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THE CHANGING SCENARIO FOR ORGAN DONATION Elisabeth Coll Torres MD PhD Organización Nacional de Trasplantes, Spain

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Page 1: THE CHANGING SCENARIO FOR ORGAN DONATIONsctransplant.org/sct2017/docs/presentations/3003/SCTPlenary3/1-EColl.pdf27.4 4.7 10.2 18.8 39.0 0 5 10 15 20 25 30 35 40 45 A: Active treatment

THE CHANGING SCENARIO FOR ORGAN DONATIONElisabeth Coll Torres MD PhD

Organización Nacional de Trasplantes, Spain

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0

5

10

15

20

25

30

35

40

45

1970 1972 1974 1976 1978 1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012

AUT

BEL

BGR

CYP

CZE

DEU

DNK

ESP

EST

FIN

FRA

GBR

GRC

HRV

HUN

IRL

ITA

LTU

LUX

LVA

MLT

NLD

POL

PRT

ROU

SVK

SVN

SWE0

50

100

150

200

250

300

1970 1972 1974 1976 1978 1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012

…and Spain is here© World Health Organization 2015

SDR, cerebrovascular diseases, all ages, per 100 000

SDR, motor vehicle traffic accidents, all ages, per 100 000

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65.2 64.4 63.461.1 60.7

55.5 56.0 55.553.4

49.151.0

47.6

32.0 32.5 32.5 33.0 33.4 32.1 32.3 32.5 32.029.2

32.8 31.4

0

10

20

30

40

50

60

70

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

Do

nan

tes

en

ME

pm

p

Donantes potenciales en ME pmp Donantes reales en ME pmp

De la Rosa et al. Am J Transplant 2012; 12:2507

Potential DBD pmp Real DBD pmp

pm

p

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‘(…) The second concept isbased on the principle of non-maleficience and justice. Thetreating physician is not obligedto perform or continue withfutile treatments, these beingthose which do not achievetheir expected objective.

In this sense, continuing futiletreatments is considered a badclinical practice since it is notrespectful with human dignity; on the other hand, theunnecessary use of health careresources is against the pricipleof distributive justice’.

Monzón JL, et al. Med Intensiva 2008;32(3):121-33.

ETHICUS STUDYICU DEATHS 18% WSLT

EPIPUSE STUDYICU DEATHS 34% WSLT

Sprung et al, 2003; JAMA 290. Hernandez-Tejedor et al, 2015; Med Intensiva:395

Page 5: THE CHANGING SCENARIO FOR ORGAN DONATIONsctransplant.org/sct2017/docs/presentations/3003/SCTPlenary3/1-EColl.pdf27.4 4.7 10.2 18.8 39.0 0 5 10 15 20 25 30 35 40 45 A: Active treatment

EXPANSION DONOR POOL40 pmp DONOR PLAN

OBJECTIVE: Donor rate 40 pmp

• DBD Optimization

• DCD

• Living Donation

• Expanded criteria/ NSR donors

• Donation in minorities

• Special Surgical TechniquesMatesanz R, et al. Transplantation proceedings, 2009

Page 6: THE CHANGING SCENARIO FOR ORGAN DONATIONsctransplant.org/sct2017/docs/presentations/3003/SCTPlenary3/1-EColl.pdf27.4 4.7 10.2 18.8 39.0 0 5 10 15 20 25 30 35 40 45 A: Active treatment

Donor Pool

Donation after

circulatory death

Living donation

Old

donors

Brain Death

optimization

Special surgical techniques (liver split and domino. double

kidney)

Transmissible

diseases

- Neoplasias

- Infections

Other

pathologies:

- HTA. DM

- Intoxications

- Rare diseases…

Donation in

minorities

Expanded criteria

Non standard risk donors

40 pmp DONOR PLAN OBJECTIVE: Donor rate 40 pmp

Page 7: THE CHANGING SCENARIO FOR ORGAN DONATIONsctransplant.org/sct2017/docs/presentations/3003/SCTPlenary3/1-EColl.pdf27.4 4.7 10.2 18.8 39.0 0 5 10 15 20 25 30 35 40 45 A: Active treatment

