Machine perfusion or cold storage in deceased-donor kidney transplantation.

BACKGROUND Static cold storage is generally used to preserve kidney allografts from deceased donors. Hypothermic machine perfusion may improve outcomes after transplantation, but few sufficiently powered prospective studies have addressed this possibility. METHODS In this international randomized, controlled trial, we randomly assigned one kidney from 336 consecutive deceased donors to machine perfusion and the other to cold storage. All 672 recipients were followed for 1 year. The primary end point was delayed graft function (requiring dialysis in the first week after transplantation). Secondary end points were the duration of delayed graft function, delayed graft function defined by the rate of the decrease in the serum creatinine level, primary nonfunction, the serum creatinine level and clearance, acute rejection, toxicity of the calcineurin inhibitor, the length of hospital stay, and allograft and patient survival. RESULTS Machine perfusion significantly reduced the risk of delayed graft function. Delayed graft function developed in 70 patients in the machine-perfusion group versus 89 in the cold-storage group (adjusted odds ratio, 0.57; P=0.01). Machine perfusion also significantly improved the rate of the decrease in the serum creatinine level and reduced the duration of delayed graft function. Machine perfusion was associated with lower serum creatinine levels during the first 2 weeks after transplantation and a reduced risk of graft failure (hazard ratio, 0.52; P=0.03). One-year allograft survival was superior in the machine-perfusion group (94% vs. 90%, P=0.04). No significant differences were observed for the other secondary end points. No serious adverse events were directly attributable to machine perfusion. CONCLUSIONS Hypothermic machine perfusion was associated with a reduced risk of delayed graft function and improved graft survival in the first year after transplantation. (Current Controlled Trials number, ISRCTN83876362.)

[1]  L. Paul,et al.  Delayed graft function in renal transplantation , 2004 .

[2]  G. Kootstra,et al.  Categories of non-heart-beating donors. , 1995, Transplantation proceedings.

[3]  C. McGhee,et al.  The New Zealand National Eye Bank Study 1991-2003: A Review of the Source and Management of Corneal Tissue , 2005, Cornea.

[4]  Lim Sm,et al.  The rectum as a novel site for islet cell transplantation. , 1994 .

[5]  Giuseppe Remuzzi,et al.  Delayed graft function in kidney transplantation , 2004, The Lancet.

[6]  W. Buurman,et al.  Kidney Transplantation Using Elderly Non‐Heart‐Beating Donors: A Single‐Center Experience , 2006, American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons.

[7]  L. Pączek,et al.  Machine Perfusion Preservation Improves Renal Allograft Survival , 2007, American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons.

[8]  M. Manyalich,et al.  Liver Transplant Using Donors After Unexpected Cardiac Death: Novel Preservation Protocol and Acceptance Criteria , 2007, American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons.

[9]  Stephen W Lagakos,et al.  Statistics in medicine--reporting of subgroup analyses in clinical trials. , 2007, The New England journal of medicine.

[10]  G. Opelz,et al.  Multicenter Analysis of Kidney Preservation , 2007, Transplantation.

[11]  J. Hermans,et al.  Effect of preservation solution on results of cadaveric kidney transplantation , 1992, The Lancet.

[12]  Jean-Paul Squifflet,et al.  Machine Perfusion Versus Cold Storage for the Preservation of Kidneys Donated After Cardiac Death: A Multicenter, Randomized, Controlled Trial , 2010, Annals of surgery.

[13]  D. Manas,et al.  Early results of a non-heartbeating donor (NHBD) programme with machine perfusion , 2000 .

[14]  J. Lingoes.  The Multivariate Analysis Of Qualitative Data , 1968 .

[15]  R. Ploeg,et al.  Perspectives in Organ Preservation , 2007, Transplantation.

[16]  N. Soomro,et al.  Do tissue damage biomarkers used to assess machine-perfused NHBD kidneys predict long-term renal function post-transplant? , 2003, Clinica chimica acta; international journal of clinical chemistry.

