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The paper presents the results of metrological tests and measurements of dimensional accuracy of models manufactured using the photo-curing additive technology of POLYJET MATRIX - PJM. The material from which the samples were manufactured was a liquid polymer resin with the commercial name MED610, which is characterized by a high degree of biocompatibility, which increases the validity of the research in medical and dental applications. The key parameter considered was the location of digital CAD models in selected places of the virtual building platform and it influence of dimensional accuracy. The research results showed a clear impact of the arrangement of models on the building platform on the accuracy of the produced models, both in terms of external and internal diameters. [ABSTRACT FROM AUTHOR]

Background: For transcoronary progenitor cells' administration, injections under flow arrest (over-the-wire balloon technique, OTW) are used universally despite lack of evidence for being required for cell delivery or being effective in stimulating myocardial engraftment. Flow-mediated endothelial rolling is mandatory for subsequent cell adhesion and extravasation.Methods: To optimize cell directing toward the coronary endothelium under maintained flow, the authors developed a cell-delivery side-holed perfusion catheter (PC). Thirty-four patients (36-69 years, 30 men) with primary stent-assisted angioplasty-treated anterior MI (peak TnI 151 [53-356]ng/dL, mean[range]) were randomly assigned to OTW or PC autologous ⁹⁹Tc-extametazime-labeled bone marrow CD34(+) cells (4.34 [0.92-7.54] × 10⁶) administration at 6-14 days after pPCI (LVEF 37.1 [24-44]%). Myocardial perfusion (⁹⁹(m)Tc-MIBI) and labeled cells' activity were evaluated (SPECT) at, respectively, 36-48 h prior to and 60 min after delivery.Results: In contrast to OTW coronary occlusions, no intolerance or ventricular arrhythmia occurred with PC cells' administration (P < .001). One hour after delivery, 4.86 [1.7-7.6]% and 5.05 [2.2-9.9]% activity was detected in the myocardium (OTW and PC, respectively, P = .84). Labeled cell activity was clearly limited to the (viable) peri-infarct zone in 88% patients, indicating that the infarct core zone may be largely inaccessible to transcoronary-administered cells.Conclusions: Irrespective of the transcoronary delivery method, only ≈ 5% of native (i.e., non-engineered) CD34(+) cells spontaneously home to the injured myocardium, and cell retention occurs preferentially in the viable peri-infarct zone. Although the efficacy of cell delivery is not increased with the perfusion method, by avoiding provoking ischemic episodes PC offers a rational alternative to the OTW delivery. [ABSTRACT FROM AUTHOR]

Aims: Infective endocarditis (IE) poses a significant clinical challenge, necessitating nuanced diagnostic tools for early and accurate detection. The diagnostic role of the hybrid technique of single-photon emission tomography-computed tomography with technetium-99 m-hexamethylpropyleneamine oxime-labelled leukocytes ([ 99m Tc]Tc-HMPAO-SPECT/CT) has evolved in recent years. This single-center study assessed whether the recent inclusion in the 2023 European Society of Cardiology modified diagnostic criteria of IE (2023 ESC) of infectious lesions detected with [ 99m Tc]Tc-HMPAO-SPECT/CT affects their diagnostic performance., Methods and Results: Between 2015 and 2019, we enrolled 205 consecutive adults with suspected IE. All participants underwent [ 99m Tc]Tc-HMPAO-SPECT/CT scans (370-740 MBq). Scans were deemed positive in the presence of intracardiac abnormal tracer uptake and/or within the cardiac implantable electronic device. Patients were prospectively followed-up for 12 ± 10 months. Local device infection (LDI) or IE was diagnosed in 75 (36.6 %) patients, while 72 (35.1 %) [ 99m Tc]Tc-HMPAO-SPECT/CT results returned positive. Moreover, extracardiac infectious foci were detected in 25 % of [ 99m Tc]Tc-HMPAO-SPECT/CT scans. The inclusion of both intracardiac and extracardiac lesions detected with [ 99m Tc]Tc-HMPAO-SPECT/CT yields significantly higher sensitivity (p = 0.003) and negative predictive value (NPV) (p = 0.009)., Conclusion: The inclusion of [ 99m Tc]Tc-HMPAO-SPECT/CT into the IE diagnostic work-up improves the appropriate classification of patients. For patients with IE, the extended inclusion of lesions detected with [ 99m Tc]Tc-HMPAO-SPECT/CT in the ESC 2023 diagnostic criteria significantly improves sensitivity and NPV while reducing potential IE misdiagnoses. This pioneering imaging modality is poised to become an integral component of clinical practice, promising to advance IE diagnosis and management., Competing Interests: Declaration of competing interest The authors have no relevant conflicts of interest to disclose., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

The article presents the results of tribological research of sample models manufactured using three separate 3D printing technologies: selective laser sintering-SLS, photo-curing of liquid polymer resins-PolyJet Matrix (PJM) and fused deposition modeling-FDM. The impact of process parameters (printing direction, layer thickness, and energy density for SLS) on tribological properties was assessed through linear wear and coefficient of friction. The research was carried out to assess the possibility of using 3D printing for the quick manufacturing of casting models, which has a significant impact on shortening the time of implementation for mass production of the casting process. The research results proved the possibility of controlling the technological process in a manner allowing to produce models with controlled properties, including tribological parameters. In addition, the results for three additive technologies and different materials were compared by using the same friction parameters., (Copyright 2023, Mary Ann Liebert, Inc., publishers.)