Brain death Optimization

QUANTITATIVE PHASE

INDICATORS

1. REFERRAL OF POTENTIAL DONORS TO CU

2. MANAGEMENT OF POTENTIAL DONORS

INSIDE CU

3. OBTAINING CONSENT TO ORGAN DONATION

QUALITATIVE PHASE

VISIT TO BPH

• STRUCTURED INTERVIEW

• TRANSPLANT COORDINATORS

• OPENED QUESTIONS

IDENTIFICATION OF BEST

PERFORMER HOSPITALS (BPH)

IDENTIFICATION AND

DESCRIPTION OF BEST PRACTICES

Matesanz R, et al. Am J Transplant 2012;12(9):2498-506

WHO IS THE

BEST?

HOW DO THEY DO IT?

Page 8: THE CHANGING SCENARIO FOR ORGAN DONATIONsctransplant.org/sct2017/docs/presentations/3003/SCTPlenary3/1-EColl.pdf27.4 4.7 10.2 18.8 39.0 0 5 10 15 20 25 30 35 40 45 A: Active treatment

Matesanz R et al. Lancet 2012Number of donors within the 12 previous months at a given date

GOOD PRACTICES GUIDELINEAVAILABLE IN SPANISH, ENGLISH, GERMAN AND ITALIAN

http://www.ont.es/publicaciones/Paginas/Publicaciones.aspx

Brain death Optimization

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TRAINING PROGRAMMESONT–SEMES

Available at http://www.ont.es

COMMON RESEARCH PROJECTS

RECOMMENDATIONS/DOCUMENTS

Brain death Optimization

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FROM 2008, COLLABORATION AGREEMENT

WITH SPANISH INTENSIVE CARE SOCIETY (SEMICYUC)

• Training Programme (+ 1000 youngintestivists trained)

• Research projects• Recommendations

Escudero D, et al. Intensive care practices in brain death diagnosis and organ donation. Anaesthesia. 2015 Oct;70(10):1130-9

Brain death Optimization

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INDICATOR SD

ORGAN DONATION

Nº Donors ---------------------------------------x 100

Nº BD people in CU

60%

Nº people in BD correctly monitored---------------------------------------------------------------------x 100

Nº BD people in CU

100%

Nº confirmed BD-------------------------------------------------x 100

Nº CU Deaths

5-30%

http://www.semicyuc.org/sites/default/files/actualizacion_indicadores_calidad_2011.pdf

Brain death Optimization

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- small interventions in deceased donation through PDSA cycles in 40

donor hospitals

Proactive follow-up system for patientswith catastrophic brain injuries – ICD-10 codified mortality, neuroimages, etc. –discusion with treating physicians.

Notification criteria with supportingmaterial

New systems of notification

Protocols on Elective Non TherapeuticIntensive Care to facilitate organ donation

Daily review of deaths

Training sessions and feed-back activities

EMERGENCY CARENEUROLOGY/NEUROSURGERY

INTERNAL MEDICINEINTENSIVE CARE

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27.4

4.7

10.2

18.8

39.0

0

5

10

15

20

25

30

35

40

45

A: Active treatment inthe ICU until brain

death (n=539)

B: Active treatment inthe ICU until the

patient suffers anunexpected CA from

which the patientcannot not be

resuscitated (n=92)

C: Admission to ICU toincorporate the optionof organ donation into

end-of-life(n=200)

D: Active treatmentinthe ICU until thedecision is made to

WLST(n=370)

E: Not admitted intoICU (n=769)

%

1 out of 4 actual donors in Spain have been admitted to the ICU to enable organ donation

N=1970 possible donorsaged ≤85

11/1/2014-4/30/2015

24% ACTUAL DONORS

Domínguez-Gil B, et al. Med. Intensiva 2016

Domínguez-Gil B, et al. Transplantation 2017

Page 14: THE CHANGING SCENARIO FOR ORGAN DONATIONsctransplant.org/sct2017/docs/presentations/3003/SCTPlenary3/1-EColl.pdf27.4 4.7 10.2 18.8 39.0 0 5 10 15 20 25 30 35 40 45 A: Active treatment

