1. Liver and Intestinal Organ Transplantation Committee
Fall 2012 Public Comment Cycle

2. Share 15 and Share 35 Recent Board Action Approved – June 2012
Share 15 and Share 35 was approved by the board in June 2012 with nearly unanimous approval for both.
Share 15 was highly supported in public comment. The response was somewhat mixed for Share 35. Based on the comments received, the Committee requested and reviewed additional data on exceptions and liver-kidneys (candidates and transplants) prior to making the final recommendation to the Board. After considering the data, the committee strongly supported including all exceptions, candidates needing a combined liver-kidney transplant, and did not recommend a “sharing threshold” for this policy. The policy for sharing a kidney with a liver is the same as it has been – this was not changed.
Presenter –in case you get questions about the public comment or committee votes, here is the breakdown:
Share 15: Of the 42 individual comments received, 76% (n=28) of those with an opinion (n=37) were in support of the proposal. All 11 regions were in support of the proposal. Four Committees voted on the proposal (Patient Affairs, Pediatric Transplantation, Transplant Administrators and Transplant Coordinators) and all were in support. The American Society of Transplantation (AST), American Society of Transplant Surgeons (ASTS) and National Association of Transplant Coordinators (NATCO) indicated their support.
Share 35: . Of the 44 individual comments received, 67% (n=39) of those with an opinion (n=26) were in support of the proposal. Five regions (55%) were in support of the proposal as written, three (27%) indicated support if amended. Two Regions (1 and 6) were opposed and one Region (Region 5) had a tie vote. Four Committees voted on the proposal (Patient Affairs, Pediatric Transplantation, Transplant Administrators and Transplant Coordinators) and all were in support. AST, ASTS and NATCO also indicated their support.
Final Committee Vote for Share 35:
No Sharing Threshold: Committee Vote 20 in favor, 2 opposed, and 1 abstention
Include All Exceptions: Committee Vote 20 in favor, 2 opposed, and 1 abstention
Include Candidates in need of Combined LI-KI: Committee Vote 27 in favor, 1 opposed and 0 abstentions

3. Policy Implementation
Share 15 and Share 35
National Share for Combined Liver-Intestine Candidate: TBD (post-Chrysalis)
HCC Imaging Criteria: TBD (post-Chrysalis)
Share 15 and Share 35 require programming, so they will be implemented after the UNOS computer system rewrite known as the Chrysalis project.
The national share for combined liver-intestine transplant candidates and the the HCC Imaging proposal were approved in November These also need programming and will be implemented after Chrysalis.

4. Combined Local and Regional Status 1A candidates 2
Combined Local and Regional Status 1B candidates 3
Local and Regional Candidates with M/P Scores >=35 by descending M/P score, Local candidates ranked above Regional candidates at each score 4
Local Candidates with MELD/PELD Scores 29-34 5
National Liver-Intestine Candidates 6
Local Candidates with MELD/PELD Scores 15-28 7
Regional Candidates with MELD/PELD Scores 15-34 8
National Status 1A candidates 9
National Status 1B candidates 10
National Candidates with MELD/PELD Scores >=15 11
Local Candidates with MELD/PELD Scores < 15 12
Regional Candidates with MELD/PELD Scores < 15 13
National Candidates with MELD/PELD Scores < 15
This is a clean version of the combined adult donor algorithm, with Share 15, 35, and the national share for combined liver-intestines.
You can see the regional tiered sharing for candidates with a MELD/PELD score of 35 or higher reflected on line number 3. The changes resulting from Share 15 national are reflected in classifications 6 through 10. Line 5 shows the liver-intestine allocation changes that the Board approved at its November 2011 meeting. Remember, this must all be programmed before it can be implemented.

5. Recent Public Comment HCC Hold Proposal Public Comment - Spring 2012
Committee reviewed comments – Sept 5
To be submitted to the Board – November 2012
No changes post-public comment
The “HCC Hold” proposal went out for public comment last spring. This proposal would allow transplant programs to voluntarily place well-compensated candidates with stable or well-treated HCC in inactive status, which we call “HCC Hold”, where livers would not be offered but accumulate exception points would be retained. There was fairly strong support from the public comment.
Of the 62 individual responses, 29 supported, 10 opposed and 23 had no opinion. Of the 39 with an opinion, 74.4% supported and 25.64% opposed.
AST opposed but ASTS supported.
The Patient Affairs and Transplant Administrators committees supported HCC hold. No other committees voted.
All regions voted in favor, except regions 5 and 10, which voted to support if amended.
The Committee reviewed the comments at its meeting Sept. 5th, and voted forward the proposal to the Board in November 2012.

