Safety and feasibility of 2 h of normothermic machine perfusion of donor kidneys in the Eurotransplant Senior Program

Abstract

Background The 5-year graft survival rate of donor kidneys transplanted in the Eurotransplant Senior Program (ESP) is only 47 per cent. Normothermic machine perfusion (NMP) may be a new preservation technique that improves graft outcome. This pilot study aimed to assess safety and feasibility of this technique within the ESP. Methods Recipients were eligible for inclusion if they received a donor kidney within the ESP. Donor kidneys underwent 2 h of oxygenated NMP with a red cell-based solution at 37°C, additional to standard-of-care preservation (non-oxygenated hypothermic machine perfusion). The primary outcome was the safety and feasibility of NMP. As a secondary outcome, graft outcome was investigated and compared with that in a historical group of patients in the ESP and the contralateral kidneys. Results Eleven patients were included in the NMP group; the function of eight kidneys could be compared with that of the contralateral kidney. Fifty-three patients in the ESP, transplanted consecutively between 2016 and 2018, were included as controls. No adverse events were noted, especially no arterial thrombosis or primary non-function of the transplants. After 120 min of oxygenated NMP, median flow increased from 117 (i.q.r. 80–126) to 215 (170–276) ml/min (P = 0.001). The incidence of immediate function was 64 per cent in the NMP group and 40 per cent in historical controls (P = 0.144). A significant difference in graft outcome was not observed. Discussion This pilot study showed NMP to be safe and feasible in kidneys transplanted in the ESP. A well powered study is warranted to confirm these results and investigate the potential advantages of NMP on graft outcome.

Additional Normothermic Machine Perfusion Versus Hypothermic Machine Perfusion in Suboptimal Donor Kidney Transplantation: Protocol of a Randomized, Controlled, Open-Label Trial

“…The present study is powered to detect a difference in the proportion of patients experiencing immediate function after transplant between the 2 study groups. In our pilot study (POSEIDON study), the proportion of kidney-related immediate function in the NMP group was 70% compared to 40% in the control group [ 21 ]. Based on the results from this pilot study, we require a sample size of 40 patients per group with a 2-sided α of 5% and power (1-β) of 80%.…”

“…Because of the normothermic nature of the perfusion, failure of the process leads to warm ischemia. During our previous pilot study, no failure occurred [ 21 ]. If a failure would occur, a highly trained transplant surgeon is present at all time during the perfusion to switch to SCS immediately.…”

“…So far, no randomized controlled trial (RCT) has been performed to establish these theoretical advantages in clinical practice. Clues about efficacy are found in cohort comparisons from two clinical studies carried out in three centers in the United Kingdom and Rotterdam, showing a clinically relevant reduction in the proportion of patients with DGF [ 20 21 22 ]. Currently, an RCT is carried out in the United Kingdom to assess the efficacy of 60 minutes additional, end-ischemic NMP compared to SCS only [ 23 ].…”

Advances in Hypothermic and Normothermic Perfusion in Kidney Transplantation

“…A recent study in the Netherlands reported the effect on recipients over the age of 65 of receiving a kidney from an ECD following 2 h of NMP [100]. The follow up included 11 patients who received a kidney stored by NMP and a historical cohort of 53 patients who received a kidney stored by HMP or SCS.…”

Optimizing porcine donor kidney preservation with normothermic or hypothermic machine perfusion: A systematic review

“…Normothermic machine perfusion (NMP) is a promising alternative to HMP for kidney preservation, and the first clinical studies comparing NMP to HMP have already started. 6 NMP offers the unique ability to fully assess kidney function and viability by allowing the restoration of the renal aerobic metabolism, as it most closely resembles the physiological environment of the kidney. 7 This could theoretically result in less ischemia‐reperfusion injury, and therefore a better survival after donation after circulatory death (DCD) and use of expanded criteria donors (ECD).…”