OPTN/UNOS- Thoracic Organ Transplantation Committee: Proposed

Modifications to Adult Heart Allocation

What problems is the proposal attempting to solve?

Each zone = 500 mile radius

© 2016 AST

Heart and Lung Allocation in Europe

Luciano Potena, MD PhDHeart and Lung Transplant Program University of Bologna

© 2016 AST

Conflict of Interest Disclosure

• I received Advisory board fees from Diaxonhit and Biotest

• My institution received research support from Novartis and Qiagen

• No off label drug or device use is mentioned in this presentation

© 2016 AST

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© 2016 AST

Heart Transplant in Europe in 2014 n=2146

15.7

8.1 8 7.97.4 7.1

6.7 6.75.9 5.7 5.6

4.8 4.84.4 4.1 4 3.8 3.7 3.7

3.1 3 2.92

1.1 1.1 1

0

2

4

6

8

10

12

14

16

18S

lovenia

Cze

ck R

ep

Au

str

ia

Cro

atia

Be

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m

Sw

eden

Fra

nce

Norw

ay

Hungary

Denm

ark

Sp

ain

Be

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s

Fin

land

Sw

itzerland

Po

rtugal

Esto

nia

Irela

nd

Germ

any

ITA

LY

Slo

vakia

Neth

erlands

UK

Po

land

Gre

ece

Russia

Latv

ia

Turk

ey

Bu

lgaria

He

art

tra

ns

pla

nts

p.m

.p.

U.S.A. 8.3 p.m.p.

© 2016 AST

Lung Transplant in Europe in 2014 n=1822

15.1

9

7 6.66.1 6 5.6 5.5 5.2 4.8 4.5

3.32.8

2.3 2.31.6 1.5

0.4 0.3 0.4 0.10

2

4

6

8

10

12

14

16A

ustr

ia

Be

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Irela

nd

Norw

ay

Sp

ain

Sw

eden

Sw

itzerland

Denm

ark

Neth

erlands

Fra

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Germ

any

UK

Fin

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nia

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.p.

© 2016 AST

8-year trend of heart and lung

transplant in Europe

0

2000

4000

6000

8000

10000

2007 2008 2009 2010 2011 2012 2013 2014

Total transplant

Heart

Lung

Data from the Council of Europe – 27 countries

© 2016 AST

Rate of thoracic transplants over the total

0%

5%

10%

15%

20%

25%

30%

2007 2008 2009 2010 2011 2012 2013 2014

Ra

te o

f tr

an

sp

lan

ts

Heart

Lung

Data from the Council of Europe – 27 countries

© 2016 AST

Variability in HT numbers

26%

340% 164%230%

19%

13%

10%

35%

-26%

-27%

-120

-100

-80

-60

-40

-20

0

20

40

60

Dif

fere

nc

e 2

01

4-2

00

7

© 2016 AST

Numbers of heart transplants in France

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Rules of priority allocation in France

Inotropes and/or ECMO with no

implantable MCS

Complicated implantable MCS

TAH or pulsatile MCS (i.e. excor) non

complicated >3 months

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Rate of urgent cases over the total in 2014(n= 423)

44%

11%2%

43% SU1

SU2

SU3

Non-Urgent

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Cumulative incidence of transplant according with priority

Mortality/deterioratio

n while on SU1= 5%

Overall 1 y mortality on WL:24%

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Survival according to urgency status

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Increasing mean age of utilized donors

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Coronary angiography increases heart utilization

In the CA performed group 74% of organs have been accepted

vs. 64% in the CA not performed group (P=0.02)

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Heart and Lung Transplant in Italy

0

50

100

150

200

250

300

350

400

2008 2009 2010 2011 2012 2013 2014 2015

Heart

Lung

Data from the National Transplant Center

© 2016 AST

Allocation system in Italy

• Standard allocation

– Based on regional donor pool

• High urgency tier

– Country-wide organ sharing area

– ECMO or complicated VAD or IABP plus ventilator

– Payback for urgency

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High urgency for lung transplant

Boffini et al. Interactive CardioVascular and Thoracic Surgery 19 (2014) 795–800

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Urgency program in Italy

0%

5%

10%

15%

20%

25%

30%

35%

2008 2009 2010 2011 2012 2013 2014 2015

Heart

Lung

Death/deterioration

while waiting in urgent status:

- Heart : 23%- Lung : 30%

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High urgency lung Tx outcomes

1-y survival for non-high urgency cases: 70%Boffini et al. Interactive CardioVascular and Thoracic Surgery 19 (2014) 795–800

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1-y heart survival trend

Data from the National Transplant Center

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Heart donor age in Bologna

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HTX 2001-10 (n=346)

Median donor age= 36(24-47)

HTX 2011-15 (n= 106)

Median donor age = 45 (18-52)

Post-HT survival and donor age in Bologna

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Ethical pillars of decision making

• Beneficence

• Non maleficence

• Autonomy – give the patient the possibility

to make an informed and rationale choice

• Distributive justice – Allocate appropriately a

scarce resource

Provide a benefit with

transplant

Do not run unacceptable

risks

Are we enough rationale

and informed to make a choice?

