In the field of liver (LT) and kidney transplantation (KT), extended criteria donors (ECD) offer an additional organ source that is more vulnerable for early allograft dysfunction (EAD) in LT and delayed graft function (DGF) in KT. We experienced a phase-1 clinical trial (ID: NCT03031067) of ex-vivo hypothermic oxygenated perfusion (HOPE) in LT or KT from ECD brain death donor (DBD).

A matched-case analysis was developed: 10 HOPE-ECD livers and kidneys, HOPE-L and -K groups, were matched 1:3 with livers and kidneys preserved with static cold storage (SCS), SCS-L and -K groups respectively. HOPE-L and SCS-L groups were matched for donor and recipient age, cold ischemia time (CIT), MELD score, portal thrombosis, previous abdominal-surgery and hepatic-steatosis. HOPE-K and SCS K-groups were matched for donor and recipient age, CIT, Karpinsky's score, induction immunosuppressive therapy, peritoneal or hemodialysis and dialyses time.

Following organs retrieval and its transfer at hospital, the grafts were connected to machine perfusion through the renal artery or hepatic portal vein cannulation during surgical back table until the implantation.

Data were reported as mean and SD or median and ranges. Mann-Whitney U test was applied for continuous data and unpaired T test for categorical data with SPSS software; p values less than 0.05 were considered statistically significant.

Organs were perfused for 1-3 hours at median hepatic flow of 100 (116-30) ml/min and median renal flow of 46 (24-85) ml/min. In LT, EAD was 0% for HOPE-L vs 26.6% in SCS-L and in KT (p=0.003), DGF was 20% for HOPE-K vs 36.6% for SCS-K (p=0.313). Primary non-function was 0% for both K-groups and 3.3% for SCS-L vs 0% for HOPE-L. Median peak aspartate aminotransferase within 7-days post-LT was significantly higher in SCS-L, 637 (124-2001) U/L, respect to HOPE-L, 344 (166-1032) U/L, p=0.007. Grafts survival at 30-days post-transplant was 93.4% for SCS-L vs 100% of HOPE-L and 96.7% for SCS-K vs 100% of HOPE-K.

Clinical outcomes support HOPE for ECD-DBD grafts as safe and efficacy to reduce the ischemic preservation injuries in KT, but in LT particularly.

CITATION INFORMATION: Ravaioli M., De Pace V., Cescon M., Del Gaudio M., Bertuzzo V. R., Siniscalchi A., D'Errico A., Comai G., La Manna G., Pinna A. D. Hypothermic Oxygenated Machine Perfusion in Liver and Kidney Transplantation of Extended Criteria Donors: A Phase-1 of Clinical Trial Am J Transplant. 2017;17 (suppl 3).

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