OPTN/UNOS-Thoracic Organ Transplantation Committee: Proposed Modifications to Adult Heart Allocation

Transcription

1 OPTN/UNOS-Thoracic Organ Transplantation Committee: Proposed Modifications to Adult Heart Allocation

2 What problems is the proposal attempting to solve?

3 Each zone = 500 mile radius

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5 Heart and Lung Allocation in Europe Luciano Potena, MD PhD Heart and Lung Transplant Program University of Bologna

6 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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10 Heart Transplant in Europe in 2014 n= U.S.A. 8.3 p.m.p Slovenia Czeck Rep Austria Croatia Belgium Sweden France Norway Hungary Denmark Spain Belarus Finland Switzerland Portugal Estonia Ireland Germany ITALY Slovakia Netherlands UK Poland Greece Russia Latvia Turkey Bulgaria Heart transplants p.m.p.

11 Lung Transplant in Europe in 2014 n= Austria Belgium Ireland Norway Spain Sweden Switzerland Denmark Netherlands France Germany UK Finland ITALY Estonia Czeck Rep Portugal Poland Latvia Turkey Russia Lung transplants p.m.p.

12 year trend of heart and lung transplant in Europe Total transplant Heart Lung Data from the Council of Europe 27 countries

13 Rate of thoracic transplants over the total 30% Rate of transplants 25% 20% 15% 10% 5% Heart Lung 0% Data from the Council of Europe 27 countries

14 Variability in HT numbers Difference % 340% 164% 230% 19% 13% 10% 35% -27% %

15 Numbers of heart transplants in France

16 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

17 Rate of urgent cases over the total in 2014 (n= 423) 43% 44% SU1 SU2 SU3 Non-Urgent 2% 11%

18 Cumulative incidence of transplant according with priority Mortality/deterioratio n while on SU1= 5% Overall 1 y mortality on WL:24%

19 Survival according to urgency status

20 Increasing mean age of utilized donors

21 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)

22 Heart and Lung Transplant in Italy Heart Lung Data from the National Transplant Center

23 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

24 High urgency for lung transplant Boffini et al. Interactive CardioVascular and Thoracic Surgery 19 (2014)

25 Urgency program in Italy 35% 30% 25% 20% 15% Heart Lung Death/deterioration while waiting in urgent status: - Heart : 23% - Lung : 30% 10% 5% 0%

26 High urgency lung Tx outcomes 1-y survival for non-high urgency cases: 70% Boffini et al. Interactive CardioVascular and Thoracic Surgery 19 (2014)

27 1-y heart survival trend Data from the National Transplant Center

28 Heart donor age in Bologna

29 Post-HT survival and donor age in Bologna HTX (n=346) Median donor age= 36(24-47) HTX (n= 106) Median donor age = 45 (18-52)

30 Ethical pillars of decision making Beneficence Non maleficence Provide a benefit with transplant Do not run unacceptable risks Autonomy give the patient the possibility to make an informed and rationale choice Distributive justice Allocate appropriately a scarce resource Are we enough rationale and informed to make a choice? What are the parameters for justice?

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32 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

33 Urgency tiers and waiting times in Europe Urgency tiers Transplant rate per tier (%) Median waiting list (days) UK Urgent Non Urgent France SU1 SU2 Regional urgency Non urgent Spain Urgent 0 Urgent 1 Non Urgent Italy Urgent Non Urgent Stehlik J et al J Heart Lung Transplant 2014; 33:977

34 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

35 Blood group disparities Italian blood group distribution 7% HTX blood groups distribution 6% 17% 39% 14% 29% 37% 51% Current waitlist blood groups distribution 2% 33% 65% 0 A B AB

36 And if this little boy were blind?

37 Survival in HF patients evaluated for transplant (n=500) 7 9 Low risk Moderate risk > 12 High risk Survival 96% 83% 59% 74% 57% 42% p<0,01 Follow-up (months)

38 Transplant Benefit at 1 and 5 years 35 Rate of expected survival gain Providing the largest transplant benefit not necessarily provides the best figures on posttransplant survival Low Intermediate High 1 y 5y

39 Survival after HT (n=275) 92% 89% 88% 86% 69% Low risk Moderate risk High risk

40 Age-stratified comorbidity risk Low-risk<60y Low-risk >60y P<0.001 High-risk>60y High-risk <60y Masetti M et al. manuscript in preparation

41 Frailty and post HT survival Jha SR et al. Transplantation 2016;100:

42 35 Donor-recipient match and outcome 30 Rate of Severe PGD 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) Sabatino M et al. manuscript in preparation

43 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)

44 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

45 Question 1 How many urgency tiers are acceptable? A. 1 B. 2 C. 3 D. more

46 Question 2 Should the donor risk be considered in the allocation algorithm? A. Yes B. No

47 Question 3 Should the recipient risk enter the allocation algorithm? A. Yes B. No