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Enhancing Liver Allocation: Strategies to Improve Transplant Outcomes and Reduce Disparities

The June 2012 report from the Liver and Intestinal Organ Transplantation Committee addresses the urgent need to reduce waitlist mortality for liver transplant candidates with high MELD scores. It highlights significant disparities in transplant outcomes across different OPOs and regions. The report proposes policy changes, including the extension of the Share 15 National and Share 35 Regional approaches, supported by data on waitlist mortality and post-transplant survival. Stakeholder feedback underscores the necessity of equitable liver allocation to those most in need.

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Enhancing Liver Allocation: Strategies to Improve Transplant Outcomes and Reduce Disparities

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  1. Liver and Intestinal Organ Transplantation Committee Report to the Board of DirectorsJune 25-26, 2012Richmond, VAKim M. Olthoff, MD, ChairDavid C. Mulligan, MD, Vice-Chair

  2. Items Submitted for Board Consideration • “Share 15 National” • “Share 35 Regional” • Endorsement of Liver Biopsy Resources (Consent Agenda)

  3. Problem Statement • Despite improvements in liver allocation and distribution, waitlist mortality remains high for patients with higher MELD scores • Significant disparity exists between OPOs and regions with regard to mean MELD at transplant and waitlist mortality • How can we direct livers to most in need?

  4. Supporting Data

  5. Competing Risk Liver Waiting List Outcome Probabilities at 1-YearCandidates Added 2007-2010 N=10319 N=15810 N=2363 *Status 1A/1B, and candidates with exceptions excluded

  6. Mean Match MELD @ Transplant* Deceased Donor Liver Transplants, 2010 by DSA within Region *Adults only, Exceptions. Some DSAs may overlap

  7. Death Rates* @ 365 Days, Candidates Listed for a DD Liver Transplant 1/1/2008-12/31/09By DSA within Region *Adults only, Calculated using Competing Risks, Exceptions, Initial MELD>=15, Candidates with an Initial Status of 1A/1B Excluded, DSAs with fewer than 10 events excluded

  8. Results: Waitlist Mortality – Intent to treat

  9. Results: Waitlist Mortality – Intent to treat

  10. Results: Waitlist Mortality – As treated Status 1A MELD/PELD 35+ 53% Temporarily inactive 6.5% changed to 1A/1B 40.5% changed to lower MELD 78% Temporarily inactive 22% changed to MELD

  11. Post Transplant Patient Survival – KM Curve

  12. Policy Development

  13. Policy Development History I • Proposal for Regional Sharing (February 2009) • Request for Forum (June 2009) • RFI and Survey (December 2009) • Forum in Atlanta (April 2010) • Board directed Committee “to develop recommendations to reduce geographic disparities in waitlist mortality”(June 2010) • Concept Paper/Survey (December 2010)

  14. Policy Development History II • Presentations at AASLD, ASTS Winter Symposium, ATC (2010 and 2011) • Public Comment (September - December 2011) • Public Webinar (October 2011) • Review of Comments (March 2012) • Final Committee Vote (May 2012)

  15. Options Considered • Full Regional Sharing – strong opposition • Concentric Circles – mixed support • Extension of Share 15 Regional – strong support • Tiered Regional Sharing – strong support for some level (29, 32, 35, other) • Net Transplant Benefit – mixed support

  16. Policy Changes Being Proposed • Extension of Regional Share 15 => Share 15 National • Share 35 Regional - Candidates with MELD/PELD scores of 35 and higher • Could be combined if both approved

  17. Current Algorithm* • Combined OPO and Regional LI Status 1A • Combined OPO and Regional LI Status 1B • OPO LI MELD/PELD ≥ 15 • Regional LI MELD/PELD ≥ 15 • OPO LI MELD/PELD < 15 • Regional LI MELD/PELD < 15 • National LI Status 1A • National LI Status 1B • National LI MELD/PELD. i.e.,: National LI MELD/PELD >=15 National LI MELD/PELD <15 *Does not include recently-approved liver-intestine policy

