Publications by authors named "Leon Bouwels"

Importance: Cardiac implantable electronic device (CIED) infection is a potentially devastating complication with an estimated 12-month mortality of 15% to 30%. The association of the extent (localized or systemic) and timing of infection with all-cause mortality has not been established.

Objective: To evaluate the association of the extent and timing of CIED infection with all-cause mortality.

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Background: The Prevention of Arrhythmia Device Infection Trial (PADIT) investigated whether intensification of perioperative prophylaxis could prevent cardiac implantable electronic device (CIED) infections. Compared with a single dose of cefazolin, the perioperative administration of cefazolin, vancomycin, bacitracin, and cephalexin did not significantly decrease the risk of infection. Our objective was to compare the microbiology of infections between study arms in PADIT.

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Background: Cardiac implantable electronic device infection is a major complication that usually requires device removal. PADIT (Prevention of Arrhythmia Device Infection Trial) was a large cluster crossover trial of conventional versus incremental antibiotics.

Objectives: This study sought to investigate independent predictors of device infection in PADIT and develop a novel infection risk score.

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Background: Infection of implanted medical devices has catastrophic consequences. For cardiac rhythm devices, pre-procedural cefazolin is standard prophylaxis but does not protect against methicillin-resistant gram-positive organisms, which are common pathogens in device infections.

Objective: This study tested the clinical effectiveness of incremental perioperative antibiotics to reduce device infection.

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Objective: Sudden cardiac arrest caused by cardiac arrhythmias is 1 of the leading causes of death worldwide. Implantable cardioverter defibrillators (ICDs) are considered as standard care for patients with increased risk of arrhythmias. However, 1 in 4 ICD patients experiences psychological distress post-ICD implantation.

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Introduction: In view of the shift from routine toward no or selective defibrillation testing, optimization of the current risk stratification for inadequate defibrillation safety margins (DSMs) could improve individualized testing decisions. Given the pathophysiological differences in myocardial substrate between ischemic and nonischemic heart disease (IHD/non-IHD) and the accompanying differences in clinical characteristics, we studied inadequate DSMs and their predictors in relation to the underlying etiology.

Methods And Results: Cohort of routine defibrillation tests (n = 785) after first implantable cardioverter defibrillator (ICD)-implantations at the Radboud UMC (2005-2014).

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Unlabelled: The Web-based distress management program for patients with an implantable cardioverter-defibrillator (ICD; WEBCARE) was developed to mitigate distress and enhance health-related quality of life in ICD patients. This study investigated the treatment effectiveness at 3-month follow-up for generic and disease-specific outcome measures.

Methods: Consecutive patients implanted with a first-time ICD from six hospitals in the Netherlands were randomized to either the "WEBCARE" or the "usual care" group.

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Background: WEB-Based Distress Management Program for Implantable CARdioverter defibrillator Patients (WEBCARE) is a Web-based randomized controlled trial, designed to improve psychological well-being in patients with an implantable cardioverter defibrillator (ICD). As in other Web-based trials, we encountered problems with attrition and adherence.

Objective: In the current study, we focus on the patient characteristics, reasons, and motivation of (1) completers, (2) those who quit the intervention, and (3) those who quit the intervention and the study in the treatment arm of WEBCARE.

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Background: It has been demonstrated that the occurrence of ischemic stroke is more prevalent in AF patients, when increased levels of inflammatory markers are present.

Objective: The aim of this study was to evaluate the effect of intensive cholesterol lowering therapy on inflammatory markers and evidence of thrombotic in elderly AF patients treated with OAC.

Methods: 34 elderly patients (69-85 yrs) were randomized to double blind treatment with atorvastatin 40 mg plus ezetimibe 10 mg (n = 17) or double placebo (n = 17) for one year.

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Objectives: In elderly patients with atrial fibrillation (AF), medial temporal lobe (MTL) atrophy and white matter lesions (WML) may account for the cognitive decline. Though a combination therapy of statins with cholesterol lowering agents like ezetimibe may be beneficial in patients with AF, its effects on MTL structure and WML remains unknown.

Methods: A parallel group double-blinded randomized trial was performed during 1 year whereby elderly stroke-free AF patients either received placebo or atorvastatin and ezetimibe on top oral anticoagulation therapy.

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