27 - "Verification and validation pipeline for the risk-informed credibility assessment of in-silico fluid simulations for left atrial appendage devices"
Host:
Oscar Camara
Full Professor at Universidad Pompeu Fabra
Oscar Camara obtained his Degree in Telecommunications Engineering at Universitat Politècnica de Catalunya, in Barcelona, in 1999. He completed his Master and PhD in Image Processing in the École Nationale Supérieure des Télécommunications in Paris in 2000 and 2003, respectively. Since 2012 he is associated professor at at UPF and full professor from 2020.
ABSTRACT: The implantation of left atrial appendage occluder (LAAO) devices is an efficient therapy to reduce the risk of thrombus formation in atrial fibrillation patients with contraindications to standard anticoagulant therapy. Clinicians need to personalise the type, size and the position implantation of the LAAO device for each patient due to the high morphological and variability of the left atrial appendage. In-silico models can provide added value for the LAAO-related medical decisions, with fluid simulations, before and after implantation, being used to optimise device design, personalise device settings and tailor patient follow-up therapy.
Despite several LAA-based fluid models available in the literature, usually applied on a limited number of patient-specific geometries, there is a lack of consensus on the most appropriate set of boundary conditions to generate realistic simulations. Systematic verification and validation studies, following the ASME V&V40 guidelines with in-vitro and/or ex-vivo data, are also missing. There is a need for building credibility of LAAO-based in-silico models to integrate them as part of the medical device certification procedures. In this talk I will present an overview of the state of the art in LAA-based fluid simulations and define the required steps to establish, plan and assess risk-informed credibility of in-silico models specific to left atrial appendage occluder devices. The work is part of the SimCardioTest European project that aims at demonstrating the feasibility, effectiveness and benefits of in-silico trials for cardiac devices and drugs.
