ORGAN DONATION AND TRANSPLANTATION IN THE RUSSIAN FEDERATION IN 2021 14th Report from the Registry of the Russian Transplant Society.

Objective: to monitor the current trends and developments in organ donation and transplantation in the Russian Federation based on data from the year 2021. Materials and methods. Heads of organ transplant centers were surveyed through questionnaires. Data control was done using the information accounting system of the Russian Ministry of Health. We performed a comparative analysis of data obtained over years from various federal subjects of the Russian Federation and transplantation centers. Results. Based on data retrieved from the 2021 Registry, 45 kidney, 29 liver and 17 heart transplantation programs were existing in the Russian Federation as of the year 2021. The kidney transplant waiting list in 2021 included about 10.5% of the 60, 000 patients receiving dialysis. Organ donation activity in 2021 was 4.5 per million population, with a 78.4% multi-organ procurement rate and an average of 3.0 organs procured from one effective donor. In 2021, there were 9.5 kidney transplants per million population, 4.2 liver transplants per million population and 2.0 heart transplants per million population. Same year, the number of transplant surgeries performed in the Russian Federation increased by 18.3% compared to the year 2020, reaching the level of 2019. In Moscow, organ donation activity was 23.7 per million population, that of 2019. In 2021, the city of Moscow and the Moscow region accounted for 12 functioning organ transplant centers, performing 57.7% of all kidney transplants and 70.5% of all extrarenal transplants in the country. The number of organ recipients in the Russian Federation has exceeded 140 per million population. Conclusion. In 2021, donor activity and volume of transplant care in Russian regions recovered. This was after the decline in 2020 that resulted from the new coronavirus disease (COVID-19) pandemic. In addition, 7 new transplant programs were established. Further development of regional organ donation and transplantation programs, improvement in their efficiency, increase in the activity of transplant centers and development of inter-regional collaboration are expected in the Russian Federation in 2022. Copyright © 2022 Russian Transplant Society. All rights reserved.

Myocarditis and pericarditis in adolescents after first and second doses of mRNA COVID-19 vaccines

Introduction: While some concerns about vaccination-related pericarditis and/or myocarditis have raised, no published data are available on pericarditis and/or myocarditis with mRNA COVID-19 vaccines in the age group of adolescents, particularly in 12-15 years. The objective of this study was to determine whether the risk of reporting pericarditis and/or myocarditis with mRNA COVID-19 vaccines varied according to dose-vaccination, age, sex and type of pericarditis and/or myocarditis in adolescents between 12-17 years. Material and methods: We performed an observational study reviewing all reports of adolescent vaccinated with mRNA COVID-19 vaccines and recorded in Vigibase®, the World Health Organization (WHO) Global Individual Case Safety Reports (ICSRs) database. We included all reports registered between January 1, 2021, and September 14, 2021. Reporting Odds Ratios (ROR) with their 95% confidence interval (CI) were calculated to estimate the risk of reporting pericarditis and/or myocarditis. Results: Among 4,942 reports with mRNA COVID-19 vaccines in adolescents, we identified 242 pericarditis and/or myocarditis. Compared with the first dose of mRNA COVID-19 vaccines, the second dose was associated with an increased risk of reporting pericarditis and/or myocarditis (ROR 4.95;95% CI 3.14, 7.89). The risk of reporting pericarditis and/or myocarditis was 10 times higher in boys than in girls and no difference between the two types of vaccines could be demonstrated. Discussion/Conclusion: This investigation including only adolescent data suggests for the first time that second dose of mRNA COVID-19 vaccines increase the risk of reporting myocarditis/pericarditis compared to the first dose particularly in boys without significant difference between Tozinameran and Elasomeran.

Myocarditis after mRNA COVID-19 vaccines: A comparative analysis using French Spontaneous Reporting Data

Introduction: Post-mRNA vaccine myocarditis emerged as a rare adverse effect quickly after adolescents and young adult populations started to be vaccinated, and it was labelled as such for both vaccines. This work aimed to study the Reporting rates (Rr) of myocarditis after mRNA-1273 and BNT162b2 injections. Material and methods: mRNA vaccine exposures were retrieved from the French SI-VAC database, while cases of myocarditis were retrieved from the French spontaneous reporting database (Base Nationale de Pharmacovigilance, BNPV) up to 30 September 2021. All cases were routinely evaluated by drug safety medical professionals and repeated at national level in the context of an intensive pharmacovigilance monitoring. Reporting rates (Rr) per 100.000 injections were calculated according to age, gender and injection rank;Poisson distribution was used to compute Rrs 95% Confidence Interval (95% CI). Results: Over the study period, almost 73 million BNT162b2 and 10 million mRNA-1273 doses were injected, and 376 and 106 confirmed cases of myocarditis were reported, respectively. These occurred in the week following the injection for 76.4% of cases reported after mRNA-1273 (n = 81) vs. 58.4% after BNT162b2 (n = 219). Rr per 100.000 injections was 1.1 (95% CI 0.9 to 1.3) for mRNA-1273 and 0.5 (0.5 to 0.6) for BNT162b2. After the second injection, the difference among vaccines was more pronounced in men aged 18-24 years (13.9 [9.2 to 20.1] for mRNA-1273 vs. 4.3 [3.4 to 5.5] for BNT162b2) and aged 25-29 years (7.0 [3.4 to 12.9] vs. 1.9 [1.2 to 2.9]);in younger people, the low number of cases did not allow any meaningful conclusion. In women, Rrs were globally lower, but differences between vaccines were close to those found for men. Discussion/Conclusion: The present study suggests that mRNA-1273 is related with a higher risk of myocarditis than BNT162b2 in people aged under 30, especially after the second injection.

