Resistance to Aortic Endograft Migration: Comparative Effectiveness of FDA Approv

主动脉内移植物迁移阻力： FDA 批准的比较有效性

基本信息

批准号：
7938651
负责人：
CHRISTOPHER K ZARINS
金额：
$ 50万
依托单位：
STANFORD UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-09-30 至 2012-02-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7938651
关键词：
Abdomen Abdominal Aortic Aneurysm Address Advocate Affect Age American Aneurysm Area Biomechanics Biomedical Engineering Blood Vessels Blood flow Caliber Cause of Death Cessation of life Clinical Complex Computer Simulation Data Development Device Designs Devices Disease Distal Effectiveness Engineering Ensure Environment Evaluation FDA approved Failure Flare Friction Generations Goals Image Immigration Implant Length Limb structure Liquid substance Longitudinal Studies Mechanics Medical Medical Device Designs Methods Morbidity - disease rate Patients Performance Perioperative Population Positioning Attribute Postoperative Period Prevalence Procedures Property Relative (related person)Research Research Personnel Resistance Solid Talents Techniques Testing Thoracic Aortic Aneurysm Three-Dimensional Imaging Time Work X-Ray Computed Tomography base clinical application comparative effectiveness compare effectiveness computer framework computer studies computerized tools cooking design effective therapy effectiveness research experience follow-up hemodynamics imaging Segmentation improved in vivo mechanical behavior medical implant migration mortality pressure public health relevance radiologist repaired response sample fixation simulation tool

项目摘要

DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (05) Comparative Effectiveness Research (CER) and specific Challenge Topic 05-EB-105: Comparative Effectiveness of Medical Implants. The prevalence of abdominal aortic aneurysms (AAA) has increased significantly in the American population, affecting 5-7% of Americans over age 60. During the past decade endovascular aneurysm repair has become the primary treatment for aneurysm disease. Currently, there are 5 FDA approved abdominal aortic aneurysm endografts: Medtronic AneuRx, Gore Excluder, Cook Zenith, Endologix Powerlink, and Medtronic Talent. Each of these devices presents different designs and fixation mechanisms. Endovascular repair is a minimally invasively procedure that reduces perioperative morbidity and mortality when compared to open repairs. However, endovascular procedures are prone to late failure due to the loss of long-term positional stability (i.e., migration) of the endograft as a result of the pulsatile forces of blood flow. Endograft failure results in costly secondary procedures, conversion to open repair, long-term surveillance, and death. Understanding the biomechanical environment experienced by endografts in vivo is a critical factor to ensure correct functioning and long term durability of the device. The goal of this work is two-fold: First, we will develop and apply a set of tools to characterize the mechanical behavior of endografts in vivo with the overall goal of determining the likelihood of migration of the endograft. Second, we will perform a comparative effectiveness study with regards to migration of the 5 AAA endografts. We will use 3D segmentation techniques to generate patient- specific computer models of AAAs with implanted endografts. Then, we will perform Computational Fluid Dynamics (CFD) analyses to evaluate the hemodynamic forces acting on the device. The CFD analysis will rely on sophisticated methods for boundary condition specification to obtain realistic distributions of flow and pressure in the computer model of the endograft. We will then perform a Computational Solid Mechanics (CSM) analysis to evaluate the fixation forces developed by the endograft in the attachment zones with the vessel wall. Longitudinal studies of serial follow-up imaging of patients treated with each endograft will provide the necessary statistical data to obtain a likelihood of migration for the computational studies. The research team we have assembled consists of leading bioengineers, mechanical engineers, radiologists, and clinicians and will be led by Dr Christopher K. Zarins at Stanford, a leading researcher in the development and clinical application of endovascular treatments for AAA disease. Dr. Zarins has been a strong advocate for using imaging and simulation tools to improve medical device design and develop safer and more effective medical products. This research will be the first attempt to characterize the problem of migration of AAA endografts using a combination of best-in-class imaging, CFD and Computational Solid Mechanics tools. Furthermore, this work will provide the first comparative effectiveness study of the 5 current FDA approved AAA endografts. Resistance to aortic endograft migration: comparative effectiveness of FDA approved devices. Public Health Relevance: Endovascular repair has become the primary treatment for abdominal aortic aneurysm (AAA) disease. There are currently 5 FDA approved endograft devices for AAA repair. The true in-vivo biomechanical environment experienced by these devices is poorly understood. Furthermore, there are currently no studies that compare the performance of the different devices with regards to their long term positional stability (migration).

描述（由申请人提供）：该应用程序解决了广泛的挑战领域 (05) 比较有效性研究 (CER) 和特定挑战主题 05-EB-105：医疗植入物的比较有效性。腹主动脉瘤 (AAA) 的患病率在美国人口中显着增加，影响 60 岁以上美国人的 5-7%。在过去十年中，血管内动脉瘤修复术已成为动脉瘤疾病的主要治疗方法。目前，FDA 批准的腹主动脉瘤内移植物有 5 种：Medtronic AneuRx、Gore Excluder、Cook Zenith、Endologix Powerlink 和 Medtronic Talent。这些设备中的每一种都具有不同的设计和固定机制。血管内修复是一种微创手术，与开放修复相比，可降低围手术期发病率和死亡率。然而，由于血流脉动力导致内移植物失去长期位置稳定性（即迁移），血管内手术很容易出现晚期失败。内移植物失败会导致昂贵的二次手术、转为开放式修复、长期监测和死亡。了解内移植物在体内经历的生物力学环境是确保设备正确运行和长期耐用性的关键因素。这项工作的目标有两个：首先，我们将开发并应用一套工具来表征内移植物体内的机械行为，总体目标是确定内移植物迁移的可能性。其次，我们将对 5 个 AAA 内移植物的迁移进行比较有效性研究。我们将使用 3D 分割技术来生成植入内移植物的 AAA 患者特定计算机模型。然后，我们将进行计算流体动力学 (CFD) 分析，以评估作用在设备上的血流动力。 CFD 分析将依靠复杂的边界条件规范方法来获得内移植物计算机模型中流量和压力的真实分布。然后，我们将进行计算固体力学 (CSM) 分析，以评估内移植物在与血管壁的附着区域产生的固定力。对每个内移植物治疗的患者进行连续随访成像的纵向研究将为计算研究提供必要的统计数据，以获得迁移的可能性。我们组建的研究团队由领先的生物工程师、机械工程师、放射科医生和临床医生组成，由斯坦福大学的 Christopher K. Zarins 博士领导，他是 AAA 疾病血管内治疗开发和临床应用的领先研究员。 Zarins 博士一直大力倡导使用成像和模拟工具来改进医疗设备设计并开发更安全、更有效的医疗产品。这项研究将是首次尝试结合一流的成像、CFD 和计算固体力学工具来表征 AAA 内移植物的迁移问题。此外，这项工作还将首次对目前 FDA 批准的 5 种 AAA 内移植物进行有效性比较研究。主动脉内移植物迁移阻力：FDA 批准的装置的比较有效性。公共卫生相关性：血管内修复已成为腹主动脉瘤（AAA）疾病的主要治疗方法。目前有 5 个 FDA 批准的用于 AAA 修复的内移植装置。人们对这些设备所经历的真实体内生物力学环境知之甚少。此外，目前还没有研究比较不同设备的长期位置稳定性（迁移）性能。