Background: Registry data add important information to randomized controlled trials (RCT) on real-life aspects of implantable cardioverter-defibrillator (ICD) patients with and without cardiac resynchronization therapy (CRT-D). This analysis of the prospectively conducted German Device Registry aims at comparing mortality rates, comorbidities, complication rates to results from RCT.
Methods: The German Device registry (DEVICE) prospectively collected data on ICD and CRT-D first implantations from 50 German centres. Demographic data, details on cardiac disease, electrocardiogram (ECG), medication, and data about procedure, complications, and hospital stay were stored in electronic case report forms. One year after device implantation patients were contacted for follow-up.
Results: DEVICE included n = 4384 first ICD/CRT-D implantations (29.3% CRT-D devices). We found a strong adherence to guidelines with over 90% of patients being on ß-blocker and ACE-inhibitor medication and adequate QRS width in the majority of CRT-D patients. Patients receiving a CRT-D were older (67.6 ± 11.0 years vs. 63.9 ± 13.4 years, p < .001) and had lower ejection fractions (mean 25% vs. 30%, p < .001) compared to ICD patients. Dilated cardiomyopathy was the predominant underlying heart disease in CRT-D (53.3%), coronary artery disease in ICD patients (64.7%). Compared to RCT our DEVICE patients had more comorbidities (17.9% chronic kidney disease [CKD]) and higher 1-year mortality rates (10.7% ICD group, 12.3% CRT group). In multivariate analysis, CKD patients had an almost 2-fold higher risk of 1-year mortality.
Conclusion: Despite relevant limitations of registry data, DEVICE highlights important differences between RCT and real-world registry data and the impact of comorbidities on mortality of ICD and CRT-D recipients.
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http://dx.doi.org/10.1111/jce.15365 | DOI Listing |
Biologicals
January 2025
Centre for Human Drug Research (CHDR), Leiden, the Netherlands; Leiden University Medical Center (LUMC), Leiden, the Netherlands.
Inno4Vac, a public-private partnership funded by the IMI2/EU/EFPIA Joint Undertaking (IMI2 JU), brings together academic institutions, SMEs, and pharmaceutical companies to accelerate and de-risk vaccine development. The project has made significant strides in the selection and production of challenge agents for influenza, respiratory syncytial virus (RSV), and toxigenic Clostridioides difficile for controlled human infection model studies (CHIMs). A regulatory workshop held on March 20, 2024, addressed the standardisation of clinical procedures, ethical considerations, endpoints, and data integrity, highlighting the ongoing initiatives related to these CHIMs.
View Article and Find Full Text PDFJ Hypertens
November 2024
Robert Koch Institute, Department of Epidemiology and Health Monitoring.
Objectives: Home blood pressure monitoring (HBPM) is valuable for the detection and monitoring of hypertension. Despite logistical advantages, HBPM has not yet been used in national blood pressure (BP) surveys. We investigated randomly selected adults' willingness to participate in an HBPM study (attitude survey) and piloted this approach (feasibility study).
View Article and Find Full Text PDFEur J Heart Fail
January 2025
Department for Internal Medicine and Cardiology, Technische Universität Dresden, Heart Centre Dresden, University Hospital, Dresden, Germany.
Aims: This study aimed to investigate incidence and predictors of weaning failure and in-hospital death after successful weaning from veno-arterial extracorporeal membrane oxygenation (VA-ECMO) in patients with cardiogenic shock (CS).
Methods And Results: Overall, 685 patients with CS treated with VA-ECMO from 23 tertiary care centres in 7 countries were analysed (median age 57 [interquartile range 49-66] years, 542 [79.1%] male, median lactate 7.
J Robot Surg
January 2025
Electronic and Biomedical Instrumentation Group, Department of Electronic Engineering, Universitat Politècnica de Catalunya, C/ Jordi Girona, 1-3, Edifici C4, 08034, Barcelona, Spain.
New procedures like the robotic approach require proficiency to ensure patient safety and satisfactory functional results. Hiatal hernia surgery serves as a suitable training procedure for upper gastrointestinal tract surgeons transitioning to the robotic approach. This study aims to evaluate the outcomes of implementing the robotic approach in hiatal hernia surgery at a tertiary hospital and to assess the associated learning curve.
View Article and Find Full Text PDFHeart
January 2025
Cardiology, University Hospital of Copenhagen, Copenhagen, Denmark.
Acute myocardial infarction-related cardiogenic shock (AMI-CS) is a severe, life-threatening condition characterised by inadequate tissue perfusion due to the heart's inability to pump blood effectively. The pathophysiology of AMI-CS usually arises from the sudden loss of myocardial contractility, leading to a decrease in cardiac output and systemic hypoperfusion. In approximately 90% of AMI-CS cases, the left ventricle is the primary site of dysfunction.
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