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Liver and Intestinal Organ Transplantation Committee

UpdateSpring 2012

Kim Olthoff, MD, ChairDavid Mulligan, MD, Vice-chair

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Proposals Circulated Fall 2011

Public Comment ended 12/23/2011 Committee met 03/15/2012, reviewed comments• Share 15 National will be submitted to the Board of

Directors in June• Share 35 Regional - Several decisions:• Will apply to MELD/PELD exceptions• No Sharing Threshold• Awaiting data on Liver-Kidney before decision• Will meet by call in April or May to vote on Board

submission

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Other Committee Initiatives

MELD Enhancements & Exceptions Subcommittee• MELD Refit (with or without Na)• Review of issues with MELD/PELD exceptions /

Review Boards• Revisit PELD Score

Liver Utilization Subcommittee• Reducing discards• “Facilitated Placement”

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Other Committee Initiatives

HCC Subcommittee• Explant Pathology Form – Going online• Will replace faxed forms• System notice 2 weeks prior

• HCC Hold Proposal (Spring 2012)• HCC Allocation Issues

Status 1 Review Subcommittee • Ongoing real-time review of Status 1A/B cases

not meeting criteria

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Questions?

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Liver and Intestinal Organ Transplantation Committee

Proposal for Public Comment

Spring 2012

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Proposal to Allow Centers to Place Liver Candidates with HCC

Exceptions on ‘HCC Hold’ Without Loss of Accumulated MELD

Exception Score

(“HCC Hold”)

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PROBLEM STATEMENT / BACKGROUND

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Problem Statement - ICurrently: Candidates listed with an HCC exception continue to

receive increases in priority every three months regardless of whether the tumors have shown progression

As score increases (22, 25, 28, etc.) candidates begin to receive offers

Centers may wish to inactivate some candidates until there is demonstrated tumor progression:

• Candidates initially listed with small tumors• Those with well-treated tumors

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Problem Statement - II No mechanism to do this without:• Automatic increases in score (if extended while

inactivated) OR• Loss of accumulated score (if not extended while

inactive If inactivated, centers must submit extensions every

three months• Otherwise candidate loses accumulated MELD

score• Score continues to increase even though risk of

drop-out may be low

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Proposal Allow centers to place liver candidates with

HCC Exceptions on ‘HCC Hold’ without loss of accumulated MELD exception score and without mandatory/standard increases in the score q 3 mo

In practice: Candidate is inactivated, reason provided is “HCC hold”

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Benefits Will eliminate offers for high-MELD patients that

the center is not yet ready to transplant• Improve efficiency of the system (fewer

turndowns)• Decrease required applications for extensions,

and tests required to complete applications Allows centers to utilize different ways of treating

these patients (e.g., TACE, RFA), while providing the safety net of transplant if/when tumor recurs or demonstrates growth

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Summary Current Process in UNet℠ Proposed Change

Centers can extend an approved HCC Exception while candidate is in inactive status.

No change.

Approved HCC Exception applications must be extended every 3 months, even while the candidate is in inactive status. If the application is not extended, the candidate will lose the accumulated exception score upon re-activation.

Approved HCC Exception applications may remain on ‘HCC hold’ as long as a candidate is in inactive status; once re-activated, the candidate will retain the accumulated exception score (most recent tumor information must be provided).

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Example A (p. 62 of proposal)

1/1/2012: Candidate has approved HCC exception, one 2.1 cm tumor (MELD 22).

Exception extended 4/1 (25) and 7/1 (28). Candidate begins receiving offers; tumor size still

2.1cm Transplant team decides to observe tumor

behavior before proceeding to transplant Candidate placed on “HCC hold,” periodically

undergoes CT to monitor the lesion.

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Example A (p. 62 of proposal)

12/10/12: CT shows tumor has grown to 2.8 cm. 12/15/12: Center submits the routine tumor

information and activates candidate Candidate’s score of 28 maintained until the next

extension

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Example B (p. 62 of proposal) 1/1/2012: Candidate has approved HCC exception, one

tumor treated with RFA that is 2.5 cm in size (MELD 22). Exception extended 4/1 (25) and 7/1 (28). Candidate begins receiving offers, however the candidate

has an ablation defect  with no evidence of viable tumor Transplant team decides to observe tumor behavior before

proceeding to transplant. Candidate placed on “HCC hold,” periodically undergoes

CT to monitor the lesion.

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Example B (p. 62 of proposal)

1/1/13: CT shows no evidence of viable tumor at the ablation site but a new 1cm hypervascular lesion with wash out on delayed phase imaging.

1/5/13: Center submits the routine tumor information and activates candidate.

Candidate’s score of 28 is maintained until the next extension

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Supporting Data

Candidates with small HCC tumors have a low probability of waiting list dropout or growth beyond current transplant criteria within 12 months of listing• Washburn et al, AJT 2010• Massie, et al, AJT 2011

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Policy

The following options are available while a candidate with an approved HCC Exception application is in inactive status: • The center may choose to submit an

extension application every 3 months, as described above; the candidate will receive a MELD/PELD score equivalent to a 10 percentage point increase in candidate mortality following each approved extension.

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Policy• The center may keep the candidate in inactive

status for any length of time, without submission of an extension application every 3 months. However, prior to reactivation, an extension application must be submitted. Once the extension application is approved, the candidate will be listed with the candidate’s previously approved exception score prior to inactivation (i.e., without loss of the accumulated MELD/PELD exception score) upon re-activation.

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Plan for EvaluatingThe Committee will review annually:How often this option is usedMean MELD/PELD scores at transplant, number and % of candidates removed from the waiting list for reasons other than transplant for candidates with HCC exceptions versus those without, by RegionOutcomes for candidates whose exception is placed on hold

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Additional Information

Additional Data Collection:

These proposals do not require additional data collection (forms) in TiediSM

 

Expected Implementation Plan:  

UNOS Information Technology (IT) staff will need to reprogram UNetSM to implement these algorithms

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Questions?