1 Thoracic Organ Transplantation Committee Fall 2015

Board-Approved Thoracic Committee Projects 2

TitleStatus Modify Pediatric Heart Allocation Proposal approved -- June IT implementation begins Fall Anticipated “go-live” in Q ECMO Data Collection Proposal approved-- June Scheduled for implementation -- Q2 of EVLP Data Collection Proposal approved -- June Pending OMB approval and implementation. Board-Approved Committee Projects 3

Status of Adult Heart Allocation Policy Revision Project 4

Problems Too many candidates waiting as Status 1A Status 1A candidates 3x more likely to die on waiting list Specific patient groups may be disenfranchised Inequities in access to organs because of artificial geographic boundaries Goals Better stratify candidates based on medical urgency Expand access to donors for the most critically ill patients Background

Modify current 3-tiered systemDevelop heart allocation scoreAdd more tiers Options Considered 6

Developed “Straw Man” Tiers Reviewed predicted waitlist and post-transplant mortality rates stratified by disease process (based on modeling performed by SRTR) Reviewed all exception request forms Clustered diseases based upon mortality into like cohorts Requested TSAM to determine predicted impact of tiers on allocation Reviewed TSAM results and currently satisfied with new tiers Submitted TSAM request to model potential changes to geographic sharing Results should be ready by Sept. or Oct. Steps Taken Thus Far 7

Review results of geographic sharing TSAM Finalize sensitized candidates discussion Develop clear definitions for tier criteria Brainstorm data collection for future heart allocation score Next Steps 8 Jan 2016 Public Comment

Joe Rogers, M.D. Committee Chair Regional representative name (RA will complete) Region X Representative address Liz Robbins Callahan, Esq. Committee Liaison Questions? 9

Extra Slides 10

TierCriteria 1 i.ECMO ii.Mechanical ventilation iii.Non-dischargeable (surgically implanted) VAD iv.Mechanical circulatory support with life-threatening ventricular arrhythmia 2 i.Intra-aortic balloon pump ii.Ventricular tachycardia/ventricular fibrillation, mechanical support not required iii.Mechanical circulatory support with device malfunction/mechanical failure iv.Total artificial heart v.Dischargeable BiVAD or RVAD vi.Acute circulatory support 3 i.Dischargeable LVAD for up to 30 days ii.Multiple inotropes or single high-dose inotropes with continuous hemodynamic monitoring iii.Mechanical circulatory support with device infection iv.Mechanical circulatory support with thromboembolism v.Mechanical circulatory support with device-related complications other than infection, thromboembolism, device malfunction/mechanical failure or life-threatening ventricular arrhythmia Proposed Tiers

TierCriteria 4 i.Diagnosis of congenital heart disease (CHD) with: a.Unrepaired/incompletely repaired complex CHD, usually with cyanosis b.Repaired CHD with two ventricles (e.g., TOF, TOGV) c.Single ventricle repaired with Fontan or modifications ii.Diagnosis of ischemic heart disease with intractable angina iii.Diagnosis of hypertrophic cardiomyopathy iv.Diagnosis of restrictive cardiomyopathy v.Diagnosis of amyloidosis vi.Stable LVAD candidates after 30 days vii.Inotropes without hemodynamic monitoring viii.Retransplant 5 Approved combined organ transplants: heart-lung; heart-liver; heart-kidney 6 All remaining active candidates Proposed Tiers

Problem DSA boundaries create inequities in access to transplant, particularly for the most urgent candidates Goal Increase the number of donors available to the most critically ill patients, without increasing the number of discarded organs Status TSAM request submitted for 4 different allocations sequences Geographic Sharing Background 13

Broader sharing Tier 1/2 Candidate tier/statusLocation Tier 1 adult + Status 1A pedDSA + Zone A Tier 1 adult + Status 1A pedZone B Tier 2 adultDSA + Zone A Tier 2 adultZone B Tier 3 adult + Status 1B pedDSA Tier 4 adultDSA Tier 3 adult + Status 1B pedZone A Tier 5 adultDSA Tier 3 adult + Status 1B pedZone B Tier 6 adult + Status 2 pedDSA Tier 1 adult + Status 1A pedZone C Tier 2 adultZone C Tier 3 adult + Status 1B pedZone C Tier 4 adultZone A Tier 5 adultZone A Tier 6 adult + Status 2 pedZone A Tier 1 adult + Status 1A pedZone D Sequence 1(Adult Donor) 14 Tier 2 adultZone D Tier 3 adult + Status 1B pedZone D Tier 4 adultZone B Tier 5 adultZone B Tier 6 adult + Status 2 pedZone B Tier 1 adult + Status 1A pedZone E Tier 2 adultZone E Tier 3 adult + Status 1B pedZone E Tier 4 adultZone C Tier 5 adultZone C Tier 6 adult + Status 2 pedZone C Tier 4 adultZone D Tier 5 adultZone D Tier 6 adult + Status 2 pedZone D Tier 4 adultZone E Tier 5 adultZone E Tier 6 adult + Status 2 pedZone E NOTE: Each classification will be further stratified by ABO-primary, then ABO- secondary blood type match.