Possible organ donors notadmitted into the ICU

1970 Possible donors

769 Not admitted into the ICU (39%)

427 No medical contraindications (56%)

49 Intubated– 39 dead ≤ 3 days378 Not intubated– 226 dead ≤ 3 days

342 NEVER REFERRED TO THE DONOR COORDINATOR

Patients dead as a result of a devastating brain injury (possible donors) ≤ 85 years

68 hospitals

1st November 2014 – 30th April 2015

Domínguez-Gil B, et al. Med Intensiva 2016

Mean age78 years

Page 15: THE CHANGING SCENARIO FOR ORGAN DONATIONsctransplant.org/sct2017/docs/presentations/3003/SCTPlenary3/1-EColl.pdf27.4 4.7 10.2 18.8 39.0 0 5 10 15 20 25 30 35 40 45 A: Active treatment

Legal, deontological and ethical framework

Identification of possible donors

Research of the will of donation. Care and

communication with the family of the

possible donor

Critical Unit management

Recommendation to implement a ICOD

program

Outcomes evaluation

EXTERNAL REVIEW PHASE

Brain death Optimization

Page 16: THE CHANGING SCENARIO FOR ORGAN DONATIONsctransplant.org/sct2017/docs/presentations/3003/SCTPlenary3/1-EColl.pdf27.4 4.7 10.2 18.8 39.0 0 5 10 15 20 25 30 35 40 45 A: Active treatment

Donor Pool

Donation after

circulatory death

Living donation

Old

donors

Brain Death

optimization

Special surgical techniques (liver split and domino. double

kidney)

Transmissible

diseases

- Neoplasias

- Infections

Other

pathologies:

- HTA. DM

- Intoxications

- Rare diseases…

Donation in

minorities

Expanded criteria

Non standard risk donors

Page 17: THE CHANGING SCENARIO FOR ORGAN DONATIONsctransplant.org/sct2017/docs/presentations/3003/SCTPlenary3/1-EColl.pdf27.4 4.7 10.2 18.8 39.0 0 5 10 15 20 25 30 35 40 45 A: Active treatment

1. Creation of new DCD programs – uDCD & cDCD

2. Increase the effectiveness of DCD - utilization rate and

number of organs recovered & transplanted per donor

3. Evaluate post-transplant outcomes with organs from DCD-

strategies for improvement

AIMS

Donation after Circulatory Death

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1. Introduction

2. Glossary & classification of DCD

3. Determination of death by circulatory criteria

4. Uncontrolled DCD

a. Out-of-hospital logistics. Donor selection criteria

b. In-hospital logistics. Donor selection criteria

c. Preservation. recovery and organ viability

d. Family approach

5. Controlled DCD

a. Donor selection criteria

b. WLST

c. Family approach

d. Extubation. cardiac arrest and death determination

e. Preservation. recovery and organ viability

f. Requisites for starting a controlled DCD program

6. Recipient selection criteria & peritransplant management. Information

to the potential recipient

7. Communication with the media

8. Ethical & legal aspects

DCD in Spain: state of the art and

recommendations

National ConsensusDocument 2012

Donation after Circulatory Death

Page 19: THE CHANGING SCENARIO FOR ORGAN DONATIONsctransplant.org/sct2017/docs/presentations/3003/SCTPlenary3/1-EColl.pdf27.4 4.7 10.2 18.8 39.0 0 5 10 15 20 25 30 35 40 45 A: Active treatment

• Training courses

Controlled and uncontrolled DCD

New scenarios for family interview

Normothermic Abdominal Perfusion

• Annual Report DCD activity in Spain

Description of procedures and trends

Outcomes: organ recovery, transplantation and post

transplant results

• National protocols on:

Liver Donation and Transplantation (2015)

Lung Donation and Transplantation (2017)

