High incidence of acute and subacute ischaemic foci on brain MRI in patients with a diagnosis of acute pulmonary embolism and confirmed patent foramen ovale

Background. Pulmonary embolism (PE) is a common and potentially life-threatening diagnosis when a certain amount of thrombotic mass obstructs blood flow through the pulmonary circulation. The finding of acute and subacute ischaemic foci on magnetic resonance imaging (MRI) of the brain in a group of patients with this diagnosis in whom we demonstrate the presence of patent foramen ovale (PFO) by transoesophageal echocardiography (TEE) is surprisingly high. Methods. A total of 129 patients with a diagnosis of pulmonary embolism (confirmed by computed tomography with contrast agent, CTA) who consented to further examination were examined by transthoracic echocardiography (TTE) and transoesophageal echocardiography (TEE) with contrast agent, underwent magnetic resonance imaging of the brain according to a specific protocol, and underwent a comprehensive baseline laboratory examination. Results. In our group of 129 patients, we found the presence of PFO in 36.4% (n=47) of them. A total of 5.4% (n=7) patients had asymptomatic acute and subacute ischaemic changes on brain MRI; 6 of them had concomitant PFO. The statistically significant correlation between troponin levels and the presence of pathological findings on MRI and the trend of a similar correlation for NT-proBNP values is also very interesting finding. Conclusions. The association between the presence of PFO and the occurrence of symptomatic or asymptomatic findings on brain MRI is a well-known fact (the issue of paradoxical embolism) but the high frequency of acute and subacute lesions on brain MRI in the group of patients with a diagnosis of acute PE is surprising

Effect of a 6-month pedometer-based walking intervention on functional capacity in patients with chronic heart failure with reduced (HFrEF) and with preserved (HFpEF) ejection fraction: study protocol for two multicenter randomized controlled trials

Abstract Background Regular physical activity is recommended for patients with chronic heart failure to improve their functional capacity, and walking is a popular, effective, and safe form of physical activity. Pedometers have shown potential to increase the amount of walking across a range of chronic diseases, but it is unknown whether a pedometer-based intervention improves functional capacity and neurohumoral modulation in heart failure patients. Methods Two multicenter randomized controlled trials will be conducted in parallel: one in patients with chronic heart failure with reduced ejection fraction (HFrEF), the other in patients with chronic heart failure with preserved ejection fraction (HFpEF). Each trial will consist of a 6-month intervention with an assessment at baseline, at 3 months, at the end of the intervention, and 6 months after completing the intervention. Each trial will aim to include a total of 200 physically inactive participants with chronic heart failure who will be randomly assigned to intervention or control arms. The 6-month intervention will consist of an individualized pedometer-based walking program with weekly step goals, behavioral face-to-face sessions with a physician, and regular telephone calls with a research nurse. The intervention will be based on effective behavioral principles (goal setting, self-monitoring, personalized feedback). The primary outcome is the change in 6-min walk distance at the end of the 6-month intervention. Secondary outcomes include changes in serum biomarkers levels, pulmonary congestion assessed by ultrasound, average daily step count measured by accelerometry, anthropometric measures, symptoms of depression, health-related quality of life, self-efficacy, and MAGGIC risk score. Discussion To our knowledge, these are the first studies to evaluate a pedometer-based walking intervention in patients with chronic heart failure with either reduced or preserved ejection fraction. The studies will contribute to a better understanding of physical activity promotion in heart failure patients to inform future physical activity recommendations and heart failure guidelines. Trial registration The trials are registered in ClinicalTrials.gov, identifiers: NCT03041610, registered 29 January 2017 (HFrEF), NCT03041376, registered 1 February 2017 (HFpEF

Risk stratification using growth differentiation factor 15 in patients undergoing transcatheter aortic valve implantation

Aims. Growth differentiation factor 15 (GDF15) shows potential predictive value in various cardiac conditions. We investigated relationships between GDF15 and clinical or procedural outcomes in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) in order to propose clinically useful predictive risk stratification model. Methods. This prospective single-center registry enrolled 88 consecutive patients with severe symptomatic aortic stenosis treated with TAVI. Clinical parameters were collected and biomarkers including GDF-15 were measured within 24 h before TAVI. All relevant clinical outcomes according to the Valve Academic Research Consortium-2 were collected over the follow-up period. Results. The cohort included 52.3% of females. The mean age of study participants was 81 years; the mean Society of Thoracic Surgeons (STS) score and logistic EuroSCORE were 3.6% and 15.4%, respectively. The mortality over the entire follow-up period was 10.2%; no death was observed within the first 30 days following TAVI. Univariate analysis showed significant associations between GDF15 and mortality (P=0.0006), bleeding (P=0.0416) and acute kidney injury (P=0.0399). A standard multivariate logistic regression model showed GDF-15 as the only significant predictor of mortality (P=0.003); the odds ratio corresponding to an increase in GDF15 of 1000 pg/mL was 1.22. However, incremental predictive value was not observed when the STS score was combined with GDF15 in this predictive model. Conclusions. Based on our observations, preprocedural elevated GDF15 levels are associated with increased mortality and demonstrate their additional value in predicting adverse clinical outcomes in a TAVI population

