Clinical Impact of Preprocedural CT-Based 3D Computational Simulation of Left Atrial Appendage Occlusion with Amulet

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.

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.

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.