Donation after Circulatory Death

Page 20: THE CHANGING SCENARIO FOR ORGAN DONATIONsctransplant.org/sct2017/docs/presentations/3003/SCTPlenary3/1-EColl.pdf27.4 4.7 10.2 18.8 39.0 0 5 10 15 20 25 30 35 40 45 A: Active treatment

869 932 1002 997 1112 1214 1302 1313 1317 1360 1387 1424 1475 1433 1462 1500 14981372

1550 1482 1496 1489 1537 15240

2835 35

4336

32 32 18 49 56 71 71 76 88 77 108130

117 161 159 193314

495

22.625

27 26.829

31.533.6 33.9

32.5 33.7 33.8 34.6 35 33.8 34.3 34.2 34.432

35.3 34.8 35.1 36

39.7

43.4

0

5

10

15

20

25

30

35

40

45

50

0

500

1000

1500

2000

2500

1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

pm

p

Ab

solu

ten

um

ber

Brain Death Donors Circulatory Death Donors Rate pmp

12 5

2351 84

211

370

24.5%

0

20

40

60

80

100

0

100

200

300

400

500

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

%

Ab

solu

ten

um

ber

IV III IIb IIa % DCD/Total Actual donors

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> 3 PMP1-3 PMP< 1 PMP

EN 3 (0.1)4 (0.9) 548 (8.5)

55 (0.9)

156 (9.2)

110 (9.7)

16 (1.9) 6 (0.7)

8 (0.8)

11 (5.5)

8 (0.1)

73 (0.5)

314 (6.8)

U.S.A.: 1494 (4.6)

6 (1.2)

IN 2015, SPAIN WAS THE 3rd COUNTRY IN ABSOLUT NUMBERS,

AFTER USA AND UK

495 (10.6) 2016

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+ 3500 from thebeggining

From 24 to 838 tx / year

Page 24: THE CHANGING SCENARIO FOR ORGAN DONATIONsctransplant.org/sct2017/docs/presentations/3003/SCTPlenary3/1-EColl.pdf27.4 4.7 10.2 18.8 39.0 0 5 10 15 20 25 30 35 40 45 A: Active treatment

Donor Pool

Donation after

circulatory death

Living donation

Old

donors

Brain Death

optimization

Special surgical techniques (liver split and domino. double

kidney)

Transmissible

diseases

- Neoplasias

- Infections

Other

pathologies:

- HTA. DM

- Intoxications

- Rare diseases…

Donation in

minorities

Expanded criteria

Non standard risk donors

Page 25: THE CHANGING SCENARIO FOR ORGAN DONATIONsctransplant.org/sct2017/docs/presentations/3003/SCTPlenary3/1-EColl.pdf27.4 4.7 10.2 18.8 39.0 0 5 10 15 20 25 30 35 40 45 A: Active treatment

PROGRESSIVE CHANGE IN ELEGIBILITY

CRITERIA FOR ORGAN

DONATION

CHANGES IN THE PROFILE OF POTENTIAL

ORGAN DONORS

IMPROVEMENTS IN THE CARE OF NEUROCRITICAL

PATIENTS

DECLINE IN MORTALITY

RELEVANT TO ORGAN DONATION

Information on the quality and safety of transplants performed with organs from these donors is ESSENTIAL to guide risk-benefit assessments in the future

Page 26: THE CHANGING SCENARIO FOR ORGAN DONATIONsctransplant.org/sct2017/docs/presentations/3003/SCTPlenary3/1-EColl.pdf27.4 4.7 10.2 18.8 39.0 0 5 10 15 20 25 30 35 40 45 A: Active treatment

• All NSRD since 01/01/2013

• Utilization NSRD

• Follow-up recipients

Donors with an increased risk of

donor related disease in the

recipient, assumed before

transplantation.