What are the parameters

for justice?

© 2016 AST

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Ideal allocation system

• High-priority patients do have a high risk without transplantation;

• Transplantation will be performed with appropriately short waiting times for the highest priority patients

• A reasonable proportion of patients can undergo transplantation at a lower priority level.

No priority system can be effective or even evaluable except in the context of a waiting list length that is matched to the current donor heart supply.

Stevenson LW, J Heart Lung Transplant 2013; 32: 861

© 2016 AST

Urgency tiers and waiting times in EuropeUrgency tiers Transplant

rate per tier (%)

Median

waiting list (days)

UK Urgent

Non Urgent

60

40

14

293

France SU1

SU2Regional urgency

Non urgent

39

89

45

9

102219

189

Spain Urgent 0

Urgent 1Non Urgent

14

2166

8

780

Italy Urgent

Non Urgent

14

86

3

292

Stehlik J et al J Heart Lung Transplant 2014; 33:977

© 2016 AST

Distributive justice:

set the line to connect competing interests

• Urgency allocation algorithms

– Need to allocate a scarce resource to individuals at greater need

– Need to allocate a scarce resource to individuals most likely to get a benefit

– Need to avoid inequalities in the access to transplant of those who would not meet urgency criteria

© 2016 AST

Blood group disparities

39%

37%

17%

7%

Italian blood group distribution

29%

51%

14%

6%

2014-15 HTX blood groups distribution

65%

33%

2%

Current waitlist blood groups distribution

0

A

B

AB

© 2016 AST

And if this little boy

were blind?

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� 7 – 9 Low risk

� 10 – 11 Moderate risk

� > 12 High risk

96%

83%

59%

74%

57%

42%

p<0,01

Follow-up (months)

Surv

ival

Survival in HF patients evaluatedfor transplant (n=500)

© 2016 AST

Transplant Benefit at 1 and 5 years

-10

-5

0

5

10

15

20

25

30

35

Low Intermediate High

Ra

te o

f e

xp

ec

ted

su

rviv

al

ga

in

1 y 5y

Providing the largest transplant benefit not

necessarily provides the best figures on post-transplant survival

© 2016 AST

Survival after HT(n=275)

� Low risk

� Moderate risk � High risk

88%

86%

69%

92%

89%

© 2016 AST

Age-stratified comorbidity risk

Low-risk<60y

Low-risk >60y

High-risk>60y

High-risk <60y

P<0.001

Masetti M et al. manuscript in preparation

© 2016 AST

Frailty and post HT survival

Jha SR et al. Transplantation 2016;100: 429–436

© 2016 AST

Donor-recipient match and

outcome

0

5

10

15

20

25

30

35

LR donor to LR

recipient (n=211)

HR donor to LR

recipient (n=212)

LR donor to HR

recipient (n=15)

HR donor to HR

recipient (n=33)

Ra

te o

f S

ev

ere

PG

D

Sabatino M et al. manuscript in preparation

© 2016 AST

Summary

• Thoracic transplantation numbers are stable overall in Europe, with some emerging countries increasing volume and remarkable loss of volume in some other countries

• Allocation policies are highly variable, but mainly based on a mixed model in which geography prevails on severity (limited number of severity tiers)

© 2016 AST

Unmet needs

• Shared policies to improve thoracic organ retrieval

• Develop tools to aid clinicians to optimize decision making about appropriate risk matching

– Balancing the risk of waiting vs. accepting borderline

donors (appropriate MCS development)

– Identify tools to objectively allocate priorities (based

on physiology and not on treatment)

– Auditing systems that set up quality standards with

outcome measures accounting for cases complexity,

and urgency appropriateness

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Question 1

How many urgency tiers are acceptable?

A. 1

B. 2

C. 3

D. more

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Question 2

Should the donor risk be considered in the allocation algorithm?

A. Yes

B. No

© 2016 AST

Question 3

Should the recipient risk enter the allocation algorithm?

A. Yes

B. No