Donor detection, Identification & Evaluation.pdf

DONOR DETECTION,
IDENTIFICATION & CLINICAL
EVALUATION
Chloë Ballesté Delpierre, MD, MSc, TPM
Associate professor, Surgery Dept. , University of Barcelona
Director International Development, DTI Foundation
Researcher Hospital Clinic of Barcelona
ESOT Councilor

Actividad global de trasplante de órganos sólidos 2020

GLOBAL POPULATION 2019
7.6 billion population
59 millions deaths/year
39.357 cadaveric donors/year
 Controlled DCD 10% : 3.935,7
 Uncontrolled DCD 1% 393,5
0.067% donors/deaths
164, 840 transplants
“We need 1M donors”
SELF-SUFFICIENCY→ 0,5%
donors/deaths

Country
Num of deaths /
Year
Deceased Donors per
Year
% Donors/death
/year
India 9.680.481 715 0,007
Japan 1.280.176 125 0,010
Bulgaria 101.717 26 0,026
Romania 255.635 85 0,033
UAE 19.984 10 0,050
China 11.430.931 5818 0,051
HK –China 57.274 29 0.051
Russia 1.417.222 740 0,052
Cyprus 8.867 6 0,068
Germany 969.932 932 0,096
Saudi Arabia 116.190 126 0,108
Turkey 500.307 619 0,124
Poland 405.793 504 0,124
South Korea 352.479 450 0,128
Hungary 126.057 180 0,143
Chile 118.214 188 0,159
Denmark 55.759 102 0,183
Belarus 124.161 248 0,200
Sweden 95.903 194 0,202
Slovenia 21.658 44 0,203
Country
Num of deaths /
Year
Deceased Donors
per Year
% Donors/death
/year
Israel 45.980 99 0,215
Slovakia 54.950 119 0,217
Switzerland 71.434 157 0,220
Uruguay 31.505 75 0,238
Italy 667.708 1495 0,224
Iran 450.094 1078 0,240
Ireland 35.201 85 0,241
Austria 86.823 211 0,243
Finland 57.388 145 0,253
Brazil 1.460.840 3768 0,258
Norway 44.286 115 0,260
Argentina 336.545 883 0,262
Croatia 54.115 142 0,262
UK 624.731 1.653 0,265
Belgium 114.863 347 0,302
Portugal 111.269 352 0,316
Australia 175.718 548 0,312
USA 2.760.905 11.870 0,430
Spain 465.147 2.301 0,495
<0.1 >0.1 >0.2 >0.3 >0.4
(*) Data 2018
Self sufficiency 0,5% donors/deaths per year
Deceased Donation 2019

Donación de órganos 2019 & Autosuficiencia
12,70%
38,40% 38,65%
87,54%
30,66%
93,68%
28,30%
12,16%
25,57%
23,46%
23,15%
59,00%
49,44%
35,78%
12,46%
22,72%
6,32%
0,00%
20,00%
40,00%
60,00%
80,00%
100,00%
120,00%
Spain USA UK Turkey China India
Living donation DCD-Donation after Circulatory Death DBCD DBD-Donation after Brain Death

DONACIÓN DE ÓRGANOS MUNDIAL 2022
38,03
37,97
24,83
24,61
24,15
23,9
23,3
23,15
22,91
22,25
21,6
21,38
21,3
21,2
19,31
19,2
18,89
18,68
18
17,92
17,5
17
15,8
14,91
13,33
13,33
12,82
12,8
11,44
11,05
11
10,25
9,82
9,22
9,2
7,8
7,38
5,85
5,59
5,29
5
5
4,8
4,51
4,4
4,4
3,92
3,6
3,5
3,45
3,16
1,95
1,65
1,43
1,37
0,95
0,91
0,9
0,85
0,75
0,7
0,61
0,57
0,5
0,5
0,4
0,25
0,25
0,1
0,05
0
5
10
15
20
25
30
35
40
Total Utilized Donors: BRAZIL, CANADA

