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Artificial intelligence in medical device software and high-risk medical devices – a review of definitions, expert recommendations and regulatory initiatives KU Leuven
Introduction: Artificial intelligence (AI) encompasses a wide range of algorithms with risks when used to support decisions about diagnosis or treatment, so professional and regulatory bodies are recommending how they should be managed. Areas covered: AI systems may qualify as standalone medical device software (MDSW) or be embedded within a medical device. Within the European Union (EU) AI software must undergo a conformity assessment procedure ...
On the use of partitioning for scheduling of surgeries in the inpatient surgical department KU Leuven
In hospitals, the efficient planning of the operating rooms (ORs) is difficult due to the uncertainty inherent to surgical services. This is especially true for the inpatient surgical department where complex and long surgeries are often performed along with surgeries on emergency patients. This paper aims to improve the scheduling of the inpatient department by partitioning the elective surgeries into the more predictable surgeries (MPS) group ...
Cardiac troponin T and NT-proBNP for detecting myocardial ischemia in suspected chronic coronary syndrome KU Leuven
BACKGROUND: Elevated N-terminal pro-B-type natriuretic peptides (NT-proBNP) and cardiac troponin T (cTnT) are associated with poor outcome in patients with chronic coronary syndrome (CCS). The performance of these biomarkers in diagnosing ischemia, and their association with myocardial hypoperfusion and hypokinesis is unclear. METHODS: Patients with suspected CCS (history of angina, estimated cardiovascular risk >15% or a positive stress ...
Cost-Minimization Analysis for Cardiac Revascularization in 12 Health Care Systems Based on the EuroCMR/SPINS Registries KU Leuven
OBJECTIVES: The aim of this study was to compare the costs of a noninvasive cardiac magnetic resonance (CMR)-guided strategy versus 2 invasive strategies with and without fractional flow reserve (FFR). BACKGROUND: Coronary artery disease (CAD) is a major contributor to the public health burden. Stress perfusion CMR has excellent accuracy to detect CAD. International guidelines recommend as a first step noninvasive testing of patients in stable ...
Operating room planning and scheduling for outpatients and inpatients: A review and future research KU Leuven
Assessment of left ventricular function in horses with aortic regurgitation by 2D speckle tracking KU Leuven Universiteit Gent
BACKGROUND: Aortic regurgitation (AR) may lead to left ventricular (LV) dilatation, cardiac arrhythmias and heart failure. Close follow-up of horses with AR is therefore paramount to detect onset of cardiac decompensation. The aim of this study was to examine whether two-dimensional speckle tracking (2DST) can be used to detect altered myocardial function in horses with chronic AR compared to control horses. Speckle tracking was performed on ...
Experimental validation of the prestretch-strain relationship as a non-invasive index of left ventricular myocardial contractility KU Leuven
BACKGROUND: The slope of the relationship between segmental PreS and total systolic shortening (S) has been proposed as a non-invasive index of left ventricular contractility. The aim of this study was to correlate this novel parameter to invasive gold standard measurements of contractility and to investigate how it is influenced by afterload. METHODS: In domestic pigs, afterload was increased by either balloon inflation in the aorta or by ...
How GDPR Enhances Transparency and Fosters Pseudonymisation in Academic Medical Research KU Leuven
The European General Data Protection Regulation (GDPR) has dotted the i's and crossed the t's in the context of academic medical research. One year into GDPR, it is clear that a change of mind and the uptake of new procedures is required. Research organisations have been looking at the possibility to establish a code-of-conduct, good practices and/or guidelines for researchers that translate GDPR's abstract principles to concrete measures ...