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Background: The European Union Directives stipulate mandatory tests for the presence of any infections in donors and donations of substances of human origin (SoHO). In some circumstances, other pathogens, including fungi and parasites, may also pose a threat to the microbial safety of SoHO., Objective: The aim of the two systematic reviews is to identify, collect, and evaluate scientific evidence for the presence of fungal and parasitic infections in donors and donations of SoHO, and their transmission via transfusion and transplantation., Methods: An algorithmic search, one each for fungal and parasitic disease, was applied to 6 scientific databases (PubMed, EMBASE, Web of Science, Scopus, Cochrane Library [trials], and CINAHL). Additionally, manual and algorithmic searches were employed in 15 gray literature databases and 22 scientific organization websites. The criteria for eligibility included peer-reviewed publications and peer-reviewed abstract publications from conference proceedings examining the prevalence, incidence, odds ratios, risk ratios, and risk differences for the presence of fungi and parasites in donors and SoHO donations, and their transmission to recipients. Only studies that scrutinized the donors and donations of human blood, blood components, tissues, cells, and organs were considered eligible. Data extraction from eligible publications will be performed independently by two reviewers. Data synthesis will include a qualitative description of the studies lacking evidence suitable for a meta-analysis and a random or fixed-effect meta-analysis model for quantitative data synthesis., Results: This is an ongoing study. The systematic reviews are funded by the European Centre for Disease Prevention and Control, and the results are expected to be presented by the end of 2021., Conclusions: The systematic reviews will provide the basis for developing a risk assessment for fungal and parasitic disease transmission via SoHO., Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42020160090; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020160090 ; PROSPERO International Prospective Register of Systematic Reviews CRD42020160110; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020160110., International Registered Report Identifier (irrid): DERR1-10.2196/25674., (©Petros C Dinas, Dragoslav Domanovic, Yiannis Koutedakis, Christos Hadjichristodoulou, Ioannis Stefanidis, Kalliope Papadopoulou, Konstantinos Dimas, Konstantinos Perivoliotis, Konstantinos Tepetes, Andreas D Flouris. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 10.06.2021.)

Background: Two selection strategies for newly-registered blood donors are available: a single-visit selection called the standard selection procedure (SSP), and a two-stage selection named predonation and donation screening (PDS). This study reviews the selection strategies for newly-registered donors currently applied in European countries., Material and Methods: We collected data on donor selection procedures, blood donation, laboratory screening and HIV, HCV and HBV positive donors/donations from 2010 to 2013 in 30 European countries by using questionnaires. We grouped the countries according to the applied selection strategy, and for each country, we calculated the 4-year prevalence of confirmed positive results indicating the presence of overall and recent HIV, HCV and HBV infections among first-time and repeat donations and among newly-registered donors., Results: Most of the 24 countries (80%) apply the SSP strategy for selection of newly-registered donors. Twenty-two countries (73.3%) employ a nucleic acid amplification testing in addition to the mandatory serological screening. The survey confirms a higher overall prevalence of HIV, HCV and HBV infections among first-time donations and newly-registered donors than among repeat donations. In contrast, the prevalence of recently acquired HIV and HCV infections was lower among first-time donations and newly-registered donors than among repeat donations, but higher for recent HBV infections (6.7/10 5 vs 2.6/10 5 in the SSP setting and 4.3/10 5 vs 0.5/10 5 in one country using PDS). The relatively low numbers of infected donors selected by PDS impeded accurate assessment of the prevalence of recent infections in first-time donations., Discussion: The data from European countries provide inconclusive evidence that applying PDS reduces the risk of donations being made in the diagnostic window of first-time donors. The impact of PDS on the risk of window-period donations and blood donor management needs further investigation.

