Abstract
With the aim to explore innovative tools for organ preservation, especially in marginal organs, we hereby describe a clinical trial of ex-vivo hypothermic oxygenated perfusion (HOPE) in the field of liver (LT) and kidney transplantation (KT) from Extended Criteria Donors (ECD) after brain death. A matched-case analysis of donor and recipient variables was developed: 10 HOPE-ECD livers and kidneys (HOPE-L and HOPE-K) were matched 1:3 with livers and kidneys preserved with static cold storage (SCS-L and SCS-K). HOPE and SCS groups resulted with similar basal characteristics, both for recipients and donors. Cumulative liver and kidney graft dysfunction were 10% (HOPE L-K) vs. 31.7%, in SCS group (p = 0.05). Primary non-function was 3.3% for SCS-L vs. 0% for HOPE-L. No primary non-function was reported in HOPE-K and SCS-K. Median peak aspartate aminotransferase within 7-days post-LT was significantly higher in SCS-L when compared to HOPE-L (637 vs.344 U/L, p = 0.007). Graft survival at 1-year post-transplant was 93.3% for SCS-L vs. 100% of HOPE-L and 90% for SCS-K vs. 100% of HOPE-K. Clinical outcomes support our hypothesis of machine perfusion being a safe and effective system to reduce ischemic preservation injuries in KT and in LT.
Highlights
Matteo Ravaioli 1*, Vanessa De Pace1, Andrea Angeletti 2, Giorgia Comai2, Francesco Vasuri2, Maurizio Baldassarre3, Lorenzo Maroni 1, Federica Odaldi1, Guido Fallani 1, Paolo Caraceni3, Giuliana Germinario1, Chiara Donadei2, Deborah Malvi2, Massimo Del Gaudio1, Valentina Rosa Bertuzzo1, Antonio Siniscalchi1, Vito Marco Ranieri, Antonietta D’Errico2, Gianandrea Pasquinelli2, Maria Cristina Morelli1, Antonio Daniele Pinna1, Matteo Cescon1 & Gaetano La Manna2
Between October 2016 and December 2017, N = 20 recipients (N = 10 liver transplant (LT) recipients and N = 10 kidney transplantation (KT) recipients) were recruited consecutively and transplanted with Extended Criteria Donors (ECD)-DBD organs preserved from surgical back-table to implantation by hypothermic oxygenated perfusion (HOPE) (Table 1)
We measured NGAL, Calbindin, Clusterin and Osteopontin in the liver perfusate: we reported different values in T1 compared to T0 (Supplementary Materials Table 5) with non statistically significant linear correlations when compared with AST, ALT and total bilirubin, or Cold ischemia time (CIT) and time of perfusion (Table 3)
Summary
Matteo Ravaioli 1*, Vanessa De Pace, Andrea Angeletti 2, Giorgia Comai, Francesco Vasuri, Maurizio Baldassarre, Lorenzo Maroni 1, Federica Odaldi, Guido Fallani 1, Paolo Caraceni, Giuliana Germinario, Chiara Donadei, Deborah Malvi, Massimo Del Gaudio, Valentina Rosa Bertuzzo, Antonio Siniscalchi, Vito Marco Ranieri, Antonietta D’Errico, Gianandrea Pasquinelli, Maria Cristina Morelli, Antonio Daniele Pinna, Matteo Cescon1 & Gaetano La Manna. Cold ischemia time (CIT) and warm ischemia time during reperfusion impair ECD grafts – being those highly vulnerable organs – but at the same time do not increase mortality risk, which remains relevant for patients in waiting list9 These evidences lead scientific transplant community to explore new strategies for the preservation of marginal grafts, Liver Transplantation Donor Age Recipient Age Cold Ischemia Time MELD score Previous abdominal surgery Portal thrombosis Kidney Transplantation Donor Age Recipient Age Cold Ischemia Time Karpinsky’s score median Type of Dialysis Peritoneal dialysis Hemodialysis Dialysis Time. Subnormothermic machine perfusion (SMP) and controlled oxygenated rewarming (COR) were experienced in animal models demonstrating the improvement in renal or liver function and superiority when compared to SCS15–17, but to present only COR in LT was applied in clinical practice with good results of feasibility and short-term transplant outcomes
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