5
5
0
6
8
7
7
7
8
8
3
2
8
6
9
9
6
0
1
0
3
7
1
0
3
2
1
1
5
5
1
2
5
0
1
3
3
4
1
3
4
5
1
3
3
5
1
4
0
9
1
4
4
3
1
4
9
5
1
5
4
6
1
5
0
9
1
5
5
0
1
5
7
7
1
6
0
6
1
5
0
2
1
6
6
7
1
6
4
3
1
6
5
5
1
6
8
2
1
8
5
1
2
0
1
9
2
1
8
3
2
2
4
1
2
3
0
2
1
7
7
7
1
9
0
4
14,3
17,8
20,2
21,7
22,6
25,0
27,0 26,8
29,0
31,5
33,6 33,9
32,5
33,7 33,8
34,6 35,1
33,8 34,3 34,2 34,4
32,0
35,3 34,8 35,1
36,0
39,7
43,4
46,9
48,0
49
37,4
40,2
0
5
10
15
20
25
30
35
40
45
50
0
500
1000
1500
2000
2500
1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
Absolute number Rate pmp
DONACIÓN CADAVÉRICA EN ESPAÑA
Source: Organización Nacional de Trasplantes

34,1
45,2
53,1
58,6 60,2
67,4
74,0 72,6
78,3
85,7
87,7 86,5
83,7
86,2 86,3 85,3 86,9
84,1 84,7 85,5 86,2
80,2
89,5 89,1 90,8
93,4
102,3 103,6
113,0 113,9
115,9
93,3
100,9
0
20
40
60
80
100
120
0
1000
2000
3000
4000
5000
6000
1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
pmp
Absolute
number
Tx Renal Tx Hepático Tx Cardiaco Tx Pulmonar Tx Pancreático Tx Intestinal Tx Total pmp
Dossier de prensa 2020
Donantes de órganos en España desde el inicio de la O.N.T.
TRASPLANTE DE ÓRGANOS SÓLIDOS EN ESPAÑA
Source: Organización Nacional de Trasplantes
4, 781
101
p.m.p.
1, 315

Keys to
success
Professionalization
of the activity
Continuing
professional
training
Cultural
change in
the hospital
Quality plan
Institution
support
Favorable
legal
framework
Inter-
hospital
network
ONT
Information
management
Donor
source
expansion

CORPORATE SOCIAL RESPONSIBILITY
Hospital Vision
Health
Professionals
Mision
Hospital
Vision
Prevention
Treatment
Education
Deceased Donation
Death referrals for
Organ & Tissues
Donation

Donor
Detection
Donor
Evaluation
Death
Diagnosis
Obtaining
Consent
Organ
Allocation
Retrieval
Transplanta
tion
Inside the
ICU
Outside
the ICU
Organ
viability
Evaluate
the donor
Legal
authorization
Family
Approach
Maintenance
Outside
the
Hospital
Clinical Donation Process

TRY TO IDENTIFY ALL POSSIBLE DONORS
The biggest problem of donation is that in many cases doctors
don’t notify potential donors to the TPM (Key donation person)

WHAT
WHO
WHERE
WHO
WHEN
HOW
DONOR
DETECTION
should I detect?
can become a donor?
are my donors?
Is responsible?
should I proceed?
to proceed?
DONOR
TPM

CARDIAC DEATH
DONORS (DCD)
DECEASED DONORS
LIVING
DONORS
BRAIN DEATH
DONORS (DBD)
WHAT DONORS?

• Demographic factors
• Hospital Accessibility
• Cultural factors
• Organizational
• Neurosurgical Unit
• Bed/ICU availability
• Donation awareness
• Admission criteria
• Clinical practice
• Donation awareness
WHO BECOMES A DONOR?

Brain death
GCS<8
HEAD TRAUMA
ANOXIC
ENCEPHALOPATY
BRAIN TUMOUR
HEMORRHAGIC
STROKE
ISCHEMIC STROKE

Do you know how many donors
could you have in your hospital ?