Broader sharing Tier 1/Tier 2, modified Candidate tier/statusLocation Tier 1 adult + Status 1A pedDSA + Zone A Tier 1 adult + Status 1A pedZone B Tier 2 adultDSA + Zone A Tier 2 adultZone B Tier 3 adult + Status 1B pedDSA Tier 3 adult + Status 1B pedZone A Tier 4 adultDSA Tier 5 adultDSA Tier 3 adult + Status 1B pedZone B Tier 6 adult + Status 2 pedDSA Tier 1 adult + Status 1A pedZone C Tier 2 adultZone C Tier 3 adult + Status 1B pedZone C Tier 4 adultZone A Tier 5 adultZone A Tier 6 adult + Status 2 pedZone A Tier 1 adult + Status 1A pedZone D Sequence 2: (Adult Donor) 15 Tier 2 adultZone D Tier 3 adult + Status 1B pedZone D Tier 4 adultZone B Tier 5 adultZone B Tier 6 adult + Status 2 pedZone B Tier 1 adult + Status 1A pedZone E Tier 2 adultZone E Tier 3 adult + Status 1B pedZone E Tier 4 adultZone C Tier 5 adultZone C Tier 6 adult + Status 2 pedZone C Tier 4 adultZone D Tier 5 adultZone D Tier 6 adult + Status 2 pedZone D Tier 4 adultZone E Tier 5 adultZone E Tier 6 adult + Status 2 pedZone E NOTE: Each classification will be further stratified by ABO-primary, then ABO- secondary blood type match.

Broader sharing all tiers Candidate tier/statusLocation Tier 1 adult + Status 1A pedDSA + Zone A + Zone B Tier 2 adultDSA + Zone A + Zone B Tier 3 adult + Status 1B pedDSA + Zone A Tier 4 adultDSA + Zone A Tier 3 adult + Status 1B pedZone B Tier 5 adultDSA + Zone A Tier 6 adult + Status 2 pedDSA + Zone A Tier 1 adult + Status 1A pedZone C Tier 2 adultZone C Tier 3 adult + Status 1B pedZone C Tier 4 adultZone B Tier 5 adultZone B Tier 6 adult + Status 2 pedZone B Tier 1 adult + Status 1A pedZone D Sequence 3: Adult Donors 16 Tier 2 adultZone D Tier 3 adult + Status 1B pedZone D Tier 4 adultZone C Tier 5 adultZone C Tier 6 adult + Status 2 pedZone C Tier 1 adult + Status 1A pedZone E Tier 2 adultZone E Tier 3 adult + Status 1B pedZone E Tier 4 adultZone D Tier 5 adultZone D Tier 6 adult + Status 2 pedZone D Tier 4 adultZone E Tier 5 adultZone E Tier 6 adult + Status 2 pedZone E NOTE: Each classification will be further stratified by ABO-primary, then ABO- secondary blood type match.

Tier priority Candidate tier/statusLocation Tier 1 adult + Status 1A pedDSA Tier 1 adult + Status 1A pedZone A Tier 1 adult + Status 1A pedZone B Tier 2 adultDSA Tier 2 adultZone A Tier 2 adultZone B Tier 3 adult + Status 1B pedDSA Tier 3 adult + Status 1B pedZone A Tier 4 adultDSA Tier 5 adultDSA Tier 6 adult + Status 2 pedDSA Tier 1 adult + Status 1A pedZone C Tier 2 adultZone C Tier 3 adult + Status 1B pedZone B Tier 4 adultZone A Tier 5 adultZone A Sequence 4: Adult Donor 17 Tier 6 adult + Status 2 pedZone A Tier 1 adult + Status 1A pedZone D Tier 2 adultZone D Tier 3 adult + Status 1B pedZone C Tier 4 adultZone B Tier 5 adultZone B Tier 6 adult + Status 2 pedZone B Tier 1 adult + Status 1A pedZone E Tier 2 adultZone E Tier 3 adult + Status 1B pedZone D Tier 4 adultZone C Tier 5 adultZone C Tier 6 adult + Status 2 pedZone C Tier 3 adult + Status 1B pedZone E Tier 4 adultZone D Tier 5 adultZone D Tier 6 adult + Status 2 pedZone D Tier 4 adultZone E Tier 5 adultZone E Tier 6 adult + Status 2 pedZone E NOTE: Each classification will be further stratified by ABO-primary, then ABO- secondary blood type match.

 All 4 allocation sequences will also be modeled for pediatric donors  For pediatric donors:  pediatric Status 1A candidates will be classified before adult Tier 1 candidates,  pediatric Status 1B candidates will be classified before adult Tier 3 candidates,  pediatric Status 2 candidates will be classified before adult Tier 6 candidates  Pediatric = candidates less than 18 years old (or registered before turning 18 years old) Pediatric Donor Sequences 18