Background: Hepatitis E virus (HEV) is endemic in EU/EEA countries, but the understanding of the burden of the infection in humans is inconsistent as the disease is not under EU surveillance but subject to national policies., Study: Countries were asked to nominate experts and to complete a standardised questionnaire about the epidemiological situation and surveillance of HEV in their respective EU/EEA country. This study reviewed surveillance systems for human cases of HEV in EU/EEA countries and nominated experts assessed the epidemiology in particular examining the recent increase in the number of autochthonous cases., Results: Surveillance systems and case definitions across EU/EEA countries were shown to be highly variable and testing algorithms were unreliable. Large increases of autochthonous cases were reported from Western EU/EEA countries with lower case numbers seen in Northern and Southern European countries. Lack of clinical awareness and variability in testing strategies might account for the observed differences in hepatitis E incidence across EU/EEA countries. Infections were predominantly caused by HEV genotype 3, the most prevalent virus type in the animal reservoirs., Conclusion: Discussions from the expert group supported joint working across countries to better monitor the epidemiology and possible changes in risk of virus acquisition at a European level. There was agreement to share surveillance strategies and algorithms but also importantly the collation of HEV data from human and animal populations. These data collected at a European level would serve the 'One Health' approach to better informing on human exposure to HEV., (Copyright © 2016. Published by Elsevier B.V.)

Background: West Nile virus (WNV) is transmitted by mosquitoes in both urban as well as in rural environments and can be pathogenic in birds, horses and humans. Extrinsic factors such as temperature and land use are determinants of WNV outbreaks in Europe, along with intrinsic factors of the vector and virus., Methods: With a multivariate model for WNV transmission we computed the probability of WNV infection in 2014, with July 2014 temperature anomalies. We applied the July temperature anomalies under the balanced A1B climate change scenario (mix of all energy sources, fossil and non-fossil) for 2025 and 2050 to model and project the risk of WNV infection in the future. Since asymptomatic infections are common in humans (which can result in the contamination of the donated blood) we estimated the predictive prevalence of WNV infections in the blood donor population., Results: External validation of the probability model with 2014 cases indicated good prediction, based on an Area Under Curve (AUC) of 0.871 (SD = 0.032), on the Receiver Operating Characteristic Curve (ROC). The climate change projections for 2025 reveal a higher probability of WNV infection particularly at the edges of the current transmission areas (for example in Eastern Croatia, Northeastern and Northwestern Turkey) and an even further expansion in 2050. The prevalence of infection in (blood donor) populations in the outbreak-affected districts is expected to expand in the future., Conclusions: Predictive modelling of environmental and climatic drivers of WNV can be a valuable tool for public health practice. It can help delineate districts at risk for future transmission. These areas can be subjected to integrated disease and vector surveillance, outreach to the public and health care providers, implementation of personal protective measures, screening of blood donors, and vector abatement activities.

Background: In an open-label blinded study, we compared intracoronary and transendocardial CD34(+) cell transplantation in patients with nonischemic dilated cardiomyopathy., Methods and Results: Of the 40 patients with dilated cardiomyopathy, 20 were randomized to receive intracoronary injection and 20 received transendocardial CD34(+) cell delivery. In both groups, CD34(+) cells were mobilized by filgrastim, collected via apheresis, and labeled with technetium-99m radioisotope for single-photon emission computed tomographic imaging. In the intracoronary group, cells were injected intracoronarily in the artery supplying segments of greater perfusion defect on myocardial perfusion scintigraphy. In the transendocardial group, electroanatomic mapping was used to identify viable but dysfunctional myocardium, and transendocardial cell injections were performed. Nuclear single-photon emission computed tomographic imaging for quantification of myocardial retention was performed 18 hours thereafter. At baseline, groups did not differ in age, sex, left ventricular ejection fraction, or N-terminal pro-brain natriuretic peptide levels. The number of CD34(+) cells was also comparable (105 ± 31 × 10(6) in the transendocardial group versus 103 ± 27 × 10(6) in the intracoronary group, P=0.62). At 18 hours after procedure, myocardial retention was higher in the transendocardial group (19.2 ± 4.8%) than in the intracoronary group (4.4 ± 1.2%, P<0.01). At 6 months, left ventricular ejection fraction improved more in the transendocardial group (+8.1 ± 4.3%) than in the intracoronary group (+4.2 ± 2.3%, P=0.03). The same pattern was observed for the 6-minute walk test distance (+125 ± 33 m in the transendocardial group versus +86 ± 13 m in the intracoronary group, P=0.03) and N-terminal pro-brain natriuretic peptide (-628 ± 211 versus -315 ± 133 pg/mL, P=0.04)., Conclusions: In patients with dilated cardiomyopathy, transendocardial CD34(+) cell transplantation is associated with higher myocardial retention rates and greater improvement in ventricular function, N-terminal pro-brain natriuretic peptide, and exercise capacity compared with intracoronary route., Clinical Trial Registration Url: http://www.clinicaltrials.gov. Unique identifier: NCT01350310.

