ABSTRACT
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.
ABSTRACT
Purpose: In the present study we want to report safety and outcome of organ transplantation from donors with active SARS-CoV-2 infection in Italy. Method(s): In November 2020 the Italian CNT allowed the use of hearts and livers from asymptomatic donors with incidentally discovered active SARS-CoV-2 infection. Organ could be offered to candidates with asymptomatic or resolved COVID-19 or with a full COVID-19 vaccination (3 doses with documented seroconversion) and to Kidney transplant candidates with resolved COVID-19 or with a full course of anti-COVID-19 vaccination. After transplantation all recipients underwent SARS-CoV-2 RNA detection on respiratory secretions on a weekly basis for up to 4 weeks after transplantation. Result(s): From November 21, 2020 to January 23, 2022 we have performed 44 solid organ transplants (33 livers, including 3 split, 5 hearts and 6 kidneys), in 34 males, and 10 females, mean age 49.5 years, range 0-70), from 32 donors (18 males, mean age 47.9, range 14-82) with active SARS-CoV-2 infection and cause of death unrelated to COVID-19. None of the recipients developed a donor derived SARS-CoV-2 infection. Conclusion(s): We believe that the use of non-lung organs from donors with active SARS-CoV-2 infection in selected and consented recipients may contribute to safely increase the donors pool.
ABSTRACT
SARSCoV2 mostly affects the respiratory system with clinical patterns ranging from the common cold to fatal pneumonia. During the first wave of the COVID-19 pandemic, owing to the high number of patients who were infected with SARSCoV2 and subsequently recovered, it has been shown that some patients with post-COVID-19 terminal respiratory failure need lung transplantation for survival. There is increasing evidence coming from worldwide observations that this procedure can be performed successfully in post-COVID-19 patients. However, owing to the scarcity of organs, there is a need to define the safety and efficacy of lung transplant for post-COVID-19 patients as compared to patients waiting for a lung transplant for other pre-existing conditions, in order to ensure that sound ethical criteria are applied in organ allocation. The Milan's Policlinic Lung Transplant Surgery Unit, with the revision of the National Second Opinion for Infectious Diseases and the contribution of the Italian Lung Transplant Centres and the Italian National Transplant Centre, set up a pivotal observational protocol for the lung transplant of patients infected and successively turned negative for SARSCoV2, albeit with lung consequences such as acute respiratory distress syndrome or some chronic interstitial lung disease. The protocol was revised and approved by the Italian National Institute of Health Ethics Committee. Description of the protocol and some ethical considerations are reported in this article.
Subject(s)
COVID-19 , Lung Transplantation , Respiratory Distress Syndrome , Humans , Lung Transplantation/adverse effects , Pandemics , SARS-CoV-2ABSTRACT
The National Transplant Centre, in order to follow the changes in communication tools and languages occurred during COVID-19 outbreak, has launched a new campaign about organ, tissue and cell donations. The methods of accessing and using information sources have also changed, focusing mainly on new digital and social platforms. On this basis, the National Transplant Centre launched an in-depth scenario research activity aiming at achieving a new strategy for the promotion of what discussed above. A new campaign was born, supported by the Ministry of Health, with the aim to give a new impulse to communication on the subject and to inform citizens on how to become donors.
ABSTRACT
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.
ABSTRACT
Objective: In September-October 2020 our Poison Centre (PC) managed a cluster of 44 workmen who consumed food contaminated by botulinum neurotoxins (BoNT) at a workplace canteen in Sicily. Case series: Of the 100 workers using the canteen, 44 presented over a 7-day period to 6 Emergency Departments (ED) in Southern Italy complaining of neurological and gastrointestinal symptoms (Table 1). Our PC, consulted first by physicians in Cefalù, made the diagnostic suspicion of foodborne botulism. Heptavalent-botulism-antitoxin (HBAT) was mobilized from different National Stockpiles (Catania, Pavia, Rome, Trieste, Naples) after approval from the Ministry of Health (MoH). The early admitted patients (7/44, 17%, 2-days after meal) worsened rapidly and 5/7 required mechanical ventilation (MV) within 24 hours. Patients with minor symptoms were discharged and managed with telephone follow-up by PC toxicologists. Conclusion: Botulism diagnosis is based on clinical suspicion;laboratory testing has a crucial role in confirmation, but analyses do not always demonstrate BoNT (15/36 tested positive in our cluster). Therefore, the positivity of at least 1 patient of a cluster confirms the diagnosis. The antitoxin should be administered as soon as clinical suspicion is made. In our outbreak, HBAT was administered due to rapid worsening of neurological symptoms, in order to prevent MV. The rapid deterioration of the first 7 patients is attributable to the ingestion of higher titre of toxin. In Italy, HBAT in the National Stockpile can be mobilized only after MoH approval. The management of the outbreak was challenging because of difficulties in the capacity of the hospitals and the urgent need for antitoxin. An efficient collaboration between local physicians, clinical toxicologists, MoH and the National Stockpile system ensured optimal management with prompt HBAT mobilization in sufficient number. This was also possible because it occured before the second COVID-19 wave in which it would have been difficult to manage 44 patients potentially requiring ICU monitoring.
ABSTRACT
Purpose The respiratory system, and namely the lung, is undoubtedly the preferential target of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The clinical pictures are extremely various, up to the intensive care unit (ICU) admission for acute respiratory distress syndrome (ARDS). Lung transplantation (LT) is a consolidate therapeutic option for end-stage chronic respiratory diseases. Its role in an acute setting is questionable, particularly due to lack of experiences, donor shortage, and the difficulty to fully evaluate the potential recipient. We report our preliminary experience with the first two cases of LT for SARS-CoV-2 related ARDS, trying to provide some food for thought. Methods We retrospectively analysed our first two cases of bilateral LT for ARDS after COVID-19. We recorded data on pre-transplantation clinical course, transplantation management and outcomes. Results The two patients had a similar clinical evolution of COVID-19. Transplantations were successful in both cases;the first patient is alive and in good condition 5 months after transplantation, while the second died 62 days after surgery. Table 1 shows clinical details and relevant time-points. Conclusion Our experience showed that LT for COVID-19 is feasible. Importantly, observing a dedicated protocol made the procedure safe for the healthcare staff involved. On the other hand, our second unsuccessful case poses relevant questions: first of all, lung transplantation should be reserved to highly selected patient, after careful clinical, infective as well as psychiatric evaluation. The ethical aspects should also be considered in this situation, with regard to the centre rate mortality on waiting list. Anyway, the potential role of LT in the acute and sub-acute/chronic settings suggests the need for maintaining LT centre active during pandemic. Finally, COVID-19, once more, imposes to share clinical experiences.