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Journalist Workshop on organ donation & transplantation
Introduction to organ donation
and transplantation
Axel Rahmel, Frankfurt/Main
Organized by the European Commission, Directorate General for Health and Food Safety; 26 November 2014 – Brussels
Task distribution in organ transplantation The German example
Donor hospital Transplant center
German Medical Association Guidelines organ donation, allocation and transplantation
Transplant law
Organ donation
Allocation Transplantation
Parliament
Coordination:
2
Patients newly registered on the waiting list for organ
transplantation (per million population)
0
20
40
60
80
100
>80 pmp
<40 pmp
Transplant Newsletter - Council of Europe/ONT 2007
Prognosis of patients on hemodialysis ERA-EDTA-Registry – Annual report 2008
3
MELD score vs. waiting list mortality Expected 3-months mortality and MELD score
0
10
20
30
40
50
60
70
80
90
100
0 5 10 15 20 25 30 35 40
3-m
on
ths
mo
rta
lity
on
th
e w
ait
ing
lis
t
MELD Score
Assist device as destination therapy in inotrope-
dependent heart failure (INTrEPID-Trial – Novacor-LVAD)
Rogers et al, JACC 2007; 50:741-7
4
0
10
20
30
40
50
60
70
80
90
100
0 1 2 3 4 5 6
Months after Device Implant
% S
urv
iva
l 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
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
5
Organ donation
Donor identification Donor
maintenance
Determination of
(brain) death Family
approach
Organization of
procurement Organ
recovery
The organ donation process
Transplantation
Data transfer
& allocation Donor
diagnostics
Transport
Last
farewell
Follow-up
donor hospital
Thank you
letter
Family support
SAE/R
6
Donor identification Donor
maintenance
Determination of
(brain) death Family
approach
Organization of
procurement Organ
recovery
The organ donation process
Transplantation
Data transfer
& allocation Donor
diagnostics
Transport
Last
farewell
Follow-up
donor hospital
Thank you
letter
Family support
SAE/R
ELIGIBLE DCD DONOR
A medically suitable person who has been
declared dead based on the irreversible
absence of circulatory and respiratory functions
as stipulated by the law of the relevant
jurisdiction, within a time frame that enables
organ recovery.
POTENTIAL DBD DONOR A person whose clinical condition is
suspected to fulfill brain death criteria.
ELIGIBLE DBD DONOR
A medically suitable person who has been
declared dead based on neurologic criteria as
stipulated by the law of the relevant jurisdiction.
Critical pathways for organ donation from ventilated patients
POSSIBLE DECEASED ORGAN DONOR* Mechanically ventilated patient with a devastating brain injury or lesion, apparently medically suitable for organ donation
NOTE: The “dead donor rule” must be respected. That is, patients may only become donors after death, and the recovery of organs must not cause a donor’s death.
UTILIZED DCD DONOR
An actual donor from whom at least one organ
was transplanted.
Reasons why a potential donor
does not become a utilized donor
System
• Failure to identify/refer a potential or eligible donor
• Brain death diagnosis could not be confirmed
(e.g does not fulfill criteria) or completed
(e.g., lack of technical resources or clinician
to make diagnosis or perform confirmatory tests)
• Circulatory death not declared within the appropriate
time frame.
• Logistical problems (e.g. no recovery team)
• Lack of appropriate recipient (e.g. child, blood type,
serology positive)
Donor/Organ
• Medical unsuitability (e.g. serology positive, neoplasia)
• Haemodynamic instability / unanticipated cardiac
arrest
• Anatomical, histological and/or functional
abnormalities of organs
• Organs damaged during recovery
• Inadequate perfusion of organs or thrombosis
Permission
• Expression intent of deceased not to be donor
• Relative’s refusal of permission for organ donation
• Refusal by coroner or other judicial officer to allow
donation for forensic reasons
POTENTIAL DCD DONOR
A person in whom the cessation of circulatory
and respiratory functions is anticipated to occur
within a time frame that will enable organ
recovery.
Donation after Circulatory Death (DCD) Donation after BrainDeath (DBD) Treating physician
to identify/refer a potential donor
ACTUAL DBD DONOR
A consented eligible donor:
A. In whom an operative incision was made
with the intent of organ recovery for the
purpose of transplantation.
and/or
B. From whom at least one organ was
recovered for the purpose of
transplantation.
UTILIZED DBD DONOR
An actual donor from whom at least one
organ was transplanted.
ACTUAL DCD DONOR
A consented eligible donor:
A. In whom an operative incision was made
with the intent of organ recovery for the
purpose of transplantation.
and/or
B. From whom at least one organ was
recovered for the purpose of
transplantation.
Organ donation may occur in medically defined circumstances other than patients with anticipated circulatory death or devastating brain injury.
