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Items Submitted for Board Consideration

Liver and Intestinal Organ Transplantation Committee Report to the Board of Directors June 25-26, 2012 Richmond, VA Kim M. Olthoff, MD, Chair David C. Mulligan, MD, Vice-Chair. Items Submitted for Board Consideration. “Share 15 National” “Share 35 Regional”

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Items Submitted for Board Consideration

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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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