Development of the VirtualTAVR system for diagnostics and preventative strategies

描述(申请人提供)：自2002年第一次手术以来，经导管主动脉瓣置换术(TAVR)有了爆炸性的增长。到目前为止，全世界已经进行了50,000多次TAVR。尽管TAVR的全球经验增加，但与TAVR相关的严重不良事件已被广泛记录在案，包括瓣环破裂、冠状动脉闭塞、瓣膜旁渗漏(PVL)、起搏器植入、血管并发症和中风。目前，还没有有效的方法来术前预测和预防这些不良事件。为了帮助临床医生采取诊断和预防策略来预防这些临床不良事件，我们建议开发一种新的虚拟TAVR系统(VirtualTAVR)，该系统可以显示用于TAVR规划的3D主动脉血管，以及与TAVR相关的基本参数的工作流报告，如环直径、横截面积以及钙化的分布和程度。该系统的独特和最重要的特点是，它可以虚拟模拟将TAV设备部署到单个患者的主动脉根部，并评估组织-设备的生物力学相互作用。模拟的结果将是指导适当的通路选择，适当的TAV大小和位置，以及患者主动脉根部所需的TAV扩张力，以避免上述不良事件。心脏瓣膜行业长期以来一直预计，价值20亿美元的外科市场将转变为价值120亿美元的TAV市场，但到目前为止，由于TAV临床试验表现不佳，这一点一直未能实现。虚拟TAVR系统提供了一种通过改善患者预后来促进这一转变的方法。更重要的是，它对 患者保健，即提高患者的生活质量，可能是不可估量的。

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.