OPTN and UNOS update policy regarding hepatocellular carcinoma [Classics Series]

This study summary is an excerpt from the book 2 Minute Medicine’s The Classics in Medicine: Summaries of the Landmark Trials

1. Administrators overseeing the national liver transplantation network approved new policy to standardize radiologic imaging criteria for patients with hepatocellular carcinoma (HCC) to qualify for exemption points. Radiologists in US liver transplantation centers asked to implement this policy.

2. This new policy recommends various technical and procedural standards for CT and MR imaging, diagnosis, and classification criteria of HCC. It also seeks to standardize reporting requirements of HCC assessment to transplant networks.

Original Date of Publication: February 2013

Study Rundown: In the United States today, there are approximately three times more patients awaiting liver transplants than those who actually receive a liver. In order to distribute livers to patients determined to be most in need, the Organ Procurement and Transplantation Network (OPTN) and United Network for Organ Sharing (UNOS) set policy in 2002 giving priority to patients most ill and most likely to benefit from transplantation. Patients with early stage HCC have very good prognosis if able to receive a transplant. Therefore, the 2002 OPTN policy was designed to be favorable to patients reported to have early stage HCC and gave exemption points to early-stage HCC patients moving them higher on the Model for End-Stage Liver Disease (MELD) scale of 6 (less ill) to 40 (gravely ill) used to guide which patients received livers. However, the 2002 OPTN/UNOS policy had little structure guiding how HCCs should be diagnosed and reported to the networks. Assessment of UNOS data in 2006 indicated radiologic and pathologic assessment of HCCs only matched for 44.1% of cases. This prompted interest in creating new policy that would enhance imaging accuracy, diagnosis, and reporting of HCC to the transplant networks in order to better distribute liver transplants to HCC patients most likely to benefit. The new liver allocation policy was approved by OPTN/UNOS in 2011. This policy outlines various technological and procedural standards for imaging, classifying, and reporting HCC studies to OPTN. Under the OPTN classification system there are two broad categories of classes, Class 0 and class 5. Class 0 imaging studies are not of sufficient standard to qualify for exception points, and Class 5 studies may qualify for exemption points. Based on characteristics of the tumor upon imaging, the HCC may be reported as Class 5A, 5A-g, 5B, 5T, or 5X, each of which may change the number of exemption points a patient may receive and change their likelihood of receiving a liver transplant.

Click to read the study in Radiology

In-Depth [policy update]: To increase the likelihood that patients with early-stage HCC receive a liver transplant, as their post transplant survival rates are high but current severity of illness is relatively low, these patients are given exception points on OPTN/UNOS transplant lists. New OPTN/UNOS recommendations aim to verify that patients receiving exemption points do indeed have early-stage HCC and outline technological and procedural standards to be met for imaging studies. Such standards include type of CT or MR scanner and contrast to be used. If a liver imaging study reported to OPTN/UNOS does not meet these recommended specifications, it is assigned as Class 0 and no exemption points can be applied. For Class 0 studies it is recommended that the imaging study be redone meeting stated standards. If the imaging study meets these standards, it is Class 5 and further categorized. If the nodule in question is 1-2 cm in diameter and meets qualitative imaging criteria for HCC it is Class 5A. If a nodule appears arterially hyperenhanced, is at least 10 mm in diameter at diagnosis, and has grown 50+% in diameter over a period of 6 months or less is Class 5A-g. A patient having 2-3 Class 5A or 5A-g lesions would qualify them for exemption points. Arterially enhanced 2-5 cm nodules with at least one of two venous phase features (washout or pseudocapsule), or arterially enhanced 2-5 cm nodules displaying 50+% growth in diameter over a period of 6 months or less is Class 5B. Exemption points may be individually requested for Class 5B nodules. Arterially enhanced 5+cm nodules with at least one of two venous features, is Class 5X and typically not eligible for liver transplant. Nodules categorized as Class 5 or confirmed as HCC upon biopsy which were subsequently treated are Class 5T. Class 5T nodules may receive exemption points based on the prior treatment and size. Reports to OPTN seeking exemption points for HCC must use the described classification system. A summary at the end of the report listing number, location, and size of nodules is strongly encouraged.

Wald C, Russo M, Heimbach J, Hussain H, Pomfret E, Bruix J. New OPTN/UNOS Policy for Liver Transplant Allocation: Standardization of Liver Imaging, Diagnosis, Classification, and Reporting of Hepatocellular Carcinoma. Radiology. 2013;266(2):376-382.

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