1 thoracic organ transplantation committee fall 2015

1

Thoracic Organ Transplantation Committee

Fall 2015

Board-Approved Thoracic Committee Projects

2

Title Status

Modify Pediatric Heart Allocation

Proposal approved -- June 2014.

IT implementation begins Fall 2015. Anticipated “go-live” in Q2 2016.

ECMO Data CollectionProposal approved-- June 2015.

Scheduled for implementation -- Q2 of 2016.

EVLP Data CollectionProposal approved -- June 2015. Pending OMB approval and implementation.

Board-Approved Committee Projects

3

Status of Adult Heart Allocation Policy Revision Project

4

Background

Options Considered

6

Steps Taken Thus Far

7

Next Steps

8

Jan 2016 Public

Comment

Joe Rogers, M.D.Committee Chair Joseph.rogers@duke.edu

Regional representative name (RA will complete) Region X Representative email address

Liz Robbins Callahan, Esq.Committee Liaison Liz.robbins@unos.org

Questions?

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Extra Slides

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Tier Criteria

1i. ECMOii. Mechanical ventilationiii. Non-dischargeable (surgically implanted) VADiv. Mechanical circulatory support with life-threatening ventricular arrhythmia

2

i. Intra-aortic balloon pumpii. Ventricular tachycardia/ventricular fibrillation, mechanical support not requirediii. Mechanical circulatory support with device malfunction/mechanical failureiv. Total artificial heartv. Dischargeable BiVAD or RVADvi. Acute circulatory support

3

i. Dischargeable LVAD for up to 30 daysii. Multiple inotropes or single high-dose inotropes with continuous hemodynamic monitoringiii. Mechanical circulatory support with device infectioniv. Mechanical circulatory support with thromboembolismv. Mechanical circulatory support with device-related complications other than infection, thromboembolism, device malfunction/mechanical failure or life-threatening ventricular arrhythmia

Proposed Tiers 1-3

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Tier Criteria

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i. Diagnosis of congenital heart disease (CHD) with:a. Unrepaired/incompletely repaired complex CHD, usually with cyanosisb. 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 anginaiii. Diagnosis of hypertrophic cardiomyopathyiv. Diagnosis of restrictive cardiomyopathyv. Diagnosis of amyloidosisvi. Stable LVAD candidates after 30 daysvii. Inotropes without hemodynamic monitoringviii. Retransplant

5 Approved combined organ transplants: heart-lung; heart-liver; heart-kidney

6 All remaining active candidates

Proposed Tiers 4-6

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Geographic Sharing Background

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Broader sharing Tier 1/2

Candidate tier/status LocationTier 1 adult + Status 1A ped DSA + Zone ATier 1 adult + Status 1A ped Zone BTier 2 adult DSA + Zone ATier 2 adult Zone B

Tier 3 adult + Status 1B ped DSATier 4 adult DSATier 3 adult + Status 1B ped Zone ATier 5 adult DSATier 3 adult + Status 1B ped Zone B

Tier 6 adult + Status 2 ped DSATier 1 adult + Status 1A ped Zone CTier 2 adult Zone CTier 3 adult + Status 1B ped Zone CTier 4 adult Zone A

Tier 5 adult Zone ATier 6 adult + Status 2 ped Zone ATier 1 adult + Status 1A ped Zone D

Sequence 1(Adult Donor)

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Tier 2 adult Zone D

Tier 3 adult + Status 1B ped Zone D

Tier 4 adult Zone B

Tier 5 adult Zone B

Tier 6 adult + Status 2 ped Zone B

Tier 1 adult + Status 1A ped Zone E

Tier 2 adult Zone E

Tier 3 adult + Status 1B ped Zone E

Tier 4 adult Zone C

Tier 5 adult Zone C

Tier 6 adult + Status 2 ped Zone C

Tier 4 adult Zone D

Tier 5 adult Zone D

Tier 6 adult + Status 2 ped Zone D

Tier 4 adult Zone E

Tier 5 adult Zone E

Tier 6 adult + Status 2 ped Zone 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/status LocationTier 1 adult + Status 1A ped DSA + Zone ATier 1 adult + Status 1A ped Zone BTier 2 adult DSA + Zone ATier 2 adult Zone BTier 3 adult + Status 1B ped DSATier 3 adult + Status 1B ped Zone ATier 4 adult DSATier 5 adult DSATier 3 adult + Status 1B ped Zone BTier 6 adult + Status 2 ped DSATier 1 adult + Status 1A ped Zone CTier 2 adult Zone CTier 3 adult + Status 1B ped Zone CTier 4 adult Zone ATier 5 adult Zone ATier 6 adult + Status 2 ped Zone ATier 1 adult + Status 1A ped Zone D

