Development of the VirtualTAVR system for diagnostics and preventative strategies

开发用于诊断和预防策略的 VirtualTAVR 系统

• 批准号: 8781886
• 负责人: Thuy M Pham
• 金额: $ 19.83万
• 依托单位: SUTRA MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-15 至 2017-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8781886
• 关键词: Adverse event; Age; Aorta; Aortic Rupture; Aortic Valve Insufficiency; Area; Biomechanics; Blinded; Blood Vessels; Calcified; Caliber; Cardiac; Clinical; Clinical Trials; Computer Simulation; Coronary; Coronary Occlusions; Coupled; Data; Databases; Development; Devices; Diagnostic; Diastole; Dilatation - action; Effectiveness; Elements; Extravasation; Gender; Geometry; Growth; Guidelines; Healthcare; Heart Valves; Height; Imagery; Implant; Individual; Industry; Intervention; Lead; Left ventricular structure; Liquid substance; Location; Marketing; Measurement; Methods; Modeling; Obstruction; Operative Surgical Procedures; Outcome; Output; Pacemakers; Patients; Performance; Phase; Plant Roots; Positioning Attribute; Procedures; Property; Quality of life; Radial; Reporting; Research Personnel; Route; Rupture; Severe Adverse Event; Simulate; Small Business Innovation Research Grant; Stents; Stroke; System; Thoracic Surgical Procedures; Tissues; Ventricular; X-Ray Computed Tomography; aortic valve; aortic valve replacement; calcification; experience; human tissue; iliac artery; implantation; improved; migration; novel; prevent; public health relevance; simulation; success; three-dimensional modeling; virtual

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.

描述（由申请人提供）：自2002年首次手术以来，经导管主动脉瓣置换术（TAVR）呈爆炸性增长。迄今为止，全球已进行了超过50，000例TAVR。尽管全球TAVR经验不断增加，但与TAVR相关的严重不良事件已被广泛记录，包括瓣环破裂、冠状动脉闭塞、瓣周漏（PVL）、起搏器植入、血管并发症和中风。目前，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虚拟TAVR系统（VirtualTAVR），该系统可以显示TAVR计划的3D主动脉血管系统，以及TAVR相关基本参数（如瓣环直径、横截面积以及钙化分布和程度）的工作流程报告。该系统的独特和最重要的特征是，它可以虚拟模拟TAV器械在个体患者主动脉根部的展开，并评价组织-器械生物力学相互作用。模拟输出将指导适当的入路选择、适当的TAV尺寸和定位以及患者主动脉根部内所需的TAV扩张力，以避免上述不良事件。长期以来，心脏瓣膜行业一直期待20亿美元的外科手术市场转变为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转变。虚拟TAVR系统提供了一种通过改善患者结局来促进这种转变的方法。更重要的是， 患者保健，即，提高患者的生活质量，这是不可估量的。