Development of the VirtualTAVR system for diagnostics and preventative strategies

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DESCRIPTION (provided by applicant): Since the first procedure in 2002, there has been an explosive growth in transcatheter aortic valve replacement (TAVR). Up to date, more than 50,000 TAVR had been performed worldwide. Despite the increased global experience with TAVR, severe adverse events associated with TAVR have been extensively documented, including annulus rupture, coronary occlusion, paravalvular leak (PVL), pacemaker implantation, vascular complications and stroke. Currently, there is no effective method to pre-operatively predict and prevent these adverse events. To assist clinicians with diagnostic and preventative strategies to prevent these clinical adverse events, we propose to develop a novel virtual TAVR system (VirtualTAVR) that can display 3D aortic vasculature for TAVR planning, coupled with a workflow report of essential TAVR-associated parameters such as annulus diameter, cross sectional area, as well as distribution and degree of calcification. The unique and most important feature of the system is that it can virtually simulate the deployment of a TAV device into an individual patient aortic root and evaluate the tissue-device biomechanical interaction. The simulation output will be guidelines for appropriate access route selection, proper TAV sizing and positioning and desired TAV expansion force inside a patient's aortic root to avoid the abovementioned adverse events. The heart valve industry has long been expecting the $2 billion surgical market to be transformed into a $12 billion TAV market, but to date this has been prevented by poor TAV clinical trial performance. The virtual TAVR system offers a way to facilitate this transformation by improving patient outcomes. More importantly, its contribution to patient healthcare, i.e., improving quality of life in patients, could be immeasurable.