introduction to organ donation and transplantation
TRANSCRIPT
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Axel Rahmel
Media workshop
Introduction to organ donation and transplantation
Brussels, 07.10.2013
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What makes organ transplantation special?
Medical
Ethical/Social
Legislation/Organization
High-tech medicine Multidisciplinary cooperation Taking calculated risks …
Definition of death Allocation of scarce resources Culture differences …
Access to transplantation International cooperation Organ trade/Transplant tourism …
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Organ Procurement Organization
Transplant- center
National Competent Authorities
Transplantat Law
Organ donation Allocation Transplantation
Distribution of tasks in organ transplantation
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Padova April 2008 4.
Each day, 10 European citizens die whilst waiting for a suitable organ transplant, that’s almost 4,000 people on a yearly basis*
*3820 deaths on the waiting list in 2009, Council of Europe data 2010
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Tip of the iceberg...
?
?
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Patients newly registered on the waiting list for organ transplantation (per million population) Transplant Newsletter - Council of Europe/ONT 2007
0
20
40
60
80
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>80 pmp
<40 pmp
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How serious is end-stage kidney disease with dialysis treatment? Quality of life
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Prognosis of patients on hemodialysis ERA-EDTA-Registry – Annual report 2008
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Liver cirrhosis – Clinical situation
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MELD score vs. waiting list mortality Expected 3-months mortality and MELD score
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3-m
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ait
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MELD Score
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Patients with end-stage heart failure
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Assist device as destination therapy in inotrope-dependent heart failure INTrEPID-Trial – Novacor-LVAD
Rogers et al, JACC 2007; 50:741-7
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0 1 2 3 4 5 6
Months after Device Implant
% S
urviv
al
Bi-VAD n=30, deaths=9
Event: Death
LVAD n=117, deaths=18
RVAD n=3, deaths=3
p < .0001
TAH n=6, deaths=2
Prognosis with Cardiac Assist Device
Jun 23, 2006 – Mar 30, 2007, n=156
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Patients on the waiting list for lung transplantation
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0 90 180 270 360
0
25
50
75
100
No LTx (n=31)
days since ventilation on HU status
su
rviv
al
(%
)
Prognosis of mechanical ventilated patients awaiting lung transplantation MHH, Germany, 2005 - 2008
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Organ donation
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Declaration of death
“Brain death”
• Death declared on the basis of neurologic criteria
• Irreversible loss of all functions of the entire brain,
including the brain stem
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Brain death – No cerebral perfusion
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Declaration of death
“Brain death”
• Death declared on the basis of neurologic criteria
• Irreversible loss of all functions of the entire brain,
including the brain stem
“Circulatory death”
• Death declared on the basis of cardiopulmonary criteria
• Permanent cessation of circulatory and respiratory
function
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Donation after cardiac/circulatory death (non heartbeating donation) in Europe
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The critical donation pathway Donation after brain death
Severe brain damage
Identify potential donor
Diagnose brain death
Refer potential donor
Approach to family
Maintain viability of
organs
Retrieve organs
Provide feedback
Donor detection
Donor referral
Family care & communication
Donor maintenance
Organ retrieval
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The probability to recieve an organ transplant is about three times higher than
the probability to become an organ donor
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Transplantation
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Organ procurement, transport and transplantation
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Survival benefit after kidney transplantation ERA-EDTA-Registry – Annual report 2008
Transplantation
Survival benefit
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Quality of life after lung transplantation
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Survival benefit after lung transplantation in mechanically ventilated patients MHH, Germany 2005-2008
0 90 180 270 360 0
25
50
75
100
No LTx (n=31)
LTx (n=53)
days since ventilation on HU status
su
rviv
al
(%
)
survival –
benefit
N = 60 %
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Quality of life after heart transplantation
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Organ allocation
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WHO GUIDING PRINCIPLES ON HUMAN CELL, TISSUE AND ORGAN TRANSPLANTATION Guiding 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…
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Heart Waiting List and Transplants Eurotransplant 1995 – 2012
732 759 782 759 702
623 596 580 570 553 542 555 577 557 561 615
577 588
0
300
600
900
1200
1500
Active waiting list Heart transplants
1262
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WHO GUIDING PRINCIPLES ON HUMAN CELL, TISSUE AND ORGAN TRANSPLANTATION Guiding 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.
