Development of the VirtualTAVR system for diagnostics and preventative strategies

描述（由申请人提供）：自2002年第一例手术以来，经导管主动脉瓣置换术（TAVR）呈爆炸式增长。迄今为止，全世界已进行了50,000多例TAVR。尽管全球对TAVR的经验不断增加，但与TAVR相关的严重不良事件已被广泛记录，包括环破裂、冠状动脉闭塞、瓣旁漏（PVL）、起搏器植入、血管并发症和中风。目前，尚无有效的方法对这些不良事件进行术前预测和预防。为了帮助临床医生制定诊断和预防策略以预防这些临床不良事件，我们建议开发一种新型的虚拟TAVR系统（VirtualTAVR），该系统可以显示3D主动脉血管系统以进行TAVR规划，并结合TAVR相关的基本参数（如环直径、横截面积、分布和钙化程度）的工作流程报告。该系统的独特和最重要的特点是，它可以虚拟地模拟TAV设备进入单个患者主动脉根部的部署，并评估组织-设备的生物力学相互作用。仿真输出将指导患者选择合适的通路、合适的TAV尺寸和定位以及TAV在患者主动脉根部所需的扩张力，以避免上述不良事件的发生。长期以来，心脏瓣膜行业一直期望将20亿美元的外科手术市场转化为120亿美元的TAV市场，但迄今为止，TAV临床试验表现不佳，阻碍了这一目标的实现。虚拟TAVR系统提供了一种通过改善患者预后来促进这种转变的方法。更重要的是，它对

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.