  18. Share 15 National* • Regional Status 1A • Regional Status 1B • Local MELD/PELD>=15 • Regional MELD/PELD>=15 • National Status 1A • National Status 1B • National MELD/PELD>=15 • Local MELD/PELD<15 • Regional MELD/PELD<15 • National MELD/PELD<15 * Adult Donors Only

  19. Share 35 Regional* 3.1 Local M/P 40 3.2 Regional 40 3.3 Local M/P 39 3.4 Regional M/P 39 3.5 Local M/P 38 3.6 Regional M/P 38 3.7 Local M/P 37 3.8 Regional M/P 37 3.9 Local M/P 36 3.10 Regional M/P 36 3.11 Local M/P 35 3.12 Regional M/P 35 • Regional Status 1A • Regional Status 1B • Local and Regional M/P >=35 • Local M/P 15-34 • Regional M/P 15-34 • Local M/P < 15 • Regional M/P <15 • National Status 1A • National Status 1B • National M/P ≥ 15 • National M/P < 15 * Adult Donors Only

  20. Share 35R, Combined with Share 15N* 3.1 Local M/P 40 3.2 Regional 40 3.3 Local M/P 39 3.4 Regional M/P 39 3.5 Local M/P 38 3.6 Regional M/P 38 3.7 Local M/P 37 3.8 Regional M/P 37 3.9 Local M/P 36 3.10 Regional M/P 36 3.11 Local M/P 35 3.12 Regional M/P 35 • Regional Status 1A • Regional Status 1B • Local and Regional M/P >=35 • Local M/P 15-34 • Regional M/P 15-34 • National Status 1A • National Status 1B • National M/P ≥ 15 • Local M/P < 15 • Regional M/P <15 • National M/P < 15 * Adult Donors Only

  21. Potential Impact LSAM MODELING REDUCTION IN WAITING LIST DEATHS PER YEAR

  22. Post-Public Comment Consideration

  23. Public Comments – Share 15 Percentages based on responses with an opinion *Ethics and MAC commented but did not vote

  24. Public Comments – Share 15 • Committees in Support: Patient Affairs, Pediatric Transplantation, Transplant Administrators and Transplant Coordinators • Societies in Support: AST, ASTS, NATCO • Opposition: increased costs/CIT; threshold of 15 being based on old analyses; patients with congenital hepatic fibrosis

  25. Plan for Evaluating the Proposal Hypothesis: Greater access to organs for sicker candidates will decrease their waiting list mortality, without a demonstrable increase in mortality for other candidates, due to the small number of candidates involved. Data to be reviewed every 6 months post-implementation: • Waiting list mortality by MELD score • Post-transplant patient and graft survival • Percent shared between OPOs • Percent shared nationally

  26. Data Collection This proposal does not require additional data collection in UNet℠.

  27. Resolution/Policy Language *** RESOLVED, that modifications to Policy 3.6 (Allocation of Livers, Adult Donor Liver Allocation Algorithm) are hereby approved as set forth in Resolution 18, effective pending programming in UNet℠ and notice to OPTN membership.

  28. Public Comments – Share 35 Percentages based on responses with an opinion *The MAC commented without voting

  29. Regional Votes – Share 35 * Votes: Yes - No - Abstention

  30. Public Comments – Share 35 • Committees in Support: Patient Affairs, Pediatric Transplantation, Transplant Administrators and Transplant Coordinators • Societies in Support: AST, ASTS, NATCO • Opposition: increased costs/CIT; potential effect on small programs; inclusion of exceptions and candidates awaiting a combined liver-kidney transplant; and use of a “sharing threshold.” • For each option, some comments and regions were in support (e.g., exceptions must be included) while others were in opposition (e.g., exceptions must be excluded).

