New Prognostic Predictive Models of Mortality of Decompensated Cirrhotic Patients Waiting for Liver Transplantation

Construction of New Predictive Mathematical Models of Mortality in Decompensated Cirrhotic Patients Who Are Candidates for Liver Transplantation

The MELD score is a predictive model of cirrhosis mortality used in France since 2007 to prioritize access to liver transplantation for patients enrolled in the national waiting list. The predictive value of this score was recently revised downward with a C index of the order of 0.65-0.67 and 20% of the patients enrolled for decompensated cirrhosis have access to liver transplantation by a subjective system of "expert component" independent of the MELD because of this lack of precision. The use of the MELD score to individually define access to the transplant should so be reconsidered. Recently new predictive models of cirrhosis mortality better than MELD have been developed and new mortality predictors independent of MELD have been published.

The goal of this study is to design prognostic predictive models of mortality for decompensated cirrhotic patients enrolled on the national liver transplant waiting list including known (MELD, MELD Na) as more recent (CLIF-C AD, CLIF - CACLF) predictive models and new objective predictors studied in combination in order to optimize the system of allocation of hepatic allografts in France.

The expected benefits of this search are twofold:

• At the individual level: The possibility for patients at high risk of death but with intermediate MELD score to be transplanted.

• Public health plan:

  • Improving the equity of graft allocation system.
  • Decreased mortality in the waiting list by improving the fairness and efficiency of the graft allocation system, a major public health issue

• An ancillary study to the SUPERMELD study is also proposed, the miR MELD study, whose main objective is to evaluate the value of plasma miRNAs in a cohort of patients with decompensated cirrhosis (acute and chronic, excluding cancer) listed for liver transplantation to predict 3-month mortality on the liver transplant waiting list or drop-out from the waitlist for being too sick.

Additional data collection of the vital status 1 year after transplantation of patients initially included in the SUPERMELD study will also be added for all transplanted patients to assess the potential acceleration of access to transplantation for certain candidates at high risk of death prior to transplantation on post-transplantation survival, and assess the transplant benefit.

Inclusion Criteria:

• Adult patients (≥18 years old) registered on national waiting list with main diagnosis "cirrhosis" within 14 days (+/-2) before or 7 days (+/-2) after the inclusion in the protocol (using the date of biobank sampling as Day 0)
• Patients enrolled on the national waiting list under the "national liver score" allocation scheme whether an expert component is considered or not
• Patients (or trusted person or family member or close relation if the patient is unable to express consent) who have been informed and signed their informed consent
• Patients affiliated to a health insurance scheme

Exclusion Criteria:

• Patients enrolled with decompensated cirrhosis associated with hepatocellular carcinoma >TNM1
• Patients on AVK (INR and therefore MELD and CLIF scores uninterpretable)
• Vulnerable population (person under guardianship or curatorship or deprived of liberty by a judicial decision)
• Pregnant and / or breastfeeding woman
• Patient candidate for a combined transplantation
• Patient with history of organ transplantation (liver, kidney, heart)