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BackgroundIntra-atrial shunts are associated with an elevated risk of embolic stroke of undetermined source (ESUS). Percutaneous occluder implantation is recommended as secondary prevention in younger patients. This study aims to compare the outcome after shunt occlusion between younger and older patients with a history of presumed paradox embolism and to evaluate the impact of high-volume shunting in an elderly population.MethodsWe conducted a single-center, retrospective, observational study, involving 187 patients who underwent interventional percutaneous PFO or ASD occlusion at our center between 2013 and 2023.ResultsThe mean age of participants was 51.8 ± 11.8 years, with 76 patients aged ≤50 years and 111 patients aged >50 years. Older patients presented more cardiovascular risk factors. The presence of atrial septum aneurysm or large shunting was evenly distributed (ASA 26.3% vs. 28.8%, p = 0.833, mean shunt defect size 6.67 vs. 7.23 mm, p = 0.151). There were no significant differences in procedural or intrahospital complications. The event rate during the 6-month follow-up was low. Recurrence of arterial embolism occurred in 1.6% of the younger and 3.8% of the older patients (p = 0.817). Comparison of high-volume shunts (defect size ≥10 mm or passage ≥20 bubbles during bubble study) with low-volume shunts in this elderly cohort with a mean age ≥50 years showed no significant difference in outcomes. There was a statistically non-significant trend toward a higher rate of residual shunt at the end of the procedure in the high-volume shunt group (2.9% vs. 9.8%, p = 0.0894). This difference was not observed at the 6-month follow-up anymore (14.5 vs. 12.1%, p = 0.628). Two unsuccessful implantation attempts were reported in the high-volume shunt group, while none were observed in the low-volume shunt group (p = 0.372). No intervention-related deaths occurred in this patient cohort during follow-up.ConclusionOcclusion of relevant, intra-atrial shunting is a safe and effective option for secondary prevention of cryptogenic embolism in patients over 50 years of age. The beneficial outcome was irrespective of a high-volume shunting before implantation.

BackgroundRemote patient management may improve prognosis in heart failure. Daily review of transmitted data for early recognition of patients at risk requires substantial resources that represent a major barrier to wide implementation. An automated analysis of incoming data for detection of risk for imminent events would allow focusing on patients requiring prompt medical intervention.MethodsWe analysed data of the Telemedical Interventional Management in Heart Failure II (TIM-HF2) randomized trial that were collected during quarterly in-patient visits and daily transmissions from non-invasive monitoring devices. By application of machine learning, we developed and internally validated a risk score for heart failure hospitalisation within seven days following data transmission as estimate of short-term patient risk for adverse heart failure events. Score performance was assessed by the area under the receiver-operating characteristic (ROCAUC) and compared with a conventional algorithm, a heuristic rule set originally applied in the randomized trial.ResultsThe machine learning model significantly outperformed the conventional algorithm (ROCAUC 0.855 vs. 0.727, p

The mortality of patients with MI has significantly decreased in recent decades, mainly due to early reperfusion therapy with a probability of surviving of more than 90% if the patient reaches the hospital [...]

BackgroundPercutaneous interventional left atrial appendage occlusion (LAAO) is a reliable, safe, and effective alternative for stroke prevention in selected patients with atrial fibrillation (AF).MethodsIn a retrospective observational study, 149 patients underwent LAAO between 2016 and 2022 at the Department of Cardiology of the Charité—Universitätsmedizin Berlin, Campus Virchow, with AF for prevention of thromboembolic complications. We compared patient characteristics, intraoperative details and postoperative outcomes between single-occlusive plug-type (SOPT) and dual-occlusive disc-type (DODT) devices.ResultsIn all patients, the device implantation was successful. 60 patients received a SOPT occluder, including Watchman (35%) and Watchman FLX Occluders (65%), while 89 patients received a DODT occluder, including Amplatzer Cardiac Plug (37.1%), the Amplatzer Amulet (25.8%), and the LAmbre occluder (37.1%) systems. Procedure duration was significantly longer for DODT occluder implantation (49 ± 33 vs. 41 ± 25 min, p = 0.018). There were no in-hospital deaths or thromboembolic events reported after LAAO in both groups. Beyond that, a low rate of bleeding or access-side-related complications and pericardial tamponades were observed. Anticoagulation at discharge varied. About 60.8% of patients received dual antiplatelet therapy at hospital discharge, and 33.1% received direct oral anticoagulants. A 6-month follow-up was obtained in 85% of the patients. All implanted devices were in the desired position. However, in 5.7% of the patients, a device-related thrombus formation was detected in the SOPT group, while no thrombus was seen in the DODT group (p = 0.11). Thromboembolic events were noticed in 3.1%, without any difference between the device types. There was a statistically non-significant trend for less residual device leaks after SOPT vs. DODT implantation (no leak in 71.7% vs. 62.2%, p = 0.07; minor leaks

Background In patients with newly diagnosed heart failure (HF) and left ventricular ejection fraction (LVEF)

IntroductionThere is a lack of real-world data directly comparing different valve prostheses for transaortic valve replacement (TAVR). We aimed to compare early clinical outcomes at 30-days between the self-expandable Portico valve (Abbott) with the balloon-expandable Edwards Sapien 3 valve (Edwards Lifesciences) (ES3).MethodsOut of 1,901 patients undergoing TAVR between January 2018 and December 2021, all patients who received either Portico valve or ES3 valve via transfemoral TAVR were matched using nearest-neighbor (1:1) propensity scoring. Primary endpoints were single safety endpoints and early safety composite endpoints defined by Valve Academic Research Consortium-2 (VARC-2) criteria. The secondary endpoint was to analyze risk predictors for new permanent pacemaker (PPM) implantation in TAVR.ResultsOut of 661 complete cases, a total of 434 patients were successfully matched based on age, sex, Euro Score II and STS-score. In the matched cohort, 217 received either a Portico or valve and 217 received an ES3 valve. The VARC-2 early safety composite scores indicated a significantly greater overall 30-day safety risk in the Portico group at 9.2% (n = 20) compared to 3.7% (n = 8) in the ES3 group (p = 0.032). The requirement for new permanent pacemaker (PPM) implantation was also higher in the Portico group, at 21.2% (n = 46) vs. 13.4% (n = 29) in the ES3 group (p = 0.042). 30-day mortality was higher was 3.7% (n = 8) in Portico group compared to 0.9% in ES3 group (p = 0.11). Furthermore, implantation of the Portico valve was identified as a significant risk predictor for new PPM implantation, alongside higher age, preprocedural atrioventricular block (AVB) and longer total procedure duration.ConclusionThis study shows significantly higher rates of early clinical complications for Portico valve prostheses compared to ES3. These findings should be especially taken into consideration when selecting valve prosthesis for high-risk patients.

