Skip to main content
Log in

Liver Allocation Policies in the USA: Past, Present, and the Future

  • Review
  • Published:
Digestive Diseases and Sciences Aims and scope Submit manuscript

Abstract

Identifying the optimal allocation policy with regard to hepatocellular carcinoma has been a persistent and evolving challenge. The current criteria for LT for HCC endorsed by the United Network of Organ Sharing (UNOS) are based on the Milan Criteria: a solitary tumor < 5 cm, or maximum of three tumors ≤ 3 cm each, without vascular invasion or evidence of extrahepatic spread. Contraindications to HCC exception points include: stage 1 HCC, ruptured HCC, extrahepatic HCC, and main portal or hepatic vein HCC invasion. Based upon projected waitlist dropout rates due to tumor growth, patients with HCC are assigned MELD standardized exception points. In addition to tumor size and number, AFP levels are an important predictor of recurrence of HCC following liver transplantation. Standardized exception points for HCC patients are not awarded to patients with AFP levels > 1000 ng/mL that do not decrease to < 500 ng/mL with treatment. Appeals for MELD exception points for patients with HCC vary widely between UNOS regions, with success of nonstandardized exception point appeals varying from 3.1 to 21% between regions. In an effort to make prioritization for HCC more consistent, a national liver review board (NLRB)is being convened that will focus on developing a national guidance for assessing common requests and addressing exception points, including for HCC.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Forner A, Reig M, Bruix J. Hepatocellular carcinoma. Lancet. 2018;391:1301–1314.

    Article  PubMed  Google Scholar 

  2. Grandhi MS, Kim AK, Ronnekleiv-Kelly SM, Kamel IR, Ghasebeh MA, Pawlik TM. Hepatocellular carcinoma: from diagnosis to treatment. Surg Oncol. 2016;25:74–85.

    Article  PubMed  Google Scholar 

  3. Rude MK, Crippin JS. Liver transplantation for hepatocellular carcinoma. Curr Gastroenterol Rep. 2015;17:11.

    Article  PubMed  Google Scholar 

  4. Wedd J, Nordstrom E, Nydam T, et al. Hepatocellular carcinoma in patients listed for liver transplantation: current and future allocation policy and management strategies for the individual patient. Liver Transpl. 2007;13:465–466.

    Google Scholar 

  5. Mazzaferro V, Regalia E, Doci R, et al. Liver Transplantaiton for the treatment of small hepatocellular carcinomas in patients with cirrhosis. N Engl J Med. 1996;334:693–699.

    Article  CAS  PubMed  Google Scholar 

  6. Iwatsuki S, Starzl TE, Sheahan DG, et al. Hepatic resection versus transplantation for hepatocellular carcinoma. Ann Surg. 1991;214:221–228.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  7. Ringe B, Wittekind C, Bechstein WO, Bunzendahl H, Pichlmayr R. The role of liver transplantation in hepatobiliary malignancy: a retrospective analysis of 95 patients with particular regard to tumor stage and recurrence. Ann Surg. 1989;209:88–98.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  8. Starzl TE, Marchioro TL, Von KK, et al. Homotranspantation of the liver in humans. Surg Gynecol Obstet. 1963;1963:659–676.

    Google Scholar 

  9. Deshpande R, Hirose R, Mulligan D. Liver allocation and distribution: time for a change. Curr Opin Organ Transpl. 2017;22:162–168.

    Article  Google Scholar 

  10. Klintmalm GB. Who should receive the liver allograft: the transplant center or the recipient? Liver Transpl Surg. 1995;1:55–58.

    Article  CAS  PubMed  Google Scholar 

  11. Coombes JM, Trotter JF. Development of the allocation system for deceased donor liver transplantation. Clin Med Res. 2005;3:87–92.

    Article  PubMed  PubMed Central  Google Scholar 

  12. Lucey MR, Brown KA, Everson GT, et al. Minimal criteria for placement of adults on the liver transplant waiting list: a report of a national conference organized by the American Society of Transplant Physicians and the American Association for the Study of Liver Diseases [see comments]. Liver Transpl Surg. 1997;3:628–637.

    Article  CAS  PubMed  Google Scholar 

  13. Kalra A, Wedd JP, Biggins SW. Changing prioritization for transplantation: MELD-Na, hepatocellular carcinoma exceptions, and more. Curr Opin Organ Transpl. 2016;21:120–126.

