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 我们已经开发了一种非侵入性技术来量化狭窄(阻塞)的严重程度。 在冠状动脉中。进行了一百万次有创冠状动脉造影术(ICA) 每年出现胸痛或已知冠状动脉稳定的患者 疾病(CAD)。该程序的目标是确定是否存在任何显著的狭窄， 限制血液流向冠状动脉中的心肌。几乎一半的ICAS最终是在 在冠状动脉内放置支架，以解除血流阻塞。心脏病专家 在导尿室进行手术，通过以下方式确定狭窄的重要性 两种方法中的一种：要么通过目测狭窄程度(‘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 流量储备分数(压力线FFR)，这是黄金标准测试。然而，压力- Wire FFR只在10%-20%的患者中进行，因为它具有侵入性，成本高，而且时间长。 消耗，并且需要更多的辐射和对比度曝光。 所提出的技术提供了准确、高度敏感和特异的、非侵入性的 方法无创冠状动脉造影术评价冠状动脉狭窄的意义 压力线FFR测量。当实时执行时，不到2分钟，这允许 心脏病专家在知情的情况下做出支架放置的决定。这样的方法将会 从成本节约和改进的角度提供压力线FFR测量的好处 减少患者症状，同时避免程序和时间的额外成本等缺点 负担。它在精确度方面比竞争对手的技术表现更好，但 在运行软件所需的时间方面优于竞争对手。这使我们能够 为量化冠状动脉狭窄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 冠状动脉狭窄病变，并结合居住地评估狭窄严重程度 血流通过狭窄段的时间。这种方法相对于 与之竞争的解决方案是其在几秒钟内交付实时虚拟解决方案的潜力。一次 实施后，该解决方案将与目前的导尿实验室设备无缝融合 为冠状动脉病变的治疗提供实时、客观的评估工具。 心脏病专家。 目标是将这项研究从最初成功的54名患者研究扩大到500名患者 (400名患者在派生队列中，100名患者在验证队列中) 冠状动脉造影术和冠状动脉造影术后已知冠心病患者的回顾性研究 用于临床适应症的压力线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.