7
Causes of Death of Organ Donors
Killed in road traffic
130
78
56
0
20
40
60
80
100
120
140
Verkehrstote/pmp 2008
USA
Spanien
Deutschland
2010: 3657 Verkehrstote
8
Reduced mortality after stroke
9
National indicators that could be relevant to a well-
established deceased donation program– ACCORD 2014
• Legal definition for brain death
• Legal definition for cardio-respiratory (circulatory) death
• Professional guidance/standards/codes of practice for the diagnosis of brain death
• Professional guidance/standards/codes of practice that support clinicians who are treating potential organ donors
• National independent ethical codes of practice or guidance that support organ
• Relevant guidance on the withdrawal or limitation of life sustaining treatment in critically ill patients
• National criteria to alert the Donor Transplant Coordinator to a potential organ donor
• Guidance or best practice documents for the process of obtaining consent for organ donation from families
• Formal training provided for healthcare professionals in the organ donation process
• National organization responsible for organ donation
• Regulatory body that has oversight of organ donation
Donor rate by number of
positive national indicators for organ donation
Spearman’s Rank correlation coefficient, r=0.2
10
11
Care of the patient
Donor identification Donor
maintenance
Determination of
(brain) death Family
approach
Organization of
procurement Organ
recovery
The organ donation process
Transplantation
Data transfer
& allocation Donor
diagnostics
Transport
Last
farewell
Follow-up
donor hospital
Thank you
letter
Family support
SAE/R
12
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
Brain death protocol
• According to the guidelines of the
federal medical counsil
• 2 qualified doctors not involved in
transplantation have to confirm
independently brain death
13
Brain death – No cerebral perfusion
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
14
Donation after cardiac/circulatory death
(non heartbeating donation) in Europe
Donor identification Donor
maintenance
Determination of
(brain) death Family
approach
Organization of
procurement Organ
recovery
The organ donation process
Transplantation
Data transfer
& allocation Donor
diagnostics
Transport
Last
farewell
Follow-up
donor hospital
Thank you
letter
Family support
SAE/R
15
Approaching the family
At a sensitive and appropriate
time, a member of the
medical team together with
the transplant coordinator
meets with the family.
After offering condolences,
the conversation begins with
whether their loved one has
made the decision to donate.
Next of kin
16
Written wish to donate
17
18
Donor identification Donor
maintenance
Determination of
(brain) death Family
approach
Organization of
procurement Organ
recovery
The organ donation process
Transplantation
Data transfer
& allocation Donor
diagnostics
Transport
Last
farewell
Follow-up
donor hospital
Thank you
letter
Family support
SAE/R
Standardized medical history
19
www.edqm.eu
Donor and organ characterization
Laboratory tests
Microbiology
(Non-)invasive tests
HLA + CM
Pathology
Inspection
Rep
ort
to
ET
Pack
ing
Transport
Rec
ove
ry
Pre
par
atio
n
Machine perfusion (with conditioning)
Allocation Post-op treatment
Inspection
Microbiology Microbiology Microbiology
Pathology Pathology Pathology
CM / (HLA)
Donor hospital Transplant center
Prior to recovery During recovery Prior to/during transplantation
After transplantation
20
Donor identification Donor
maintenance
Determination of
(brain) death Family
approach
Organization of
procurement Organ
recovery
The organ donation process
Transplantation
Data transfer
& allocation Donor
diagnostics
Transport
Last
farewell
Follow-up
donor hospital
Thank you
letter
Family support
SAE/R
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 o
ffic
e
ET A
C
21
Donor identification Donor
maintenance
Determination of
(brain) death Family
approach
Organization of
procurement Organ
recovery
The organ donation process
Transplantation
Data transfer
& allocation Donor
diagnostics
Transport
Last
farewell
Follow-up
donor hospital
Thank you
letter
Family support
SAE/R
North
North Rhine-
Westphalia
Baden-
Wuerttemberg Bavaria
Middle
East
Hamburg
Gießen
Homburg
Berlin Hannover
Mainz
München (2)
Transplant center (Heart/Lung)
North-East
24 Recovery teams
(Thoracic organs)
30 Recovery teams
(Abdominal organs) Göttingen
Kiel
Dresden
Jena
Erlangen/
Würzburg
Regensburg
Sub-regional recovery
(Liver/Pancreas/Kidney)
Organization of organ recovery
Oeynhausen
Münster
Leipzig Köln
Aachen
Frankfurt
Heidelberg
Freiburg
Stuttgart
Rostock
Düsseldorf
Essen
Regional DSO base
22
Donor identification Donor
maintenance
Determination of
(brain) death Family
approach
Organization of
procurement Organ
recovery
The organ donation process
Transplantation
Data transfer
& allocation Donor
diagnostics
Transport
Last
farewell
Follow-up
donor hospital
Thank you
letter
Family support
SAE/R
Core Tasks of an organ procurement organization
Responsibilities towards the donor
(an his family)
• Respect and follow the wish of the donor
In case of an organ donor:
• Realize the wish to help patients in need beyond his own
death
• Careful handling of this ultimate gift
• Respect the dignity of the donor at all times
• Support the family during donation and beyond
23
Core Tasks of an organ procurement organization
Careful organ and donor characterization to
• Make selection of the best recipient possible
• Allow decision about acceptance of donor organ possible (by recipient / transplant center)
Preserve (improve) organ quality
• Careful treatment of donor and donor organs
• Care of the donor in intensive care after determination of death
• Procurement, preservation, packing and transport of the organ(s)
Responsibilities towards the recipient
Survival benefit after kidney transplantation ERA-EDTA-Registry – Annual report 2008
Transplantation
Survival benefit
24
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 %
www.dso.de
Thank you for your
attention
Ent-
nahme-
teams
Organ donation
A common task Eurotransplant
Deutsche Stiftung
Organtransplantation
Bundesärztekammer
Deutsche
Krankenhausgesellschaft
Spitzenverband
der Krankenkassen
TxB
Entnahme
Kranken-
häuser
Trans-
plantations-
Zentren