POTENTIAL FOR DONATION
KNOW YOUR HOSPITAL
3 – 5% OF ALL HOSPITAL DEATHS PROGRESS TO BD
10 – 15% OF ALL ICU DEATHS PROGRESS TO BD
50-75% OF ALL BD BECOMES A DONOR
Donor
Detection
Donor
Evaluation
Death
Diagnosis
Obtaining
Consent
Organ
Allocation
Retrieval
Transplan
tation
Mantainance

50.0
1.37
9.1
Hospitals w/o
neurosurgery
54.6
% ACTUAL
DONORS/ BD
2.4
12.6
All Hospitals
% BD / ICU
deaths
% BD/ Hospital
deaths
55.5
2.9
13.7
Hospitals with
neurosurgery
KNOW YOUR HOSPITAL
ONT “QUALITY PROGRAM 1999-2012”
POTENTIAL FOR DONATION

I`m too busy
Don´t know
who to call?
The patient
can`t be a
donor
Not sure if he
is brain dead
or not
Dont need to
call anybody.
I dont agree
with donation
The treating doctor (ICU)
should refer all possible donors to the TPM
BUT
WHO IS RESPONSIBLE?

LACK OF DETECTION
WHO IS RESPONSIBLE?

Person
• Responsible for detection and follow-up of possible donors
• Member of transplant coordination team
• Methods to permanently locate him
Protocols
• For detection and identification of possible donors
• Adapted to the particularities of the hospital
Collaboration and information
• Of all personal involved in the process
• On regular bases
WHO IS RESPONSIBLE?
Transplant Procurement Manager

When to proceed?
TOO EARLY TOO LATE
‘TPM DONOR RULE’
To allow as many as possible deceased
patients and their families to meet their
wish to donate their organs after death
‘DEAD DONOR RULE’
Patients may only become donors
after death, and the recovery of
organs must not cause a donor’s death

A person with a
devastating brain
injury or lesion and
apparently
medically suitable
for organ donation
Possible
donor
A person whose
clinical condition is
suspected to fulfil
brain death criteria
Potential
donor
A medically suitable
person who has been
declared dead based
on neurologic criteria
as stipulated by the
law of the relevant
jurisdiction
Eligible donor
A consented eligible
donor in whom an
operative incision was
made with the intent
of organ
recovery………
Actual
donor
Brain
Death
diagnosis
GCS < 5
WHEN TO PROCEED?
F O L L O W U P
D O N O R E V A L U A T I O N
D O N O R M A N A G E M E N T
CONSENT TX TEAM
COORDINATION

TRANSPL INT. 2011
APR;24(4):373-8

33
How to proceed?
ACTIVE
DETECTION
PASIVE
DETECTION

ACTIVE
DETECTION
HOW TO PROCEED?
REVIEW ADMISSION LIST DAILY AND
IDENTIFY BRAIN INJURED PATIENTS
….. MAKE SURE DONATION IS CONSIDERED
WHEN BRAIN DEATH OCCURS
IDENTIFY YOURSELF AND YOUR TASK
ORGANIZE TRAINING SESSIONS
DAILY VISIT TO ICU/EMERGENCY….
DISCUSS POSSIBLE/POTENTIAL DONORS

HOW TO PROCEED?
PASIVE
DETECTION
WAIT TO BE CALLED BY THE
ATTENDING DOCTOR……
❑ ONLY DO EVALUATION
❑ MAY BE INCORRECT DETECTION

THE SPANISH MODEL
No
detection,
1,1%
Medical
contraindication,
25%
Coroner
refusals, 1,4%
Family
refusals,
1,2%
Management
problems, 2,8%
Organizational
problems ,
0,5%
No adequate
recipient, 0,7%

ICUs staff…
Transplant
Procurement
Management (TPM)
Good relationships
Who is responsible?
The most effective tool is:
Refer to the TPM all
patients with brain
death suspicion Explain them your purpose
Teach
Visit
…

DONOR CLINICAL EVALUATION: GENERAL
ASSESSMENT
Establish donor suitability
Ensure that each organ and / or tissue obtained
is of acceptable quality and does not pose an
unacceptable risk to the recipient
Acceptance criteria established in accordance
with accepted and agreed medical standards

• To Know the cause of death (CT Scan)
• Avoid disease transmission to the immuno-
suppressed recipient
• Assess the degree of oxygenation and tissue
perfusion of each organ
Key Points:

TPM Transplant Teams
The person who knows better the Donor
The person who knows better the Recipient
&
Who takes the Decission?

DONOR
CLINICAL
EVALUATION
- Age and Origin
- Cause of Death
- Pathological history and risk behavior
- Previous treatments
- Complete physical exam
- Current Medical History
- Complementary exams (analytical, microbiological,
morphological and functional tests, etc.)
-Evaluation during Recovery
-Post-mortem or autopsy exams

SOCIAL & MEDICAL HISTORY REVIEW
Cause of Death: Exclude absolute
contraindications
(Identify Infectious & Neoplasic Diseases).