    Article  Google Scholar 

  14. Infante-Rivard C, Esnaola S, Villeneuve J-P. Clinical and statistical validity of conventional prognostic factors in predicting short-term survival among cirrhotics. Hepatology. 1987;7:660–664.

    Article  CAS  PubMed  Google Scholar 

  15. Schilsky ML, Moini M. Advances in liver transplantation allocation systems. World J Gastroenterol. 2016;22:2922–2930.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  16. Roayaie KFS. Allocation policy for hepatocellular carcinoma in the MELD Era: Room for improvement? Liver Transpl. 2007;13:465–466.

    Article  Google Scholar 

  17. Fraley DS, Burr R, Bernardini J, Angus D, Kramer DJ, Johnson JP. Impact of acute renal failure on mortality in end-stage liver disease with or without transplantation. Kidney Int. 1998;54:518–524.

    Article  CAS  PubMed  Google Scholar 

  18. Services D of H and H. Organ procurement and transplantation network: final rule with comment period. Fed Regist. 1998;63:16296–16338.

    Google Scholar 

  19. Kalra A, Biggins SW. New paradigms for organ allocation and distribution in liver transplantation. Curr Opin Gastroenterol. 2018;34:123–131.

    PubMed  Google Scholar 

  20. Procurement O, Policies AC, Impact P, Final D, Committee R, Procurement O, et al. Organ Procurement and transplantation: assessing current policies and the potential impact of the DHHS final rule committee on organ procurement and transplantation policy. Institute of Medicine [Internet]; vol. 254, pp 0-309; 1999. Available from: http://www.nap.edu/catalog/9628.html.

  21. Malinchoc M, Kamath PS, Gordon FD, Peine CJ, Rank J, Ter Borg PCJ. A model to predict poor survival in patients undergoing transjugular intrahepatic portosystemic shunts. Hepatology. 2000;31:864–871.

    Article  CAS  PubMed  Google Scholar 

  22. Kamath PS, Wiesner RH, Malinchoc M, et al. A model to predict survival in patients with end-stage liver disease. Hepatology. 2001;33:464–470.

    Article  CAS  PubMed  Google Scholar 

  23. McDiarmid SV, Anand R, Lindblad AS. Development of a pediatric end-stage liver disease score to predict poor outcome in children awaiting liver transplantation. Transplantation. 2002;74:173–181.

    Article  PubMed  Google Scholar 

  24. Barbara L, Benzi G, Gaiani S, et al. Natural history of small untreated hepatocellular carcinoma in cirrhosis: a multivariate analysis of prognostic factors of tumor growth rate and patient survival. Hepatolog [Internet]. 1992;16:132–137.

    Article  CAS  Google Scholar 

  25. Cheng SJ, Freeman RB, Wong JB. Predicting the probability of progression-free survival in patients with small hepatocellular carcinoma. Liver Transpl. 2002;8:323–328.

    Article  PubMed  Google Scholar 

  26. Sharma P, Balan V, Hernandez JL, et al. Liver transplantation for hepatocellular carcinoma: the MELD impact. Liver Transpl. 2004;10:36–41.

    Article  PubMed  Google Scholar 

  27. Wiesner RH, Freeman RB, Mulligan DC. Liver transplantation for hepatocellular cancer: the impact of the MELD allocation policy. Gastroenterology. 2004;127:261–267.

    Article  Google Scholar 

  28. Freeman RB, Wiesner RH, Edwards E, Harper A, Merion R, Wolfe R. Results of the first year of the new liver allocation plan. Liver Transpl. 2004;10:7–15.

    Article  PubMed  Google Scholar 

  29. Yao FY, Bass NM, Nikolai B, et al. Liver transplantation for hepatocellular carcinoma: analysis of survival according to the intention-to-treat principle and dropout from the waiting list. Liver Transpl [Internet]. 2002;8:873–883.

    Article  Google Scholar 

  30. Freeman RB, Edwards EB, Harper AM. Waiting list removal rates among patients with chronic and malignant liver diseases. Am J Transpl. 2006;6:1416–1421.

    Article  CAS  Google Scholar 

  31. Merion RM, Schaubel DE, Dykstra DM, Freeman RB, Port FK, Wolfe RA. The survival benefit of liver transplantation. Am J Transpl. 2005;5:307–313.

    Article  Google Scholar 

  32. Elwir S, Lake J. Current status of liver allocation in the United States. Gastroenterol Hepatol (NY) [Internet]. 2016;12:166–170.

    Google Scholar 

  33. Massie AB, Chow EKH, Wickliffe CE, et al. Early changes in liver distribution following implementation of Share 35. Am J Transpl. 2015;15:659–667.

