Renal Transplantation After Ex Vivo Normothermic Perfusion: The First Clinical Study

Abstract

Ex vivo normothermic perfusion (EVNP) is a novel method of preservation that restores circulation and allows an organ to regain function prior to transplantation. The aim of this study was to assess the effects of EVNP in kidneys from marginal donors. Eighteen kidneys from extended criteria donors (ECD) underwent a period of EVNP immediately before transplantation. Kidneys were perfused with a plasma free redcell based solution at a mean temperature of 34.6• C. The outcome of these kidneys was compared to a control group of 47 ECD kidneys that underwent static cold storage (CS). The mean donor age was 61 ± 1 years in the EVNP and 62 ± 6 years in the CS group (p = 0.520). EVNP kidneys were perfused for an average of 63 ± 16 min and all were transplanted successfully. The delayed graft function rate (DGF), defined as the requirement for dialysis within the first 7 days was 1/18 patients (5.6%) in the EVNP group versus 17/47 (36.2%) in the CS group (p = 0.014). There was no difference in graft or patient survival at 12 months (p = 0.510, 1.000). This first series of EVNP in renal transplantation demonstrates that this technique is both feasible and safe. Our preliminary data suggests that EVNP offers promise as a new technique of kidney preservation.

Successful Transplantation of Human Kidneys Deemed Untransplantable but Resuscitated by Ex Vivo Normothermic Machine Perfusion

“…Each kidney underwent EVNP for a period of 60 min using a technique that has previously been described in detail 6, 7, 8. In brief, the organs were perfused with a warmed (35.2°C), oxygenated plasma‐free red cell–based solution at a pressure of 75 mmHg.…”

“…Preservation techniques such as ex vivo normothermic machine perfusion (EVNP) can be used to resuscitate and assess the quality of the kidney before transplantation 5, 6, 7. In an earlier laboratory study, we assessed the quality of 22 human kidneys declined for transplantation primarily due to inadequate in situ perfusion using EVNP 3, 5.…”

Normothermic <em>Ex Vivo</em> Kidney Perfusion for the Preservation of Kidney Grafts prior to Transplantation

“…In a porcine model, beneficial results were presented for kidneys perfused ex vivo under normothermic conditions 10,11 . The first clinical trial performed in 2013 demonstrated a lower rate of delayed graft function when kidneys retrieved from extended criteria donors were perfused for 1 hr immediately before transplant 12 .…”

Current perspectives in transplant medicine: hypothermic oxygenated perfusion

“…In kidney transplantation, Nicholson and Hosgood have described a very low DGF rate of only 5.6% after NMP, despite the fact that they used marginal donors. 51 The rate of DGF in these 18 patients is significantly lower than the 20.8% seen in the Eurotransplant trial using HMP. 22 The OCS™ Liver PROTECT clinical trial is currently initiating and Peter Friend's group from Oxford and Birmingham has just published the results of a Phase I study with 20 patients showing that NMP for liver transplantation is safe and feasible.…”