Hypertension
Diabetes Mellitus
Hyperlipidemia
Obesity
Alcoholism
Smoking or other Drug abuse

Transmissible pre-existent diseases:
Neoplasms
Hematologic diseases
Infectious Diseases
Diseases from unknown etiology
Severe food allergies
Systemic pre-existent diseases:
Systemic Arteriosclerosis
Vasculitis
Collagen diseases

PREVIOUS TREATMENTS
- Nephrotoxic: AAS, Ibuprofen, lithium,…
-Hepatotoxic: Parecetamol, AAS, Metotrexate,...
Could condition the validity of a specific organ, although they do not usually represent a
contraindication

RISK HABITS
Drug abuse (iv)
Sexual behavour

- History of travelling to tropical or endemic areas of infections
(malaria, trypanosomiasis, strongyloidiasis, etc.)
PREVIOUS TRAVELS

- History of previous transfusion or organ and/or tissue transplant

SOCIAL &
MEDICAL
HISTORY
REVIEW

SOCIAL & MEDICAL
HISTORY REVIEW
- History of congenital & hereditary diseases
- Relevant Family medical history

SOCIAL & MEDICAL
HISTORY REVIEW
- History of Chemical or radiation exposure

- Weight
- Height
- BMI, BS
- Perimeters
PHYSICAL EXAMINATION

- Document external donor examination

PHYSICAL
EXAMINATION
- Document external donor
examination

HEMODYNAMIC
STATE
- Cardiac rate, Arterial Pressure, liquid balance. Episodes of
HTA or ht / CA (bCPR, aCPR, periods)
- Use of inotropes, vasoactive drugs & other treatments
- UCI stay (days), duration of MV & conditions. Hypoxemia,
acidosis.
- Metabolic: electrolytes, glycemia, coagulation.
- Hypothermia

LABORATORY
TESTS
- Record of the Time of sampling
- Performed in accredited centers with properly validated
techniques.
-Sample Valid:
• Before the cessation of circulation
• Hemodilution calculation

GENERAL DETERMINATIONS
- ABO Blood Group –Rh
- Immunological Typing (HLA)
- Blood blood cell count
- Coagulation
-Biochemical parameters
-Arterial Gasometry
-Tumor markers (b-HCG)
-Cultures

SEROLOGICAL
TESTS
- Mandatory: HIV Ab
HCV Ab
HBVs Ag
- Others: HIV Ag
HBVc Ab / HBVs Ab
RPR
CMV Ab
HTLV I/II Ab
Trypanosoma Cruzii Ab
Toxoplama Ab
Strongylodes Ab
EBV Ab

SEROLOGICAL
TESTS
No Diagnosis Test can reduce to 0 the
Window Period
-NAT tests: HIV
HCV
HBV

COMPLEMENTARY
TESTS
- CT Scan (Cranial, Thoracic, Abdominal)
- X-Ray (Thorax, abdomen, fractures)
- Untrasound (abdominal, ecocardiography)
- EKG
- Coronary Angiography
- Fibrobronchospcopy

HIV: Positivity or Risk Factors
ABSOLUTE CONTRAINDICATIONS

Use of grafts from “High risk donors”
• Issue in controversy, varies by transplant group
• Use of the RNA (nuclear acid testing-NAT), if possible:
NAT reduces the WP (Kucirka, AJT 2011): (false positives)
- in 50% for HIV
- in 10% for HCV
• Informed Consent from the recipient. No risk-benefit studies
• Reserve these organs for HIV and HCV recipients?
• Other categories: donors with recent infections, HEMODILUTION,
NO family?

Graft and Patient Survival among 27
Human Immunodeficiency Virus (HIV)–
Positive Patients Who Received Kidney
Transplants from HIV-Positive Donors.
Muller E et al. N Engl J Med 2015;372:613-620

Active Cancer :
Exceptions:
Primary Tumors from the CNS
In situ Ca. of the cervix
Cutaneous Basocelular Ca.
Renal Ca. (Furhman grades I-II)

Risk Factors: craneotomy, ventricular dreinage, etc.