Sequence 2: (Adult Donor)

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Tier 2 adult Zone D

Tier 3 adult + Status 1B ped Zone D

Tier 4 adult Zone B

Tier 5 adult Zone B

Tier 6 adult + Status 2 ped Zone B

Tier 1 adult + Status 1A ped Zone E

Tier 2 adult Zone E

Tier 3 adult + Status 1B ped Zone E

Tier 4 adult Zone C

Tier 5 adult Zone C

Tier 6 adult + Status 2 ped Zone C

Tier 4 adult Zone D

Tier 5 adult Zone D

Tier 6 adult + Status 2 ped Zone D

Tier 4 adult Zone E

Tier 5 adult Zone E

Tier 6 adult + Status 2 ped Zone E

NOTE: Each classification will be further stratified by ABO-primary, then ABO-secondary blood type match.

Broader sharing all tiers

Candidate tier/status Location

Tier 1 adult + Status 1A ped DSA + Zone A + Zone B

Tier 2 adult DSA + Zone A + Zone B

Tier 3 adult + Status 1B ped DSA + Zone A

Tier 4 adult DSA + Zone A

Tier 3 adult + Status 1B ped Zone B

Tier 5 adult DSA + Zone A

Tier 6 adult + Status 2 ped DSA + Zone A

Tier 1 adult + Status 1A ped Zone C

Tier 2 adult Zone C

Tier 3 adult + Status 1B ped Zone C

Tier 4 adult Zone B

Tier 5 adult Zone B

Tier 6 adult + Status 2 ped Zone B

Tier 1 adult + Status 1A ped Zone D

Sequence 3: Adult Donors

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Tier 2 adult Zone D

Tier 3 adult + Status 1B ped Zone D

Tier 4 adult Zone C

Tier 5 adult Zone C

Tier 6 adult + Status 2 ped Zone C

Tier 1 adult + Status 1A ped Zone E

Tier 2 adult Zone E

Tier 3 adult + Status 1B ped Zone E

Tier 4 adult Zone D

Tier 5 adult Zone D

Tier 6 adult + Status 2 ped Zone D

Tier 4 adult Zone E

Tier 5 adult Zone E

Tier 6 adult + Status 2 ped Zone E

NOTE: Each classification will be further stratified by ABO-primary, then ABO-secondary blood type match.

Tier priority

Candidate tier/status Location

Tier 1 adult + Status 1A ped DSA

Tier 1 adult + Status 1A ped Zone A

Tier 1 adult + Status 1A ped Zone B

Tier 2 adult DSA

Tier 2 adult Zone A

Tier 2 adult Zone B

Tier 3 adult + Status 1B ped DSA

Tier 3 adult + Status 1B ped Zone A

Tier 4 adult DSA

Tier 5 adult DSA

Tier 6 adult + Status 2 ped DSA

Tier 1 adult + Status 1A ped Zone C

Tier 2 adult Zone C

Tier 3 adult + Status 1B ped Zone B

Tier 4 adult Zone A

Tier 5 adult Zone A

Sequence 4: Adult Donor

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Tier 6 adult + Status 2 ped Zone ATier 1 adult + Status 1A ped Zone DTier 2 adult Zone DTier 3 adult + Status 1B ped Zone CTier 4 adult Zone BTier 5 adult Zone BTier 6 adult + Status 2 ped Zone BTier 1 adult + Status 1A ped Zone ETier 2 adult Zone ETier 3 adult + Status 1B ped Zone DTier 4 adult Zone CTier 5 adult Zone C Tier 6 adult + Status 2 ped Zone CTier 3 adult + Status 1B ped Zone ETier 4 adult Zone DTier 5 adult Zone DTier 6 adult + Status 2 ped Zone DTier 4 adult Zone ETier 5 adult Zone ETier 6 adult + Status 2 ped Zone 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

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