Moving toward evidence-based liver allocation in patients with primary sclerosing cholangitis


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Model for End-Stage Liver Disease


primary sclerosing cholangitis

The prevailing perception promoted by patient advocate groups is that patients with cholestatic liver disease, including patients with primary sclerosing cholangitis (PSC), are disadvantaged by the Model for End-Stage Liver Disease (MELD) allocation scheme. Indeed, recent studies have shown that PSC patients more frequently received MELD exception points than patients with all other liver disease etiologies.[1] Furthermore, 75% of these PSC patients applying for MELD exception points did not meet the criteria recommended at the 2006 consensus meeting on MELD exceptions (≥2 episodes of bacteremia or ≥1 septic complication).[2, 3] Nevertheless, 80% of PSC patients not meeting MELD exception criteria were approved by the regional review board, and they were more likely to undergo transplantation than those PSC patients meeting the criteria.[1] Furthermore, PSC patients were found to undergo living donor transplantation at a higher rate than patients with other etiologies.[4] In reality, in the MELD era, PSC patients have the best waiting-list survival and have one of the best survival rates after transplantation.[4, 5] However, quality-of-life issues (often related to pruritus) and an increased risk of cholangiocarcinoma have often been noted as reasons for seeking MELD exceptions.[6, 7]

It must be noted that the consensus recommendation regarding MELD exception points for PSC patients with recurrent bacterial cholangitis or septic complications is not evidence-based. Therefore, in PSC patients, the question remains: what role does sepsis play with respect to wait-list mortality and posttransplant survival?

This question of wait-list mortality risk in PSC patients with bacterial cholangitis is addressed in this issue of Liver Transplantation by Goldberg et al.[8] The authors found that transplant candidates on the wait list with PSC who had episodes of bacterial cholangitis did not have an increased risk of wait-list mortality. They also found that none of 30 patients who were removed from the wait list for death or clinical deterioration had known or reported bacterial cholangitis as the reason for delisting. In addition, the MELD scores at transplantation and at wait-list removal were not different for PSC patients with bacterial cholangitis and PSC patients without bacterial cholangitis; this suggests that bacterial cholangitis alone does not result in a significantly increased MELD score that would change wait-list outcomes.

There were several limitations to the study: it was retrospective, was performed at 2 centers (both in a region providing transplantation for patients with high MELD scores), and was based on relatively few patients. Furthermore, the definition of cholangitis was based on physician documentation rather than blood cultures or cholangiographic data. In this study, there was no single clinical finding that was considered confirmatory for bacterial cholangitis, and the diagnosis was based on an individual physician's clinical judgment. In addition, it is unknown how many of the PSC patients were on prophylactic antibiotic therapy when they developed bacterial cholangitis. Of course, the difficulty in defining bacterial cholangitis also remains a challenge for those granting exception points, for which less stringent criteria may be used.

Although the limitations of this study are typical of a retrospective study, it remains interesting that none of the wait-list removals or deaths of PSC patients and none of the patients experiencing clinical deterioration were directly related to bacterial cholangitis. This suggests that the conclusions of this study may be valid. The results of the study also reaffirm a continuing need for standardization throughout the country for granting MELD exception points and the importance of evidence-based data to support the allocation policy.