cvSim+CCTA to noninvasively assess hemodynamic significance of coronary lesions

描述（由申请人提供）：Cardiovascular Simulation, Inc .开发了cvSim-3DTM软件，用于增强冠状动脉计算机断层血管造影（CCTA）和患者特定血流数据，并为评估冠状动脉病变的血流动力学意义提供非侵入性替代心导管诊断。我们估计，即使考虑到CCTA和cvSim-3DTM的成本，这将为美国医疗保健系统每年节省至少60亿美元，并为患者提供更好的护理。在美国每年接受诊断性心导管插入术（第二大最常见的医疗程序）的患者中，大约50%的患者没有血流动力学上的显著病变。来自DEFER和FAME研究的最新临床数据表明，没有明显血流动力学病变的患者应该接受药物治疗，而不是血管成形术和支架植入术。CCTA提供了前所未有的无创冠状动脉可视化和识别冠状动脉疾病患者的能力，但不足以确定中度病变患者是否可以从经皮冠状动脉介入治疗（PCI）中获益。从根本上说，CCTA提供了关于冠状动脉解剖和疾病形态的详细信息，但缺乏冠状动脉血流的生理学信息。我们已经开发出了量化人类冠状动脉患者特异性模型中的血流的方法，并预测冠状动脉病变在静止和生理挑战期间的血流动力学意义。该方法包括根据CCTA数据创建主动脉根部和冠状动脉的三维有限元模型，耦合主动脉入口的集总参数心脏模型和主动脉和冠状动脉出口边界的集总参数模型，并使用定制的计算流体动力学方法模拟脉动血流量和压力。我们相信，我们的软件与CCTA结合使用，将能够可靠地识别不具有血流动力学意义的病变，从而大大减少每年进行的诊断性心导管插导术的数量。这项SBIR资助的I期目的是进行一项试点临床相关性研究，以证明和评估我们的冠状动脉血流建模方法。

DESCRIPTION (provided by applicant): Cardiovascular Simulation, Inc has developed software, cvSim-3DTM, to augment coronary computed tomographic angiography (CCTA) with patient-specific blood flow data and provide a noninvasive alternative to diagnostic cardiac catheterization for assessing the hemodynamic significance of coronary artery lesions. We estimate that, even accounting for the costs of CCTA and cvSim-3DTM, this would save the U.S. health care system at least $6 billion annually and result in better care for patients. Of the patients who get diagnostic cardiac catheterization (the 2nd most common medical procedure) in the U.S. each year, approximately 50% of them do not have hemodynamically significant lesions. Recent clinical data from the DEFER and FAME studies indicate that patients without hemodynamically significant lesions should be treated with medical therapy, not angioplasty and stenting. CCTA has provided an unprecedented ability to noninvasively visualize the coronary arteries and identify patients with coronary artery disease, but is insufficient for determining whether patients with intermediate lesions would benefit from percutaneous coronary interventions (PCI). Fundamentally, CCTA provides exquisite information on coronary anatomy and morphology of disease, but lacks physiologic information on coronary blood flow. We have developed methods to quantify blood flow in patient-specific models of the human coronary arteries and predict the hemodynamic significance of coronary lesions at rest and during physiologic challenge. This approach involves creating a three-dimensional finite element model of the aortic root and coronary arteries from CCTA data, coupling a lumped parameter heart model at the aortic inlet and lumped parameter models at the aortic and coronary outlet boundaries and simulating pulsatile blood flow and pressure using custom computational fluid dynamics methods. We believe that our software, used in conjunction with CCTA, will be able to reliably identify the lesions that are not hemodynamically significant, and therefore dramatically reduce the number of diagnostic cardiac catheterizations that are performed each year. The purpose of Phase I of this SBIR grant is to conduct a pilot clinical correlation study to demonstrate and evaluate our methods for modeling coronary blood flow. PUBLIC HEALTH RELEVANCE: Cardiovascular Simulation, Inc's has developed software, cvSim-3DTM, to simulate coronary blood flow in patient-specific models created from coronary computed tomographic angiography (CCTA) data and predict hemodynamic significance of lesions. This software will be used to model coronary blood flow from CCTA data in 30 patients, and then will be evaluated by comparing predictions for each patient to pressure measurements made during diagnostic cardiac catheterization.