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Balancing urgency and outcome “Transplant window“-concept
-> Increasing organ failure ->
Mortality
Med. Therapy
Transplantation
benefit
“too early”
“too late”
“Transplantation window”
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Basic principles of 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
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Urgency Outcome
Balancing urgeny and outcome
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Examples of the consequences of allocation trade-offs
Recipient
60 years with
Diabetes
20 years without Diabetes
20 years with
Diabetes
Lifespan without transplant*
4 years 16 years 9 years
Lifespan with transplant*
9 years 22 years 16 years
Incremantal survival
5 years 6 years 7 years
*Median survival for this specific patient group (US data)
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Examples of the consequences of allocation trade-offs
Recipient
60 years with
Diabetes
20 years without Diabetes
20 years with
Diabetes
Lifespan without transplant*
4 years 16 years 9 years
Lifespan with transplant*
9 years 22 years 16 years
Incremantal survival
5 years 6 years 7 years
*Median survival for this specific patient group (US data)
Allocation to the most urgent patient
(maximize waiting list survival)
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Examples of the consequences of allocation trade-offs
Recipient
60 years with
Diabetes
20 years without Diabetes
20 years with
Diabetes
Lifespan without transplant*
4 years 16 years 9 years
Lifespan with transplant*
9 years 22 years 16 years
Incremantal survival
5 years 6 years 7 years
*Median survival for this specific patient group (US data)
Allocation to the patient with best outcome
(maximize post transplant survival)
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Examples of the consequences of allocation trade-offs
Recipient
60 years with
Diabetes
20 years without Diabetes
20 years with
Diabetes
Lifespan without transplant*
4 years 16 years 9 years
Lifespan with transplant*
9 years 22 years 16 years
Incremantal survival
5 years 6 years 7 years
*Median survival for this specific patient group (US data)
Allocation to the patient largest benefit
(maximize incremental survival)
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Queuing: longest waiting first
• Waiting time is easy to understand
• “first come first served” is considered to be a fair way
to do things
Organ Allocation Principles Queuing
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Determination of the Matchlist Selection and Ranking
A
H J
E
I
D
F G
C B
Waiting list Day 1
Donor A 65 yrs, 50kg
X X
X X X X
Matchlist 1 Pat. „C“ is number 2 on the matchlist
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A
H J
E
I
D
F
C B
Waiting list Day 2
K G
D
Determination of the Matchlist Selection and Ranking
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A
H J
E
I
D
F
C B
Waiting list
Donor B 40 yrs, 75kg
K X X
Matchlist 2 Pat. „C“ is number 5 on the matchlist
Determination of the Matchlist Selection and Ranking
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Manipulation of waiting list data in Germany
Manipulation of lab values
• Wrongly labeled blood samples
• Manipulation of blood samples
■ Adding urine to increase creatinine
■ Adding citrate to increase INR
Incorrect information entered into ENIS
• „Patient on dialysis“ although there was no renal replacement
therapy
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Death on the waiting list and delisting due to deterioration Liver-Tx Germany 2010-2012
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Jan Feb Mrt Apr May Jun Jul Aug Sep Oct Nov Dec
Cu
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lati
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um
ber o
f p
ati
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2010
2011
2012
+14%
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Summary
• Organ transplantation gives huge benefit to the patients
both with regard to survival and quality of life
• Main limit to organ transplantation is donor shortage
• Organ donation can be improved by a well organized and
structured approach, learning from best practices is
important
• Transparent organ allocation based on sound medical
and ethical allocation principles is necessary to address
the needs of patients on the waiting list and make best
use of the available donor organs
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