Liver listing and allocation forum - May 2016

The Liver Listing and Allocation Forum was an important step in the collaborative work of the Canadian Liver Transplant Network (CLTN), the Canadian Society for Transplantation (CST), and Canadian Blood Services. The purpose of the Forum was to identify, review, and build on current listing and allocation strategies for liver transplant with a view to developing interprovincial/territorial policies for Canada. The ultimate goal was to achieve consensus to ensure fair and transparent access based on the identification of leading practices, leading to improved system performance.

Executive Summary including Recommendations

Background

Canadian Blood Services, in collaboration with the Canadian Liver Transplant Network and the Canadian Society for Transplantation, hosted a gathering of about 40 experts in Vancouver on May 26-27 2016 to identify, review, and build on current listing and allocation strategies for transplants of livers from deceased donors. The ultimate aim was to develop recommendations for Canadian transplant programs to ensure fair access to livers for patients on transplant waitlists.

Approach

The Forum process began with comprehensive planning, including scoping and initial development of challenge questions, 2 and then moved to knowledge assembly that culminated in an on-site expert meeting focussed on building consensus. Background documents on liver transplant were provided to Forum participants beforehand including:

Two draft policies developed by the MELD-PELD Liver Forum Working Group: (a) MELDNa for liver transplant allocation, and (b) allocation of livers to pediatric recipients according to the Canadian Pediatric Allocation of Livers System (CPALS).
Three literature reviews on (a) MELD-Na and 5vMELD versus MELD, (b) pediatric scoring models, and (c) scoring systems for hepatocellular carcinoma (HCC), based on reviews of the international literature.
An environmental scan of HCC practices in Canada and internationally, including within it a list of selected publications from Canadian universities that were related to HCC and liver transplant.

Topic areas were addressed during the Forum using a consistent process: (a) presentations by experts were followed by question-and-answer sessions; (b) discussions among experts addressed key clinical “challenge questions” both in plenary and in small groups; (c) a Forum Recommendations Group convened to review and refine the outcomes of the plenary discussions and to finalize recommendations and key discussion points related to the questions. Areas for further research were also identified throughout the Forum. 2 “Challenge questions” are used to structure expert discussions in order to address policy and practice issues. The goal is to achieve consensus recommendations. To the extent practical, challenge questions are accompanied by information to inform discussions such as available evidence and environmental scans.

Forum Recommendations

The main Forum output was 21 consensus-based recommendations for Canadian liver transplant programs, including key discussion points related to the questions asked (as the basis for each recommendation), and areas for further research. The recommendations were developed in six areas:

A. General Principles
B. Policy: Adult Scoring System
C. Policy: Pediatric Scoring System
D. HCC Eligibility Criteria
E. HCC Management: Bridging Therapy
F. HCC Management: Downstaging

A. General Principles

1. It is recommended that liver transplant programs offer livers from deceased donors first to patients at the highest risk of death, or drop-out for cause.

2. It is recommended that programs strive for similar rates of deaths and drop-outs for all indications for patients on the waitlist, based on exception points where required.

3. It is recommended that recording and sharing of outcomes data for waitlisted and transplanted patients be mandatory.

4. It is recommended that the minimum acceptable estimated 5-year patient survival rate be 60% for allocating a deceased donor liver for transplant.

5. It is recommended that the liver transplant community support Canadian programs to generate new knowledge by exploring novel approaches to liver transplant (for HCC) if (a) outcomes are expected to match or exceed the minimum 60% 5-year survival benchmark, and (b) results are reported and shared.

B. Policy: Adult Scoring System

6. It is recommended that the proposed MELD-Na policy be implemented by Canadian liver transplant programs (as amended in Recommendation 6).

7. It is recommended that a new laboratory testing frequency guideline based on MELD-Na scores be adopted: for MELD-Na ≥ 30, lab results must be captured at least every 7 days; for MELD-Na 21-29, lab results must be captured at least every 30 days; and for MELD-Na ≤ 20, lab results must be captured at least every 90 days. Non-adherence to this schedule will result in reversion to a patient’s previous lower MELD-Na score. There are two steps in the implications for non-adherence: (a) Beyond the deadline (with 3 days grace for MELD-Na > 30) the program will receive a warning and the patient will revert to the most recent lower MELD (if there is only one MELD score on record, the patient will drop to the median of the next lower category, e.g., > 30 drops to 25); (b) Beyond the deadline by 7 days (this includes 14 days for MELD-Na > 30), the patient will be inactivated on the waitlist.

8. It is recommended that programs monitor the frequency of patient non-adherence with required laboratory testing to identify opportunities for performance improvement.

C. Policy: Pediatric Scoring System

9. It is recommended that a Canadian pediatric allocation policy (CPALS) (Appendix 3) be implemented by pediatric liver transplant programs (including the detail contained in Recommendation 9).

10. It is recommended that patients listed as pediatric maintain their MELD exception points beyond their 18th birthdays until liver transplant occurs.

D. HCC Eligibility Criteria

11. It is recommended that programs use the TTV/AFP criteria (TTV ≤ 115 cm3 and AFP ≤ 400 ng/mL) for eligibility rather than using the Milan Criteria.

12. It is recommended that programs follow the standardized diagnostic guidelines developed by the American Association for the Study of Liver Diseases (AASLD).

13. It is recommended that patients who are not eligible for liver transplant because they are beyond the HCC listing guidelines at evaluation should not subsequently be determined to be eligible based on deterioration of medical status.

14. It is recommended that patients should not be offered a liver transplant when a curative intent can be achieved by other means.

15. It is recommended that salvage transplant3 be offered only to patients who meet liver transplant listing criteria prior to resection. Salvage transplant is where liver resection was employed as first-line treatment of patients with small HCCs and good liver function, with secondary liver transplant used in cases of tumour recurrence.

D. HCC Allocation – Exception Points

16. It is recommended that LTAC develop common approaches for liver transplant for HCC to ensure transparency and accountability.

17. It is recommended that LTAC explore a national system for awarding exception points for liver transplant for HCC, taking into consideration regional variations, e.g., differences in live and deceased donor rates, median MELD score at time of transplant, and patient populations.

E. HCC Management: Bridging Therapy

18. It is recommended that access to bridging therapy while on the waitlist be considered a standard of care. 19. It is recommended that access to bridging therapy within 4-6 weeks of the decision to bridge is desirable, given the potential for rapid progression of HCC.

F. HCC Management: Downstaging

20. It is recommended that downstaging for patients with HCC be accepted as reasonable treatment.

21. It is recommended that macrovascular invasion and extrahepatic metastases be considered contraindications for downstaging.

Full Report

PDF copies of the following reports are available by request. Submit a request by sending an email to OTDT@blood.ca, please include the title and use the subject line: PDF Document Request. Liver Listing and Allocation Forum (May 2016)