    Article  CAS  Google Scholar 

  34. Edwards EB, Harper AM, Hirose R, Mulligan DC. The impact of broader regional sharing of livers: 2-year results of “share 35”. Liver Transpl. 2016;22:399–409.

    Article  PubMed  Google Scholar 

  35. Northup PG, Intagliata NM, Shah NL, Pelletier SJ, Berg CL, Argo CK. Excess mortality on the liver transplant waiting list: Unintended policy consequences and model for end-stage liver disease (MELD) inflation. Hepatology. 2015;61:285–291.

    Article  PubMed  Google Scholar 

  36. Massie AB, Caffo B, Gentry SE, et al. MELD exceptions and rates of waiting list outcomes. Am J Transpl. 2011;11:2362–2371.

    Article  CAS  Google Scholar 

  37. Roberts JP, Venook A, Kerlan R, Yao F. Hepatocellular carcinoma: ablate and wait versus rapid transplantation. Liver Transpl.. 2007;13:465–466.

    Google Scholar 

  38. Pompili M, Francica G, Ponziani FR, Iezzi R, Avolio AW. Bridging and downstaging treatments for hepatocellular carcinoma in patients on the waiting list for liver transplantation. World J Gastroenterol. 2013;19:7515–7530.

    Article  PubMed  PubMed Central  Google Scholar 

  39. OPTN. HCC policy changes affect applications for non-automatic exception requests [Internet]. HRSA. 2015. Available from: https://optn.transplant.hrsa.gov/news/hcc-policy-changes-affect-applications-for-non-automatic-exception-requests/.

  40. OPTN/UNOS. OPTN/UNOS policy notice modification to hepatocellular carcinoma (HCC) extension criteria. 2018.

  41. Heimbach JK, Hirose R, Stock PG, et al. Delayed hepatocellular carcinoma MELD exception score improves disparity in access to liver transplant in the US julie. Hepatology. 2015;61:1643–1650.

    Article  PubMed  PubMed Central  Google Scholar 

  42. Yao FY, Mehta N, Flemming J, et al. Downstaging of hepatocellular cancer before liver transplant: long-term outcome compared to tumors within Milan criteria. Hepatology. 2015;61:1968–1977.

    Article  PubMed  PubMed Central  Google Scholar 

  43. OPTN/UNOS. Liver review board guidance documents liver review board guidance documents. 2017.

  44. Hameed B, Mehta N, Sapisochin G, Roberts JYF. Alpha-fetoprotein level > 1000 ng/mL as an exclusion criterion for liver transplantation in patients with hepatocellular carcinoma meeting the milan criteria. Liver Transpl. 2007;13:465–466.

    Google Scholar 

  45. Soriano A, Varona A, Gianchandani R, et al. Selection of patients with hepatocellular carcinoma for liver transplantation: past and future. World J Hepatol. 2016;8:58–68.

    Article  PubMed  PubMed Central  Google Scholar 

  46. Biggins SW, Kim WR, Terrault NA, et al. Evidence-based incorporation of serum sodium concentration Into MELD. Gastroenterology. 2006;130:1652–1660.

    Article  PubMed  Google Scholar 

  47. Biggins SW, Rodriguez HJ, Bacchetti P, Bass NM, Roberts JP, Terrault NA. Serum sodium predicts mortality in patients listed for liver transplantation. Hepatology. 2005;41:32–39.

    Article  CAS  PubMed  Google Scholar 

  48. Kim WR, Biggins SW, Kremers WK, et al. Hyponatremia and mortality among patients on the liver-transplant waiting list. N Engl J Med [Internet]. 2008;359:1018–1026.

    Article  CAS  Google Scholar 

  49. Trotter JF, Brimhall B, Arjal R, Phillips C. Specific laboratory methodologies achieve higher model for endstage liver disease (MELD) scores for patients listed for liver transplantation. Liver Transpl. 2004;10:995–1000.

    Article  PubMed  Google Scholar 

  50. https://optn.transplant.hrsa.gov/governance/public-comment/liver-and-intestine-distribution-using-distance-from-donor-hospital/.

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Michael Charlton.

Ethics declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Pillai, A., Couri, T. & Charlton, M. Liver Allocation Policies in the USA: Past, Present, and the Future. Dig Dis Sci 64, 985–992 (2019). https://doi.org/10.1007/s10620-019-05549-y

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10620-019-05549-y

Keywords

Navigation