6. Ongoing Committee Initiatives
Reducing discards
Facilitated Placement
HCC Allocation Issues - SRTR modeling
MELD Refit (with or without Na)
Review of MELD/PELD exceptions and RRB practices
Several subcommittees are working on important ongoing initiatives.
The Liver Utilization Working Group is looking at ways to reduce discards and facilitate placement of hard to place livers in a way that is equitable and transparent. The group is trying to identify a set of characteristics of donors more likely to be shared, for potential development of a facilitated placement proposal.
The HCC Working Group is exploring changes to the HCC exception policy, perhaps requiring a waiting period before exception points are assigned, capping the score that can be assigned, and/or assigning scores based on the MELD score at transplant in each region. The Committee will send a questionnaire out to the liver program directors asking for feedback on these issues. Please be on the lookout for that questionnaire!
The MELD Exceptions and Enhancements subcommittee has been reviewing SRTR analyses of a revised MELD score. The subcommittee has looked at a MELD score with updated component coefficients for INR, creatinine, and bilirubin based on current data, with and without the addition of serum sodium. Based on the data reviewed the Committee hopes to have a proposal out for public comment in the spring of 2013 that would add serum sodium to the current MELD formula. The subcommittee is also reviewing trends in MELD/PELD exceptions and will explore ways to make the reviews and criteria more uniform across regions.

7. Adult Non-Status 1 Deceased Donor Liver Txs January 1, 2009 - June 30, 2012
This slide shows the variation among regions in the percentage of patients transplanted with HCC and other exceptions versus the calculated MELD score.

8. New Committee Initiatives
Standard MELD Exception for recipients of DCDs
Revisiting the PELD allocation score
Exploring alternative options for liver distribution with regard to geographic disparity
The MELD Exceptions subcommittee has been discussing a proposal for a standard MELD exception for recipients of DCD liver who later develop strictures, possibly similar to the current exception for HAT.
The PELD subcommittee will consider revising the PELD score, because a high proportion of pediatric patients are transplanted in Status 1 or with a PELD exception.
The Committee is also exploring the concept of redistricting liver distribution units. Sommer Gentry presented this concept at ATC a year ago. This research project is looking at ways to create new/different distribution units that would reduce geographic inequities without substantial increases in travel time.

9. Adult Non-Status 1 Deceased Donor Liver Txs January 1, 2009 - June 30, 2012
This shows how the mean MELD score at transplant varies widely by region.

10. Liver Biopsy Resources
Donor liver biopsy form
Photo documentation resource guide
Steatosis guide
On OPTN Website: esources.asp
Just as a reminder, there are several resources that have been approved by the board that now available for OPOs and pathologists.
The donor liver biopsy form may be used by OPOs to obtain appropriate and consistent biopsy information from their local pathologists. It is easy to upload this information for online access and consideration by transplant centers. Using this standardized reporting and presentation format to routinely report biopsy findings can promote more efficient and well-informed decision-making regarding organ offers.
The photo documentation resource guide is meant to assist liver organ placement. A few standardized photos in situ and on the back-bench can provide substantial information to augment (but not replace) clinical judgment and/or biopsy results. This guide describes when and how such photos can be made available for online access by the transplant centers. It also may assist center staff who must review and interpret any biopsy images provided by the OPO.
The steatosis guide can assist pathologists in assessing the percent steatosis of deceased donor livers.
You can find all of these on the OPTN website under the resource tab by clicking professional resources.

11. Liver Committee Contacts:
Chair: Kim Olthoff, MD
Vice Chair: David Mulligan, MD
Policy Analyst/Committee Liaison: Ann Harper
Here are the contacts for our committee leadership and UNOS staff liaison.
Does anyone have any questions for me?