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Randomized Controlled Trial
. 2023 Nov 1;278(5):e912-e921.
doi: 10.1097/SLA.0000000000005934. Epub 2023 Jun 26.

Normothermic Machine Perfusion of Donor Livers for Transplantation in the United States: A Randomized Controlled Trial

William C Chapman  1 , Andrew S Barbas  2 , Anthony M D'Alessandro  3 , Rodrigo Vianna  4 , Chandrashekhar A Kubal  5 , Peter Abt  6 , Christopher Sonnenday  7 , Rolf Barth  8 , Josue Alvarez-Casas  9 , Hasan Yersiz  10 , Devin Eckhoff  11 , Robert Cannon  12 , Yuri Genyk  13 , Linda Sher  13 , Andrew Singer  14 , Sandy Feng  15 , Garrett Roll  15 , Ari Cohen  16 , Maria B Doyle  1 , Debra L Sudan  2 , David Al-Adra  3 , Adeel Khan  1 , Vijay Subramanian  17 , Nader Abraham  2 , Kim Olthoff  6 , Akin Tekin  4 , Lynn Berg  3 , Constantin Coussios  18 , Chris Morris  18 , Lucy Randle  18 , Peter Friend  18 , Stuart J Knechtle  2
Affiliations
Randomized Controlled Trial

Normothermic Machine Perfusion of Donor Livers for Transplantation in the United States: A Randomized Controlled Trial

William C Chapman et al. Ann Surg. .

Abstract

Objective: To compare conventional low-temperature storage of transplant donor livers [static cold storage (SCS)] with storage of the organs at physiological body temperature [normothermic machine perfusion (NMP)].

Background: The high success rate of liver transplantation is constrained by the shortage of transplantable organs (eg, waiting list mortality >20% in many centers). NMP maintains the liver in a functioning state to improve preservation quality and enable testing of the organ before transplantation. This is of greatest potential value with organs from brain-dead donor organs (DBD) with risk factors (age and comorbidities), and those from donors declared dead by cardiovascular criteria (donation after circulatory death).

Methods: Three hundred eighty-three donor organs were randomized by 15 US liver transplant centers to undergo NMP (n = 192) or SCS (n = 191). Two hundred sixty-six donor livers proceeded to transplantation (NMP: n = 136; SCS: n = 130). The primary endpoint of the study was "early allograft dysfunction" (EAD), a marker of early posttransplant liver injury and function.

Results: The difference in the incidence of EAD did not achieve significance, with 20.6% (NMP) versus 23.7% (SCS). Using exploratory, "as-treated" rather than "intent-to-treat," subgroup analyses, there was a greater effect size in donation after circulatory death donor livers (22.8% NMP vs 44.6% SCS) and in organs in the highest risk quartile by donor risk (19.2% NMP vs 33.3% SCS). The incidence of acute cardiovascular decompensation at organ reperfusion, "postreperfusion syndrome," as a secondary outcome was reduced in the NMP arm (5.9% vs 14.6%).

Conclusions: NMP did not lower EAD, perhaps related to the inclusion of lower-risk liver donors, as higher-risk donor livers seemed to benefit more. The technology is safe in standard organ recovery and seems to have the greatest benefit for marginal donors.

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Conflict of interest statement

C.C., C.M., L.R., and P.F.: are employed by Organox. The remaining authors report no conflicts of interest.

Comment in

References

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    1. Watson CJE, Gaurav R, Fear C, et al. Predicting early allograft function after normothermic machine perfusion. Transplantation. 2022;106:2391–2398.

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