Amyloid cardiomyopathy (CA) was previously considered a rare disease; however, rapid advancements in imaging modalities have led to an increased frequency of its diagnosis. The aim of this prospective study was to assess the prevalence and clinical phenotype of transthyretin amyloidosis (ATTR) cardiomyopathy in patients exhibiting unexplained increased left ventricular (LV) wall thickness. From 2020 to 2022, we enrolled 100 consecutive adults with unexplained increased LV wall thickness in the study. The analysis included clinical data, electrocardiography, transthoracic echocardiography, single-photon emission computed tomography/computed tomography with 3,3-disphono-1,2-propanodicarboxylic acid, genetic testing. Overall, 18% of patients were diagnosed with CA, comprising 5% with light-chain amyloidosis, and 12% with ATTR. To evaluate associations with the ATTR diagnosis, a LOGIT model and multivariate analysis were applied. Notably, age, polyneuropathy, gastropathy, carpal tunnel syndrome, lumbar spine stenosis, low voltage, ventricular arrhythmia, LV mass, LV ejection fraction, global longitudinal strain (GLS), E/A, E/E', right ventricle (RV) thickness, right atrium area, RV VTI, TAPSE, apical sparing, ground glass appearance of myocardium, thickening of interatrial septum, thickening of valves, and the "5-5-5" sign were found to be significantly associated with ATTR (p < 0.05). The best predictive model for ATTR diagnoses exhibited an area under the curve of 0.99, including LV mass, GLS and RV thickness. This study, conducted at a cardiology referral center, revealed that a very considerable proportion of patients with unexplained increased LV wall thickness may suffer from underlying CA. Moreover, the presence of ATTR should be considered in patients with increased LV mass accompanied by reduced GLS and RV thickening., (© 2024. The Author(s).)

The growing application of additive technologies in various industrial fields determines the undertaking of research in this direction. The need to study mechanical properties, including rheological properties, is necessitated by the use of additively manufactured models as utility models. Furthermore, the values of mechanical properties are affected by the technological parameters of 3D printing. One of the popular engineering materials used in 3D printing is acrylonitrile butadiene and styrene, commonly known by the abbreviated name ABS, which is quite hard and resistant to high temperatures. This article presents a study of the rheological properties of ABS material using multiparameter ideal body models. Two rheological phenomena of stress relaxation and creep were evaluated. The effects of two technological parameters, layer height and printing direction, on the resulting values of elastic moduli and dynamic viscosity coefficients were also evaluated. The elastic moduli and dynamic viscosity coefficients were calculated using the Maxwell-Wiechert and Kelvin-Voight models. The study showed the effect of layer height on rheological properties. Moreover, very good fit was obtained between the multiparameter rheological models and the experimental curves, which are shown by the average value of χ 2 ¯ = 0 . 001 and R 2 ¯ = 0 . 9991 . The presented research can be used by designers to design machine parts or car or aircraft components. Moreover, research expands knowledge of the mechanical properties of additively manufactured parts., Competing Interests: No competing financial interests exist., (Copyright 2024, Mary Ann Liebert, Inc., publishers.)

In connection with the growing demand of the medical and medicine-related industry for materials exhibiting biocompatible properties used as part of three-dimensional (3D) printing additive technologies. The article presents research results concerning rheological and selected mechanical properties of a modern, photocurable MED610 resin, which is also used mainly in medicine, as well as dentistry. The article also shows extensive results of testing bending stress relaxation and creep, as well as the tensile strength of samples created with the PolyJet Matrix (PJM) technology. The authors used various sample types, including ones of unique shape and a hexagonal cellular structure. The analysis of the impact of element orientation on the working platform of the machine (3D printer) on the obtained test results (so-called printing direction-Pd) was also taken into account as a key technological parameter of the 3D printing process. Experimental rheological curves were matched with theoretical curves resulting from the application of a five-parameter Maxwell-Wiechert (M-W) model in the case of stress relaxation and a five-parameter Kelvin-Voigt model for creep. Very good matches were achieved, mean coefficients Chi 2  = 0.9956 for matching the five-parameter M-W model and mean coefficients R 2  = 0.9956 for matching the five-parameter M-W model and mean coefficients Chi 2  = 0.000006 and R 2  = 0.9992 enable recommending the obtained results to be used for various engineering calculations, especially computer simulations. Moreover, the use of relaxation curves can significantly increase the construction capabilities within the design process, which includes the MED610 material., Competing Interests: No competing financial interests exist., (Copyright 2024, Mary Ann Liebert, Inc., publishers.)