  31. Response to Public Comment - I Sharing threshold • Very complicated in concept and would be in practice • LSAM modeling – affected only 5% of transplants (ranging from 4.68% to 5.16% across the proposals modeled) CIT • SRTR analyses showed that CIT does not correlate well with distance, ranging from 6 hours for very short distances, to 7 hours for distances of 250 miles or more. • This may be more related to center practices for transplantation of local versus imported donors.

  32. Response to Public Comment - II Variance for Hawaii • HI may submit a variance application Inclusion or Exclusion of Exceptions • See additional data • HAT • HCC • Others Inclusion of SLK • See additional data

  33. Additional Data Requested to Assess Inclusion of Exceptions and SLKs

  34. MELD/PELD 35+ Candidates 2009 – 2011: By Region The percentage of all candidates listed who entered MP35+ ranged by region from 6.4% to 14.9%. Regions 2,5 and 7 had the largest numbers.

  35. MELD/PELD 35+ Candidates 2009 –2011: Categories of Exceptions and Standard Cases About 90% of the candidates in MP35+ were assigned standard MELD/PELD scores; less than 1% were HCC exceptions.

  36. MELD/PELD 35+ Candidates 2009 –2011: Rates of Death* and Transplant By Kidney Listing/Dialysis Being either on the KI WL or on dialysis was associated with higher death rates and lower transplant rates. Candidates on KI WL and on dialysis (N=430) had highest death rates at 90 days (39.1%) and lowest transplant rate (49.8%) (data not shown). *Includes candidates removed for too sick

  37. MELD/PELD 35+ DD Txs 2009 –2011: 1 Yr Graft/Patient Survival Rates by Type of Exception and Standard MELD/PELD Category Note: All Exceptions vs. All Non-Exceptions (Graft: 86.7% vs. 78.4% Patient: 90.0% vs. 81.2%) Standard MELD recipients on dialysis had the lowest survival at 1 year; Non-HAT exceptions had the highest 1-year survival.

  38. MELD/PELD 35+ DD Txs, 2009 –2011: 1-Yr Graft/Patient Survival Rates by Dialysis Status, Kidney Listing, and Kidney Transplant Recipients on dialysis had lower graft and patient survival rates; Recipients listed for a KI that did not receive a KI transplant with the liver had the lowest survival rates (at 10 months).

  39. Final Proposal • 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 • Submit Share 35 to the Board: 27 in favor, 1 opposed, and 0 abstentions

  40. Plan for Evaluating the Proposal Hypothesis: Greater access to organs for sicker candidates will decrease their waiting list mortality, without a demonstrable increase in mortality for other candidates, due to the small number of candidates involved. Data to be reviewed every 6 months post-implementation: • Waiting list mortality by MELD score • Post-transplant patient and graft survival • Percent shared between OPOs • Percent shared nationally • Percent of MELD exceptions scores transplanted at high MELDs (35+)

  41. Data Collection This proposal does not require additional data collection in UNet℠.

  42. Resolution/Policy Language *** RESOLVED, that modifications to Policy 3.6 (Allocation of Livers, Adult Donor Liver Allocation Algorithm) are hereby approved as set forth in Resolution 19, effective pending programming in UNet℠ and notice to OPTN membership

  43. BIOPSY RESOURCES

  44. Biopsy Resources • Organ Availability Committee (OAC) developed a standardized liver biopsy reporting form and accompanying resource document – Committee Dissolved in 2011 • Purpose: to improve the accuracy and completeness of the information surgeons need when considering a liver for their patients. • Designed for OPOs to make available to their pathologists. • Not mandatory, forms; would be provided by OPOs as a resource. • Photo resource document: standardized photographs in situ and on the back-bench to assist in decision-making regarding organ suitability by augmenting (but not replacing) clinical judgment and/or biopsy results. • Will be helpful when the procuring team is not the transplanting team.

  45. Photo Documentation Resource Guide

  46. Resolution *** RESOLVED, that the Liver Biopsy Form and Resource Documents developed by the Organ Availability Committee and set forth in Exhibit H to the Liver and Intestinal Organ Committee‘s report to the Board, are hereby approved and effective pending notice to OPTN membership.

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