Effect of Mandatory 6‐Month Waiting Period on Waitlist and Transplant Outcomes in Patients With Hepatocellular Carcinoma

Abstract

BaCKgRoUND aND aIMS: Organ Procurement and Transplantation Network/United Network for Organ Sharing (OPTN/UNOS) policy mandates a 6-month waiting period before exception scores are granted to liver transplant candidates with hepatocellular carcinoma (HCC). This study aims to evaluate waitlist and posttransplant outcomes in patients with HCC, before and after implementation of the 6-month waiting rule. appRoaCH aND ReSUltS: We examined two groups from the UNOS registry: Group 1 (pre-6-month rule) consisted of patients registered as transplant candidates with HCC from January 1, 2013, to October 7, 2015 (n = 4,814); group 2 (post-6-month rule) consisted of patients registered from October 8, 2015, to June 30, 2018 (n = 3,287). As expected, the transplant probability was higher in the first 6 months after listing in group 1 than group 2 at 42.0% versus 6.3% (P < 0.001). However, the 6-month waitlist mortality/dropout rate was lower in group 2 at 1.2% than group 1 at 4.1% (P < 0.001). To assess regional parity of transplant, UNOS regions were categorized into three groups based on Model for End-Stage Liver Disease score at transplant: lowerscore (regions 3, 10, and 11), middle-score (1, 2, 6, 8, and 9), and higher-score region groups (4, 5, and 7). Outcomes were compared from the time exception points were given, which we defined as conditional waitlist outcomes. Conditional waitlist mortality/dropout decreased, and transplant probability increased in all region groups, but the benefits of the policy were more pronounced in the higher and middle-score groups, compared with the lower-score group. The decline in waitlist mortality/dropout was only significant in the high Model for End-Stage Liver Disease group (P < 0.001). No effect was observed on posttransplant mortality or percent of patients within Milan criteria on explant. CoNClUSIoNS: The HCC policy change was associated with decreased waitlist mortality/dropout and increased transplant probability. The policy helped to decrease but did not eliminate regional disparities in transplant opportunity without an effect on posttransplant outcomes.

T2 Hepatocellular Carcinoma Exception Policies That Prolong Waiting Time Improve the Use of Evidence-based Treatment Practices

“…Our study expands several recent studies evaluating the impacts of the 2015 HCC exception policy change. 13 – 15 Ishaque et al showed that the policy resulted in decreased transplantation rates and increased mortality/dropout for HCC candidates, attenuating the advantage they have compared with non-HCC candidates. Brondfield et al demonstrated longer waitlist times, particularly in short-wait regions, and decreased regional variability in dropout rates.…”

“…This ensured that all imaging findings were available during candidates’ waiting time but also led to a smaller-sized postpolicy cohort than that reported by other investigators. 13 – 15 …”

Disease‐specific waitlist outcomes in liver transplantation – a retrospective study

“…Patients who received MELD exceptions for hepatocellular carcinoma (HCC) and non‐HCC were separately analyzed and initial MELD‐Na score was included in the risk adjustment. For patients with HCC exception, 180‐day and 1‐year waitlist outcomes were assessed, because of mandatory 6‐month waiting rule before being granted for an exception score [7]. For those with MELD exception for other reasons, 90‐day and 1‐year outcomes were evaluated.…”

Impact of Bridging Locoregional Therapies for Hepatocellular Carcinoma on Post‐transplant Clinical Outcome

“…For instance, in regions 1 or 9 of the United States, which have long wait lists, more than 70% of the patients with HCC have been waiting for more than a year to undergo LT 4 . In 2015, UNOS/OPTN policy was modified to mandate a 6‐month delay before patients with HCC are given exception points, making wait times even longer 5 …”

“…For instance, in regions 1 or 9 of the United States, which have long wait lists, more than 70% of the patients with HCC have been waiting for more than a year to undergo LT. 4 In 2015, UNOS/OPTN policy was modified to mandate a 6-month delay before patients with HCC are given exception points, making wait times even longer. 5 Locoregional therapies (LRTs) like transarterial chemoembolization (TACE) or ablation are used to prevent tumor progression while waiting on the list. Achieving lower viable tumor burden in the explant has been shown to be associated with lower risk for recurrence.…”