Background Even after atrial fibrillation (AF) catheter ablation, many patients still experience relevant symptom burden. The objective of the MENTAL AF trial was to determine whether app‐based mental training (MT) during the 3 months following pulmonary vein isolation reduces AF‐related symptoms. Methods and Results Patients scheduled for pulmonary vein isolation were enrolled and randomized 1:1 to either app‐based MT or usual care. Of 174 patients, 76 in the MT and 75 in the usual care group were included in the final analysis. The intervention was delivered by a daily 10‐minute app‐based MT. The primary outcome was the intergroup difference of the mean AF6 sum score, an AF‐specific questionnaire, during the 3‐month study period. Secondary outcomes included quality‐of‐life measures such as the AFEQT (Atrial Fibrillation Effect on Quality of Life). Mean age (SD) was 61 (8.7) years and 61 (41%) were women. The mean AF6 sum score over the study period was 8.9 (6.9) points in the MT group and 12.5 (10.1) in the usual care group (P=0.011). This referred to a reduction in the AF6 sum score compared with baseline of 75% in MT and 52% for usual care (P

Background: Early detection of atrial fibrillation (AF) could improve patient outcomes. P-wave duration (PWD) and interatrial block (IAB) are known predictors of new-onset AF and could improve selection for AF screening. This meta-analysis reviews the published evidence and offers practical implications. Methods: Publication databases were systematically searched, and studies reporting PWD and/or morphology at baseline and new-onset AF during follow-up were included. IAB was defined as partial (pIAB) if PWD≥120 ms or advanced (aIAB) if the P-wave was biphasic in the inferior leads. After quality assessment and data extraction, random-effects analysis calculated odds ratio (OR) and confidence intervals (CI). Subgroup analysis was performed for those with implantable devices (continuous monitoring). Results: Among 16,830 patients (13 studies, mean 66 years old), 2,521 (15%) had new-onset AF over a median of 44 months. New-onset AF was associated with a longer PWD (mean pooled difference: 11.5 ms, 13 studies, p

Background: Subpopulations of myocardial c-kitpos cells have the ability to stimulate regeneration in ischemic heart disease by paracrine effects. The left atrial appendage (LAA), which is easy accessible during cardiac surgery, may represent a perfect source for c-kitpos cell extraction for autologous cell therapies in the living human. So far, frequency and distribution of c-kitpos cells in LAA are unknown. Methods: LAAs of patients who underwent cardiac surgery due to coronary artery disease (coronary artery bypass graft, CABG), valvular heart disease or both and of two body donors were examined. Tissue was fixed in 4 % paraformaldehyde, embedded in paraffin, dissected in consecutive sections and stained for c-kitpos cells. In parallel, grade of fibrosis, amount of fat per section and cells positive for mast cell tryptase were examined. Results: We collected 27 LAAs (37.0 % female, mean left ventricular ejection fraction 50.4 %, 63.0 % persistent atrial fibrillation (AF)). Most of the patients underwent combined CABG and valve surgery (51.9 %). C-kitpos cells were detected in 3 different regions: A) Attached to the epicardial fat layer, B) close to vascular structures and C) between cardiomyocytes. C-kitpos cells ranged from 0.05 c-kitpos cells per mm2 to 67.5 c-kitpos cells per mm2. We found no association between number of c-kitpos cells and type of AF, amount of fibrosis or amount of fat. Up to 72 % of c-kitpos cells also showed a positive staining for mast cell tryptase. Conclusion: C-kitpos cells are frequent in LAAs of cardiovascular patients with a rather homogenous distribution throughout the LAA. The LAA can therefore be considered as a source for extraction of a reasonable quantity of autologous cardiac progenitor cells in the living human patient.

Abstract Background Pulmonary vein (PV) stenosis represents a rare but serious complication following radiofrequency ablation of atrial fibrillation with a comprehensive diagnosis including morphological stenosis grading together with the assessment of its functional consequences being imperative within the relatively narrow window for therapeutic intervention. The present study determined the clinical utility of a combined, single-session cardiovascular magnetic resonance (CMR) imaging protocol integrating pulmonary perfusion and PV angiographic assessment for pre-procedural planning and follow-up of patients referred for interventional PV stenosis treatment. Methods CMR examinations (cine imaging, dynamic pulmonary perfusion, three-dimensional PV angiography) were performed in 32 consecutive patients prior to interventional treatment of PV stenosis and at 1-day and 3-months follow-up. Degree of PV stenosis was visually determined on CMR angiography; visual and quantitative analysis of pulmonary perfusion imaging was done for all five lung lobes. Results Interventional treatment of PV stenosis achieved an acute procedural success rate of 90%. Agreement between visually evaluated pulmonary perfusion imaging and the presence or absence of a ≥ 70% PV stenosis was nearly perfect (Cohen’s kappa, 0.96). ROC analysis demonstrated high discriminatory power of quantitative pulmonary perfusion measurements for the detection of ≥ 70% PV stenosis (AUC for time-to-peak enhancement, 0.96; wash-in rate, 0.93; maximum enhancement, 0.90). Quantitative pulmonary perfusion analysis proved a very large treatment effect attributable to successful PV revascularization already after 1 day. Conclusion Integration of CMR pulmonary perfusion imaging into the clinical work-up of patients with PV stenosis allowed for efficient peri-procedural stratification and follow-up evaluation of revascularization success.