Aims: This prospective, single-center study sought to assess to what extent there is interference between the hybrid technique of single-photon emission tomography-computed tomography with technetium99m-hexamethylpropyleneamine oxime-labeled leukocytes (99mTc-HMPAO-SPECT/CT) and antimicrobial therapy in patients with infective endocarditis (IE)., Methods and Results: During the years 2015-2019, we enrolled 205 consecutive adults with suspected IE, all underwent 99mTc-HMPAO-SPECT/CT. The study population was divided into those who had received antimicrobial therapy up to 30 days prior to 99mTc-HMPAO-SPECT/CT (group 1, n = 96) and those who had not (group 2, n = 109). Patients were prospectively observed for 12 ± 10 months. Group 1 presented higher positive predictive values (91.89% vs. 60.00%, = 0.001), and decreased negative predictive values (77.97% vs. 90.54%, P = 0.04). Patients treated with antimicrobial therapy displayed false-negative 99mTc-HMPAO-SPECT/CT results more often [odds ratio (OR), 4.63; 95% confidence interval (CI), 1.41-15.23, P = .01], particularly when intravenous (OR 5.37; 95% CI 1.73-16.62, P = .004), definite (OR 9.43; 95% CI 2.65-33.51, P = .001), and combination antibiotic regimens (OR 8.1; 95% CI 2.57-25.64, P = .001) had been administered., Conclusion: Prior antibiotic therapy affects 99mTc-HMPAO-SPECT/CT diagnostic properties. Patients treated with antimicrobial therapy display false-negative 99mTc-HMPAO-SPECT/CT results more often, especially if intravenous, definite, or combination regimens are administered., (© 2022. The Author(s) under exclusive licence to American Society of Nuclear Cardiology.)

The number of patients with coronary artery disease and ischaemic heart failure - and those with terminal heart failure - is increasing despite improvements in medical and interventional therapies of ischaemic heart disease - and, over the next decades, it is projected to continue to increase further. Observer-independent, reproducible imaging techniques play a fundamental role in objective evaluation of both conventional (such as surgical or percutaneous) myocardial revascularization and novel therapeutic approaches to reduce myocardial ischaemia, improve contractility and prevent adverse myocardial remodelling. To be applicable to clinical practice, the clinical study design and data should best be rooted in everyday clinical practice. Accurate and reproducible assessment of left ventricular ejection fraction, left ventricular volumes, myocardial perfusion and function is one of the most important objectives of cardiac imaging. Current techniques used both in clinical studies and in everyday clinical practice include 2- and 3-dimensional echocardiography, magnetic resonance imaging, single-photon emission computed tomography and positron emission tomography; each of these has its strengths and limitations. We review present evidence on the role of single-photon emission computed tomography as a technique that may offer, through being observer-independent, the most objective evaluation of evolution of left ventricular perfusion, volumes and ejection fraction., Competing Interests: The authors declare no conflict of interest., (Copyright: © 2023 Termedia Sp. z o. o.)

Despite unquestionable progress in interventional and pharmacologic therapies of ischemic heart disease, the number of patients with chronic ischemic heart failure is increasing and the prognosis remains poor. Repair/restoration of functional myocardium through progenitor cell-mediated (PCs) healing and renovation of injured myocardium is one of the pivotal directions in biomedical research. PCs release numerous pro-angiogenic and anti-apoptotic factors. Moreover, they have self-renewal capability and may differentiate into specialized cells that include endothelial cells and cardiomyocytes. Uptake and homing of PCs in the zone(s) of ischaemic injury (i.e., their effective transplantation to the target zone) is an essential pre-requisite for any potential therapeutic effect; thus effective cell tracking is fundamental in pre-clinical and early clinical studies. Another crucial requirement in rigorous research is quantification of the infarct zone, including the amount of non-perfused and hypo-perfused myocardium. Quantitative and reproducible evaluation of global and regional myocardial contractility and left ventricular remodeling is particularly relevant in clinical studies. Using SPECT, our earlier work has addressed several critical questions in cardiac regenerative medicine including optimizing transcoronary cell delivery, determination of the zone(s) of myocardial cell uptake, and late functional improvement in relation to the magnitude of cell uptake. Here, we review the role of single-photon emission computed tomography (SPECT), a technique that offers high-sensitivity, quantitative cell tracking on top of its ability to evaluate myocardial perfusion and function on both cross-sectional and longitudinal bases. SPECT, with its direct relevance to routine clinical practice, is a fundamental tool in evaluation of myocardial reparation and regeneration therapies., Competing Interests: The authors declare no conflict of interest., (Copyright: © 2023 Termedia Sp. z o. o.)