Non Standard Risk Donors

Page 27: THE CHANGING SCENARIO FOR ORGAN DONATIONsctransplant.org/sct2017/docs/presentations/3003/SCTPlenary3/1-EColl.pdf27.4 4.7 10.2 18.8 39.0 0 5 10 15 20 25 30 35 40 45 A: Active treatment

Infections:

• CNS infections

• TBC

• Emerging infections

• Bacteriemias

• Endocarditis

Malignancies:

Prior or present history of malignancy

Poisoning:

• Cocaine

• Ecstasy

• Hydrocarbons

• Mushrooms

• Organophosphates

• Ethylene glycol Methanol

• Rodenticide

• Other

Other diseases:

• Myeloproliferative disorders

• Amyotrophic lateral sclerosis

• Systemic lupus erythematosus

• Multiple Sclerosis

• Other (rare diseases)

3 months

6-12-24 months

3 months

12-24 months

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176 actual donors

155 utlized donors

430 transplants

1Transmission*/Relatedproblem 84% follow-up

TRANSPLANT RESULTS

No Graftloss/Patient death

attributable to NSRD

*cardiacrecipient HCV

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2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

≥80 0.9 0.7 1 1.2 1.7 2.1 2 2.4 3 3.7 4.9 6.5 7.5 8.4 8.9 9.7 9.8

70-79 11.4 12.7 13.7 15.2 16.5 16.1 17.6 18.6 20.4 21.7 20.6 25.8 22.8 23.1 21.2 22.5 22.6

60-69 19.2 20.4 19.7 17.5 20 19.8 19.2 21.9 20.9 19.5 21.1 21.4 20.5 20.9 23.7 21 22.1

45-59 28 28.8 30 28.7 30 29.2 29 29.1 28.7 29.8 32.4 28 28.4 30.5 28.8 31 29.4

30-44 16.9 16.3 15.5 16.2 14.7 15.9 16.7 16.1 15.9 14.8 12.7 12.7 13.5 10.8 11.8 10.3 9.8

15-29 19.8 17.8 15.3 16.6 12.9 13 12.5 9.3 8.8 7.2 6.6 4.1 5.7 3.7 4 3.9 4.5

0-14 3.7 3.2 4.8 4.5 4.2 3.9 3 2.6 2.3 3.4 1.7 1.6 1.7 2.5 1.5 1.6 1.8

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

≥80 70-79 60-69 45-59 30-44 15-29 0-14

>50%

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3

4

5

5

4

5

6

7

8

6

10

12

10

10

12

7

10

16

11

16

13

11

10

13

10

17

16

13

19

16

15

21

16

2

1

0

0

2

1

2

3

2

4

2

1

4

5

4

10

8

2

8

4

7

10

12

10

13

7

9

12

8

11

15

14

19

0.0 5.0 10.0 15.0 20.0 25.0 30.0 35.0 40.0

CY (n=5)

EL (n=50)

MK (n=10)

BG (n=38)

TR (n=407)

RO (n= 138)

LU (n=4)

IS (n=3)

LT (n=31)

DE (n=864)

SK (n=64)

IE (n=63)

DK (n=80)

LV (n=29)

PL (n=594)

NL (n=282)

SE (n=166)

EE (n=23)

EU28 (n=10033)

HU (n=203)

UK (n=1309)

SI (n=44)

NO (n=114)

FI (n=121)

IT (n=1384)

CZ (n=261)

AT (n= 212)

FR (n=1635)

BE (n=299)

PT (n=289)

MT (n=12)

HR (n=151)

ES (n=1682)

Actual Total ≤ 60 years PMP Actual Total > 60 years PMP

2014 data

‘(…)the number of donors >70 years increased from 3.8 to 8.8 pmp (a 132% increase) in Spain and they now constitute 25.4% of all Spanish organ donors.

In contrast, the number of US donors >70 years increased from 1.0 to 1.3 pmp, and they constitute only 4.4% of total deceased donors’.

