TY - JOUR
T1 - Hypothermic machine perfusion in liver transplantation — A randomized trial
AU - van Rijn, Rianne
AU - Schurink, Ivo J.
AU - de Vries, Yvonne
AU - van den Berg, Aad P.
AU - Cerisuelo, Miriam Cortes
AU - Murad, Sarwa Darwish
AU - Erdmann, Joris I.
AU - Gilbo, Nicholas
AU - de Haas, Robbert J.
AU - Heaton, Nigel
AU - van Hoek, Bart
AU - Huurman, Volkert A.L.
AU - Jochmans, Ina
AU - van Leeuwen, Otto B.
AU - de Meijer, Vincent E.
AU - Monbaliu, Diethard
AU - Polak, Wojciech G.
AU - Slangen, Jules J.G.
AU - Troisi, Roberto I.
AU - Vanlander, Aude
AU - de Jonge, Jeroen
AU - Porte, Robert J.
N1 - Funding Information:
Supported by a grant for applied medical research (1404-012) from Fonds NutsOhra.
Publisher Copyright: Copyright © 2021 Massachusetts Medical Society.
PY - 2021/4/15
Y1 - 2021/4/15
N2 - Transplantation of livers obtained from donors after circulatory death is associated with an increased risk of nonanastomotic biliary strictures. Hypothermic oxygenated machine perfusion of livers may reduce the incidence of biliary complications, but data from prospective, controlled studies are limited. METHODS In this multicenter, controlled trial, we randomly assigned patients who were undergoing transplantation of a liver obtained from a donor after circulatory death to receive that liver either after hypothermic oxygenated machine perfusion (machine-perfusion group) or after conventional static cold storage alone (control group). The primary end point was the incidence of nonanastomotic biliary strictures within 6 months after transplantation. Secondary end points included other graft-related and general complications. RESULTS A total of 160 patients were enrolled, of whom 78 received a machine-perfused liver and 78 received a liver after static cold storage only (4 patients did not receive a liver in this trial). Nonanastomotic biliary strictures occurred in 6% of the patients in the machine-perfusion group and in 18% of those in the control group (risk ratio, 0.36; 95% confidence interval [CI], 0.14 to 0.94; P=0.03). Postreperfusion syndrome occurred in 12% of the recipients of a machine-perfused liver and in 27% of those in the control group (risk ratio, 0.43; 95% CI, 0.20 to 0.91). Early allograft dysfunction occurred in 26% of the machine-perfused livers, as compared with 40% of control livers (risk ratio, 0.61; 95% CI, 0.39 to 0.96). The cumulative number of treatments for nonanastomotic biliary strictures was lower by a factor of almost 4 after machine perfusion, as compared with control. The incidence of adverse events was similar in the two groups. CONCLUSIONS Hypothermic oxygenated machine perfusion led to a lower risk of nonanastomotic biliary strictures following the transplantation of livers obtained from donors after circulatory death than conventional static cold storage. (Funded by Fonds NutsOhra; DHOPE-DCD ClinicalTrials.gov number, NCT02584283).
AB - Transplantation of livers obtained from donors after circulatory death is associated with an increased risk of nonanastomotic biliary strictures. Hypothermic oxygenated machine perfusion of livers may reduce the incidence of biliary complications, but data from prospective, controlled studies are limited. METHODS In this multicenter, controlled trial, we randomly assigned patients who were undergoing transplantation of a liver obtained from a donor after circulatory death to receive that liver either after hypothermic oxygenated machine perfusion (machine-perfusion group) or after conventional static cold storage alone (control group). The primary end point was the incidence of nonanastomotic biliary strictures within 6 months after transplantation. Secondary end points included other graft-related and general complications. RESULTS A total of 160 patients were enrolled, of whom 78 received a machine-perfused liver and 78 received a liver after static cold storage only (4 patients did not receive a liver in this trial). Nonanastomotic biliary strictures occurred in 6% of the patients in the machine-perfusion group and in 18% of those in the control group (risk ratio, 0.36; 95% confidence interval [CI], 0.14 to 0.94; P=0.03). Postreperfusion syndrome occurred in 12% of the recipients of a machine-perfused liver and in 27% of those in the control group (risk ratio, 0.43; 95% CI, 0.20 to 0.91). Early allograft dysfunction occurred in 26% of the machine-perfused livers, as compared with 40% of control livers (risk ratio, 0.61; 95% CI, 0.39 to 0.96). The cumulative number of treatments for nonanastomotic biliary strictures was lower by a factor of almost 4 after machine perfusion, as compared with control. The incidence of adverse events was similar in the two groups. CONCLUSIONS Hypothermic oxygenated machine perfusion led to a lower risk of nonanastomotic biliary strictures following the transplantation of livers obtained from donors after circulatory death than conventional static cold storage. (Funded by Fonds NutsOhra; DHOPE-DCD ClinicalTrials.gov number, NCT02584283).
UR - http://www.scopus.com/inward/record.url?scp=85102639245&partnerID=8YFLogxK
U2 - 10.1056/nejmoa2031532
DO - 10.1056/nejmoa2031532
M3 - Article
C2 - 33626248
AN - SCOPUS:85102639245
SN - 0028-4793
VL - 384
SP - 1391
EP - 1401
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 15
ER -