PILOT STUDY FOR THE EVALUATION OF AN INNOVATIVE DEVICE IN LIVER TRANSPLANTATION USING GRAFTS FROM DONORS AFTER CIRCULATORY DEATH

The Italian law requires 20 minutes of continuous, flat-line electrocardiogram to declare death. In the setting of organ donation after cardio-circulatory death, such prolonged warm ischemia time prompted introduction of abdominal normothermic regional perfusion immediately after death declaration followed by post-procurement, ex-situ machine perfusion. This is a pilot study for the evaluation of an innovative device, such as ex-vivo graft perfusion, subsequently to NRP use in liver transplantation, using grafts from donors after circulatory death.Because of the exploratory characteristics of the present study, no sample size calculation was performed. We had seven recipients receiving grafts from DCD donors after at least 4 hours of ECMO and stored for at least 4 hours in MP before transplantation. We firstly analyzed the data of this group and than compared them with LT with grafts from two different kinds of extended criteria donors in order to valuate the IRI in terms of ITBL, PGD and DGF: a) seven recipients receiving grafts ≥80 years old from DBD donors preserved using the standard static hypothermic method (CS group) and b) seven recipients, from the historical database of our center, receiving grafts from DBD donors who experienced at least 20 minutes of no flow during the 24-48 hours of observation and preserved using the standard static hypothermic method (NF-CS group). The primary endpoint of the study is the evaluation of the preservation efficacy of ex-vivo MP following the NRP (ECMO) in LT performed using DCD donors by means of graft and patient survival 6 months after liver transplantation. The secondary endpoint was to evaluate IRI by means of post LT transaminases after surgery, evaluation of liver and bile duct histology and incidence of biliary complications after 6 months from transplantation.