Abstract Background The SARS-CoV-2 variant B.1.1.529 (Omicron) was first described in November 2021 and became the dominant variant worldwide. Existing data suggests a reduced disease severity with Omicron infections in comparison to B.1.617.2 (Delta). Differences in characteristics and in-hospital outcomes of COVID-19 patients in Germany during the Omicron period compared to Delta are not thoroughly studied. ICD-10-code-based severe acute respiratory infections (SARI) surveillance represents an integral part of infectious disease control in Germany. Methods Administrative data from 89 German Helios hospitals was retrospectively analysed. Laboratory-confirmed SARS-CoV-2 infections were identified by ICD-10-code U07.1 and SARI cases by ICD-10-codes J09-J22. COVID-19 cases were stratified by concomitant SARI. A nine-week observational period between December 6, 2021 and February 6, 2022 was defined and divided into three phases with respect to the dominating virus variant (Delta, Delta to Omicron transition, Omicron). Regression analyses adjusted for age, gender and Elixhauser comorbidities were applied to assess in-hospital patient outcomes. Results A total cohort of 4,494 inpatients was analysed. Patients in the Omicron dominance period were younger (mean age 47.8 vs. 61.6; p

Abstract Background Severe acute respiratory infections (SARI) are the most common infectious causes of death. Previous work regarding mortality prediction models for SARI using machine learning (ML) algorithms that can be useful for both individual risk stratification and quality of care assessment is scarce. We aimed to develop reliable models for mortality prediction in SARI patients utilizing ML algorithms and compare its performances with a classic regression analysis approach. Methods Administrative data (dataset randomly split 75%/25% for model training/testing) from years 2016–2019 of 86 German Helios hospitals was retrospectively analyzed. Inpatient SARI cases were defined by ICD-codes J09-J22. Three ML algorithms were evaluated and its performance compared to generalized linear models (GLM) by computing receiver operating characteristic area under the curve (AUC) and area under the precision-recall curve (AUPRC). Results The dataset contained 241,988 inpatient SARI cases (75 years or older: 49%; male 56.2%). In-hospital mortality was 11.6%. AUC and AUPRC in the testing dataset were 0.83 and 0.372 for GLM, 0.831 and 0.384 for random forest (RF), 0.834 and 0.382 for single layer neural network (NNET) and 0.834 and 0.389 for extreme gradient boosting (XGBoost). Statistical comparison of ROC AUCs revealed a better performance of NNET and XGBoost as compared to GLM. Conclusion ML algorithms for predicting in-hospital mortality were trained and tested on a large real-world administrative dataset of SARI patients and showed good discriminatory performances. Broad application of our models in clinical routine practice can contribute to patients’ risk assessment and quality management.

Abstract Background In Germany, CRT devices with defibrillator capability (CRT-D) have become the predominant treatment strategy for patients with heart failure and cardiac dyssynchrony. However, according to current guidelines, most patients would also be eligible for the less expensive CRT pacemaker (CRT-P). We conducted a cost-effectiveness analysis for CRT-P devices compared to CRT-D devices from a German payer’s perspective. Methods Longitudinal health claims data from 3569 patients with de novo CRT implantation from 2014 to 2019 were used to parametrise a cohort Markov model. Model outcomes were costs and effectiveness measured in terms of life years. Transition probabilities were derived from multivariable parametric survival regression that controlled for baseline differences of CRT-D and CRT-P patients. Deterministic and probabilistic sensitivity analyses were conducted. Results The Markov model predicted a median survival of 84 months for CRT-P patients and 92 months for CRT-D patients. In the base case, CRT-P devices incurred incremental costs of € − 13,093 per patient and 0.30 incremental life years were lost. The ICER was € 43,965 saved per life year lost. In the probabilistic sensitivity analysis, uncertainty regarding the effectiveness was observed but not regarding costs. Conclusion This modelling study illustrates the uncertainty of the higher effectiveness of CRT-D devices compared to CRT-P devices. Given the difference in incremental costs between CRT-P and CRT-D treatment, there would be significant potential cost savings to the healthcare system if CRT-D devices were restricted to patients likely to benefit from the additional defibrillator.

Background. Primary preventive implantation of implantable defibrillator (ICD) is according to current guidelines indicated in patients with heart failure NYHA (New York Heart Association) class II/III and LVEF

Aims: Left-ventricular-assist-devices (lvad) are an established treatment for patients with severe heart failure with reduced ejection fraction (HF) and reduce mortality. However, HF patients have significant substrate for ventricular tachycardia (VT) and the lvad itself might be pro-arrhythmogenic. We investigated the mechanism of VT in lvad-patients in relation to the underlying etiology and provide in silico and ex-vivo data for ablation in these HF patients.Methods and Results: We retrospectively analyzed invasive electrophysiological (EP) studies of 17 patients with VT and lvad. The mechanism of VT was determined using electroanatomical, entrainment and activation time mapping. Ischemic cardiomyopathy was present in 70% of patients. VT originated from the lvad region in >30%. 1/6 patients with VT originating from the lvad region had episodes before lvad implantation, while 7/11 patients with VT originating from other regions had episodes before implantation. Number and time of radiofrequency (RF)-ablation lesions were not different between VTs originating from the lvad or other regions. Long-term freedom from VT was 50% upon ablation in patients with VT originating from the lvad region and 64% if ablation was conducted in other regions. To potentially preemptively mitigate lvad related VT in patients undergoing lvad implantation, we obtained in silico derived data and performed ex-vivo experiments targeting ventricular myocardium. Of the tested settings, application of 25 W for 30 s was safe and associated with optimal lesion characteristics.Conclusion: A significant percentage of patients with lvad undergoing VT ablation exhibit arrhythmia originating in close vicinity to the device and recurrence rates are high. Based on in silico and ex-vivo data, we propose individualized RF-ablation in selected patients at risk for/with lvad related VT.

