Organ Recovery Systems
CLINICAL EVIDENCE


The Machine Preservation Trial

Moers C, Smits JM, Maathius MH, et al. Machine Perfusion or Cold Storage in Deceased-Donor Kidney Transplantation. N Engl J Med 2009;360:7-19

The Machine Preservation Trial is the first prospective, international randomized controlled trial comparing machine perfusion on the LifePort with static cold storage.

Rationale – Rates of 1-year graft survival are significantly reduced in patients who experience delayed graft function (DGF).1 The use of donation after cardiac death (DCD) kidneys and expanded criteria donor (ECD) kidneys is increasing as the number of standard criteria donor (SCD) organs and organs donated after brain death decreases.2 The risk of DGF is higher in DCD and ECD kidneys than in SCD kidneys.3,4 Retrospective studies have suggested that machine perfusion could reduce the risk of DGF in all kidney types from deceased donors.5-7 The Machine Preservation Trial prospectively compared machine perfusion with cold storage, with a primary endpoint of DGF.

Study design - 336 kidney pairs (672 recipients) were included in the analysis. Kidney pairs were from consecutive donors and all commonly-used deceased-donor kidney types were included. From each donor pair, one kidney was randomized to machine perfusion with LifePort and the other to static cold storage. The trial was conducted in the North Rhine-Westphalia Region of Germany, The Netherlands, and Belgium in collaboration with Eurotransplant and the Deutsche Stiftung Organ transplantation.

Key Clinical Data

In the overall analysis with all kidney types, compared with static cold storage, machine perfusion with LifePort:

  • Significantly reduces the risk of DGF (adjusted odds ratio, 0.57; p=0.01)
  • Significantly reduces the incidence of DGF (20.8% vs 26.5%; p=0.05) Relative Risk 0.78
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  • Significantly reduces the duration of DGF (10 days vs. 13; p=0.04)
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  • Significantly reduces the risk of graft failure within the first year (hazard ratio, 0.52; p=0.03)
  • Significantly improves 1-year graft survival (94% vs. 90%; p=0.04)
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  • Significantly lowers daily serum creatinine values in first 2 weeks post-transplant (p=0.01)
  • Significantly reduces the incidence of functional DGF (22.9% vs. 30.1%; p=0.03)

Read the paper: Machine Perfusion or Cold Storage in Deceased-Donor Kidney Transplantation

References

  1. McLaren AJ, Jassem W, Gray DW, et al. Delayed graft function: risk factors and the relative effects of early function and acute rejection on long-term survival in cadaveric renal transplantation. Clin Transplant 1999;13:266-72.
  2. Cohen B, Smits JM, Haase B, et al. Expanding the donor pool to increase renal transplantation. Nephrol Dial Transplant 2005;20:34-41.
  3. Moers C, Leuvenink HG, Ploeg RJ. Non-heart beating organ donation: overview and future perspectives. Transplant Int 2007; 20:567-75.
  4. Snoeijs MG, Schaefer S, Christiaans MH, et al. Kidney transplantation using elderly non-heart-beating donors: a single-center experience. Am J Transplant 2006;6:1066-71.
  5. Wight J, Chilcott J, Holmes M, Brewer N. The clinical and cost-effectiveness of pulsatile machine perfusion versus cold storage of kidneys for transplantation retrieved from heart-beating and non-heartbeating donors. Health Technol Assess 2003;7:1-94.
  6. Schold JD, Kaplan B, Howard RJ, Reed AI, Foley DP, Meier-Kriesche HU. Are we frozen in time? Analysis of the utilization and efficacy of pulsatile perfusion in renal transplantation. Am J Transplant 2005;5:1681-8.
  7. Wight JP, Chilcott JB, Holmes MW, Brewer N. Pulsatile machine perfusion vs. cold storage of kidneys for transplantation:a rapid and systematic review. Clin Transplant 2003;17:293-307.