SITUACIÓN ACTUAL DE LA DONACIÓN Y PERSPECTIVAS A MEDIO PLAZO

Barcelona 22 de Noviembre 2012

Martí Manyalich, MD, PhD, Assoc.Prof. Universitat de Barcelona

Asesor de Trasplantes Hospital Clínic de Barcelona

Jornadas de Otoño “Trasplante Hepático”

International Registry in Organ Donation

­IRODaT­

35,3

35

29,3

28,5

26

25,6

24,8

23,5

23,2

21,9

20,3

19,4

18

17,9

17,6

17,25

17

15,5

15,5

15,4

15,1

15,1

14,7

14,5

13,2

13,1

13,1

12,8

12,7

12,2

11,8

11

10,7

10,1

8,6

7,4

7,2

7,2

6,9

6,6

6,3

6,2

5,8

5,6

4,7

4,6

3,8

3,7

3,4

3,3

3,1

2,5

2,1

1,8

0,9

0,6

0,6

0,5

0,1

Spain

Croatia

Belgium

Portu

gal

USA

Norway

France

Puerto Rico

Austria

Italy

Uruguay

Estonia

Luxembourg

Latvia

Czech Rep

Finland

UK

Slovenia

Sweden

*Canada

Australia

Argentina

Germany

Poland

Netherlands

Denmark

Hungary

Switzerland

Slovak Rep

Lithuania

Israel

Colom

bia

Brazil

Belarus

New

Zealand

Panama

South Ko

rea

Greece

*Cyprus

Chile

Iceland

Costa Rica

Taiwan

Iran

Hong Ko

ng

Turkey

Venezuela

Rom

ania

Saudi A

rabia

Russia

Mexico

Lebanon

Ecuador

Dom

inican Rep

Japan

Bulgaria

Tunisia

*Ukraine

Morocco

0

5

10

15

20

25

30

35

40

Deceased Donors (pmp) 2011

International Registry in Organ Donation

­IRODaT­

International Registry in Organ Donation

­IRODaT­

Global Activity in Organ Transplantation 2010 Estimates

Trasplante Hepático. Actividad en España

1993­2011

The Declaration of Istanbul

Propuestas

1. Responder a las necesidades de aumentar la donación de cadaver.

2. Asegurar la protección y seguridad de los donantes vivos. Combatir el turismo de trasplante, el trafico de órganos y el comercio de trasplante.

Turkey, 30.5.2008

World Health Organization

Who Guiding Principles on Human Cell, Tissue and Organ Transplantation.

Endorsed by the 63rd World Health Assembly in May 2010,

in Resolution WHA63.22

Revised Guiding Principles summarized:

3. Donation from deceased persons should be developed to its maximum therapeutic potential.

4. In general, living donors should be genetically, legally or emotionally related to their recipients.

The Madrid Resolution on Organ Donation & Transplantation

•National Responsibility in Meeting the Needs of Patients.

•Guided by the WHO Principles •Participants in the Madrid Consultation urged WHO, its Member States and professionals in the field to regard organ donation and transplantation as part of every nation’s responsibility to meet the health needs of the population in a comprehensive manner, addressing the conditions leading to transplantation from prevention to treatment.

•Every country, in light of its own level of economic and health system development, should progress towards the global goal of meeting patients' needs on the basis of resources obtained within the country,for that country’s population, and through regulated and ethical regional or international cooperation when needed. The strategy of striving for self‐sufficiency encompasses the following features: actions should (i) begin locally; (ii) include broad public health measures both to decrease the disease burden in a population and to increase the availability of organ transplantation; (iii) enhance cooperation among the stakeholders involved and (iv) be carried out on the basis of the WHO Guiding Principles and the Declaration of Istanbul, in particular emphasizing voluntary donation, non‐ commercialization, maximization of donation from the deceased, support for living kidney donation, and meeting the needs of the local population in preference to “transplant tourists”.

Critical Pathway for Organ Donation

Beatriz Domínguez­Gil, Francis L. Delmonico, Faissal A.M. Shaheen, Rafael Matesanz, Kevin O’Connor, Marina Minima, Elmi Muller, Kimberly Young, Martí Manyalich, Jeremy Chapman, Günter Kirste, Mustafa Al­Mousawi, Leen Coene, Valter Duro García, Seguei Gautier, Tomonori Hasegawa, Vivekanand Jha, Tong Kiat Kwek, Zhonghua Klaus Chen, Bernard Loty, Alessandro Nanni Costa, Howard M. Nathan, Turger Ploeg, Oleg Reznik, John D. Rosendale, Annika Tibell, George Tsoulfas, Anantharaman Vathsala and Luc Noël.

The critical pathway for deceased donation: reportable uniformity in the approach to deceased donation. Transplant Internacional 24 (2011):373­378

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* POSSIBLE DECEASED ORGAN DONOR

A patient with a devastating brain injury or lesion OR a patient with circulatory failure AND apparently medically suitable for organ donation

UTILIZED DCD DONOR

An actual donor from whom at least one organ was transplanted.

POTENTIAL DCD DONOR

A.A person whose circulatory and respiratory functions have ceased and resuscitative measures are not to be attempted or continued.

or

B.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 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.

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.

or B. From whom at least one organ was

recovered for the purpose of transplantation.

Donation after Circulatory Death (DCD)

*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.

