Debunking the “6-Month Rule” for Liver Transplantation: Relapse Prevention in Alcohol-Related Cirrhosis

For patients with alcohol-related liver disease (ALD) who require transplantation, there is mixed evidence supporting the “6-month rule”, in which patients must abstain from alcohol consumption for 6 months prior to transplantation. A wide range of variables should be considered when assessing the risk for relapse in this patient population, instead of providing an arbitrary timeline, according to study results published in Gastroenterology. The study also found that a program providing direct monitoring and relapse prevention treatment may help to reduce post-transplantation return to drinking.

Increasing evidence suggests that the traditional 6-month rule is not adequate in predicting survival and relapse rates in patients with ALD who require liver transplantation. Re-evaluation is needed to assess the appropriate access to transplants for these patients. To address this, a team of investigators for the Ontario ALD Pilot Program initiated a prospective pilot program in 2018 to challenge the 6-month rule paradigm. They aimed to determine patient suitability for transplant and the risk for relapse via selective criteria, to enlist a team of clinicians to assess and mitigate these risks, and to assess pre- and post-liver transplant alcohol use, intervening when appropriate.

Of the 703 referrals, 439 patients were included in the initial assessment and 164 patients met the criteria for the pilot study and were evaluated for transplantation. Of the 101 patients who underwent medical evaluation and were listed for transplants, 44 patients (23 outpatients, 21 inpatients) underwent transplantation through the ALD Pilot Program; 4 of these patients underwent transplantation from a live donor.

Model for end-stage live disease (MELD) scores ranged from 20 to 30 for 12 outpatients and was higher than 30 among 13 inpatients. Compared with 111 patients who received a transplant with more than 6 months of abstinence from alcohol use, patients with ALD who received transplantations were significantly younger (P <.01), and had significantly higher MELD scores at listing (P <.01), and at transplantation (P <.01). In addition, patients in the ALD program spent significantly less time on the waitlist for transplant compared against patients with other indications for liver transplantation (P <.05).

In assessing psychological characteristics of patients who underwent transplantation, 86% met the criteria for alcohol use disorder but 84% never accessed treatment for alcohol use disorder. After an average of 30 days, 38 patients were discharged home after transplantation, 1 patient was still admitted in hospital, and 5 patients died after an average of 29.6 days post-transplantation. Causes of death, however, were not associated with alcohol use.

Of the 44 patients who underwent liver transplantation, 3 patients returned to alcohol use within an average of 260 days after surgery. Of these patients, the relapse rate was twice as high among patients with more than 6 months of abstinence in the program (P =.21).

Multivariable analysis results suggested that age at transplantation (odds ratio [OR], 0.92; P <.05) and MELD score at listing (OR, 0.90; P <.05) were significantly associated with risk for relapse into alcohol use; however, severe AUD was not significantly linked to risk for relapse in the study population.

Investigators acknowledge they did not assess the profiles of patients referred for transplantation prior to the pilot program being developed, and thus could not conduct comparative analyses.

“Though some risk for relapse to problematic alcohol use will inherently continue to exist in ALD patients, the results of our pilot show that this risk should not be enough to prevent patients from accessing transplantation, and that it can realistically be mitigated through appropriate measures,” the researchers noted. “Liver transplant does not cure alcohol use disorder, but the implementation of our standardized selection criteria and evidence-based intervention provides a foundation for the provision of more equitable transplant care for those with ALD,” they concluded.

Reference

Carrique L, Quance J, Tan A, et al. Results of early transplantation for alcohol-related cirrhosis: integrated addiction treatment with low rate of relapse. Gastroenterol. Published online August 6, 2021. doi: 10.1053/j.gastro.2021.08.004