Rationale: CD34+ transplantation in dilated cardiomyopathy was associated with short-term improvement in left ventricular ejection fraction and exercise tolerance., Objective: We investigated long-term effects of intracoronary CD34+ cell transplantation in dilated cardiomyopathy and the relationship between intramyocardial cell homing and clinical response., Methods and Results: Of 110 dilated cardiomyopathy patients, 55 were randomized to receive CD34+ stem cell transplantation (SC group) and 55 received no cell therapy (controls). In the SC group, CD34+ cells were mobilized by granulocyte colony-stimulating factor and collected via apheresis. Patients underwent myocardial scintigraphy and cells were injected in the artery supplying segments with the greatest perfusion defect. At baseline, 2 groups did not differ in age, sex, left ventricular ejection fraction, or N-terminal B-type natriuretic peptide levels. At 5 years, stem cell therapy was associated with increased left ventricular ejection fraction (from 24.3 ± 6.5% to 30.0 ± 5.1%; P=0.02), increased 6-minute walk distance (from 344 ± 90 m to 477 ± 130 m; P<0.001), and decreased N-terminal B-type natriuretic peptide (from 2322 ± 1234 pg/mL to 1011 ± 893 pg/mL; P<0.01). Left ventricular ejection fraction improvement was more significant in patients with higher myocardial homing of injected cells. During follow-up, 27 (25%) patients died and 9 (8%) underwent heart transplantation. Of the 27 deaths, 13 were attributed to pump failure and 14 were attributed to sudden cardiac death. Total mortality was lower in the SC group (14%) than in controls (35%; P=0.01). The same was true of pump failure (5% vs. 18%; P=0.03), but not of sudden cardiac death (9% vs. 16%; P=0.39)., Conclusions: Intracoronary stem cell transplantation may be associated with improved ventricular function, exercise tolerance, and long-term survival in patients with dilated cardiomyopathy. Higher intramyocardial homing is associated with better stem cell therapy response.

Background: We investigated clinical effects of intracoronary transplantation of CD34+ cells in patients with dilated cardiomyopathy (DCM)., Methods: Of 55 patients with DCM, 28 were randomized to CD34+ transplantation (SC group), and 27 patients did not receive stem cell therapy (controls). In the SC group, peripheral blood CD34+ cells were mobilized by granulocyte-colony stimulating factor and collected via apheresis. Patients underwent myocardial scintigraphy and CD34+ cells were injected in the coronary artery supplying the segments with reduced viability., Results: At baseline, the 2 groups did not differ in age, gender, left ventricular ejection fraction (LVEF), or NT-proBNP levels. At 1 year, stem cell therapy was associated with an increase in LVEF (from 25.5 ± 7.5% to 30.1 ± 6.7%; P = .03), an increase in 6-minute walk distance (from 359 ± 104 m to 485 ± 127 m; P = .001), and a decrease in NT-proBNP (from 2069 ± 1996 pg/mL to 1037 ± 950 pg/mL; P = .01). The secondary endpoint of 1-year mortality or heart transplantation was lower in patients receiving SC therapy (2/28, 7%) than in controls (8/27, 30%) (P = .03), and SC therapy was the only independent predictor of outcome on multivariable analysis (P = .04)., Conclusions: Intracoronary stem cell transplantation could lead to improved ventricular remodeling, better exercise tolerance and potentially improved survival in patients with DCM., (Copyright © 2011 Elsevier Inc. All rights reserved.)