Hypothermic Oxygenated Perfusion in Extended Criteria Donor Liver Transplantation - A Randomized Clinical Trial.
Ravaioli, M., et al.American Journal of Transplantation 2022 [record in progress].
Aims
The aim of this study was to compare the effect of hypothermic oxygenated perfusion (HOPE) versus static cold storage (SCS) in extended criteria donor (ECD) liver transplantation.
Interventions
Participants undergoing transplantation of an ECD liver graft were randomly assigned to receive a liver after HOPE or after SCS alone.
Participants
135 potential ECD liver grafts were randomised, of which 110 were used for liver transplantation.
Outcomes
The primary outcome was the incidence of early allograft dysfunction (EAD). The secondary outcome were patient survival, graft survival, the early allograft failure simplified estimation (EASE) risk score, and the rate of graft or other graft-related complications.
Follow-up
1 year
CET Conclusions
This is an interesting and well-conducted trial in ECD liver transplantation. Livers were randomised to standard static cold storage (SCS) or to a period of Hypothermic Oxygenated Perfusion (HOPE), using the Vitasmart device (Bridge to Life, DG, USA). Organs in the HOPE group had a period of SCS of 4-5 hours on average prior to starting HOPE for 2-3 hours on average. No organ was discarded during perfusion. The study was single centre and designed with a prior power calculation to determine sample size. The primary endpoint was Early Allograft Dysfunction (EAD) using a well-established composite definition. There was a significant reduction in EAD with HOPE compared to SCS (13% versus 35%) and also a significant reduction in re-transplantation (0% versus 11%). This form of HOPE, using just portal vein perfusion in ECD liver transplantation, is associated with better early allograft function, which is very likely to impact on longer term function and graft survival.
Data analysis
Per protocol analysis
Trial registration
ClinicalTrials.gov - NCT03837197