically includes a balancing system between countries

International organ exchange and balancing within EurotransplantBasic principles

Prevent cross-border organ exchange when medically not indicated by giving preference to national (regional/local) allocation

■ Kidney: distance points■ Non-renal organs: National allocation except for

international mandatory exchange and prevention of organ loss

Ethical basis: short ischemic time leads to better transplant outcome

Origin of transplanted donor organs Eurotransplant 01.01.2001 – 31.12.2005

Own countryOther ET countryOutside ET/ other EOEO

International organ exchange Basic principles of balancing

• International organ exchange imbalances (in spite of the preferentially national allocation system) are addressed by organ specific balancing systems

• Different mechanisms for balancing• Aim of the mechanisms used is a

“reasonable balance” between “import” and “export” of donor organs per country

Summary

• An organ allocation system should be transparent, objective and reliable

• The allocation rules should have a solid ethical foundation and should be based on evidence-based medical criteria

• Continuous monitoring of the allocation rules and their impact is essential

• International cooperation helps addressing the needs of special patient groups and is in line with the self-sufficiency principle

• Without access to the waiting list the best allocation cannot help

Axel Rahmel

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