Halldorson J et al, . LiverTransplant 2013; 19

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0

10

20

30

40

50

60

70

80

90

100

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

Edad

máx

ima

del

do

nan

te

TX. RIÑÓN TX. HÍGADO TX. CORAZÓN TX. PULMÓN TX. PÁNCREAS

94

9079 86

55

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66752648

1246

999

2478

1161

51

2921854

1218

18308 353

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Kidney (N=11315) Liver (N=5380) Heart (N=1297) Lung (N=1309)

=< 60 years > 60-70 years > 70-80 years > 80 years

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• OLD FOR OLD

• BETTER THAN REMAINING ON DYALISIS

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Donor age is not the only relevant factor in the outcome of LT, however, surgical factors such as IT or hemodynamic instability during surgery, and recipient factors, such as MELD score are also essential. Therefore, avoiding these factors as much as possible in LT performed with elderly donors may lead to outcomes similar to those with transplants performed with younger donors

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RECIPIENT SELECTION

Page 36: THE CHANGING SCENARIO FOR ORGAN DONATIONsctransplant.org/sct2017/docs/presentations/3003/SCTPlenary3/1-EColl.pdf27.4 4.7 10.2 18.8 39.0 0 5 10 15 20 25 30 35 40 45 A: Active treatment

Donor Pool

Donation after

circulatory death

Living donation

Old

donors

Brain Death

optimization

Special surgical techniques (liver split and domino. double

kidney)

Transmissible

diseases

- Neoplasias

- Infections

Other

pathologies:

- HTA. DM

- Intoxications

- Rare diseases…

Donation in

minorities

Expanded criteria

Non standard risk donors

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Information program to patients

Information and training professionals

Expand living donors pool: Crossover-Donor Kidney

program, good samaritan

Living Donation

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16 15 15 2035

22 20 19 17 1931 34

60 61

87102

137156

235240

320

361

382

423

388

343

0

50

100

150

200

250

300

350

400

450

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

OBJECTIVE: > 10-15%KIDNEY TRASPLANTS

15%

Living Donation

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OBJECTIVE: FULL INTEGRATION OF IMMIGRANTS AND MINORITIES TO DONATION AND TRANSPLANTATION

POBLATIONAL SURVEY: ATTITUDES OF IMMIGRANT POPULATION TOWARDS ORGAN DONATION

(in collaboration with Faculty of Psychology, Universidad Autónoma de Madrid)

• Lack of information on donation and transplantation

• Family interview is essential

• Three collectives reluctant to donation:

North Africa

Sub-Saharan Africa

Asia

Specially for religious reasons- Muslims with strong religious beliefs.

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Information and awareness of donation and

transplantation: Donación sin fronteras campaign,

En el lado de lado de la vida (silent short film)

Enhance collaboration between transplant

network and cultural mediators (Symposium,

workshops)

Strengthen relations with the most representative

social organizations of the different groups

• Muslims

• Gypsies

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01

23334

56666

788

101011

11111112

1317

181818

202323

2526

353738

394040

43454546

485151

5353

5657

5862

6668

696970

7174

7577

8386

8789

9393

101

0 25 50 75 100 125

Luxembourg (n=0)

Armenia (n=6)

Malasya (n=97)

Dominicana (n=41)

Macedonia (n=12)

Venezuela (n=192)

Bosnia and Herzegovina (n=27)

Guatemala (n=135)

Russian Federation (n=1473)

Azerbaijan (n=110)

Greece (n=126)

Georgia (n=50)

Romania (n=345)

Chile (n=321)

Mexico (n=2960)

Colombia (n=1204)

Uruguay (n=119)

Estonia (n=49)

Latvia (n=79)

Iran (n=3370)

Germany (n=3668)

Hungary (n=479)

New Zealand (n=203)

Israel (n=433)

Ireland (n=266)

Australia (n=1485)

Finland (n=373)

Canada (n=2492)

Czech Republic (n=749)

Netherlands (n=1263)

Norway (n=430)

Belgium (n=987)

United States of America (n=29851)

Spain (n=4641)

Recipients of solid organs pmp

Recipients of organs from Deceased Donors pmp

Recipients of organs from Living Donors pmp

Patients transplanted pmp 2015

2016

104 pmp

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The difficulty of changing "Because it has always been done like this“ is a challenge.

‘To improve is to change; to be perfect is to change often’

― Winston Churchill

‘Nothing happens until something moves’ ― Albert Einstein

THANK YOU VERY MUCH FOR YOUR

ATTENTION

[email protected]