Method for Rapid Non-Invasive Assessment of Coronary Stenosis

vCardio，Inc 冠状动脉狭窄的快速无创评估方法 项目摘要 我们开发了一种非侵入性技术，用于量化狭窄（堵塞）的严重程度 在冠状动脉中。进行了一百万次侵入性冠状动脉造影（伊卡）手术 每年在胸痛或已知冠状动脉稳定的患者中， 疾病（CAD）。手术的目的是确定是否存在任何显著的狭窄， 限制了冠状动脉中流向心肌的血液。几乎一半的国际资本协定的高潮是 在冠状动脉内放置支架，以缓解血流阻塞。心脏病专家 在导管插入实验室中执行该过程通过以下方式确定狭窄的重要性： 两种方法之一：或者通过视觉估计狭窄程度（“目测”狭窄）， 这是常规做法，在大多数患者中都是这样做的，或者通过侵入性测量 血流储备分数（压力导丝FFR），这是黄金标准测试。然而，压力- 仅在10-20%的患者中进行了导丝FFR，因为它是侵入性的、昂贵的和耗时的- 并且需要更多的辐射和对比度曝光。 所提出的技术提供了一个准确的，高度敏感和特异性，非侵入性 方法通过冠状动脉造影评估冠状动脉狭窄的意义， 压力导丝FFR测量。当实时执行时，在2分钟内，这允许 心脏病专家做出关于支架置入的知情决定。这种方法将 提供压力导丝血流储备分数测量在成本节约和改进方面的优势 在患者症状方面，同时避免手术和时间的额外费用等缺点 负担与竞争技术相比，它在准确性方面表现良好，但 在运行软件所需的时间方面优于竞争对手上级。这使我们能够 为冠状动脉狭窄的量化提供真正的实时解决方案。 我们的方法使用降阶建模方法来模拟冠状动脉血流， 狭窄的冠状动脉病变，并评估狭窄的严重程度， 血流通过狭窄节段的时间。这种方法的主要优点是， 竞争解决方案的另一个优势是其在几秒钟内提供实时虚拟解决方案的潜力。一旦 实施后，该解决方案将与当前的导管插入实验室设备无缝融合 并提供了一种实时、客观的工具，用于通过治疗来评估冠状动脉病变， 心脏病专家 目的是将研究从最初成功的54例患者研究扩展至500例患者 (400推导队列中的100例患者和验证队列中的100例患者）， 在接受过冠状动脉造影术的已知CAD患者中进行的回顾性研究， 用于临床适应症的压力导丝FFR测量。

vCardio, Inc Method for Rapid Non-Invasive Assessment of Coronary Stenosis Project Summary We have developed a non-invasive technique for quantifying the severity of stenosis (blockage) in coronary arteries. One million invasive coronary angiography (ICA) procedures are performed every year in patients who present with chest pain or are known to have stable coronary artery disease (CAD). The goal of the procedure is to determine if there is any significant stenosis that limits blood flow to the heart muscle in the coronary arteries. Almost half of ICAs culminate in stent placement in coronary arteries in order to relieve the blockage of blood flow. The cardiologist performing the procedure in the catheterization lab determines the significance of the stenosis by one of two methods: either by visually estimating the degree of stenosis (‘eyeballing’ the stenosis), which is the routine practice and is done in the majority of patients, or by invasively measuring fractional flow reserve (pressure-wire FFR), which is the Gold Standard test. However, pressure- wire FFR is only performed in 10-20% of patients because it is invasive, expensive, and time- consuming, and requires more radiation and contrast exposure. The proposed technology provides an accurate, highly sensitive and specific, non-invasive method to assess the significance of coronary stenosis through coronary angiography without pressure-wire FFR measurement. When performed in real-time, under 2 minutes, this allows the cardiologist to make an informed decision regarding stent placement. Such a method would deliver the benefits of pressure-wire FFR measurement in terms of cost savings and improvement in patient symptoms, while avoiding disadvantages such as extra cost for the procedure and time burden. It performs favorably compared to competing technology in terms of accuracy but is superior to competition with regards to the time required to run the software. This allows us to provide a truly real-time solution for quantification of coronary stenosis. Our approach uses reduced order modeling methods to model coronary blood flow across stenotic coronary lesions and assess the degree of stenosis severity by incorporating residence time of blood flow through the stenotic segments. The major advantage of this approach over the competing solutions is its potential to deliver a real-time virtual solution within seconds. Once implemented, the solution would merge seamlessly with the current catheterization lab equipment and provide a real-time, objective tool for assessment of coronary lesions by the treating cardiologists. The objective is to scale the study from an initial successful 54 patient study up to 500 patients (400 patients in derivation cohort and 100 patients in validation cohort) by conducting a retrospective study in patients with known CAD who have undergone coronary angiography and pressure-wire FFR measurement for clinical indications.