Hypothermic Machine Perfusion in Liver Transplantation - A Randomized Trial.van Rijn, R., et al.
New England Journal of Medicine 2021 [record in progress].
The aim of this study was to compare the effect of hypothermic oxygenated machine perfusion with that of static cold preservation in recipients of liver transplants from donors after circulatory death.
Participants were randomised to either the machine-perfusion group or the control group.
160 liver transplant patients aged ≥ 18 years.
The primary outcome was the occurrence of nonanastomotic biliary strictures during a period of 6 months following transplantation. The secondary endpoints were graft-related and general complications.
This is a well-conducted, multicenter randomised controlled trial (RCT) that took place across 6 transplant centres in 3 European countries, and included 160 patients. Livers from donation after circulatory death were randomised by a centralised, computerised system, with stratification for centre and recipient Primary Sclerosing Cholangitis. The livers were randomised to either static cold storage, or static cold storage followed by minimum 2 hours perfusion in the Liver Assist device from Organ Assist, which provides dual oxygenated cold perfusion. Median perfusion time in the study was short (2 hours 12 minutes) but this meant that the overall cold ischaemic time was longer in the perfused group (8 hours 44 minutes versus 6 hours 49 minutes). The study found a significant reduction in symptomatic, non-anastomotic, biliary strictures associated when livers were perfused (6% versus 18%). Importantly, radiologists were blinded to group allocation and scans were reviewed by two radiologists independently, with discrepancies reviewed by a third. There was also a significant reduction in the risk of post-reperfusion syndrome with perfused livers. There was one case of primary non-function in the control group and none in the study group. There was no significant difference in early allograft dysfunction. This well-conducted study clearly shows that a short period of oxygenated hypothermic perfusion of DCD livers can reduce the incidence of non-anastomotic biliary strictures compared to static cold storage alone, despite a longer overall period of cold storage.
ClinicalTrials.gov - NCT02584283