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
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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
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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
lgiu
m
Sw
eden
Fra
nce
Norw
ay
Hungary
Denm
ark
Sp
ain
Be
laru
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.
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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
lgiu
m
Irela
nd
Norw
ay
Sp
ain
Sw
eden
Sw
itzerland
Denm
ark
Neth
erlands
Fra
nce
Germ
any
UK
Fin
land
ITA
LY
Esto
nia
Cze
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ep
Po
rtugal
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Latv
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Turk
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Russia
Lu
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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
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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
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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
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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
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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?
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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
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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
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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)
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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
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Survival after HT(n=275)
� Low risk
� Moderate risk � High risk
88%
86%
69%
92%
89%
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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
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Frailty and post HT survival
Jha SR et al. Transplantation 2016;100: 429–436
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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)
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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
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Question 3
Should the recipient risk enter the allocation algorithm?
A. Yes
B. No