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Ultrasound Guided Mitral Valve Ablation

超声引导二尖瓣消融术

基本信息

批准号：
9100913
负责人：
WILLIAM D MERRYMAN
金额：
$ 38.09万
依托单位：
VANDERBILT UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-07-01 至 2016-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9100913
关键词：
Ablation Age Aged, 80 and over American Animal Model Biomechanics Canis familiaris Cardiac Cardiovascular Diseases Catheters Cessation of life Chest Clinic Clinical Clinical effectiveness Comorbidity Development Devices Disease Doctor of Philosophy Elements Excision Family suidae Geometry Goals Gold Health Heart Valve Diseases Image Lead Legal patent Lesion Life Light Mitral Valve Mitral Valve Insufficiency Mitral Valve Prolapse Modeling Operative Surgical Procedures Patients Population Positioning Attribute Procedures Property Radiofrequency Interstitial Ablation Research Source Techniques Testing Thoracic Surgical Procedures Time Tissues Ultrasonography Validation clinical efficacy hemodynamics high risk image guided in vivo interest novel older patient radiofrequency repaired translational approach treatment strategy valve replacement

项目摘要

DESCRIPTION (provided by applicant): Heart valve disease is the 3rd most prevalent source of cardiovascular disease, leading to ~20,000 deaths per year in the U.S. alone. Moreover, there are an estimated 95,000 valve procedures performed each year in the U.S. and 43% of these are mitral valve (MV) procedures. These numbers will increase substantially in the coming years as our population continues to live longer. Over the next 50 years, the population of Americans age 65+ will more than double - from 34 to 79 million. In fact, the oldest of the old (85+) are currently the fastest growing segment of the population and will more than quadruple by 2050. These numbers are alarming in light of what is known of heart valve disease, particularly in the MV. Today, the 'gold standard' for long-term treatment for MV prolapse, leading to mitral regurgitation (MR), is open-chest repair or replacement surgery, which is highly undesirable for elderly patients. There is a strong clinical need for percutaneous treatment for patients with MMVD as an alternative to open-chest surgery. The goal of this proposal is to develop an imaging strategy for an integrated catheter to reduce the size of enlarged, myxomatous MV leaflets, providing a percutaneous alternative to open-chest surgical leaflet resection. The novelty of this integrated catheter is that it simultaneously uses cryo-anchoring to adhere to a moving MV leaflet, while ablating with radiofrequency (RF) energy to alter the size and intrinsic biomechanical properties of the leaflet tissue. The primary advancements of this proposal will be to successfully guide the catheter and quantify real-time changes of MV geometry and hemodynamics with ultrasound imaging in vivo. First, we will develop the imaging strategy to quantify changes to MV leaflet geometry and hemodynamic function in a swine model (Aim 1). Then, we will demonstrate this strategy's ability to treat myxomatous MV leaflets that lead to MR in a canine model (Aim 2). The endpoint of this research will be demonstration of image-guided delivery of RF energy and validation of reduced MR for the percutaneous treatment of myxomatous MV leaflets. Further, successful completion of each aim will position this strategy for translation into the clinic.

描述（由申请人提供）：心脏瓣膜疾病是心血管疾病的第三大常见来源，仅在美国每年就导致约 20,000 人死亡。此外，美国每年估计进行 95,000 例瓣膜手术，其中 43% 是二尖瓣 (MV) 手术。随着我们人口的寿命继续延长，这些数字在未来几年将大幅增加。未来 50 年，美国 65 岁以上人口将增加一倍以上——从 34 万人增至 7900 万人。事实上，老年人中最年长的人（85 岁以上）目前是人口增长最快的部分，到 2050 年将增加四倍多。鉴于心脏瓣膜疾病（尤其是二尖瓣疾病）的已知情况，这些数字令人震惊。如今，导致二尖瓣反流 (MR) 的二尖瓣脱垂长期治疗的“黄金标准”是开胸修复或置换手术，这对于老年患者来说是非常不受欢迎的。对于MMVD 患者来说，作为开胸手术的替代方案，经皮治疗有着强烈的临床需求。该提案的目标是开发一种集成导管的成像策略，以减小扩大的粘液性 MV 瓣叶的尺寸，为开胸手术瓣叶切除术提供经皮替代方案。这种集成导管的新颖之处在于它同时使用冷冻锚定粘附在移动的 MV 小叶上，同时用射频 (RF) 能量消融以改变小叶组织的大小和内在生物力学特性。该提案的主要进展是成功引导导管并通过体内超声成像量化 MV 几何形状和血流动力学的实时变化。首先，我们将开发成像策略来量化猪模型中 MV 瓣叶几何形状和血流动力学功能的变化（目标 1）。然后，我们将展示该策略在犬模型中治疗导致 MR 的粘液瘤 MV 传叶的能力（目标 2）。这项研究的终点将是演示图像引导的射频能量传递，并验证减少 MR 用于粘液瘤 MV 瓣叶的经皮治疗。此外，成功完成每个目标将使该策略转化为临床。