This is the first clinical study with the application of cytokine adsorption with CytoSorb® during ex-vivo lung perfusion (EVLP) on pulmonary grafts deemed unacceptable for direct transplantation at donation site. From July 2011 to March 2020, 54 EVLP procedures were carried out, 21 of which have been performed integrating CytoSorb® in the circuit, providing by far the largest published human case series to date in this application.
In all enrolled grafts, a significant increase of inflammatory mediators (IL-6, MCP1, GCSF, IL-10) was observed over time during EVLP and this cytokines increase has been correlated with the poor organs’ quality and limited suitability for transplantation.
Of the CytoSorb® treated lungs, 16 (76%) were able to be transplanted , instead, out of the 33 non CytoSorb® treated grafts, only 22 (67%) have been transplanted.
Among the transplanted grafts after EVLP, the CytoSorb® group experienced a significant decreased IL-6, IL-10, MCP1 and GCSF concentration compared to the control group.
This reduction of inflammatory mediators, effectively achieved by means of CytoSorb®, resulted in better organ function after transplantation with lower incidence of sever grade 3 PGD in the treated group and lower need of post-transplant VV-ECMO.
There was also a significantly lower in-hospital (0 v 5, p = 0.03) and 1-year mortality rate (0 v 8, p = 0.01) in the CytoSorb® treated group.
This interventional first in-human study confirms the safety and efficacy of inflammatory mediators’ removal by adsorption already showed by other experimental studies, also on other organs’ ex-vivo perfusion, such as kidneys and livers. In order to reduce their levels during EVLP, allowing grafts’ manipulation and achieving the proper organ reconditioning, leading to better transplant short-term outcomes and 1-year survival, increasing the number of donor lungs available and suitable for transplantation.
The results showed in this study confirm also other clinical experience of applying cytokine removal in many other clinical fields, such as critical care patients with sepsis, septic shock, cardiac surgery complications, organ failure, etc.
Open-access publication: https://www.frontierspartnerships.org/articles/10.3389/ti.2023.10777/full