Kidneys for Transplant Function Earlier and Last Longer When Preserved in a Machine Compared to the Traditional Box of Ice
Depending on the type of deceased donor,* 15Ã¢Ë†´50 percent of transplanted kidneys do not function immediately following transplantation and many patients will require dialysis treatments for a certain period after transplantation.(2,3,4) As a result, these kidneys have an increased risk of rejection (3) and survival of the kidney graft may be compromised. This in turn will put pressure on the already long transplant waiting lists.(3,4)
“This is a truly important finding for the thousands of people on transplant waiting lists around the world”, said
Facts about the trial
- The Machine Preservation Trial was an investigator-driven study, run by an independent scientific steering committee across
The Netherlands, Belgiumand the German federal state of North Rhine Westphalia, in close collaboration with Eurotransplant International Foundation (the international organ exchange organisation for Austria, Belgium, Croatia, Germany, Luxemburg, The Netherlandsand Slovenia) as the central trial assistance desk. Principal investigators were Rutger Ploeg(Groningen, The Netherlands), Andreas Paul( Essen, Germany), and Jacques Pirenne (Leuven, Belgium).
- During the time of the trial, every deceased donor in the area was considered for inclusion in the study. 336 pairs of kidneys were enrolled in the study. One kidney from each pair was randomly assigned to machine preservation, and the other one to cold storage. Kidneys were transplanted in recipients across the Eurotransplant area.
- The manufacturers, Organ Recovery Systems of
Chicago, USAprovided the LifePort Kidney Transporters used in the study. The machines were used for the preservation and transport of kidneys from organ recovery until transplantation.
- The primary endpoint was delayed graft function defined as the need for dialysis in the first week post transplantation. Evidence suggests that organs that do not function immediately after transplantation have an increased risk of rejection and survival of the transplanted kidney may be inferior.(2)
- Secondary endpoints included: patient and graft survival up to 12 months after transplantation, duration of delayed graft function, length of stay in hospital, primary non-function of the transplanted kidney, serum creatinine and clearance after transplantation, acute rejection and calcineurin inhibitor toxicity.
Results from the study
- Machine perfusion significantly reduced the risk of delayed graft function compared to cold storage. 70 out of 336 kidney recipients in the machine perfusion group developed delayed graft function compared with 89 out of 336 patients in the cold storage group (adjusted odds ratio 0.57; P=0.01).
- In case delayed graft function occurred, its duration was shorter after machine perfusion compared with cold storage (10 days vs. 13 days; P=0.03).
- One year graft survival was superior in the machine perfusion group (94% vs. 90%; P=0.04) and machine perfusion was associated with a reduced risk of graft failure in the first year post-transplant (hazard ratio 0.52; P=0.03).
- Serum creatinine values were significantly lower for machine perfused kidney recipients compared to those cold stored in the first two weeks post transplantation (P=0.01).
- There were no significant differences observed for the other secondary endpoints.
- No serious adverse events were directly attributable to machine perfusion.
Facts about transplantation
- More than 1.5 million people worldwide suffer from end stage renal disease.(5)
- In the
USAalone, for example, there are currently 82,435 people waiting for a kidney transplant. To date this year 4,213 kidneys have been recovered from deceased donors.(6)
- Eurotransplant International Foundation (Eurotransplant) is the international organ exchange organisation for
Austria, Belgium, Croatia, Germany, Luxemburg, The Netherlandsand Sloveniaand serves a population of 118 million.
- In the Eurotransplant area there are currently 10,719 people waiting for a kidney transplant (active waiting list of
September 30, 2008).(7)
- In 2007, 3,420 people received a kidney transplant in the Eurotransplant region.(7)
Notes to editors:
* Deceased donors include:
- Brain dead donors – patients who meet the legal and medical criteria for brain stem death, whose organs are removed for transplantation.
- Donors after cardiac death (DCD) – organ donors who have been declared dead because their heart has stopped (also called non-heart-beating donors).
- Expanded criteria donors (ECD) – brain dead donors or donors after cardiac death over the age of 60 years, or between 50 and 60 years with additional health conditions such as high blood pressure, stroke, or a sub-optimal kidney function prior to organ retrieval.
Trial organisational structure Scientific steering committee Rutger J. Ploeg (coordination principal investigator, The Netherlands) Andreas Paul (principal investigator, North Rhine Westphalia, Germany) Jacques Pirenne (principal investigator, Belgium) Cyril Moers (secretary) Mark-Hugo Maathuis (regional perfusion center liaison) Jaap Homan van der Heide (member) Ernst van Heurn (member) Jean-Paul Squifflet (member) Jurgen Treckmann (member)
Central trial assistance Arie Oosterlee (Eurotransplant, general director) Axel Rahmel (Eurotransplant, medical director) Jacqueline Smits (Eurotransplant, statistician) Margitta van Kasterop-Kutz (Eurotransplant, data manager) Gunter Kirste (Deutsche Stiftung Organtransplantation, general director) Ulrike Wirges (Deutsche Stiftung Organtransplantation, director North Rhine Westphalia)
Regional perfusion center coordinators Henri Leuvenink (Groningen, The Netherlands) Frank van Gelder (Leuven, Belgium) Bogdan Napieralski (Essen, Germany)
(1) Moers C, Smits JM, Maathuis M-HJ et al. Machine perfusion or cold storage in deceased-donor kidney transplantation. N Engl J Med 2009;360:7-19.
(2) Koning OH, Ploeg RJ, van Bockel JH et al. Risk factor for delayed graft function in cadaveric kidney transplantation: a prospective study of renal function and graft survival after preservation with
(3) Daly PJA, Power RE, Healy DA et al. Delayed graft function: a dilemma in renal transplantation. BJU International 2005;96:498-501.
(4) Perico N, Cattaneo D, Sayegh MH, Remuzzi G. Delayed graft function in kidney transplantation. Lancet 2004; 364: 1814.
SOURCE Mechanical Perfusion Study Scientific Steering Committee