Proposal to Modify the Adult Heart Allocation System: Round 2

1. Proposal to Modify the Adult Heart Allocation System: Round 2 Thoracic Organ Transplantation Committee

2. What problems will the proposal solve? • High waiting list mortality rates, particularly for the most urgent candidates • High # of exception requests indicates certain candidates not served well by current system • Policy out of date re: increased use of mechanical circulatory support devices (MCSD) and associated complications • Current geographic sharing scheme is inequitable and inconsistent with the Final Rule

3. January 2016 Proposal • Added more urgency stratifications based on relative waiting list mortality rates for all adult heart candidates • Modified geographic sharing scheme to provide most urgent candidates access to donors from a broader geographic area

4. Feedback to January 2016 Proposal Themes related to statuses • Distinguish between patient need and therapeutic preference • Define biventricular heart failure rather than treatment employed • Limit time for highest priority statuses to combat potential behavior changes • Better define qualifying devices for each status • Still split on VAD for 30 days

5. Feedback to January 2016 Proposal Themes related to broader sharing • Support: • Don’t have to accept an organ from farther away just because it’s offered • Distance doesn’t necessarily translate to longer ischemic time • Current boundaries are arbitrary • Organs are a shared national resource • Oppose • Concern about cost/difficulty of more remote recoveries • Will increase ischemic time affecting outcomes • Harm to relationships between OPOs & hospitals • Zone B is too far • Policy changes should be made one at a time

6. Supporting Evidence • TSAM supports framework established in original proposal • Clinical consensus from public comment and post-public comment outreach informed proposed physiologic criteria used to refine statuses

7. Post-Public Comment Outreach

8. Survey Results Summary • VA ECMO: ~80% supported VA ECMO in Status 1 • Over half supported extension at Status 1 • 60% preferred requiring failed weaning for extension • Percutaneous devices: ~40% preferred 14 days in Status 2, though 30% preferred unlimited time • >60% of both groups of respondents preferred failed weaning for extension • Stable LVAD: 55% supported 30 days of elective Status 3 time for stable LVAD • Geography: >60% preferred sharing just through DSA + Zone A • Of these respondents, 55% preferred sharing only for Status 1 and 42% preferred both Status 1 and 2

9. What are the proposed solutions?

10. What are the proposed solutions? *Non-dischargeable refers to devices that are not FDA approved for use outside the hospital

11. What are the proposed solutions?

12. How will members implement this proposal?

13. How will the OPTN implement this proposal? • Target Board Date: Dec. 2016 • Effective date depends on programming • UNOS will give members time to update their candidate data before implementation • Members will need to verify information after implementation date • Exceptions (approved and in flight) will be null upon implementation • Accumulated waiting time will transfer • Proposal does not affect methods for routine monitoring

14. Questions? Kevin Chan, M.D. Committee Chair kevichan@med.umich.edu Liz Robbins Callahan, Esq. Project Liaison Liz.robbins@unos.org

15. Supplemental slides

16. Proposed Statuses 1-3

17. Proposed Statuses 4-6 *Candidates may qualify for more than one status, but their programs should register them in the most urgent status for which they qualify **Transplant programs can request exceptions to register candidates in statuses 1-4 if they don’t qualify based on policy but are as urgent as other candidates in those statuses

18. AHA Definition of Cardiogenic shock • The definition of CS includes hemodynamic parameters: persistent hypotension (systolic blood pressure <80 to 90 mm Hg or mean arterial pressure 30 mm Hg lower than baseline) with severe reduction in cardiac index (<1.8 L/min/m2 without support or <2.0 to 2.2 L/min/m2 with support) and adequate or elevated filling pressure (eg, left ventricular [LV] end-diastolic pressure >18 mm Hg or right ventricular [RV] end-diastolic pressure >10 to 15 mm Hg).

19. Proposed Data Elements • Refer to Appendix B for the full list of proposed data elements • We are seeking your input regarding all these data points, and how often to report them (especially for the lower urgency candidates). • These data will inform a heart allocation score in the future

20. Regional Review Board Changes • RRBs will review exceptions and extensions for Statuses 1-4 • RRBs will review cases outside of their region to eliminate some risk of bias in reviewing cases from their own region