Transplantation. 95(9):1129-1133, May 15, 2013.
DOI: 10.1097/TP.0b013e3182875e00

Active Cancer :
Exceptions:
Previous Cancer < 5 years
NEVER: Breast, melanoma, lymphoma, colon, lung,
coriocarcinoma.

- Tumors with rare belated M1
- Rate of disease-free survival > 85%
- Early stage without lymph node invasion or
remote M1.
-Treated for curative purposes in recognized centers
-Free follow-up> 5 years

Active Cancer :
Exceptions:
Previous Cancer > 5 years
NEVER: Breast, melanoma, lymphoma, colon, lung,
coriocarcinoma.
Bacterian, fungal or viral Sepsis with multiorgan failure
(Creutzfeldt-Jakob, Bovine Spongiform Encephalopathy, Prion diseases, Tropical diseases)

- Bacterian Meningitis or bacteremia:
• Hemodynamic stability, without multi-organ dysfunction
• Cultures made and Germ identified
• Sensitive antibiogram
• Treatment at least 48h
• Good clinical response to treatment
• Continuation treatment at the recipient (10-14d)
• Anatomical and functional integrity of the organ to be recovered
Bacterial acute systemic Infections

No contraindication / Individual Assessment
Valid the other organs Valid all organs
Bacterial acute local Infections

“The biggest risk a patient runs on a transplant waiting list is not
being transplanted”
TRANSMISSION RISK (DONOR) MORTALITY RISK (RECIPIENT)
INFORMED CONSENT

RECOMMENDATIONS ABOUT RISK
ASSESSMENT IN THE
TRANSMISSION OF MALIGNANT
DISEASES FROM THE DONOR
Risk Levels & Risk Assessment

MACROSCOPIC EVALUATION
Colour, surface, edges, anatomy, vascular appearance, contractility
Search for possible incidental neoplasms
POST-PERFUSION STATUS
EVALUATION DURING RECOVERY

EX SITU MACHINE PERFUSION
Renal, Hepatic, Pulmonar…
HISTOLOGIC ASSESSMENT
Biopsies - Autopsy
EVALUATION AFTER RECOVERY

Specific Considerations
- Age
- In most cases they ONLY improve the quality of life
- Much higher demand
- More Strict evaluation than with organs (Standards)
- Specific contraindications for tissues
- Longer time for complementary tests
- Preservation Methods (sterilizing, disinfectant, few viable cells)
TISSUE DONOR CLINICAL EVALUATION

• Older than 60 years old
• Age over 50 with 2 of the 3 following factors:
✓ Hypertension
✓ Terminal Serum Creatinine > 1.5 mg/dl.
✓ Cause of death: CVA
(associated with renal living or deceased donors)
What is ECD (Extended Criteria
Donors)?
Donors with Medical “Complexities”

• ECD: Increase from 30% in 2000 to 60% in 2016
• Comparison between 2000 vs 2016, Increase in CVRF:
Hypertension 29.4% vs 40.4%
Diabetes Mellitus 6.5% vs 20%
Cardiopathy 8.5% vs 22.4%
0-15 16-30 31-45 46-59 60-69 70-79 ≥ 80
ME 0 5,6 6,5 10,3 22,2 34,8 61,5
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Non Valid Kidneys regarding Donor Age
0-15 16-30 31-45 46-59 60-69 70-79 ≥ 80
MA 0 11,1 23,4 38,5 50 0 0
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%

TAKE HOME MESSAGE
1. Self- sufficiency: 0,5% of all the deaths
2. Professionalized TPM: The role of the TPM is key to the
identification of potential donors
3. Donor detection is the key point to increase the actual donor
number →Proper detection is the first step in the donation process
4. Improper detection is an important cause of donor loss
5. Active detection, written protocols and auditing your own hospital
potentiality is an objective way to improve towards quality
standards.
6. Any way is appropriate, one of the most important factors is the
attitude (and the capacity for empathy)
7. The organization must adapt to the characteristics of the Hospital
8. Donor suitability → Organ Viability
9. Deep and accurate evaluation
10. Risk vs Benefit

Spanish background
It’s a matter of
Knowledge
& Passion
Experience

Donor detection, Identification & Evaluation.pdf

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