General anesthesia or conscious sedation in paroxysmal atrial fibrillation catheter ablation

Background. Catheter ablation of paroxysmal atrial fibrillation (AF) can be performed under general anesthesia or conscious sedation. The influence of type of anesthesiology care on procedural characteristics and ablation outcome in patients in whom intracardiac echocardiography (ICE) and elimination of adenosine-mediated dormant conduction (DC) is used is not entirely known. Methods. 150 patients with paroxysmal AF were randomized to point-by-point radiofrequency catheter isolation of pulmonary veins (PVI) under general anesthesia (n=77) or conscious sedation (n=73). Adenosine-mediated dormant conduction was eliminated in all patients. Antiarrhythmic medication was discontinued after PVI. During twelve months of follow-up, all patients underwent four times 7-day ECG monitorings. Results. There was no difference between groups in AF recurrence (28.6% vs. 31.5%, P=0.695). Patients in conscious sedation had longer procedure times (160 ± 32.1 vs. 132 ± 31.5 min, P<0.001), longer RF energy application times (40 ± 15 vs. 29 ± 11 min, P<0.001) and longer fluoroscopy times (6.2 min ± 5.3 vs. 4.3 min ± 2.2, P<0.001) with similar complication rates. Conclusion. Conscious sedation is not inferior to general anesthesia in regard to arrhythmia recurrence or complication rates of catheter ablation of paroxysmal atrial fibrillation. However, it is associated with longer procedure times, longer time of radiofrequency energy application and longer fluoroscopy times

Statistical analysis plan for a randomized controlled trial examining pedometer-based walking intervention in patients with heart failure with reduced ejection fraction: the WATCHFUL trial

Abstract Background Physical activity is an effective management strategy for heart failure with reduced ejection fraction, but patients’ compliance is challenging. Walking is a suitable form of physical activity due to its convenience and sustainability, and it can potentially improve functional capacity in heart failure patients. Objectives The WATCHFUL trial aims to determine whether a pedometer-based walking intervention combined with face-to-face sessions and regular telephone contact improves functional capacity in heart failure patients. Methods The WATCHFUL trial is a 6-month multicenter, parallel-group, randomized, controlled, superiority trial with a 6-month follow-up. A total of 202 patients were recruited for the trial. The primary analysis will evaluate the change in distance walked during the 6-min walk test from baseline to 6 months based on the intention-to-treat population; the analysis will be performed using a linear mixed-effect model adjusted for baseline values. Missing data will be imputed using multiple imputations, and the impact of missing data will be assessed using a sensitivity analysis. Adverse events are monitored and recorded throughout the trial period. Discussion The trial has been designed as a pragmatic trial with a scalable intervention that could be easily translated into routine clinical care. The trial has been affected by the COVID-19 pandemic, which slowed patients’ recruitment and impacted their physical activity patterns. Conclusions The present publication provides details of the planned statistical analyses for the WATCHFUL trial to reduce the risks of reporting bias and erroneous data-driven results. Trial registration ClinicalTrials.gov (identifier: NCT03041610, registered: 3/2/2017)

Additional file 1 of Statistical analysis plan for a randomized controlled trial examining pedometer-based walking intervention in patients with heart failure with reduced ejection fraction: the WATCHFUL trial

Additional file 1. Statistical Analysis Plan Checklist

Soft x-ray free-electron laser induced damage to inorganic scintillators

An irreversible response of inorganic scintillators to intense soft x-ray laser radiation was investigated at the FLASH (Free-electron LASer in Hamburg) facility. Three ionic crystals, namely, Ce:YAG (cerium-doped yttrium aluminum garnet), PbWO4 (lead tungstate), and ZnO (zinc oxide), were exposed to single 4.6 nm ultra-short laser pulses of variable pulse energy (up to 12 μJ) under normal incidence conditions with tight focus. Damaged areas produced with various levels of pulse fluences, were analyzed on the surface of irradiated samples using differential interference contrast (DIC) and atomic force microscopy (AFM). The effective beam area of 22.2 ± 2.2 μm2 was determined by means of the ablation imprints method with the use of poly(methyl methacrylate) - PMMA. Applied to the three inorganic materials, this procedure gave almost the same values of an effective area. The single-shot damage threshold fluence was determined for each of these inorganic materials. The Ce:YAG sample seems to be the most radiation resistant under the given irradiation conditions, its damage threshold was determined to be as high as 660.8 ± 71.2 mJ/cm2. Contrary to that, the PbWO4 sample exhibited the lowest radiation resistance with a threshold fluence of 62.6 ± 11.9 mJ/cm2. The threshold for ZnO was found to be 167.8 ± 30.8 mJ/cm2. Both interaction and material characteristics responsible for the damage threshold difference are discussed in the article