Organ donation and transplantation in the Russian Federation in 2020: 13th report from the registry of the Russian transplant society

Objective: to monitor the current trends and developments in organ donation and transplantation in the Russian Federation based on the 2020 data. Materials and methods. Heads of organ transplant centers were surveyed through questionnaires. Data control was done using the information accounting system of the Russian Ministry of Health. Between separate federal subjects of the Russian Federation and between transplantation centers, comparative analysis of data obtained over years was performed. Results. Based on data retrieved from the 2020 Registry, 44 kidney, 29 liver and 16 heart transplantation programs were functioning in the Russian Federation in 2020. The kidney transplant waitlist in 2020 included about 11.5% of the total 60,000 patients receiving dialysis. Organ donation activity in 2020 was 3.9 per million population, with a 74.6% multi-organ procurement rate and an average of 2.9 organs being procured from one effective donor. In 2020, there were 7.7 kidney transplants per million population, 3.8 liver transplants per million population and 1.7 heart transplants per million population. Same year, the number of transplant surgeries performed in the Russian Federation fell by 19.2% to 13.4 per million population against the background of the outbreak caused by the new coronavirus disease COVID-19. The city of Moscow and the Moscow region in 2020 accounted for 13 out of the 14 functioning organ transplantation centers, performing 66.3% of all kidney transplants and 72.4% of all extrarenal transplants in the country. The number of organ recipients in the Russian Federation have exceeded 130 per million population. Conclusion. In 2020, despite the new coronavirus disease COVID-19 pandemic and accompanying restrictive measures, transplant centers continued to perform organ transplants, run a waiting list and monitor organ recipients. However, the number of effective donors (-22.9%) and organ transplants (-19.2%) decreased, tentatively to the 2017 levels. In 2021, transplant centers with support from health authorities will have to restore the volume of transplant care with consideration to the real needs of the population and the donor resource. The COVID-19 factor, including vaccination of the population, as well as financial support to transplantation programs, will be decisive in shaping the trend of transplantation care and organ donation in the federal subjects of the Russian Federation in the coming 1-2 years.

COVID-19 in solid organ transplant recipients: initial report from national multicenter observational study "ROKKOR-recipieni"

We herein present our initial report from «ROKKOR-recipient», a national multicenter observational study. The prevalence, risk factors, clinical manifestations and outcomes ofthe novel coronavirus disease 2019 (COVID-19) in solid organ transplant recipients receiving immunosuppressive therapy were investigated. The study enrolled 251 COVID-19 patients (220 kidney recipients, 7 liver recipients, 1 liver-kidney recipient, and 23 heart recipients). The subjects came from 20 regions in Russia. The symptoms, clinical presentation, imaging and lab test results, therapy and outcomes of COVID-19 were described. It was established that solid organ transplant recipients with COVID-19 have a higher risk of developing adverse events. Predictors of adverse events include associated cardiovascular diseases, pulmonary diseases, diabetes, and kidney failure. Symptoms of the disease include dyspnea, rash and catarrhal signs, as well as initial low blood oxygen saturation (SpO₂ <92%), leukocytosis (white blood cell count >10 х 10⁹/L), elevated creatinine levels (>130 mumol/L) and a marked decrease in glomerular filtration rate, requiring hemodialysis. Performing organ transplant surgery in COVID-19 does not increase the risk of adverse events but could save the lives of waitlisted terminally ill patients. В статье представлены первые результаты национального многоцентрового исследования «РОККОР-реципиент», имевшего целью изучить распространенность, факторы риска, клинические проявления и исходы новой коронавирусной инфекции (COVID-19) у реципиентов солидных органов, получающих иммуносупрессивную терапию. В исследование включен 251 пациент (220 реципиентов почки, 7 реципиентов печени, 1 реципиент печени и почки, 23 реципиента сердца) из 20 регионов России c COVID-19. Описаны симптомы, клинические проявления, результаты инструментальных и лабораторных обследований, терапия и исходы коронавирусной инфекции. Выявлено, что наличие трансплантированного органа повышает риск нежелательных событий на фоне COVID-19, предикторами которых являются сопутствующие сердечно-сосудистые, легочные заболевания, сахарный диабет и почечная недостаточность, наличие в качестве симптомов манифестации заболевания одышки, сыпи и катаральных явлений, а также исходно низкая сатурация кислорода (SpO₂ <92%), лейкоцитоз более 10 х 10⁹/л, повышение уровней креатинина более 130 мкмоль/л и значимое снижение скорости клубочковой фильтрации, требующее проведения гемодиализа. Выполнение трансплантации органов на фоне пандемии COVID-19 не повышает риск развития нежелательных событий у реципиентов, но позволяет спасти жизни больных с терминальными заболеваниями, включенных в лист ожидания.

[COVID-19: On the verge of madness]. / COVID-19 : aux frontières de la folie.

Disorganizations due to the current coronavirus SARS-CoV-2 pandemic that have required a national quarantine from the 17th of march to the 11 of May 2020, mangle and question. In view of the situation's extreme traumatic character and of the pathological consequences observed, we are going to try to give meaning to an almost chaotic situation. Our shared production, coming out of two psychologists - one being in quarantine and the other one not - crossed diary trying to put the theory in favor of the clinic, has for aim to build a support structuring thought. In fact, the breaking of COVID-19's death anxiety creates hysterical looking defense mechanisms within the entire society. When the extreme and sudden situation that we are describing can be understood as a paradoxical injunction as much as a denial of the split, we will focus our analyzes on both societal and hospital realities, that seems to jeopardize humanity, dignity, solidarity, equity, justice and autonomy principles. Describing, trying to put into words and analyzing all movements concerning the current situation, could lead to giving meaning to a situation which seems already deprived.