Résumé
Background/aims: Controlled DCD organ donation (cDCD) is a strategic target for the Italian transplantation network. Italian peculiarities in cDCD donation make published results questionable and raise concern over organ ischemic damage. Consequently, normothermic regional perfusion (NRP) has been strongly recommended in potential cDCD donors. In 2019 the randomized multicenter DONARE study was designed to describe ischemic-reperfusion and inflammatory biomarkers during NRP and to test the potential benefit of apheresis by an adsorbent filter (CytoSorb) included in the NRP circuit. The aim of this report is to describe the modulation of the clinical characteristics and of the NRP in the DONARE study enrolled cases. Method(s): The study protocol was defined by the DCD national working group and proposed to all the Italian DCD donation centers. The coordinating center (CNT) has monitored the evolving cDCD activity to preserve the study capacity of representing the Italian scenario. Samples have been blindly centralized to an independent laboratory for cytokines profiling. The outcomes of transplanted organs have been recorded in the national quality database. Result(s): From September 2020 to June 2022, 27 out of the 40 planned cases have been enrolled in six centers: 4 in 2020, 12 in 2021 and 11 within June 2022. Approval is still pending in other centers. Main causes of exclusion among potential cDCD donors were: age above 65 (in 2020), e-CPR prior- to-death, shortage in personnel and COVID-19 restrictions. The age limit for enrolment (<65yrs) was abolished by amendment due to the national trend: mean age of enrolled cases increased from 57+/-6 in 2020 to 67+/-6 years in 2022. Mean NRP duration decreased from 223,3+/-39,2 in 2020 to 168,9+/-42,6 minutes in 2022;serial samples (4/2 with/without Cytosorb, from T0 to T4) from different points of the NRP circuit have been completed throughout the procedure in all the cases. All the enrolled cases became utilized donors. No study-related adverse event has been reported. Conclusion(s): Coordination of multicenter studies in the rapidly evolving scenario of controlled DCD donation should take advantage of continuous monitoring of real-life procedures and auditing of adherence to operational recommendations. The interim evaluation confirms the feasibility and safety of the study.
Résumé
Background and aims: Solid organ transplant recipients (SOTRs) have been considered as an extremely vulnerable population in respect to SARS-CoV-2 infection. We aimed to assess the incidence and lethality rate of SARS-CoV-2 infection in different organ transplant settings using the liver as a comparator. Methods: In this nationwide population-based study we compared the crude incidence and lethality rates of SARS-CoV-2 infection [95% Bonferroni adjusted CI (Ba-CI)] among Italian LTRs as compared to non-liver SOTRs and to general population. The following independent groups had been compared: Italian general population, all SOTRs, liver transplant recipients (LTRs) and non-Liver SOTRs in area with different incidence of infection. Incidence rate ratio (IRR) and lethality rate ratio (LRR) was assessed. Community risk exposures in transplant settings were assessed. Results: From February 21 to June 22, 2020, there were 450 cases of SARS-CoV-2 infections over 14168 LTRs (n=89) and 29815 non-liver SOTRs (n= 361). A significantly lower risk of infection [IRR 0.56 (Ba-CI 0.34-0.92), 0.45 (Ba-CI 0.26-0.79), 0.52 (Ba-CI 0.36-0.75)] and a lower lethality rate ratio [(LRR 0.61 (Ba-CI 0.23-1.57), 0.37 (0.08-1.76), 0.52 (0.23-1.18] was found among LTRs as compared to non-liver SOTRs in the three areas. Excluding Lombardy, the risk of infection and lethality in LTRs was lower compared to general population. Non-Liver SOTRs showed an increased risk of infection and lethality at all geographic levels compared to general population. No significant difference in the adherence to mitigation policies was found. Conclusions: Liver transplantation was associated with a significantly lower risk of SARS-CoV-2 infection and lethality in respect to non-liver solid organ transplants. A separate evaluation of organ-specific risk stratification analysis and vaccination responses in transplant population is needed.