Introduction: Infarct size (IS) is a fundamental determinant of left-ventricular (LV) remodelling (end-systolic and end-diastolic volume change, ΔESV, ΔEDV) and adverse clinical outcomes after myocardial infarction (MI). Our prior work found that myocardial uptake of transcoronary-delivered progenitor cells is governed by IS., Aim: To evaluate the relationship between IS, stem cell uptake, and the magnitude of LV remodelling in patients receiving transcoronary administration of progenitor cells shortly after MI., Material and Methods: Thirty-one subjects (age 36-69 years) with primary percutaneous coronary intervention (pPCI)-treated anterior ST-elevation MI (peak CK-MB 584 [181-962] U/l, median [range]) and sustained left ventricle ejection fraction (LVEF) ≤ 45% were studied. On day 10 (median) 4.3 × 10 6 (median) autologous CD34+ cells (50% labelled with 99m Tc-extametazime) were administered via the infarct-related artery (left anterior descending). ΔESV, ΔEDV, and mid circumferential myocardial strain (mCS) were evaluated at 24 months., Results: Infarct mass (cMRI) was 57 [11-112] g. Cell label myocardial uptake (whole-body γ-scans) was proportional to IS ( r = 0.62), with a median 2.9% uptake in IS 1 st tercile (≤ 45 g), 5.2% in 2 nd (46-76 g), and 6.7% in 3 rd (> 76 g) ( p = 0.0006). Cell uptake in proportion to IS attenuated the IS-ΔESV ( p = 0.41) and IS-ΔEDV ( p = 0.09) relationship. At 24 months, mCS improved in IS 2 nd tercile ( p = 0.028) while it showed no significant change in smaller ( p = 0.87) or larger infarcts ( p = 0.58)., Conclusions: This largest human study with labelled CD34+ cell transplantation shortly after MI suggests that cell uptake (proportional to IS) may attenuate the effect of IS on LV adverse remodelling. To boost this effect, further strategies should involve cell types and delivery techniques to maximize myocardial uptake., Competing Interests: The authors declare no conflict of interest., (Copyright: © 2023 Termedia Sp. z o. o.)

Competing Interests: The authors declare no conflict of interest.

Introduction: CIRCULATE-AMI (NCT03404063), a cardiac magnetic resonance imaging (cMRI) infarct size-reduction-powered double-blind randomized controlled trial (RCT) of standardized Wharton jelly multipotent stem cells (WJMSCs, CardioCell Investigational Medical Product) vs. placebo (2 : 1) transcoronary transfer on acute myocardial infarction (AMI) day ~5-7, is preceded by safety and feasibility evaluation in a pilot study cohort (CIRCULATE-AMI PSC)., Aim: To evaluate WJMSC transplantation safety and evolution of left ventricular (LV) remodeling in CIRCULATE-AMI PSC., Material and Methods: In 10 consecutive patients (32-65 years, peak CK-MB 533 ±89 U/l, cMRI-LVEF 40.3 ±2.7%, cMRI-infarct size 20.1 ±2.8%), 30 × 10 6 WJMSCs were administered using a novel cell delivery-dedicated, coronary-non-occlusive method (CIRCULATE catheter). Other treatment was guideline-based., Results: WJMSC transfer was safe and occurred in the absence of coronary (TIMI-3 in all) or myocardial (corrected TIMI frame count (cTFC) 45 ±8 vs. 44 ±9, p = 0.51) flow deterioration or troponin elevation. By 3 years, 1 patient died from a new, non-index territory AMI; there were no other major adverse cardiovascular and cerebrovascular events (MACCE) and no adverse events that might be related to WJMSCs. cMRI infarct size was reduced from 33.2 ±7.6 g to 25.5 ±6.4 g at 1 year and 23.1 ±5.6 g at 3 years ( p = 0.03 vs. baseline). cMRI, SPECT, and echo showed a consistent, statistically significant increase in LVEF at 6-12 months (41.9 ±2.6% vs. 51.0 ±3.3%, 36.0 ±3.9% vs. 44.9 ±5.0%, and 38.4 ±2.5% vs. 48.0 ±2.1% respectively, p < 0.01 for all); the effect was sustained at 3 years., Conclusions: CIRCULATE-AMI PSC data suggest that WJMSC transcoronary application ~5-7 days after large AMI in humans is feasible and safe and it may be associated with a durable LVEF improvement. CIRCULATE-AMI RCT will quantify the magnitude of LV adverse remodeling attenuation with CardioCell/placebo administration., Competing Interests: The authors declare no conflict of interest., (Copyright: © 2022 Termedia Sp. z o. o.)

This paper presents the metrological quality and mechanical properties of models in the form of hook holders manufactured from MED610 polymer material using PolyJet Matrix (PJM) technology. Measurements in the dimensional and shape analysis were made using the optical method with a microscope. The mechanical test was estimated by static tensile testing of the fabricated parts. A comprehensive approach to both the analysis of test results based on standardized samples and real hook models makes the presented results of great scientific and engineering value and creates the possibility of practical use in the medical industry, which has not been so comprehensively presented in the currently published research papers. Analyzing the results of measurements of the geometrical characteristics of the elements, it can be concluded that the PolyJet Matrix 3D printing technology has demonstrated a high level of precision in manufacturing the prototype parts. The static tensile test of samples, taking into account the printing directions, showed a high anisotropy of mechanical properties. The results of both strength and simulation tests indicate that it is necessary to assume a relatively high safety factor, the value of which depends on the direction of printing, which, in the case of such a responsible medical application, is very important.

Background: Transthyretin amyloidosis (ATTR) is a rare, life-threatening systemic disorder. We present first findings on the cardiac hereditary ATTR in Poland., Methods: Sixty-eight consecutive patients with suspected or known cardiac amyloidosis were evaluated, including blood tests, standard 12-lead electrocardiography (ECG) and transthoracic echocardiography. ATTR was confirmed histologically or non-invasively using 99mTc-DPD scintigraphy. Transthyretin (TTR) gene sequencing was performed., Results: In 2017-2019, 10 unrelated male patients were diagnosed with hereditary ATTR. All patients had very uncommon TTR gene mutations: 7 patients had p.Phe53Leu mutation, 2 patients had p.Glu109Lys mutation and 1 patient had p.Ala101Val mutation. The age of onset ranged from 49 to 67 years (mean [SD] age, 58.7 [6.4] years). On ECG, most patients (70%) had pseudoinfarct pattern and/or low QRS voltage. The maximal wall thickness (MWT) on echocardiography varied considerably among the patients from moderate (16 mm) to massively increased (30 mm). Most patients (90%) had decreased left ventricular ejection fraction (mean [SD], 43 [11] %). On follow-up, we observed progressive heart failure in almost all cases. The first patient with p.Phe53Leu mutation died of heart failure, the second died suddenly, the third successfully underwent combined heart and liver transplant with 15 months survival from the surgery. The patient with p.Ala101Val mutation died of stroke., Conclusions: According to available data, this is the first time that the types of TTR mutations and the clinical characteristics of Polish patients with cardiac hereditary ATTR have been described. Previous literature data about Polish background in families with p.Phe53Leu mutation and the present results, suggest that this TTR mutation might be endemic in the Polish population.

Introduction: Cell therapy has the potential to improve symptoms and clinical outcomes in refractory angina (RFA). Further analyses are needed to evaluate factors influencing its therapeutic effectiveness., Aim: Assessment of electromechanical (EM) parameters of the left ventricle (LV) and investigation of correlation between EM parameters of the myocardium and response to CD133+ cell therapy., Material and Methods: Thirty patients with RFA (16 active and 14 placebo individuals) enrolled in the REGENT-VSEL trial underwent EM evaluation of the LV with intracardiac mapping system. The following parameters were analyzed: unipolar voltage (UV), bipolar voltage (BV), local linear shortening (LLS). Myocardial ischemia was evaluated with single-photon emission computed tomography (SPECT). The median value of each EM parameter was used for intra-group comparisons., Results: Global EM parameters (UV, BV, LLS) of LV in active and placebo groups were 11.28 mV, 3.58 mV, 11.12%, respectively; 13.00 mV, 3.81 mV, 11.32%, respectively. EM characteristics analyzed at global and segmental levels did not predict response to CD133+ cell therapy in patients with RFA (Global UV, BV and LLS at rest R = -0.06; R = 0.2; R = -0.1 and at stress: R = 0.07, R = 0.09, R = -0.1, respectively; Segmental UV, BV, LLS at rest R = -0.2, R = 0.03, R = -0.4 and at stress R = 0.02, R = 0.2, R = -0.2, respectively). Multiple linear regression of the treated segments showed that only pre-injection SPECT levels were significantly correlated with post-injection SPECT, either at rest or stress ( p < 0.05)., Conclusions: Electromechanical characteristics of the left ventricle do not predict changes of myocardial perfusion by SPECT after cell therapy. Baseline SPECT results are only predictors of changes of myocardial ischemia observed at 4-month follow-up., Competing Interests: Dr Wojakowski received a lecture honorarium from Biosense Webster, a Johnson & Johnson company. The other authors declare no conflict., (Copyright: © 2021 Termedia Sp. z o. o.)

Background: Antiphospholipid syndrome (APS) is a systemic autoimmune disease characterized by arterial or venous thrombosis (or both), and/or pregnancy morbidity in association with the presence of antiphospholipid antibodies. The prevalence of APS is estimated at 40 to 50 cases per 100,000 people. The most common sites of thrombosis are cerebral arteries and deep veins of the lower limbs. People with a definite APS diagnosis have an increased lifetime risk of recurrent thrombotic events., Objectives: To assess the effects of antiplatelet (AP) or anticoagulant agents, or both, for the secondary prevention of recurrent thrombosis, particularly ischemic stroke, in people with APS., Search Methods: We last searched the MEDLINE, Embase, CENTRAL, Cochrane Stroke Group Trials Register, and ongoing trials registers on 22 November 2019. We checked reference lists of included studies, systematic reviews, and practice guidelines. We also contacted experts in the field., Selection Criteria: We included randomized controlled trials (RCTs) that evaluated any anticoagulant or AP agent, or both, in the secondary prevention of thrombosis in people with APS, according to the criteria valid when the study took place. We did not include studies specifically addressing women with obstetrical APS., Data Collection and Analysis: Pairs of review authors independently worked on each step of the review, following Cochrane methods. We summarized the evidence using the GRADE approach., Main Results: We identified eight studies including 811 participants that compared different AP or anticoagulant agents. NOAC (non-VKA oral anticoagulant: rivaroxaban 15 or 20 mg/d) versus standard-dose VKA (vitamin K antagonist: warfarin at moderate International Normalized Ratio [INR] - 2.5) or adjusted [INR 2.0-3.0] dose): In three studies there were no differences in any thromboembolic event (including death) and major bleeding (moderate-certainty evidence), but an increased risk of stroke (risk ratio [RR] 14.13, 95% confidence interval [CI] 1.87 to 106.8; moderate-certainty evidence). One of the studies reported a small benefit of rivaroxaban in terms of quality of life at 180 days measured as health state on Visual Analogue Scale (mean difference [MD] 7 mm, 95% CI 2.01 to 11.99; low-certainty evidence), but not measured as health utility on a scale from 0 to 1 (MD 0.04, 95% CI -0.02 to 0.10; low-certainty evidence). High-dose VKA (warfarin with a target INR of 3.1 to 4.0 [mean 3.3] or 3.5 [mean 3.2]) versus standard-dose VKA (warfarin with a target INR of 2.0 to 3.0 [mean 2.3] or 2.5 [mean 2.5]): In two studies there were no differences in the rates of thrombotic events and major bleeding (RR 2.22, 95% CI 0.79 to 6.23, low-certainty evidence), but an increased risk of minor bleeding in one study during a mean of 3.4 years (standard deviation [SD] 1.2) of follow-up (RR 2.55, 95% CI 1.07 to 6.07). In both trials there was evidence of a higher risk of any bleeding (hazard ratio [HR] 2.03 95% CI 1.12 to 3.68; low-certainty evidence) in the high-dose VKA group, and for this outcome (any bleeding) the incidence is not different, only the time to event is showing an effect. Standard-dose VKA plus a single AP agent (warfarin at a target INR of 2.0 to 3.0 plus aspirin 100 mg/d) versus standard-dose VKA (warfarin at a target INR of 2.0 to 3.0): One high-risk-of-bias study showed an increased risk of any thromboembolic event with combined treatment (RR 2.14, 95% CI 1.04 to 4.43; low-certainty evidence) and reported on major bleeding with five cases in the combined treatment group and one case in the standard-dose VKA treatment group, resulting in RR 7.42 (95% CI 0.91 to 60.7; low-certainty evidence) and no differences for secondary outcomes (very low- to low-certainty evidence). Single/dual AP agent and standard-dose VKA (pooled results): Two high-risk-of-bias studies compared a combination of AP and VKA (aspirin 100 mg/d plus warfarin or unspecified VKA at a target INR of 2.0 to 3.0 or 2.0 to 2.5) with a single AP agent (aspirin 100 mg/d), but did not provide any conclusive evidence regarding the effects of those drugs in people with APS (very low-certainty evidence). One of the above-mentioned studies was a three-armed study that compared a combination of AP and VKA (aspirin 100 mg/d plus warfarin at a target INR of 2.0 to 2.5) with dual AP therapy (aspirin 100 mg/d plus cilostazol 200 mg/d) and dual AP therapy (aspirin 100 mg/d plus cilostazol 200 mg/d) versus a single AP treatment (aspirin 100 mg/d). This study reported on stroke (very low-certainty evidence) but did not report on any thromboembolic events, major bleeding, or any secondary outcomes. We identified two ongoing studies and three studies are awaiting classification., Authors' Conclusions: The evidence identified indicates that NOACs compared with standard-dose VKAs may increase the risk of stroke and do not appear to alter the risk of other outcomes (moderate-certainty evidence). Using high-dose VKA versus standard-dose VKA did not alter the risk of any thromboembolic event or major bleeding but may increase the risk of any form of bleeding (low-certainty evidence). Standard-dose VKA combined with an AP agent compared with standard-dose VKA alone may increase the risk of any thromboembolic event and does not appear to alter the risk of major bleeding or other outcomes (low-certainty evidence). The evidence is very uncertain about the benefit or harm of using standard-dose VKA plus AP agents versus single or dual AP therapy, or dual versus single AP therapy, for the secondary prevention of recurrent thrombosis in people with APS (very low-certainty evidence)., (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Aims: The hybrid technique of single-photon emission tomography and computed tomography with technetium99m-hexamethylpropyleneamine oxime-labelled leucocytes (99mTc-HMPAO-SPECT/CT) is an emerging diagnostic technique in patients with cardiac device-related infective endocarditis (CDRIE). This prospective study assessed the 99mTc-HMPAO-SPECT/CT diagnostic profile and its added value to the modified Duke criteria (mDuke) in CDRIE diagnostic work-up., Methods and Results: The study examined 103 consecutive patients with suspected CDRIE, who underwent 99mTc-HMPAO-SPECT/CT. Diagnostic accuracy was calculated based on a final clinical CDRIE diagnosis, including microbiology, echocardiography, and a 6-month follow-up. Subsequently, we compared the diagnostic value of the initial mDuke classification with a classification including 99mTc-HMPAO-SPECT/CT positive results as an additional major CDRIE criterion: mDuke-SPECT/CT.Overall, CDRIE was diagnosed in 31 (31%) patients, whereas 35 (34%) 99mTc-HMPAO-SPECT/CT were positive. 99mTc-HMPAO-SPECT/CT was characterized by 86% accuracy, 0.69 Cohen's kappa coefficient, 84% sensitivity, 88% specificity, 93% negative, and 74% positive predictive values. The original mDuke displayed 83% accuracy, 0.52 kappa, whereas mDuke-SPECT/CT had 88% accuracy, and 0.73 kappa. Compared with mDuke, mDuke-SPECT/CT showed significantly higher sensitivity (87% vs. 48%, P < 0.001). According to mDuke, 49.5% of patients had possible CDRIE, and after reclassification, that figure dropped to 37%. Furthermore, having assessed the diagnosis categorization improvement following the incorporation of 99mTc-HMPAO-SPECT/CT, the net reclassification index value was found to be 31.4%., Conclusion: In patients with CDRIE, 99mTc-HMPAO-SPECT/CT provides high diagnostic accuracy, whereas a negative scan excludes CDRIE with high probability. Inclusion of 99mTc-HMPAO-SPECT/CT into mDuke diagnostic criteria yields significantly higher sensitivity and a reduction in possible CDRIE diagnoses., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Objectives: This was a prospective, single-center study designed to assess the prognostic value of the hybrid technique of single photon emission tomography and computed tomography with the application of technetium 99 m-hexamethylpropyleneamine oxime-labelled autologous leukocytes ( 99 mTc-HMPAO-SPECT/CT) in patients with cardiac device-related infective endocarditis (CDRIE)., Background: CDRIE entails the risk of complications and an increase in mortality rates, both in-hospital and long-term. The prognostic value of 99 mTc-HMPAO-SPECT/CT in the course of CDRIE has not been evaluated so far., Methods: The project enrolled 103 consecutive patients with suspected CDRIE, all of whom underwent 99m Tc-HMPAO-SPECT/CT. The resulting scans were then classified as positive if the presence of abnormal tracer uptake involving cardiac and intravascular sections of the device electrodes was found. Patients were prospectively observed for a mean time of 17.48 ± 11.9 months. All-cause mortality, in-hospital mortality, and complete hardware removal were assessed, followed by a composite endpoint including complications, namely embolic events, new onset heart failure, uncontrolled infection, renal replacement therapy, reoperation, new heart rhythm, and conduction disturbances., Results: In the analysis, despite a noticeable trend, all-cause mortality rates were not found to be statistically significantly higher among the 35 patients who registered positive results using 99m Tc-HMPAO-SPECT/CT for CDRIE (group 1) than among the 68 patients from group 2 whose 99m Tc-HMPAO-SPECT/CT results were negative (20% vs. 10.3%, respectively; p = 0.14). However, group 1 did present higher in-hospital mortality (11.4% vs. 0%, respectively; odds ratio: 19.6; 95% confidence interval [CI]: 1.02 to 374.70), an increased rate of complications (43% vs. 9%, respectively; hazard ratio [HR]: 5.9; 95% CI: 2.27 to 15.20), and underwent hardware removal more frequently (57% vs. 16%, respectively; HR: 4.3; 95% CI: 2.07 to 19.08)., Conclusions: In patients with suspected CDRIE, positive 99m Tc-HMPAO-SPECT/CT results were associated with increased rates of in-hospital mortality and complications., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aim: Optimal revascularization strategy in multivessel (MV) coronary artery disease (CAD) eligible for percutaneous management (PCI) and surgery remains unresolved. We evaluated, in a randomized clinical trial, residual myocardial ischemia (RI) and clinical outcomes of MV-CAD revascularization using coronary artery bypass grafting (CABG), hybrid coronary revascularization (HCR), or MV-PCI., Methods: Consecutive MV-CAD patients ( n  = 155) were randomized (1 : 1 : 1) to conventional CABG (LIMA-LAD plus venous grafts) or HCR (MIDCAB LIMA-LAD followed by PCI for remaining vessels) or MV-PCI (everolimus-eluting CoCr stents) under Heart Team agreement on equal technical and clinical feasibility of each strategy. SPECT at 12 months (primary endpoint of RI that the trial was powered for; a measure of revascularization midterm efficacy and an independent predictor of long-term prognosis) preceded routine angiographic control., Results: Data are given, respectively, for the CABG, HCR, and MV-PCI arms. Incomplete revascularization rate was 8.0% vs. 7.7% vs. 5.7% ( p =0.71). Hospital stay was 13.8 vs. 13.5 vs. 4.5 days ( p < 0.001), and sick-leave duration was 23 vs. 16 vs. 8 weeks ( p < 0.001). At 12 months, RI was 5 (2, 9)% vs. 5 (3, 7)% vs. 6 (3, 10)% (median; Q1, Q3) with noninferiority p values of 0.0006 (HCR vs. CABG) and 0.016 (MV-PCI vs. CABG). Rates of angiographic graft stenosis/occlusion or in-segment restenosis were 20.4% vs. 8.2% vs. 5.9% ( p =0.05). Clinical target vessel/graft failure occurred in 12.0% vs. 11.5% vs. 11.3% ( p =0.62). Major adverse cardiac and cerebral event (MACCE) rate was similar (12% vs. 13.4% vs. 13.2%; p =0.83)., Conclusion: In this first randomized controlled study comparing CABG, HCR, and MV-PCI, residual myocardial ischemia and MACCE were similar at 12 months. There was no midterm indication of any added value of HCR. Hospital stay and sick-leave duration were shortest with MV-PCI. While longer-term follow-up is warranted, these findings may impact patient and physician choices and healthcare resources utilization. This trial is registered with NCT01699048., Competing Interests: None of the authors has any disclosure relevant to this manuscript to report., (Copyright © 2020 Vladimir Ganyukov et al.)

Infective endocarditis (IE) is a life-threatening disease, establishing a diagnosis is often challenging. The aim of this prospective study was to evaluate and compare the diagnostic performance of the combined use of single photon emission tomography and computed tomography with technetium99m-hexamethylpropyleneamineoxime-labeled leukocytes (99mTc-HMPAO-SPECT/CT) with transthoracic echocardiography (TTE) in patients with suspected IE. We enrolled 40 consecutive patients (12 females, 28 males, mean age: 58.6 ± 18) with suspected IE in the years 2015-2016. All patients underwent clinical evaluation, TTE and 99mTc-HMPAO-SPECT/CT for the assessment of lesions typical for IE. Scans were evaluated for the presence and location of increased radioactivity foci, corresponding to the accumulation of radiolabeled leukocytes in inflammatory lesions. After 6 months, the patients were re-evaluated clinically and with TTE. Final IE diagnosis was established in 14 (35%) patients. Lesions typical for IE were shown in 28 (70%) TTEs and 16 (40%) 99mTc-HMPAO-SPECT/CTs. The latter tests were characterized by 90% accuracy, 93% sensitivity, 88% specificity, 96% negative predictive value (NPV), 81% positive predictive value (PPV). TTE demonstrated 60% accuracy, 93% sensitivity, 42% specificity, 92% NPV, and 46% PPV. 99mTc-HMPAO-SPECT/CT was characterized by a lower number of false-positive results compared to TTE (3 vs. 15). In patients with suspected IE, 99mTc-HMPAO-SPECT/CT yields a smaller number of false-positive results, significantly higher diagnostic accuracy, specificity and PPV than TTE. It helps to differentiate IE infectious and sterile echocardiographic lesions and reduces by 27% the number of misdiagnosed IE classified in the 'possible IE' category by modified Duke Criteria.

Background: Lead-dependent infective endocarditis (LDIE) is a life-threatening complication of permanent transvenous cardiac pacing. According to the 2015 European Society of Cardiology (ECS) guidelines, the diagnosis of LDIE is based on the modified Duke criteria (MDC), while single-photon emission computed tomography with conventional computed tomography (SPECT-CT) with radioisotope-labeled leukocytes serves as an additional tool in difficult cases. The major challenge is to differentiate between true vegetation and a thrombus., Objectives: The aim of the study was to evaluate the usefulness of SPECT-CT with radioisotope-labeled leukocytes in diagnosing LDIE in patients with intracardiac masses (ICMs)., Material and Methods: The prospective registry included 40 consecutive patients admitted with an ICM on the lead and suspicion of LDIE. The confirmation or rejection of the LDIE diagnosis was made according to an algorithm based on the MDC. The cohort was divided into 2 groups: patients with definite and possible LDIE diagnoses based on the MDC (the LDIE-positive group), and patients with negative LDIE diagnoses according to the MDC (the LDIE-negative group). All patients underwent SPECT-CT with radioisotope-labeled leukocytes. The diagnostic ability of SPECT-CT was compared to the gold standard MDC., Results: The LDIE-positive group with diagnosis based on the MDC consisted of 19 patients (LDIE definite - 11; LDIE possible - 8). The LDIE diagnosis was rejected on the basis of the MDC in 21 patients. The SPECT-CT results were compared with the MDC results and showed 73.7% sensitivity, 81.0% specificity, 77.5% accuracy, 77.8% positive predictive value (PPV), 77.3% negative predictive value (NPV), likelihood ratio positive (LR+) 3.868, likelihood ratio negative (LR-) 0.325, and moderate agreement (κ = 0.548, p < 0.001). After the exclusion of 5 patients treated with antibiotics at the time of the SPECT-CT, LR+ and LRimproved to 5.250 and 0, respectively, and inter-test agreement amounted to almost perfect concordance (κ = 0.773, p < 0.001)., Conclusions: Single-photon emission computed tomography with conventional CT with radioisotopelabeled leukocytes is a useful, efficient, single-step test for diagnosing LDIE.

Introduction: The aim of presented study was comparison of urinary 1-hydroxypyrene concentration among coke plant workers (before and after working week) and among non-exposed individuals from the same area, taking smoking status into consideration., Material and Methods: 647 coke plant workers and 206 individuals living in the same area were analysed with respect to urinary 1-OHP concentration and smoking status. Urinary samples were measured using high performance liquid chromatography (HPLC) with fluorescent detection. Concentrations were normalized with respect to creatinine concentration. For workers, two samples were collected before and after working week. Multiple regression was performed to distinguish and quantify the influence of cigarette smoking and occupational PAH exposition on the urinary 1-OHP levels., Results: Average urinary 1-OHP concentration of samples collected before the working week was: 1.07 μg/g; after the working week: 2.36 μg/g and for control: 0.74 μg/g. The samples collected at the beginning of the working week were not suitable for assessment of the workers' background (non-occupational) exposition. Smoking cigarettes induced a rise in urinary 1-OHP level by 16%, on average (CI: 5% - 28%), and working for a whole working week at the coke plant made urinary 1-OHP levels, on average, 3.21 times higher (CI: 2.91 - 3.54)., Conclusions: Working at the coke plant increases significantly urinary 1-OHP concentration in comparison to non-occupationally exposed individuals, both for samples collected before and after the working week. Smoking remains a significant source of PAHs exposition, despite the fact that occupational exposure is greater. Health promotion programmes should address both the occupational health risks reduction and smoking prevention.