Integrated Open-Source Framework for Simulation of Transcatheter Pulmonary Valves in Native Right Ventricular Outflow Tracts.

Background-: Pulmonary insufficiency is a consequence of transannular patch repair in Tetralogy of Fallot (ToF), leading to late morbidity and mortality. Transcatheter native outflow tract pulmonary valve replacement (TPVR) has become common, but assessment of patient candidacy and selection of the optimal device remains challenging. We demonstrate an integrated open-source workflow for simulation of TPVR in image-derived models to inform device selection. Methods-: Machine learning-based segmentation of CT scans was implemented to define the right ventricular outflow tract (RVOT). A custom workflow for device positioning and pre-compression was implemented in SlicerHeart. Resulting geometries were exported to FEBio for simulation. Visualization of results and quantification were performed using custom metrics implemented in SlicerHeart and FEBio. Results-: RVOT model creation and device placement could be completed in under 1 minute. Virtual device placement using FE simulations visually mimicked actual device placement and allowed quantification of vessel strain, stress, and contact area. Regions of higher strain and stress were observed at the proximal and distal end locations of the TPVs where the devices impinge the RVOT wall. No other consistent trends were observed across simulations. The observed variability in mechanical metrics across RVOTS, stents, and locations in the RVOT highlights that no single device performs optimally in all anatomies, thereby reinforcing the need for simulation-based patient-specific assessment. Conclusions-: This study demonstrates the feasibility of a novel open-source workflow for the rapid simulation of TPVR which with further refinement may inform assessment of patient candidacy and optimal device selection.