BackgroundMobile health (mHealth) approaches are already having a fundamental impact on clinical practice in cardiovascular medicine. A variety of different health apps and wearable devices for capturing health data such as electrocardiograms (ECGs) exist. However, most mHealth technologies focus on distinct variables without integrating patients’ quality of life, and the impact on clinical outcome measures of implementing those digital solutions into cardiovascular health care is still to be determined. ObjectiveWithin this document, we describe the TeleWear project, which was recently initiated as an approach for contemporary patient management integrating mobile-collected health data and the standardized mHealth-guided measurement of patient-reported outcomes (PROs) in patients with cardiovascular disease. MethodsThe specifically designed mobile app and clinical frontend form the central elements of our TeleWear infrastructure. Because of its flexible framework, the platform allows far-reaching customization with the possibility to add different mHealth data sources and respective questionnaires (patient-reported outcome measures). ResultsWith initial focus on patients with cardiac arrhythmias, a feasibility study is currently carried out to assess wearable-recorded ECG and PRO transmission and its evaluation by physicians using the TeleWear app and clinical frontend. First experiences made during the feasibility study yielded positive results and confirmed the platform’s functionality and usability. ConclusionsTeleWear represents a unique mHealth approach comprising PRO and mHealth data capturing. With the currently running TeleWear feasibility study, we aim to test and further develop the platform in a real-world setting. A randomized controlled trial including patients with atrial fibrillation that investigates PRO- and ECG-based clinical management based on the established TeleWear infrastructure will evaluate its clinical benefits. Widening the spectrum of health data collection and interpretation beyond the ECG and use of the TeleWear infrastructure in different patient subcohorts with focus on cardiovascular diseases are further milestones of the project with the ultimate goal to establish a comprehensive telemedical center entrenched by mHealth.

Cardiac sarcoidosis can mimic any cardiomyopathy in different stages. Noncaseating granulomatous inflammation can be missed, because of the nonhomogeneous distribution in the heart. The current diagnostic criteria show discrepancies and are partly nonspecific and insensitive. Besides the diagnostic pitfalls, there are controversies in the understanding of the causes, genetic and environmental background, and the natural evolution of the disease. Here, we review the current pathophysiological aspects and gaps that are relevant for future cardiac sarcoidosis diagnostics and research.

Objectives: SARS-CoV-2 rapid antigen tests (RAT) provide fast identification of infectious patients when RT-PCR results are not immediately available. We aimed to develop a prediction model for identification of false negative (FN) RAT results. Methods: In this multicenter trial, patients with documented paired results of RAT and RT-PCR between October 1st 2020 and January 31st 2021 were retrospectively analyzed regarding clinical findings. Variables included demographics, laboratory values and specific symptoms. Three different models were evaluated using Bayesian logistic regression. Results: The initial dataset contained 4,076 patients. Overall sensitivity and specificity of RAT was 62.3% and 97.6%. 2,997 cases with negative RAT results (FN: 120; true negative: 2,877; reference: RT-PCR) underwent further evaluation after removal of cases with missing data. The best-performing model for predicting FN RAT results containing 10 variables yielded an area under the curve of 0.971. Sensitivity, specificity, PPV and NPV for 0.09 as cut-off value (probability for FN RAT) were 0.85, 0.99, 0.7 and 0.99. Conclusion: FN RAT results can be accurately identified through ten routinely available variables. Implementation of a prediction model in addition to RAT testing in clinical care can provide decision guidance for initiating appropriate hygiene measures and therefore helps avoiding nosocomial infections.

BackgroundThis study compared patient profiles and clinical courses of SARS-CoV-2 infected inpatients over different pandemic periods.MethodsIn a retrospective cross-sectional analysis, we examined administrative data of German Helios hospitals using ICD-10-codes at discharge. Inpatient cases with SARS-CoV-2 infection admitted between 03/04/2020 and 07/19/2022 were included irrespective of the reason for hospitalization. All endpoints were timely assigned to admission date for trend analysis. The first pandemic wave was defined by change points in time-series of incident daily infections and compared with different later pandemic phases according to virus type predominance.ResultsWe included 72,459 inpatient cases. Patients hospitalized during the first pandemic wave (03/04/2020–05/05/2020; n = 1,803) were older (68.5 ± 17.2 vs. 64.4 ± 22.6 years, p < 0.01) and severe acute respiratory infections were more prevalent (85.2 vs. 53.3%, p < 0.01). No differences were observed with respect to distribution of sex, but comorbidity burden was higher in the first pandemic wave. The risk of receiving intensive care therapy was reduced in all later pandemic phases as was in-hospital mortality when compared to the first pandemic wave. Trend analysis revealed declines of mean age and Elixhauser comorbidity index over time as well as a decline of the utilization of intensive care therapy, mechanical ventilation and in-hospital mortality.ConclusionCharacteristics and outcomes of inpatients with SARS-CoV-2 infection changed throughout the observational period. An ongoing evaluation of trends and care pathways will allow for the assessment of future demands.

Abstract Aims Models predicting mortality in heart failure (HF) patients are often limited with regard to performance and applicability. The aim of this study was to develop a reliable algorithm to compute expected in‐hospital mortality rates in HF cohorts on a population level based on administrative data comparing regression analysis with different machine learning (ML) models. Methods and results Inpatient cases with primary International Statistical Classification of Diseases and Related Health Problems (ICD‐10) encoded discharge diagnosis of HF non‐electively admitted to 86 German Helios hospitals between 1 January 2016 and 31 December 2018 were identified. The dataset was randomly split 75%/25% for model development and testing. Highly unbalanced variables were removed. Four ML algorithms were applied, and all algorithms were tuned using a grid search with multiple repetitions. Model performance was evaluated by computing receiver operating characteristic areas under the curve. In total, 59 125 cases (69.8% aged 75 years or older, 51.9% female) were investigated, and in‐hospital mortality was 6.20%. Areas under the curve of all ML algorithms outperformed regression analysis in the testing dataset with values of 0.829 [95% confidence interval (CI) 0.814–0.843] for logistic regression, 0.875 (95% CI 0.863–0.886) for random forest, 0.882 (95% CI 0.871–0.893) for gradient boosting machine, 0.866 (95% CI 0.854–0.878) for single‐layer neural networks, and 0.882 (95% CI 0.872–0.893) for extreme gradient boosting. Brier scores demonstrated a good calibration especially of the latter three models. Conclusions We introduced reliable models to calculate expected in‐hospital mortality based only on administrative routine data using ML algorithms. A broad application could supplement quality measurement programs and therefore improve future HF patient care.

Abstract Background Four-dimensional cardiovascular magnetic resonance (CMR) flow assessment (4D flow) allows to derive volumetric quantitative parameters in mitral regurgitation (MR) using retrospective valve tracking. However, prior studies have been conducted in functional MR or in patients with congenital heart disease, thus, data regarding the usefulness of 4D flow CMR in case of a valve pathology like mitral valve prolapse (MVP) are scarce. This study aimed to evaluate the clinical utility of cine-guided valve segmentation of 4D flow CMR in assessment of MR in MVP when compared to standardized routine CMR and transthoracic echocardiography (TTE). Methods Six healthy subjects and 54 patients (55 ± 16 years; 47 men) with MVP were studied. TTE severity grading used a multiparametric approach resulting in mild/mild-moderate (n = 12), moderate-severe (n = 12), and severe MR (n = 30). Regurgitant volume (RVol) and regurgitant fraction (RF) were also derived using standard volumetric CMR and 4D flow CMR datasets with direct measurement of regurgitant flow (4DFdirect) and indirect calculation using the formula: mitral valve forward flow - left ventricular outflow tract stroke volume (4DFindirect). Results There was moderate to strong correlation between methods (r = 0.59–0.84, p

Abstract Atrial fibrillation (AF) leads to remodeling characterized by changes in both size and shape of the left atrium (LA). Here we aimed to study the effect of hypertrophic cardiomyopathy (HCM) on the pattern of LA remodeling in AF-patients. HCM-patients (n = 23) undergoing AF ablation (2009–2012) were matched and compared with 125 Non-HCM patients from our prospective registry. Pre-procedural CT data were analyzed (EnSite Verismo, SJM, MN) to determine the maximal sagittal (anterior–posterior, AP), coronal (superior-inferior, SI and transversal, TV) dimensions and the sphericity index (LAS). Volume (LAV) was rendered after appendage (LAA) and pulmonary vein (PV) exclusion. A cutting plane, between PV ostia/LAA and parallel to the posterior wall, divided LAV into anterior- (LA­A) and posterior-LA (LA­P) parts. The ratio LA-A/LAV was defined as asymmetry index (ASI). HCM patients had a wider inter-ventricular septum and a smaller LV than Non-HCM patients. LA volume (LAV 166 ± 72 vs. 130 ± 36 ml, p = 0.03) and LA diameters were significantly larger in HCM patients. Anterior volume (LA-A: 112 ± 48 vs. 83 ± 26 ml, p

Abstract Aims The Covid‐19 pandemic affects care for cardiovascular conditions, but data on heart failure (HF) are scarce. This study aims to analyse HF care and in‐hospital outcomes during the pandemic in Germany. Methods and results A total of 9452 HF admissions were studied using claims data of 65 Helios hospitals; 1979 in the study period (13 March 30 April 2020) and 4691 and 2782 in two control periods (13 March to 30 April 2019 and 1 January to 12 March 2020). HF admissions declined compared with both control periods by 29–38%. Cardiac resynchronization therapy was implanted in 0.55% during the study period, 0.32% [odds ratio (OR) 1.66, 95% confidence interval (CI) 0.68–4.04, P = 0.27] in the previous year and 0.43% (OR 1.35, 95% CI 0.64–2.84, P = 0.43) in the same year control. Intensive care treatment was 6.22% during the study period, 4.49% in the previous year (OR 1.46, 95% CI 1.13–1.89, P

Introduction: Preprocedural cardiovascular magnetic resonance (CMR) or computed tomography (CT) imaging of the left atrium/pulmonary veins is usually employed to guide catheter ablation of atrial fibrillation (AFCA). Incidental findings (IFs) are common on cardiac imaging prior to AFCA. However, previous studies have mainly focused on extracardiac IFs detected on CT scan. We aimed to assess the prevalence of relevant cardiac and extracardiac IFs on routine preprocedural CMR in a large patient cohort scheduled for first-time AFCA and report its impact on clinical decision-making and management. Methods and results: We included 2000 consecutive patients (62 ± 10 years; 59% male) who underwent CMR prior to first-time AFCA between April 2015 and March 2019. Among these patients 172 (8.6%) had a total of 184 major IFs. Detection of major IFs resulted in cancellation of the scheduled AFCA procedure in 88 patients (4.4%). Forty-two patients (2.1%) have never been ablated, 46 (2.3%) underwent postponed AFCA after a median time of 83 (32–213) days. The remaining 84 patients (4.2%) underwent an individualized approach to AFCA. The most common major IFs were accessory or anomalous PVs in 76 (3.8%), extracardiac abnormalities suspicious of malignancy in 29 (1.5%), and positive stress perfusion imaging in 19 (7.2% of 261 tested) patients. In 19 patients (1.0%) preprocedural CMR provided the diagnosis of a previously unknown structural cardiac disease. Conclusions: Unexpected relevant findings on routine preprocedural CMR affected clinical decision-making and management in 8.6% of patients scheduled for first-time AFCA. However, whether preprocedural CMR imaging may improve overall clinical outcome needs to be addressed in future research.

Summary: Background: Cardiac autonomic dysfunction after myocardial infarction identifies patients at high risk despite only moderately reduced left ventricular ejection fraction. We aimed to show that telemedical monitoring with implantable cardiac monitors in these patients can improve early detection of subclinical but prognostically relevant arrhythmic events. Methods: We did a prospective investigator-initiated, randomised, multicentre, open-label, diagnostic trial at 33 centres in Germany and Austria. Survivors of acute myocardial infarction with left ventricular ejection fraction of 36–50% had biosignal analysis for assessment of cardiac autonomic function. Patients with abnormal periodic repolarisation dynamics (≥5·75 deg2) or abnormal deceleration capacity (≤2·5 ms) were randomly assigned (1:1) to telemedical monitoring with implantable cardiac monitors or conventional follow-up. Primary endpoint was time to detection of serious arrhythmic events defined by atrial fibrillation 6 min or longer, atrioventricular block class IIb or higher and fast non-sustained (>187 beats per min; ≥40 beats) or sustained ventricular tachycardia or fibrillation. This study is registered with ClinicalTrials.gov, NCT02594488. Findings: Between May 12, 2016, and July 20, 2020, 1305 individuals were screened and 400 patients at high risk were randomly assigned (median age 64 years [IQR 57–73]); left ventricular ejection fraction 45% [40–48]) to telemedical monitoring with implantable cardiac monitors (implantable cardiac monitor group; n=201) or conventional follow-up (control group; n=199). During median follow-up of 21 months, serious arrhythmic events were detected in 60 (30%) patients of the implantable cardiac monitor group and 12 (6%) patients of the control group (hazard ratio 6·33 [IQR 3·40–11·78]; p

Abstract Background Data on the usefulness of cardiovascular magnetic resonance (CMR) imaging for clinical decision making in patients with an implanted cardioverter defibrillator (ICD) are scarce. The present study determined the impact of CMR imaging on diagnostic stratification and treatment decisions in ICD patients presenting with electrical instability or progressive heart failure symptoms. Methods 212 consecutive ICD patients underwent 1.5 T CMR combining diagnostic imaging modules tailored to the individual clinical indication (ventricular function assessment, myocardial tissue characterization, adenosine stress-perfusion, 3D-contrast-enhanced angiography); four CMR examinations (4/212, 2%) were excluded due to non-diagnostic CMR image quality. The resultant change in diagnosis or clinical management was determined in the overall population and compared between ICD patients for primary (115/208, 55%) or secondary prevention (93/208, 45%). Referral indication consisted of documented ventricular tachycardia, inadequate device therapy or progressive heart failure symptoms. Results Overall, CMR imaging data changed diagnosis in 40% (83/208) with a significant difference between primary versus secondary prevention ICD patients (37/115, 32% versus 46/93, 49%, respectively; p = 0.01). The information gain from CMR led to an overall change in treatment in 21% (43/208) with a similar distribution in primary versus secondary prevention ICD patients (25/115,22% versus 18/93,19%, p = 0.67). The effect on treatment change was highest in patients initially scheduled for ventricular tachycardia ablation procedure (18/141, 13%) with revision of the treatment plan to medical therapy or coronary revascularization. Conclusions CMR imaging in ICD patients presenting with electrical instability or worsening heart failure symptoms provided diagnostic or management-changing information in a considerable proportion (40% and 21%, respectively).

Background. Catheter ablation of ventricular tachycardia (VT) in patients with ischemic cardiomyopathy (ICM) is an effective tool to prevent VT recurrences. Chronic total occlusion (CTO) represents a clinically relevant entity in ICM patients and is an independent predictor of ventricular arrhythmia and mortality. The effects of CTO on the outcome of VT ablation are not well-studied. Objective. This analysis aimed to identify the impact of CTO, revascularized, or not revascularized, on the outcome of VT ablation. Methods and Results. Of 385 consecutive subjects with ICM-VT who underwent catheter VT ablation for monomorphic VT at Heart Center Leipzig between 2008 and 2017, 108 patients without CTO and 191 patients with CTO were included in the analysis. Within a median follow-up time of 557 days (IQR 149, 1095), VT recurred in 77 (40%) patients in the CTO and 40 (37.0%) in the non-CTO cohort (p=0.62). In a multivariable model, a 10% stepwise change in LVEF as well as ICD on admission was associated with VT recurrence (HRadj 1.82, 95% CI 1.04–3.18 and HRadj 1.35, 95% CI 1.23–1.61, respectively). Of the CTO cohort before ablation, 45% had received revascularization, which was independently associated with a higher risk for VT recurrence (HR 2.12, 95% CI 1.35–3.34) as compared to nonrevascularized CTO. Conclusion. In ICM patients with and without CTO, VT ablation was associated with equal effectiveness with regard to VT recurrence. However, in revascularized CTO patients, the risk of recurrence of VT after ablation was significantly increased.

Aim To discuss ethical issues related to a complex study (PROFID) involving the development of a new, partly artificial intelligence-based, prediction model to enable personalised decision-making about the implantation of an implantable cardioverter defibrillator (ICD) in postmyocardial infarction patients, and a parallel non-inferiority and superiority trial to test decision-making informed by that model.Method The position expressed in this paper is based on an analysis of the PROFID trials using concepts from high-profile publications in the ethical literature.Results We identify ethical issues related to the testing of the model in the treatment setting, and to both the superiority and the non-inferiority trial. We underline the need for ethical-empirical studies about these issues, also among patients, as a parallel to the actual trials. The number of ethics committees involved is an organisational, but also an ethical challenge.Conclusion The PROFID trials, and probably other studies of similar scale and complexity, raise questions that deserve dedicated parallel ethics and social science research, but do not constitute a generic obstacle. A harmonisation procedure, comparable to the Voluntary Harmonization Procedure (VHP) for medication trials, could be needed for this type of trials.

Background: After the first COVID-19 infection wave, a constant increase of pulmonary embolism (PE) hospitalizations not linked with active PCR-confirmed COVID-19 was observed, but potential contributors to this observation are unclear. Therefore, we analyzed associations between changes in PE hospitalizations and (1) the incidence of non-COVID-19 pneumonia, (2) the use of computed tomography pulmonary angiography (CTPA), (3) volume depletion, and (4) preceding COVID-19 infection numbers in Germany.Methods: Claims data of Helios hospitals in Germany were used, and consecutive cases with a hospital admission between May 6 and December 15, 2020 (PE surplus period), were analyzed and compared to corresponding periods covering the same weeks in 2016–2019 (control period). We analyzed the number of PE cases in the target period with multivariable Poisson general linear mixed models (GLMM) including (a) cohorts of 2020 versus 2016–2019, (b) the number of cases with pneumonia, (c) CTPA, and (d) volume depletion and adjusted for age and sex. In order to associate the daily number of PE cases in 2020 with the number of preceding SARS-CoV-2 infections in Germany, we calculated the average number of daily infections (divided by 10,000) occurring between 14 up to 90 days with increasing window sizes before PE cases and modeled the data with Poisson regression.Results: There were 2,404 PE hospitalizations between May 6 and December 15, 2020, as opposed to 2,112–2,236 (total 8,717) in the corresponding 2016–2019 control periods (crude rate ratio [CRR] 1.10, 95% CI 1.05–1.15, P < 0.01). With the use of multivariable Poisson GLMM adjusted for age, sex, and volume depletion, PE cases were significantly associated with the number of cases with pneumonia (CRR 1.09, 95% CI 1.07–1.10, P < 0.01) and with CTPA (CRR 1.10, 95% CI 1.09–1.10, P < 0.01). The increase of PE cases in 2020 compared with the control period remained significant (CRR 1.07, 95% CI 1.02–1.12, P < 0.01) when controlling for those factors. In the 2020 cohort, the number of preceding average daily COVID-19 infections was associated with increased PE case incidence in all investigated windows, i.e., including preceding infections from 14 to 90 days. The best model (log likelihood −576) was with a window size of 4 days, i.e., average COVID-19 infections 14–17 days before PE hospitalization had a risk of 1.20 (95% CI 1.12–1.29, P < 0.01).Conclusions: There is an increase in PE cases since early May 2020 compared to corresponding periods in 2016–2019. This surplus was significant even when controlling for changes in potential modulators such as demographics, volume depletion, non-COVID-19 pneumonia, CTPA use, and preceding COVID-19 infections. Future studies are needed (1) to investigate a potential causal link for increased risk of delayed PE with preceding SARS-CoV-2 infection and (2) to define optimal screening for SARS-CoV-2 in patients presenting with pneumonia and PE.

Atrial fibrillation (AF) is the most common arrhythmia that leads to thrombus formation, mostly in the left atrial appendage (LAA). The current standard of stratifying stroke risk, based on the CHA2DS2-VASc score, does not consider LAA morphology, and the clinically accepted LAA morphology-based classification is highly subjective. The aim of this study was to determine whether LAA blood-borne particle residence time distribution and the proposed quantitative index of LAA 3D geometry can add independent information to the CHA2DS2-VASc score. Data were collected from 16 AF subjects. Subject-specific measurements included left atrial (LA) and LAA 3D geometry obtained by cardiac computed tomography, cardiac output, and heart rate. We quantified 3D LAA appearance in terms of a novel LAA appearance complexity index (LAA-ACI). We employed computational fluid dynamics analysis and a systems-based approach to quantify residence time distribution and associated calculated variable (LAA mean residence time, tm) in each subject. The LAA-ACI captured the subject-specific LAA 3D geometry in terms of a single number. LAA tm varied significantly within a given LAA morphology as defined by the current subjective method and it was not simply a reflection of LAA geometry/appearance. In addition, LAA-ACI and LAA tm varied significantly for a given CHA2DS2-VASc score, indicating that these two indices of stasis are not simply a reflection of the subjects' clinical status. We conclude that LAA-ACI and LAA tm add independent information to the CHA2DS2-VASc score about stasis risk and thereby can potentially enhance its ability to stratify stroke risk in AF patients.

The World Heart Federation (WHF) commenced a Roadmap initiative in 2015 to reduce the global burden of cardiovascular disease and resultant burgeoning of healthcare costs. Roadmaps provide a blueprint for implementation of priority solutions for the principal cardiovascular diseases leading to death and disability. Atrial fibrillation (AF) is one of these conditions and is an increasing problem due to ageing of the world’s population and an increase in cardiovascular risk factors that predispose to AF. The goal of the AF roadmap was to provide guidance on priority interventions that are feasible in multiple countries, and to identify roadblocks and potential strategies to overcome them. Since publication of the AF Roadmap in 2017, there have been many technological advances including devices and artificial intelligence for identification and prediction of unknown AF, better methods to achieve rhythm control, and widespread uptake of smartphones and apps that could facilitate new approaches to healthcare delivery and increasing community AF awareness. In addition, the World Health Organisation added the non-vitamin K antagonist oral anticoagulants (NOACs) to the Essential Medicines List, making it possible to increase advocacy for their widespread adoption as therapy to prevent stroke. These advances motivated the WHF to commission a 2020 AF Roadmap update. Three years after the original Roadmap publication, the identified barriers and solutions were judged still relevant, and progress has been slow. This 2020 Roadmap update reviews the significant changes since 2017 and identifies priority areas for achieving the goals of reducing death and disability related to AF, particularly targeted at low-middle income countries. These include advocacy to increase appreciation of the scope of the problem; plugging gaps in guideline management and prevention through physician education, increasing patient health literacy, and novel ways to increase access to integrated healthcare including mHealth and digital transformations; and greater emphasis on achieving practical solutions to national and regional entrenched barriers. Despite the advances reviewed in this update, the task will not be easy, but the health rewards of implementing solutions that are both innovative and practical will be great.

Introduction: Although an undoubted association between epicardial fat tissue (EFT) and atrial fibrillation (AF) has been recently approved, the association between EFT and post-ablation AF recurrence is not evident yet. This study aimed to assess the association between EFT and AF recurrence after ablation. Methods: The present study was a systematic review and meta-analysis using related literature available in electronic databases until July 2018 via “atrial fibrillation” and “epicardial fat” as the main keywords. Considering the different methods of EFT measurement, three different pooled meta-analyses were conducted in this study including: 1) comparison of total EFT volume, 2) left atrium (LA)-EFT volume, and 3) EFT thickness between two groups with and without AF recurrence estimating standardized mean difference (SMD) through a random and non-random effect meta-analysis. Statistical analysis was also performed using Comprehensive Meta-analysis (CMA) Software. Results: Following a search into a total number of 518 articles, the findings of 12 studies published in 10 articles were enrolled in this meta-analysis. Accordingly, the results of meta-analysis showed that LA-EFT and total EFT volumes were higher in recurrent subjects (LA-EFT: SMD = 0.862 ml; I2 = 0.00, 95% confidence interval (CI) = 0.567–1.156; total EFT: SMD = 1.017 ml, I2 = 0.00, 95% CI = 0.748–1.286). Besides, a significant higher EFT thickness in patients with AF recurrence compared to those with no AF recurrence was observed (SMD = 0.808 mm, I2 = 91.07, 95% CI = 0.215–1401). Conclusion: The total EFT and LA-EFT volumes, as well as EFT thickness, seemed to be associated with AF recurrence in patients undergoing AF ablation. Keywords: Epicardial fat, Adipose tissue, Atrial fibrillation, Recurrence, Risk assessment, Prognosis

Background: Left atrium (LA) remodeling is associated with atrial fibrillation (AF) and reduced success after AF ablation, but its relation with low-voltage areas (LVA) is not known. This study aimed to evaluate the relation between regional LA changes and LVAs in AF patients. Methods: Pre-interventional CT data of patients (n = 24) with LA-LVA (

BackgroundDuring the early phase of the Covid-19 pandemic, reductions of hospital admissions with a focus on emergencies have been observed for several medical and surgical conditions, while trend data during later stages of the pandemic are scarce. Consequently, this study aims to provide up-to-date hospitalization trends for several conditions including cardiovascular, psychiatry, oncology and surgery cases in both the in- and outpatient setting.Methods and findingsUsing claims data of 86 Helios hospitals in Germany, consecutive cases with an in- or outpatient hospital admission between March 13, 2020 (the begin of the "protection" stage of the German pandemic plan) and December 10, 2020 (end of study period) were analyzed and compared to a corresponding period covering the same weeks in 2019. Cause-specific hospitalizations were defined based on the primary discharge diagnosis according to International Statistical Classification of Diseases and Related Health Problems (ICD-10) or German procedure classification codes for cardiovascular, oncology, psychiatry and surgery cases. Cumulative hospitalization deficit was computed as the difference between the expected and observed cumulative admission number for every week in the study period, expressed as a percentage of the cumulative expected number. The expected admission number was defined as the weekly average during the control period. A total of 1,493,915 hospital admissions (723,364 during the study and 770,551 during the control period) were included. At the end of the study period, total cumulative hospitalization deficit was -10% [95% confidence interval -10; -10] for cardiovascular and -9% [-10; -9] for surgical cases, higher than -4% [-4; -3] in psychiatry and 4% [4; 4] in oncology cases. The utilization of inpatient care and subsequent hospitalization deficit was similar in trend with some variation in magnitude between cardiovascular (-12% [-13; -12]), psychiatry (-18% [-19; -17]), oncology (-7% [-8; -7]) and surgery cases (-11% [-11; -11]). Similarly, cardiovascular and surgical outpatient cases had a deficit of -5% [-6; -5] and -3% [-4; -3], respectively. This was in contrast to psychiatry (2% [1; 2]) and oncology cases (21% [20; 21]) that had a surplus in the outpatient sector. While in-hospital mortality, was higher during the Covid-19 pandemic in cardiovascular (3.9 vs. 3.5%, OR 1.10 [95% CI 1.06-1.15], PConclusionsThere have been varying changes in care pathways and in-hospital mortality in different disciplines during the Covid-19 pandemic in Germany. Despite all the inherent and well-known limitations of claims data use, this data may be used for health care surveillance as the pandemic continues worldwide. While this study provides an up-to-date analysis of utilization of hospital care in the largest German hospital network, short- and long-term consequences are unknown and deserve further studies.

The human gut microbiome and its metabolite Trimethylamine N-oxide (TMAO) are sensitive to the human diet and are involved in the complex pathomechanisms that underpin diabetes, obesity, and cardiovascular diseases. A potential involvement of increased TMAO in atrial fibrillation (AF) manifestation and progression is not clear. We measured TMAO in peripheral blood of 45 AF patients and 20 non-AF individuals (matched for age, sex, BMI, prevalence of hypertension and diabetes). TMAO levels in AF (median [IQR] 3.5 µM [2.51–4.53]) were comparable with those in non-AF individuals (3.62 µM [2.49–5.46]) (p = 0.629). There was no association between TMAO and AF progression phenotypes (p = 0.588). In 35 AF patients, TMAO was additionally measured 12–18 months after AF catheter ablation. TMAO levels at baseline and follow-up were correlated (r = 0.481, p = 0.003), and TMAO was increased independent from the success (restoration of sinus rhythm) of the ablation procedure.The data of this pilot study indicate that TMAO is not generally higher in AF and is not associated with AF progression phenotypes. The observed TMAO increase 12–18 months after AF catheter ablation needs further investigation in a larger cohort.

Key Clinical Message This case emphasizes the value of cardiac MRI and genetic testing in the early phase of ARVD/C. It also emphasizes the increased risk of SCD for patients with ARVD/C participating in competitive sports, even with immediate cardiopulmonary resuscitation.