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Background: Evidence suggests a benefit of a rhythm control approach in patients with a recent diagnosis of atrial fibrillation (AF). This study sought to evaluate clinical characteristics, treatment strategies and outcomes in patients with first diagnosed AF (FDAF) undergoing a non-invasive rhythm control strategy in an emergency department (ED). Methods: This analysis uses data from the Heidelberg Registry of Atrial Fibrillation (HERA-FIB). HERA-FIB is a retrospective single-centre observational study which consecutively included patients presenting to the ED of the University Hospital of Heidelberg between June 2009 and March 2020 with a sequential follow-up for all-cause mortality, stroke, major bleeding events and myocardial infarction (MI). Outcomes of patients with FDAF were related to treatment strategy (non-invasive rhythm vs. rate control). Results: Among the 2,758 (27%) patients who presented with FDAF, a non-implementation of a non-invasive rhythm control strategy at admission was observed in 75.4% and associated with an excess of all-cause mortality hazard ratio (HR): 1.61 (95%CI 1.30–1.99), p < 0.0001 and incident MI HR: 1.88 (95% CI 1.22–2.90), p = 0.0043 during follow-up. The non-implementation of a non-invasive rhythm control remained an independent predictor for all-cause mortality and MI even after adjustment for significant univariate variables with an adjusted HR of 1.52 (95%CI: 1.14–2.04, p = 0.0043) and 1.89 (95%CI: 1.03–3.45, p = 0.0392), respectively. Conclusion: Real-world data from FDAF patients presenting to an ED showed a benefit regarding all-cause mortality and MI favouring a non-invasive rhythm control strategy. Further prospective research is needed to validate this hypothesis. Trial registration: The trial was registered at ClinicalTrials.gov Identifier: NCT05995561. [ABSTRACT FROM AUTHOR]

Background: The impact of impaired kidney function on outcomes and treatment benefits of vitamin-K antagonists (VKA) versus direct oral anticoagulants (DOAC) in patients with atrial fibrillation (AF) has insufficiently been investigated in randomized controlled studies (RCTs). Most studies and registries are either biased due to incomplete enrolment of consecutive patients in large pharma industry sponsored registries, or due to short recruitment periods or incomplete assessment of important variables in national registries. Methods: This study uses data from the Heidelberg Registry of Atrial Fibrillation (HERA-FIB), a retrospective single-center registry of 10,222 consecutive patients with AF presenting to the emergency department of University Hospital of Heidelberg from June 2009 until March 2020. Rates of all-cause mortality, stroke, major bleeding and myocardial infarction (MI) were related to the presence and severity of impaired presenting kidney function, as well as to assigned treatment with VKA vs. DOAC. Results: The risks for all-cause mortality (HR: 3.26, p<0.001), stroke (HR: 1.58, p<0.001), major bleeding (HR: 2.28, p<0.001) and MI (HR: 2.48, p<0.001) were significantly higher in patients with an eGFR<60 ml/min at admission and increased with decreasing eGFR. After adjustment for variables of CHA2DS2VASc-score, presence of eGFR <60 ml/min remained as an independent predictor for all-cause mortality, major bleeding and MI. The hazard ratio (HR) for all-cause mortality, major bleedings and MI was significantly lower in patients receiving DOAC compared to VKA. Conclusion: Findings from our large real-life registry confirm the data from RCTs and extend our knowledge on the effectiveness and safety of DOACs to subjects that were underrepresented in RCTs. [ABSTRACT FROM AUTHOR]

Introduction With the establishment of the Data Sharing Framework (DSF) as a distributed business process engine in German research networks, it is becoming increasingly important to coordinate authentication, authorization, and role information between peer-to-peer network components. This information is provided in the form of an allowlist. This paper presents a concept and implementation of an Allowlist Management Application. State of the Art In research networks using the DSF, allowlists were initially generated manually. Concept The Allowlist Management Application provides comprehensive tool support for the participating organizations and the administrators of the Allowlist Management Application. It automates the process of creating and distributing allowlists and additionally reduces errors associated with manual entries. In addition, security is improved through extensive validation of entries and enforcing review of requested changes by implementing a four-eyes principle. Implementation Our implementation serves as a preliminary development for the complete automation of onboarding and allowlist management processes using established frontend and backend frameworks. The application has been deployed in the Medical Informatics Initiative and the Network University Medicine with over 40 participating organizations. Lessons learned We learned the need for user guidance, unstructured communication in a structured tool, generalizability, and checks to ensure that the tool's outputs have actually been applied. [ABSTRACT FROM AUTHOR]

Aims: Oncological patients suspected at risk for cardiotoxicity are recommended to undergo intensified cardiological surveillance. We investigated the value of cardiac biomarkers and patient‐related risk factors [age, cardiovascular risk factors (CVRFs), and cardiac function] for the prediction of all‐cause mortality (ACM) and the development of cardiotoxicity. Methods and results: Between January 2016 and December 2020, patients with oncological diseases admitted to the Cardio‐Oncology Unit at the Heidelberg University Hospital were included. They were evaluated by medical history, physical examination, 12‐lead electrocardiogram, 2D echocardiography, and cardiac biomarkers [high‐sensitivity cardiac troponin T (hs‐cTnT) and N‐terminal pro‐brain natriuretic peptide (NT‐proBNP)]. The primary endpoint was defined as ACM and the secondary endpoint was defined as cardiotoxicity, as defined by the European Society of Cardiology. Of the 1971 patients enrolled, the primary endpoint was reached by 490 patients (25.7%) with a median of 363.5 [interquartile range (IQR) 121.8, 522.5] days after presentation. Hs‐cTnT of ≥ 7 ng/L [odds ratio (OR) 1.82, P < 0.001] and NT‐proBNP (OR 1.98, P < 0.001) were independent predictors of ACM, while reduced left ventricular ejection fraction was not associated with increased ACM (P = 0.85). The secondary endpoint was reached by 182 patients (9.2%) with a median of 793.5 [IQR 411.2, 1165.0] days. Patients with multiple CVRFs (defined as high risk, n = 886) had an increased risk of cardiotoxicity (n = 100/886, 11.3%; hazard ratio 1.57, P = 0.004). They showed elevated baseline values of hs‐cTnT (OR 1.60, P = 0.006) and NT‐proBNP (OR 4.00, P < 0.001) and had an increased risk of ACM (OR 1.43, P = 0.031). Conclusions: In cancer patients, CVRF accumulation predicts cardiotoxicity whereas elevated hs‐cTnT or NT‐proBNP levels are associated with ACM. Accordingly, less intensive surveillance protocols may be warranted in patients with low cardiac biomarker levels and absence of CVRFs. [ABSTRACT FROM AUTHOR]

Common syntax and data semantics are core components of healthcare interoperability standards. However, interoperable data exchange processes are also needed to enable the integration of existing systems between organizations. While solutions for healthcare delivery processes are available and have been widely adopted, support for processes targeting bio-medical research is limited. Our Data Sharing Framework creates a platform to implement research processes like cohort size estimation, reviews and approvals of research proposals, consent checks, record linkage, pseudonymization and data sharing across organizations. The described framework implements a distributed business process engine for executing BPMN 2.0 processes with synchronization and data exchange using FHIR R4 resources. Our reference implementation has been rolled out to 38 organizations across three research consortia in Germany and is available as open source under the Apache 2.0 license. [ABSTRACT FROM AUTHOR]