Hypothermic Machine Perfusion in Liver Transplantation - A Randomized Trial

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

doi:10.1056/NEJMoa2031532

Hypothermic Machine Perfusion in Liver Transplantation - A Randomized Trial

DHOPE-DCD Trial Investigators, Rianne van Rijn, Ivo J Schurink, Yvonne de Vries, Aad P van den Berg, Miriam Cortes Cerisuelo, Sarwa Darwish Murad, Joris I Erdmann, Nicholas Gilbo, Robbert J de Haas, Nigel Heaton, Bart van Hoek, Volkert A L Huurman, Ina Jochmans, Otto B van Leeuwen, Vincent E de Meijer, Diethard Monbaliu, Wojciech G Polak, Jules J G Slangen, Roberto I TroisiAude Vanlander, Jeroen de Jonge, Robert J Porte^*

^*Corresponding author voor dit werk

Groningen Institute for Organ Transplantation (GIOT)

Onderzoeksoutput: Article › Academic › peer review

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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

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.

Originele taal-2	English
Pagina's (van-tot)	1391-1401
Aantal pagina's	11
Tijdschrift	New England Journal of Medicine
Volume	384
Nummer van het tijdschrift	15
Vroegere onlinedatum	24-feb.-2021
DOI's	https://doi.org/10.1056/NEJMoa2031532
Status	Published - 15-apr.-2021

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10.1056/NEJMoa2031532

Hypothermic Machine Perfusion in Liver Transplantation - A Randomized TrialFinal publisher's version, 474 KBLicentie: Taverne

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DHOPE-DCD Trial Investigators, van Rijn, R., Schurink, I. J., de Vries, Y., van den Berg, A. P., Cortes Cerisuelo, M., Darwish Murad, S., Erdmann, J. I., Gilbo, N., de Haas, R. J., Heaton, N., van Hoek, B., Huurman, V. A. L., Jochmans, I., van Leeuwen, O. B., de Meijer, V. E., Monbaliu, D., Polak, W. G., Slangen, J. J. G., ... Porte, R. J. (2021). Hypothermic Machine Perfusion in Liver Transplantation - A Randomized Trial. New England Journal of Medicine, 384(15), 1391-1401. https://doi.org/10.1056/NEJMoa2031532

@article{7fa644930fc64b85a4c2d51cb7c4fded,

title = "Hypothermic Machine Perfusion in Liver Transplantation - A Randomized Trial",

abstract = "BACKGROUNDTransplantation 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.METHODSIn 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.RESULTSA 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.CONCLUSIONSHypothermic 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.",

author = "{DHOPE-DCD Trial Investigators} and {van Rijn}, Rianne and Schurink, {Ivo J} and {de Vries}, Yvonne and {van den Berg}, {Aad P} and {Cortes Cerisuelo}, Miriam and {Darwish Murad}, Sarwa and Erdmann, {Joris I} and Nicholas Gilbo and {de Haas}, {Robbert J} and Nigel Heaton and {van Hoek}, Bart and Huurman, {Volkert A L} and Ina Jochmans and {van Leeuwen}, {Otto B} and {de Meijer}, {Vincent E} and Diethard Monbaliu and Polak, {Wojciech G} and Slangen, {Jules J G} and Troisi, {Roberto I} and Aude Vanlander and {de Jonge}, Jeroen and Porte, {Robert J}",

note = "Copyright {\textcopyright} 2021 Massachusetts Medical Society.",

year = "2021",

month = apr,

day = "15",

doi = "10.1056/NEJMoa2031532",

language = "English",

volume = "384",

pages = "1391--1401",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "MASSACHUSETTS MEDICAL SOC",

number = "15",

}

DHOPE-DCD Trial Investigators, van Rijn, R, Schurink, IJ, de Vries, Y, van den Berg, AP, Cortes Cerisuelo, M, Darwish Murad, S, Erdmann, JI, Gilbo, N, de Haas, RJ, Heaton, N, van Hoek, B, Huurman, VAL, Jochmans, I, van Leeuwen, OB , de Meijer, VE, Monbaliu, D, Polak, WG, Slangen, JJG, Troisi, RI, Vanlander, A, de Jonge, J & Porte, RJ 2021, 'Hypothermic Machine Perfusion in Liver Transplantation - A Randomized Trial', New England Journal of Medicine, vol. 384, nr. 15, blz. 1391-1401. https://doi.org/10.1056/NEJMoa2031532

TY - JOUR

T1 - Hypothermic Machine Perfusion in Liver Transplantation - A Randomized Trial

AU - DHOPE-DCD Trial Investigators

AU - van Rijn, Rianne

AU - Schurink, Ivo J

AU - de Vries, Yvonne

AU - van den Berg, Aad P

AU - Cortes Cerisuelo, Miriam

AU - Darwish Murad, Sarwa

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

PY - 2021/4/15

Y1 - 2021/4/15

N2 - BACKGROUNDTransplantation 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.METHODSIn 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.RESULTSA 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.CONCLUSIONSHypothermic 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.

AB - BACKGROUNDTransplantation 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.METHODSIn 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.RESULTSA 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.CONCLUSIONSHypothermic 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.

U2 - 10.1056/NEJMoa2031532

DO - 10.1056/NEJMoa2031532

M3 - Article

C2 - 33626248

SN - 0028-4793

VL - 384

SP - 1391

EP - 1401

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 15

ER -

Hypothermic Machine Perfusion in Liver Transplantation - A Randomized Trial

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