[17]  L. Toledo-Pereyra,et al.  A prospective controlled trial of cold-storage versus machine-perfusion preservation in cadaveric renal transplantation. , 1990, Transplantation.

[18]  P. Friend,et al.  Liver and kidney preservation by perfusion , 2002, The Lancet.

[19]  W. Jassem,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 , 1999, Clinical transplantation.

[20]  R. Ploeg,et al.  Non‐heart beating organ donation: overview and future perspectives , 2007, Transplant international : official journal of the European Society for Organ Transplantation.

[21]  M. Buyse,et al.  Cancer clinical trials : methods and practice , 1986 .

[22]  N. Matsuno,et al.  The effect of machine perfusion preservation versus cold storage on the function of kidneys from non-heart-beating donors. , 1994, Transplantation.

[23]  Prof. Dr. A. v. Hippel,et al.  Eine neue Methode der Hornhauttransplantation , 1888, Albrecht von Graefes Archiv für Ophthalmologie.

[24]  G. Rakhorst,et al.  Improved Kidney Graft Function After Preservation Using a Novel Hypothermic Machine Perfusion Device , 2007, Annals of surgery.

[25]  A. Matas,et al.  Delayed graft function, acute rejection, and outcome after cadaver renal transplantation. The multivariate analysis. , 1995, Transplantation.

[26]  G. Garcı́a-Cardeña,et al.  Organ procurement and perfusion before transplantation. , 2009, The New England journal of medicine.

[27]  J. Schold,et al.  Are We Frozen in Time? Analysis of the Utilization and Efficacy of Pulsatile Perfusion in Renal Transplantation , 2005, American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons.

[28]  R. Ploeg,et al.  THE COST‐EFFECTIVENESS OF PRESERVATION WITH UW AND EC SOLUTION FOR USE IN CADAVERIC KIDNEY TRANSPLANTATION IN THE CASE OF SINGLE KIDNEY DONORS , 1993, Transplantation.

[29]  G. Persijn,et al.  Changing patterns in organ donation in Eurotransplant, 1990–1994 , 1997, Transplant international : official journal of the European Society for Organ Transplantation.

[30]  D.,et al.  Regression Models and Life-Tables , 2022 .

[31]  F. Delmonico,et al.  Outcome of Kidney Transplantation Using Expanded Criteria Donors and Donation After Cardiac Death Kidneys: Realities and Costs , 2007, American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons.

[32]  H. Sollinger,et al.  A new perfusate for kidney preservation. , 1982, Transplantation.

[33]  Ulrich Frei,et al.  Expanding the donor pool to increase renal transplantation. , 2005, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.

[34]  R. Hené,et al.  Preservation of non-heart-beating donor kidneys: a clinical prospective randomised case-control study of machine perfusion versus cold storage. , 2001, Transplantation Proceedings.

[35]  J Chilcott,et al.  The clinical and cost-effectiveness of pulsatile machine perfusion versus cold storage of kidneys for transplantation retrieved from heart-beating and non-heart-beating donors. , 2003, Health technology assessment.

[36]  P. Daly,et al.  Delayed graft function: a dilemma in renal transplantation , 2005, BJU international.

[37]  T. Iwahori,et al.  Application of Machine Perfusion Preservation as a Viability Test for Marginal Kidney Graft , 2006, Transplantation.

[38]  J. Chilcott,et al.  Pulsatile machine perfusion vs. cold storage of kidneys for transplantation: a rapid and systematic review , 2003, Clinical transplantation.

[39]  D. Bloch,et al.  A simple method of sample size calculation for linear and logistic regression. , 1998, Statistics in medicine.

[40]  F. Delmonico,et al.  Expanded criteria donors for kidney transplantation , 2003, American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons.

[41]  G. Kootstra,et al.  Effect of machine perfusion preservation on delayed graft function in non-heart-beating donor kidneys – early results , 1997, Transplant international : official journal of the European Society for Organ Transplantation.

[42]  R. Mendez,et al.  Pulsatile Perfusion Reduces the Incidence of Delayed Graft Function in Expanded Criteria Donor Kidney Transplantation , 2006, American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons.