Impact of gender in patients with device-related thrombosis after left atrial appendage closure - A sub-analysis from the multicenter EUROC-DRT-registry.

BACKGROUND: Device-related thrombosis (DRT) is a common finding after left atrial appendage closure (LAAC) and is associated with worse outcomes. As women are underrepresented in clinical studies, further understanding of sex differences in DRT patients is warranted. METHODS AND RESULTS: This sub-analysis from the EUROC-DRT-registry compromises 176 patients with diagnosis of DRT after LAAC. Women, who accounted for 34.7% (61/176) of patients, were older (78.0 ± 6.7 vs. 74.9 ± 9.1 years, p = .06) with lower rates of comorbidities. While DRT was detected significantly later in women (173 ± 267 vs. 127 ± 192 days, p = .01), anticoagulation therapy was escalated similarly, mainly with initiation of novel oral anticoagulant (NOAC), vitamin K antagonist (VKA) or heparin. DRT resolution was achieved in 67.5% (27/40) of women and in 75.0% (54/72) of men (p = .40). In the remaining cases, an intensification/switch of anticoagulation was conducted in 50.% (9/18) of men and in 41.7% (5/12) of women. Final resolution was achieved in 72.5% (29/40) cases in women, and in 81.9% (59/72) cases in men (p = .24). Women were followed-up for a similar time as men (779 ± 520 vs. 908 ± 687 days, p = .51). Kaplan-Meier analysis revealed no difference in mortality rates in women (Hazard Ratio [HR]: 1.73, 95%-Confidence interval [95%-CI]: .68-4.37, p = .25) and no differences in stroke (HR: .83, 95%-CI: .30-2.32, p = .72) within 2 years after LAAC. CONCLUSION: Evaluation of risk factors and outcome revealed no differences between men and women, with DRT in women being diagnosed significantly later. Women should be monitored closely to assess for DRT formation/resolution. Treatment strategies appear to be equally effective.

Influencing factors of anti-SARS-CoV-2-spike-IgG antibody titers in healthcare workers: A cross-section study.

Against the background of the current COVID-19 infection dynamics with its rapid spread of SARS-CoV-2 variants of concern (VOC), the immunity and the vaccine prevention of healthcare workers (HCWs) against SARS-CoV-2 continues to be of high importance. This observational cross-section study assesses factors influencing the level of anti-SARS-CoV-2-spike IgG after SARS-CoV-2 infection or vaccination. One thousand seven hundred and fifty HCWs were recruited meeting the following inclusion criteria: age ≥18 years, PCR-confirmed SARS-CoV-2 infection convalescence and/or at least one dose of COVID-19 vaccination. anti-SARS-CoV-2-spike IgG titers were determined by SERION ELISA agile SARS-CoV-2 IgG. Mean anti-SARS-CoV-2-spike IgG levels increased significantly by number of COVID-19 vaccinations (92.2 BAU/ml for single, 140.9 BAU/ml for twice and 1144.3 BAU/ml for threefold vaccination). Hybrid COVID-19 immunized respondents (after infection and vaccination) had significantly higher antibody titers compared with convalescent only HCWs. Anti-SARS-CoV-2-spike IgG titers declined significantly with time after the second vaccination. Smoking and high age were associated with lower titers. Both recovered and vaccinated HCWs presented a predominantly good humoral immune response. Smoking and higher age limited the humoral SARS-CoV-2 immunity, adding to the risk of severe infections within this already health impaired collective.

The relationship between mental health, sleep quality and the immunogenicity of COVID-19 vaccinations.

Sleep modulates the immune response, and sleep loss can reduce vaccine immunogenicity; vice versa, immune responses impact sleep. We aimed to investigate the influence of mental health and sleep quality on the immunogenicity of COVID-19 vaccinations and, conversely, of COVID-19 vaccinations on sleep quality. The prospective CoVacSer study monitored mental health, sleep quality and Anti-SARS-CoV-2-Spike IgG titres in a cohort of 1082 healthcare workers from 29 September 2021 to 19 December 2022. Questionnaires and blood samples were collected before, 14 days, and 3 months after the third COVID-19 vaccination, as well as in 154 participants before and 14 days after the fourth COVID-19 vaccination. Healthcare workers with psychiatric disorders had slightly lower Anti-SARS-CoV-2-Spike IgG levels before the third COVID-19 vaccination. However, this effect was mediated by higher median age and body mass index in this subgroup. Antibody titres following the third and fourth COVID-19 vaccinations ("booster vaccinations") were not significantly different between subgroups with and without psychiatric disorders. Sleep quality did not affect the humoral immunogenicity of the COVID-19 vaccinations. Moreover, the COVID-19 vaccinations did not impact self-reported sleep quality. Our data suggest that in a working population neither mental health nor sleep quality relevantly impact the immunogenicity of COVID-19 vaccinations, and that COVID-19 vaccinations do not cause a sustained deterioration of sleep, suggesting that they are not a precipitating factor for insomnia. The findings from this large-scale real-life cohort study will inform clinical practice regarding the recommendation of COVID-19 booster vaccinations for individuals with mental health and sleep problems.

Real-time cardiac MRI using an undersampled spiral k-space trajectory and a reconstruction based on a variational network.

PURPOSE: Cardiac MRI represents the gold standard to determine myocardial function. However, the current clinical standard protocol, a segmented Cartesian acquisition, is time-consuming and can lead to compromised image quality in the case of arrhythmia or dyspnea. In this article, a machine learning-based reconstruction of undersampled spiral k-space data is presented to enable free breathing real-time cardiac MRI with good image quality and short reconstruction times. METHODS: Data were acquired in free breathing with a 2D spiral trajectory corrected by the gradient system transfer function. Undersampled data were reconstructed by a variational network (VN), which was specifically adapted to the non-Cartesian sampling pattern. The network was trained with data from 11 subjects. Subsequently, the imaging technique was validated in 14 subjects by quantifying the difference to a segmented reference acquisition, an expert reader study, and by comparing derived volumes and functional parameters with values obtained using the current clinical gold standard. RESULTS: The scan time for the entire heart was below 1 min. The VN reconstructed data in about 0.9 s per image, which is considerably shorter than conventional model-based approaches. The VN furthermore performed better than a U-Net and not inferior to a low-rank plus sparse model in terms of achieved image quality. Functional parameters agreed, on average, with reference data. CONCLUSIONS: The proposed VN method enables real-time cardiac imaging with both high spatial and temporal resolution in free breathing and with short reconstruction time.

Evaluation of combined late gadolinium-enhancement and functional cardiac magnetic resonance imaging using spiral real-time acquisition.

The purpose of the current study was to implement and validate joint real-time acquisition of functional and late gadolinium-enhancement (LGE) cardiac magnetic resonance (MR) images during free breathing. Inversion recovery cardiac real-time images with a temporal resolution of 50 ms were acquired using a spiral trajectory (IR-CRISPI) with a pre-emphasis based on the gradient system transfer function during free breathing. Functional and LGE cardiac MR images were reconstructed using a low-rank plus sparse model. Late gadolinium-enhancement appearance, image quality, and functional parameters of IR-CRISPI were compared with clinical standard balanced steady-state free precession breath-hold techniques in 10 patients. The acquisition of IR-CRISPI in free breathing of the entire left ventricle took 97 s on average. Bland-Altman analysis and Wilcoxon tests showed a higher artifact level for the breath-hold technique (p = 0.003), especially for arrhythmic patients or patients with dyspnea, but an increased noise level for IR-CRISPI of the LGE images (p = 0.01). The estimated transmural extent of the enhancement differed by not more than 25% and did not show a significant bias between the techniques (p = 0.50). The ascertained functional parameters were similar for the breath-hold technique and IR-CRISPI, that is, with a minor, nonsignificant (p = 0.16) mean difference of the ejection fraction of 2.3% and a 95% confidence interval from -4.8% to 9.4%. IR-CRISPI enables joint functional and LGE imaging in free breathing with good image quality but distinctly shorter scan times in comparison with breath-hold techniques.

Cardiac real-time MRI using a pre-emphasized spiral acquisition based on the gradient system transfer function.

PURPOSE: Segmented Cartesian acquisition in breath hold represents the current gold standard for cardiac functional MRI. However, it is also associated with long imaging times and severe restrictions in arrhythmic or dyspneic patients. Therefore, we introduce a real-time imaging technique based on a spoiled gradient-echo sequence with undersampled spiral k-space trajectories corrected by a gradient pre-emphasis. METHODS: A fully automatic gradient waveform pre-emphasis based on the gradient system transfer function was implemented to compensate for gradient inaccuracies, to optimize fast double-oblique spiral MRI. The framework was tested in a phantom study and subsequently transferred to compressed sensing-accelerated cardiac functional MRI in real time. Spiral acquisitions during breath hold and free breathing were compared with this reference method for healthy subjects (N = 7) as well as patients (N = 2) diagnosed with heart failure and arrhythmia. Left-ventricular volumes and ejection fractions were determined and analyzed using a Wilcoxon signed-rank test. RESULTS: The pre-emphasis successfully reduced typical artifacts caused by k-space misregistrations. Dynamic cardiac imaging was possible in real time (temporal resolution < 50 ms) with high spatial resolution (1.34 × 1.34 mm2 ), resulting in a total scan time of less than 50 seconds for whole heart coverage. Comparable image quality, as well as similar left-ventricular volumes and ejection fractions, were observed for the accelerated and the reference method. CONCLUSION: The proposed technique enables high-resolution real-time cardiac MRI with no need for breath holds and electrocardiogram gating, shortening the duration of an entire functional cardiac exam to less than 1 minute.

Interventional closure of aortomitral perforation after TAVR: A case report.

Despite TAVR emerging as the gold standard for a broad spectrum of patients, it is associated with serious complications. In this report we present a case, where a TAVR procedure led to a perforation at the aortomitral continuity, discuss the risk factors for the occurrence of perforations and how we decided to treat the patient.

"Blind" pericardiocentesis: A comparison of different puncture directions.

BACKGROUND: "Blind" pericardiocentesis is the standard procedure for emergency pericardial drainage when ultrasound guidance is unavailable. Under these circumstances, puncture site and needle direction are exclusively oriented according to certain anatomic landmarks. In the literature, different techniques for this "blind" method have been described. Goal of this retrospective study was to compare the potential success and complication rate of 13 simulated puncture directions. METHODS: Simulated pericardiocentesis was performed in 150 CT scans from patients with moderate to severe pericardial effusions (greater than 1 cm distance between epicardium and pericardium). Thirteen different puncture techniques with varying puncture sites, direction of the puncture, and the angle were compared. A simulated pericardiocentesis was classified as "successful" when the effusion was reached. It was classified as "successful without a complication" when no adjacent structure was penetrated by the simulated puncture (lung, liver, internal thoracic artery, LAD, colon, and stomach). An attempt was declared as "unsuccessful" when the pericardial effusion was not reached at all, or the reached effusion measured less than 0.5 cm between the epicardium and pericardium at the location where the needle entered the pericardium. RESULTS: A subxiphoidal puncture technique starting in Larrey's triangle (sternocostal triangle) and directed toward the left midclavicular point with a 30° inclination resulted in the highest success rate (131 of 150 cases = 87%). In parallel the lowest complication rate (7 of 150 = 5%) was found using this technique, as well. In contrast, pericardiocentesis performed using other puncture directions resulted in lower success (66%-85%) and higher complication rates (9%-31%). CONCLUSION: This CT-based simulation study revealed that blind pericardiocentesis guided by anatomical landmarks only is best performed in a subxiphoid approach with a needle direction to the left midclavicular point with a 30° inclination. Nevertheless, injury of adjacent structures occurred frequently (5%) even when applying this puncture technique. Thus, blind pericardiocentesis can be performed with a high success rate and seems adequate to be performed under emergency conditions. However, planned procedures should be performed under image guidance.

Does Simulation-Based Training Improve Procedural Skills of Beginners in Interventional Cardiology?--A Stratified Randomized Study.

OBJECTIVE: To assess whether mentored simulation-based-training can improve the procedural skills of beginners in coronary interventional procedures. BACKGROUND: Simulation based-catheter training is a valuable tool to practice interventional procedures. Whether this type of training enhances the procedural skills of fellows learning percutaneous coronary interventions has never been studied. METHODS: Eighteen cardiology fellows were randomized either into the simulation-based training (n = 9) or the control group (n = 9). The simulation group received 7.5 hours of virtual reality (VR) simulation training, whereas the control group attended 4.5 hours of lectures. Each participant had to perform a simple (pre-evaluation) and a more complex (post-evaluation) catheter intervention on a pulsatile coronary flow model in a catheterization laboratory. All procedures were videotaped, analyzed, and rated by 3 expert interventionalists, who were blinded to the randomization. To assess the individual performance level, a "skills score" was determined, comprising 14 performance characteristics (5-level Likert scale, maximum score of 70 points). RESULTS: The "skills score" increased by 5.8 ± 6.1 points in the VR simulation group and decreased by 6.7 ± 8.4 in the control group (P = 0.003) from the simple stenosis at pre- to the more complex lesion at post-evaluation demonstrating the effectiveness of simulation-based training. CONCLUSION: This pilot study suggests that curriculum-based mentored VR simulation training improves the performance level of cardiology fellows in coronary interventions. Further investigation to evaluate the effect on clinical outcomes is warranted.

Next generation coronary CT angiography: in vitro evaluation of 27 coronary stents.

OBJECTIVES: To evaluate in-stent lumen visibility of 27 modern and commonly used coronary stents (16 individual stent types, two stents at six different sizes each) utilising a third-generation dual-source CT system. METHODS: Stents were implanted in a plastic tube filled with contrast. Examinations were performed parallel to the system's z-axis for all stents (i.e. 0°) and in an orientation of 90° for stents with a diameter of 3.0 mm. Two stents were evaluated in different diameters (2.25 to 4.0 mm). Examinations were acquired with a collimation of 96 × 0.6 mm, tube voltage of 120 kVp with 340 mAs tube current. Evaluation was performed using a medium-soft (Bv40), a medium-sharp (Bv49) and a sharp (Bv59) convolution kernel optimised for vascular imaging. RESULTS: Mean visible stent lumen of stents with 3.0 mm diameter ranged from 53.3 % (IQR 48.9 - 56.7 %) to 73.9 % (66.7 - 76.7 %), depending on the kernel used at 0°, and was highest at an orientation of 90° with 80.0 % (75.6 - 82.8 %) using the Bv59 kernel, strength 4. Visible stent lumen declined with decreasing stent size. CONCLUSIONS: Use of third-generation dual-source CT enables stent lumen visibility of up to 80 % in metal stents and 100 % in bioresorbable stents. KEY POINTS: • Blooming artefacts impair in-stent lumen visibility of coronary stents in CT angiography. • CT enables stent lumen visibility of up to 80 % in metal stents. • Stent lumen visibility varies with stent orientation and size. • CT angiography may be a valid alternative for detecting in-stent restenosis.

[Update on endocarditis 2024]. / Update Endokarditis 2024.

Infective endocarditis (IE) is a life-threatening disease with an increasing incidence despite improved preventive measures. The revision of the European Society of Cardiology (ESC) guidelines on infective endocarditis in 2023 brings significant innovations in prevention, diagnostics, and treatment. Many measures for prophylaxis and prevention have been more clearly defined and given higher recommendation levels. In the diagnostics of IE the use of other imaging modalities besides echocardiography, such as cardiac computed tomography (CT), positron emission tomography (PET)/CT or single photon emission computed tomography (SPECT)/CT with radioactively labeled leukocytes was more strongly emphasized. The diagnostics and treatment of IE associated with a cardiac implantable electronic device (CIED) were also revised. An essential innovation is also the possibility of an outpatient antibiotic treatment for certain patients after initial treatment in hospital. The indications for surgery have also been revised and, in particular, the timing of surgery has been more clearly defined. This article provides an overview of the most important changes.

Investigating the Small Pixel Effect in Ultra-High Resolution Photon-Counting CT of the Lung.

OBJECTIVES: The aim of this study was to investigate potential benefits of ultra-high resolution (UHR) over standard resolution scan mode in ultra-low dose photon-counting detector CT (PCD-CT) of the lung. MATERIALS AND METHODS: Six cadaveric specimens were examined with 5 dose settings using tin prefiltration, each in UHR (120 × 0.2 mm) and standard mode (144 × 0.4 mm), on a first-generation PCD-CT scanner. Image quality was evaluated quantitatively by noise comparisons in the trachea and both main bronchi. In addition, 16 readers (14 radiologists and 2 internal medicine physicians) independently completed a browser-based pairwise forced-choice comparison task for assessment of subjective image quality. The Kendall rank coefficient ( W ) was calculated to assess interrater agreement, and Pearson's correlation coefficient ( r ) was used to analyze the relationship between noise measurements and image quality rankings. RESULTS: Across all dose levels, image noise in UHR mode was lower than in standard mode for scan protocols matched by CTDI vol ( P < 0.001). UHR examinations exhibited noise levels comparable to the next higher dose setting in standard mode ( P ≥ 0.275). Subjective ranking of protocols based on 5760 pairwise tests showed high interrater agreement ( W = 0.99; P ≤ 0.001) with UHR images being preferred by readers in the majority of comparisons. Irrespective of scan mode, a substantial indirect correlation was observed between image noise and subjective image quality ranking ( r = -0.97; P ≤ 0.001). CONCLUSIONS: In PCD-CT of the lung, UHR scan mode reduces image noise considerably over standard resolution acquisition. Originating from the smaller detector element size in fan direction, the small pixel effect allows for superior image quality in ultra-low dose examinations with considerable potential for radiation dose reduction.

Heterologous and homologous COVID-19 mRNA vaccination schemes for induction of basic immunity show similar immunogenicity regarding long-term spike-specific cellular immunity in healthcare workers.

Healthcare workers (HCWs) are recommended to receive at least three spike-antigen exposures to generate basic immunity and to mediate herd protection of vulnerable patients. So far, less attention has been put on the cellular immune response induced by homologous (three BTN162b2mRNA doses) or heterologous (mRNA-1273 as third dose building on two BTN162bmRNA doses) and the immunological impact of breakthrough infections (BTIs). Therefore, in 356 vaccinated HCWs with or without BTIs the Anti-SARS-CoV-2-Spike-IgG concentrations and avidities and B- and T-cell-reactivity against SARS-CoV-2-Spike-S1- and Nucleocapsid-antigens were assessed with Interferon-gamma-ELISpot and by flow-cytometry. HCWs who had hybrid immunity due to BTIs exhibited strong T-cell-reactivity against the Spike-S1-antigen. A lasso regression model revealed a significant reduction in T-cell immune responses among smokers (p < 0.0001), with less significant impact observed for age, sex, heterologous vaccination, body-mass-index, Anti-Nucleocapsid T-cell reactivity, days since last COVID-19-immunization, and Anti-SARS-CoV-2-Spike-IgG. Although subgroup analysis revealed higher Anti-SARS-CoV-2-Spike-IgG after heterologous vaccination, similar cellular reactivity and percentages of Spike-reactive T- and B-cells were found between homologous and heterologous vaccination. Anti-SARS-CoV-2-Spike-IgG concentrations and avidity significantly correlated with activated T-cells. CD4 + and CD8 + responses correlated with each other. A strong long-term cellular immune response should be considered as baseline for recommendations of booster doses in HCWs with prioritization of smokers. HCWs presented significant T-cellular reactivity towards Spike-S1-antigen with particularly strong responses in hybrid immunized HCWs who had BTIs. HCWs without BTI presented similar percentages of Spike-specific B- and T-cells between homologous or heterologous vaccination indicating similar immunogenicity for both mRNA vaccines, BNT162b2mRNA and mRNA-1273.

SARS-CoV-2 antigen rapid detection tests: test performance during the COVID-19 pandemic and the impact of COVID-19 vaccination.

BACKGROUND: SARS-CoV-2 antigen rapid detection tests (RDTs) emerged as point-of-care diagnostics alongside reverse transcription polymerase chain reaction (RT-qPCR) as reference. METHODS: In a prospective performance assessment from 12 November 2020 to 30 June 2023 at a single centre tertiary care hospital, the sensitivity and specificity (primary endpoints) of RDTs from three manufacturers (NADAL®, Panbio™, MEDsan®) were compared to RT-qPCR as reference standard among patients, accompanying persons and staff aged ≥ six month in large-scale, clinical screening use. Regression models were used to assess influencing factors on RDT performance (secondary endpoints). FINDINGS: Among 78,798 paired RDT/RT-qPCR results analysed, overall RDT sensitivity was 34.5% (695/2016; 95% CI 32.4-36.6%), specificity 99.6% (76,503/76,782; 95% CI 99.6-99.7%). Over the pandemic course, sensitivity decreased in line with a lower rate of individuals showing typical COVID-19 symptoms. The lasso regression model showed that a higher viral load and typical COVID-19 symptoms were directly significantly correlated with the likelihood of a positive RDT result in SARS-CoV-2 infection, whereas age, sex, vaccination status, and the Omicron VOC were not. INTERPRETATION: The decline in RDT sensitivity throughout the pandemic can primarily be attributed to the reduced prevalence of symptomatic infections among vaccinated individuals and individuals infected with Omicron VOC. RDTs remain valuable for detecting SARS-CoV-2 in symptomatic individuals and offer potential for detecting other respiratory pathogens in the post-pandemic era, underscoring their importance in infection control efforts. FUNDING: German Federal Ministry of Education and Research (BMBF), Free State of Bavaria, Bavarian State Ministry of Health and Care.

Virus variant-specific clinical performance of SARS coronavirus two rapid antigen tests in point-of-care use, from November 2020 to January 2022.

OBJECTIVES: Antigen rapid diagnostic tests (RDTs) for SARS coronavirus 2 (SARS-CoV-2) are quick, widely available, and inexpensive. Consequently, RDTs have been established as an alternative and additional diagnostic strategy to quantitative reverse transcription polymerase chain reaction (RT-qPCR). However, reliable clinical and large-scale performance data specific to a SARS-CoV-2 virus variant of concern (VOC) are limited, especially for the Omicron VOC. The aim of this study was to compare RDT performance among different VOCs. METHODS: This single-centre prospective performance assessment compared RDTs from three manufacturers (NADAL, Panbio, MEDsan) with RT-qPCR including deduced standardized viral load from oropharyngeal swabs for detection of SARS-CoV-2 in a clinical point-of-care setting from November 2020 to January 2022. RESULTS: Among 35 479 RDT/RT-qPCR tandems taken from 26 940 individuals, 164 of the 426 SARS-CoV-2 positive samples tested true positive with an RDT corresponding to an RDT sensitivity of 38.50% (95% CI, 34.00-43.20%), with an overall specificity of 99.67% (95% CI, 99.60-99.72%). RDT sensitivity depended on viral load, with decreasing sensitivity accompanied by descending viral load. VOC-dependent sensitivity assessment showed a sensitivity of 42.86% (95% CI, 32.82-53.52%) for the wild-type SARS-CoV-2, 43.42% (95% CI, 32.86-54.61%) for the Alpha VOC, 37.67% (95% CI, 30.22-45.75%) for the Delta VOC, and 33.67% (95% CI, 25.09-43.49%) for the Omicron VOC. Sensitivity in samples with high viral loads of ≥106 SARS-CoV-2 RNA copies per mL was significantly lower in the Omicron VOC (50.00%; 95% CI, 36.12-63.88%) than in the wild-type SARS-CoV-2 (79.31%; 95% CI, 61.61-90.15%; p 0.015). DISCUSSION: RDT sensitivity for detection of the Omicron VOC is reduced in individuals infected with a high viral load, which curtails the effectiveness of RDTs. This aspect furthert: limits the use of RDTs, although RDTs are still an irreplaceable diagnostic tool for rapid, economic point-of-care and extensive SARS-CoV-2 screening.

Symptomatic vs. non-symptomatic device-related thrombus after LAAC: a sub-analysis from the multicenter EUROC-DRT registry.

BACKGROUND: Device-related thrombus (DRT) after left atrial appendage closure (LAAC) is associated with adverse outcomes, i.e. ischemic stroke or systemic embolism (SE). Data on predictors of stroke/SE in the context of DRT are limited. AIMS: This study aimed to identify predisposing factors for stroke/SE in DRT patients. In addition, the temporal connection of stroke/SE to DRT diagnosis was analyzed. METHODS: The EUROC-DRT registry included 176 patients, in whom DRT after LAAC were diagnosed. Patients with symptomatic DRT, defined as stroke/SE in the context of DRT diagnosis, were compared against patients with non-symptomatic DRT. Baseline characteristics, anti-thrombotic regimens, device position, and timing of stroke/SE were compared. RESULTS: Stroke/SE occurred in 25/176 (14.2%) patients diagnosed with DRT (symptomatic DRT). Stroke/SE occurred after a median of 198 days (IQR 37-558) after LAAC. In 45.8% stroke/SE occurred within one month before/after DRT diagnosis (DRT-related stroke). Patients with symptomatic DRT had lower left ventricular ejection fractions (50.0 ± 9.1% vs. 54.2 ± 11.0%, p = 0.03) and higher rates of non-paroxysmal atrial fibrillation (84.0% vs. 64.9%, p = 0.06). Other baseline parameters and device positions were not different. Most ischemic events occurred among patients with single antiplatelet therapy (50%), however, stroke/SE was also observed under dual antiplatelet therapy (25%) or oral anticoagulation (20%). CONCLUSION: Stroke/SE are documented in 14.2% and occur both in close temporal relation to the DRT finding and chronologically independently therefrom. Identification of risk factors remains cumbersome, putting all DRT patients at substantial risk for stroke/SE. Further studies are necessary to minimize the risk of DRT and ischemic events.

A Skill Trainer for Balloon/Stent Exchange in Percutaneous Coronary Intervention-Concept and Evaluation.

BACKGROUND: To prevent complications, uncontrolled movement of the guidewire during a coronary intervention should be avoided. Unintentional withdrawal of the wire can result in the inability to recross a lesion with the risk of myocardial infarction. On the other hand, unintended forward pushing can lead to a coronary perforation. Thus, interventionalists in training should practice keeping the coronary guidewire in a stable position to prevent complications. For this purpose, a skill trainer has been developed, which provides the possibility of unlimited practice outside of the cath lab.The purpose of this study was to assess the effectiveness and the validity of this skills trainer. METHODS: Ten novices and 10 participants with experience in diagnostic catheterization underwent training on the skills trainer consisting of 25 procedures. To assess the efficacy of the training module, the mean score of the first 3 procedures was compared with the final 3 procedures in the novice and the advanced group. To determine the construct validity of the simulator, a group of experts (E; performed >1000 percutaneous coronary interventions) also underwent evaluation on the skills trainer. For each procedure, the change in position of the guidewire as well as the time was determined and combined into a skills score with a maximum of 15 points. RESULTS: The novice and the advanced group improved significantly throughout the training on the simulator (N: 7.1 ± 2.6 to 12.2 ± 2.0, P = 0.007; A: 8.3 ± 2.0 to 13.2 ± 1.0, P = 0.005, Wilcoxon).The experts scored significantly higher than novices or the advanced participants during their first 3 procedures (E: 12.9 ± 1.0; N: 7.1 ± 2.6, P = 0.001; A: 8.3 ± 2.0, P = 0.001; Mann-Whitney U ). CONCLUSIONS: This low-cost task trainer is a valid and effective tool to train adequate balloon/stent exchange while keeping the guidewire in a stable position. Whether the skills acquired on the task trainer can be transferred to procedures performed on patients needs further investigation.

Clinical and echocardiographic risk factors for device-related thrombus after left atrial appendage closure: an analysis from the multicenter EUROC-DRT registry.

BACKGROUND: Data on Device-related Thrombus (DRT) after left atrial appendage closure (LAAC) remain scarce. This study aimed to investigate risk factors for DRT from centers reporting to the EUROC-DRT registry. METHODS: We included 537 patients (112 with DRT and 425 without DRT) who had undergone LAAC between 12/2008 and 04/2019. Baseline and implantation characteristics, anti-thrombotic treatment and clinical outcomes were compared between both groups in uni- and multivariate analyses. Additional propensity-score matching (PSM) was conducted to focus on the role of implantation characteristics. RESULTS: Patients with DRT showed higher rates of previous stroke/transient ischemic attack (TIA) (49.1% vs. 34.7%, p < 0.01), spontaneous echocardiographic contrast (SEC) (44.9% vs. 27.7%, p < 0.01) and lower left atrial appendage (LAA) peak emptying velocity (35.4 ± 18.5 vs. 42.4 ± 18.0 cm/s, p = 0.02). Occluders implanted in DRT patients were larger (25.5 ± 3.8 vs. 24.6 ± 3.5 mm, p = 0.03) and implanted deeper in the LAA (mean depth: 7.6 ± 4.7 vs. 5.7 ± 4.7 mm, p < 0.01). Coverage of the appendage ostium was achieved less often in DRT patients (69.5% vs. 81.5%, p < 0.01), while DRT patients were less frequently on oral anticoagulation (7.1% vs. 16.7%, p < 0.01). Multivariate analysis identified age, prior stroke/TIA and SEC as independent risk factors for DRT. After PSM, implantation depth was found to be predictive. Rates of stroke/TIA were higher in DRT patients (13.5% vs. 3.8%, Hazard Ratio: 4.21 [95%-confidence interval: 1.88-9.49], p < 0.01). CONCLUSIONS: DRT after LAAC is associated with adverse outcome and appears to be of multifactorial origin, depending on patient characteristics, anticoagulation regimen and device position.

Photon-Counting Computed Tomography for Coronary Stent Imaging: In Vitro Evaluation of 28 Coronary Stents.

OBJECTIVES: The aim of this study was to assess in-stent lumen visibility and quantitative image characteristics of different coronary stents using a novel photon-counting detector (PCD) computed tomography (CT) system in comparison to a state-of-the-art energy-integrating detector (EID) CT scanner. MATERIALS AND METHODS: In this in vitro phantom study, 28 different coronary stents ranging from 2.25 to 4.5 mm lumen diameter were expanded into plastic tubes filled with contrast agent. Stent-containing plastic tubes were positioned in a custom-made emulsion-filled phantom, which was inserted into an anthropomorphic phantom simulating a medium-sized patient. Computed tomography scans were acquired parallel to the scanners' z axis using a novel cadmium telluride-based PCD CT system (SOMATOM CountPlus; Siemens Healthcare GmbH, Forchheim Germany), operating in 2 different modes (standard-resolution mode [SR] and ultra-high-resolution [UHR] mode), and a latest generation dual-source EID CT system (SOMATOM Force; Siemens Healthcare GmbH, Forchheim). CTDIvol-matched images were reconstructed with comparable convolution kernels and using the same reconstruction parameters. In-stent lumen visibility (in %), increase in in-stent attenuation (expressed as Δ in-stent CT attenuation), and image noise (in Hounsfield unit) were manually measured. Parts of the image analysis (in-stent lumen visibility) were additionally performed in an automated way. Differences were tested using Wilcoxon signed rank test. RESULTS: The best in-stent lumen visibility was achieved with the PCD-UHR mode and the lowest noise levels with the PCD-SR mode. The median in-stent lumen visibility was significantly higher (P < 0.001) with PCD (SR, 66.7%; interquartile range [IQR], 63.3-72.3; UHR, 68.9%; IQR, 64.4-74.4) compared with EID (65.4%; IQR, 62.2-70.4). The Δ in-stent CT attenuation was significantly lower for PCD in both SR (78 HU; IQR, 46-108; P = 0.024) and UHR (85 HU; IQR, 59-113; P = 0.006) compared with EID (108 HU; IQR, 85-126). Image noise was significantly lower (P < 0.001) for PCD-SR (21 HU; IQR, 21-21) compared with EID images (25 HU; IQR, 24-25.0). CONCLUSIONS: The PCD provides superior in-stent lumen visibility and quantitative image characteristics when compared with conventional EID.