cvSim+CCTA to noninvasively assess hemodynamic significance of coronary lesions

描述（由申请人提供）：Cardiovascular Simulation，Inc开发了软件cvSim-3DTM，用于使用患者特定血流数据增强冠状动脉计算机断层扫描血管造影术（CCTA），并为诊断性心导管插入术提供无创替代方法，以评估冠状动脉病变的血流动力学意义。我们估计，即使考虑到CCTA和cvSim-3DTM的成本，这也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（第二常见的医疗程序）的患者中，约50%的患者没有血流动力学显著病变。DEFER和FAME研究的最新临床数据表明，没有血流动力学显著病变的患者应接受药物治疗，而不是血管成形术和支架植入术。CCTA提供了一种前所未有的无创性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会从经皮冠状动脉介入治疗（PCI）中受益。从根本上说，CCTA提供了关于冠状动脉解剖和疾病形态的精细信息，但缺乏关于冠状动脉血流的生理信息。我们已经开发出方法来量化人体冠状动脉的患者特定模型中的血流，并预测静息和生理挑战期间冠状动脉病变的血流动力学意义。该方法涉及从CCTA数据创建主动脉根和冠状动脉的三维有限元模型，在主动脉入口处耦合集总参数心脏模型，在主动脉和冠状动脉出口边界处耦合集总参数模型，并使用自定义计算流体动力学方法模拟脉动血流和压力。我们相信，我们的软件与CCTA结合使用，将能够可靠地识别血流动力学不显著的病变，从而大大减少每年进行的诊断性心脏导管插入术的数量。该SBIR资助的第一阶段的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。 公共卫生相关性：Cardiovascular Simulation，Inc开发了cvSim-3DTM软件，用于在根据冠状动脉计算机断层扫描血管造影（CCTA）数据创建的患者特定模型中模拟冠状动脉血流，并预测病变的血流动力学意义。该软件将用于根据30例患者的CCTA数据对冠状动脉血流进行建模，然后通过将每例患者的预测值与诊断性心脏导管插入术期间进行的压力测量值进行比较来进行评价。

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.