Reasons why a potential donor does not become a utilized donor

System • Failure to identify/refer a potential or eligible donor • Brain death diagnosis not 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 • Expressed 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

Organ Donors 2010

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Spain USA UK

DBD DCD LD

*Percentage over the total number of donors

77.8%

7.4%

14.8%

6,46%

45%

31.2%

18%

50.8%

48,54%

1625 1436 1364

1112 1169 1132 1071 1097 1032 944

1136 1264 1262

101 116 121 38 41 22 25 67 116 124 129 133 106

0

500

1000

1500

2000

2500

3000

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

Liver waiting list Deceased donor transplants Living donor transplants

Liver waiting list and transplants Eurotransplant 1995 ‐ 2007

2429

ALTERNATIVAS PARA LA DONACIÓN

1) Donantes en muerte encefálica (DBD)

2) Donantes a corazón parado (DCD)

3) Donantes vivos (LD)

4) Rescate órganos. Domino, Split.

5) Criterios Distribucion

6) Terapia celular: Utilización de hepatocitos

Donantes muerte encefálica

(DBD)

•DISMINUCIÓN

•DE LAS MUERTES

•ENCEFÁLICAS

DONACIONES DE

ÓRGANOSPARA TRASPLANTE

•IMPRESCINDIBLE OPTIMIZAR LA DONACIÓN EN MUERTE ENCEFÁLICA Y

•BUSCAR VÍAS ALTERNATIVAS QUE ASEGUREN LA DISPONIBILIDAD DE ÓRGANOS PARA TRASPLANTE

•TRÁFICO

•ENF. CEREBROVASC.

•CRANIECTOMÍA

Desciende el potencial de donación en muerte encefálica en

España

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

•IMPRESCINDIBLE OPTIMIZAR LA DONACIÓN EN MUERTE ENCEFÁLICA Y

•BUSCAR VÍAS ALTERNATIVAS QUE ASEGUREN LA DISPONIBILIDAD DE ÓRGANOS PARA TRASPLANTE

23

Spain. Age groups

Spain: mean age of deceased donor

Causa de muerte de los donantes

Causas de muerte en los donantes hepáticos

Hígados no válidos para trasplante. 1990­2011

Mejora Continua de la obtenció de Órganos

üUSA . Give of Life. (40 pmp)

ü Teheran. Modelo Shiraz

ü Urgéncias­ OPO

üVentilación electiva para muerte encefálica

üDCD controlada

ü DCD no controlada, Mayor Potencial

ü Donantes vivos

ü Higados descartados para trasplantes

Donantes a corazón parado

CPR in Europe

¢ 350.000 cases/year ¢ 1000 cases/day ¢ Recuperated 40% ¢ Hospital survival 15% ¢ One year survival 12%

Bernd Böttiger, Colonia­Germany European resucitation councill (ERC) 1 st Pan­hellenic congress on Emergency Prehospital Care. April 2012.

Thessaloniki, Greece.

Potential uDCD in Europe

¢ 1000 cpr/day ¢ 600 no recuperated. Potential uDCD ¢ 400 recuperated ¢ 250 death in hospital. Potential cDCD ¢ 150 alive in hospital

Bernd Böttiger, Colonia­Germany European resucitation councill (ERC) 1 st Pan­hellenic congress on Emergency Prehospital Care. April 2012. Thessaloniki, Greece.

Adapted by M. Manyalich analisys

Uncontrolled­ DCD

Necesita:

1. Sistema de emergencias

2. Equipo de donación a corazón parado

3. Sistema de re­circulación normotérmica

4. Perfusión ex­situ para realizar la validación órganos:

Riñón, pulmón, corazón e hígado.

Organ Care System

Machine Preservation Equipment

LifePort ® Kidney Transporter: • Stand­alone machine • Portable

Normothermic Ex Vivo Lung Perfusion (EVLP)

TransMedic preserved hearts up to 12h • Prediction of viability in marginal organs (?)

Heart perfusion Machines

Dr. C. Fondevila

Donación en asistolia en el mundo. Número absoluto (pmp) de donantes en asistolia. Año 2011

Canadá: 65 (1,9)

Estados Unidos: 1055 (3,4)

Australia: 86 (3,8)

Nueva Zelanda: 2 (0,5)

Singapur: 3 (0,6)*

Rep.Corea: 4 (0,1)*

Japón: 81 (0,6)*

>3 pmp 1­3 pmp < 1pmp

Rusia: 187 (1,3)

*Dato correspondiente a 2010

•1 (0,2)

•117 (2,5)

•6 (0,1)

•58 (0,9)

•405 (6,5)

•1 (0,1)

•13 (5,9)

•6 (0,7) •3 (0,4) •64 (5,8)

•117 (7)

Donación en asistolia en Europa. Número absoluto (pmp) de donantes en asistolia. Año 2011

•>3 pmp

•1­3 pmp

•< 1pmp

El tipo de donación en asistolia predominante varía entre países. Europa 2008

NO CONTROLADA CONTROLADA

Austria 3 ­

Bélgica 2 40

España 77 ­

Francia 47 ­

Holanda 6 85

Italia 2 ­

Letonia ­ 11

Reino Unido ­ 264

Rep. Checa ­ 1

Suiza ­ ­

137 401

Controlada predominante en Australia, Can adá y Estados Unidos

Domínguez­Gil et al. Transplant Int 2011; 24: 276

Centros de uDCD en España

Donación en asistolia en España por Centros

•32

•18

•49 •56

•71 •71 •76

•88 •77

•108

•130 •117