Abstract
Aims Standard of care (SoC) device size selection with transoesophageal echocardiography (TOE) and computed tomography (CT) in LAAO can be challenging due to a certain degree of variability at both patient and device levels. The aim of this study was to prospectively evaluate the clinical impact of 3D computational modelling software in the decision-making of left atrial appendage occlusion (LAAO) with Amplatzer Amulet. Methods and Results SoC preprocedural assessments as well as CT-based 3D computational simulations (FEops) were performed in 15 consecutive patients scheduled for LAAO with Amulet. Preprocedural device size selection and degree of confidence were determined after SoC and after FEops-based assessments and compared to the implanted device. FEops-based preprocedural assessment correctly selected the implanted device size in 11 out of 15 patients (73.3%), compared to 7 patients (46.7%) for SoC-based assessment. In 4 patients (26.7%), FEops induced a change in device size initially selected by SoC. In the 7 patients (46.7%) in which FEops confirmed the SoC device size selection, the degree of confidence of the size selection increased from 6.4 ± 1.4 for SoC to 8.1 ± 0.7 for FEops. One patient (6.7%) could not be implanted for anatomical reason, as correctly identified by FEops. Conclusions Preprocedural 3D computational simulation by FEops impacts Amulet size selection in LAAO compared to TOE and CT-based SoC assessment. Operators could consider FEops computational simulation in their preprocedural device size selection.
Highlights
Left atrial appendage (LAA) occlusion is a well-accepted alternative to oral anticoagulant in the prevention of stroke or systemic thromboembolism in patients with atrial fibrillation (AF) [1]
FEops-based preprocedural assessment correctly selected the Amulet size in 11 patients (73.3%), compared to 7 patients (46.7%) for the standard of care
FEops correctly induced a change in device size in 4 patients (26.7%)
Summary
Left atrial appendage (LAA) occlusion is a well-accepted alternative to oral anticoagulant in the prevention of stroke or systemic thromboembolism in patients with atrial fibrillation (AF) [1]. Additional challenges might derive from information overload from multimodality imaging (2D or 3D transoesophageal echocardiography, computed tomography, plain angiography, intracardiac echo, etc.) and slow democratic decisionmaking process of large implanting teams (operators, echocardiographers, product specialists, fellows, nursing staff, etc). All these challenges are reflected in the 6.1% to 38% change in device sizes during implantation [2,3,4], inability to close the LAA in 1–2.7% up to 4.4% of the cases [2,3,4], procedural complications, lengthy procedures, and so forth. All these numbers are perhaps even higher in unpublished series and early-operator learning curves
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