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Hypothermic Machine Perfusion in Liver Transplantation ! A Randomized Trial

List of authors.
  • Rianne van Rijn, M.D., Ph.D.,
  • Ivo J. Schurink, B.Sc.,
  • Yvonne de Vries, M.D., Ph.D.,
  • Aad P. van den Berg, M.D., Ph.D.,
  • Miriam Cortes Cerisuelo, M.D., Ph.D.,
  • Sarwa Darwish Murad, M.D., Ph.D.,
  • Joris I. Erdmann, M.D, Ph.D.,
  • Nicholas Gilbo, M.D., Ph.D.,
  • Robbert J. de Haas, M.D., Ph.D.,
  • Nigel Heaton, M.D., Ph.D.,
  • Bart van Hoek, M.D., Ph.D.,
  • Volkert A.L. Huurman, M.D., Ph.D.,
  • Ina Jochmans, M.D., Ph.D.,
  • Otto B. van Leeuwen, Ph.D.,
  • Vincent E. de Meijer, M.D., Ph.D.,
  • Diethard Monbaliu, M.D., Ph.D.,
  • Wojciech G. Polak, M.D., Ph.D.,
  • Jules J.G. Slangen, M.D.,
  • Roberto I. Troisi, M.D., Ph.D.,
  • Aude Vanlander, M.D., Ph.D.,
  • Jeroen de Jonge, M.D., Ph.D.,
  • and Robert J. Porte, M.D., Ph.D.
  • for the DHOPE-DCD Trial Investigators*

Abstract

Background

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

Download a PDF of the Research Summary.

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.)

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Hypothermic Machine Perfusion in Liver Transplantation from DCD
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Funding and Disclosures

Supported by a grant for applied medical research (1404-012) from Fonds NutsOhra.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

Dr. Jochmans reports receiving travel support from Astellas Pharma; and Dr. Porte, receiving donated supplies from Bridge to Life. No other potential conflict of interest relevant to this article was reported.

This article was published on February 24, 2021, at NEJM.org.

A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.

We thank the patients who participated in this trial and the doctors, transplantation and research coordinators, operating room staff, and organ perfusionists working at the six collaborating transplantation centers for their contributions to this trial.

Author Affiliations

From the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation (R.R., Y.V., O.B.L., V.E.M., R.J.P.), the Departments of Gastroenterology and Hepatology (A.P.B.) and Radiology (R.J.H., J.J.G.S.), University of Groningen, University Medical Center Groningen, Groningen, the Departments of Surgery (I.J.S., W.G.P., J.J.) and Gastroenterology and Hepatology (S.D.M.), Erasmus University Medical Center, Rotterdam, and the Departments of Surgery (J.I.E., V.A.L.H.) and Gastroenterology and Hepatology (B.H.), Leiden University Medical Center, Leiden ! all in the Netherlands; the Institute of Liver Studies, Kings College Hospital NHS Foundation Trust, London (M.C.C., N.H.); the Transplantation Research Group, the Department of Microbiology, Immunology, and Transplantation, Katholieke Universiteit Leuven, and the Department of Abdominal Transplantation Surgery and Coordination, University Hospitals Leuven, Leuven (N.G., I.J., D.M.), and the Department of Transplant Surgery, Ghent University Hospital, Ghent (R.I.T., A.V.) ! both in Belgium.

Address reprint requests to Dr. Porte at the Department of Surgery, Section of Hepatobiliary Surgery and Liver Transplantation, University Medical Center Groningen, P.O. Box 30.001, 9700RB Groningen, the Netherlands, or at .

A complete list of collaborators and their roles in the DHOPE-DCD trial is provided in the Supplementary Appendix, available at NEJM.org.

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