In-Vivo Patient-Specific Optimization of Transcatheter-Edge-to-Edge Repair in Mitral Regurgitation

二尖瓣反流经导管边对边修复的体内患者特异性优化

• 批准号: 10751196
• 负责人: Natalie Simonian
• 金额: $ 3.92万
• 依托单位: UNIVERSITY OF TEXAS AT AUSTIN
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10751196
• 关键词: Adverse effects; Age; Behavior; Biological Markers; Biomechanics; Blinded; Blood; Calibration; Cardiomyopathies; Cardiovascular Diseases; Characteristics; Clinical; Clinical Trials; Clip; Complex; Computer Models; Contracts; Data; Data Set; Databases; Disease; Elements; Etiology; Extravasation; Geometry; Growth; Heart; Heterogeneity; Human; Image; Ischemia; Lead; Left atrial structure; Left ventricular structure; Link; Lung; Methods; Mitral Valve; Mitral Valve Insufficiency; Myocardial Infarction; Nature; Operative Surgical Procedures; Outcome; Patient imaging; Patient-Focused Outcomes; Patients; Population; Positioning Attribute; Postoperative Period; Procedures; Process; Prognostic Factor; Property; Race; Radial; Recurrence; Reporting; Selection for Treatments; Shapes; Stress; Techniques; Testing; Therapeutic; Three-Dimensional Echocardiography; Time; Tissues; Treatment Efficacy; Treatment outcome; Variant; Work; case-by-case basis; clinical imaging; cohort; computational pipelines; experience; imaging modality; improved; in silico; in vivo; insight; mechanical load; novel; outcome prediction; patient population; patient stratification; postoperative state; pre-doctoral; preoperative state; repair model; repaired; sex; simulation; success; three-dimensional modeling; treatment optimization; treatment strategy; trial comparing

PROJECT SUMMARY Mitral regurgitation (MR) is a prevalent and deadly disease characterized by the inability of the mitral valve (MV) leaflets to coapt properly, permitting backflow of blood from the left ventricle into the left atrium. The etiologies of MR are complex and diverse, ranging from myxomatous degeneration of the valvular tissue to myocardial infarction to non-ischemic cardiomyopathy. Several types of treatment are available, but the efficacy of these interventions remains suboptimal and unpredictable. One of these options is the relatively recent transcatheter edge-to-edge leaflet clipping technique called the MitraClip procedure (or TEER). Though the procedure is safe, its outcomes in clinical trials, particularly compared to other surgical and therapeutic treatments, have been highly contradictory, largely due to the multifactorial nature of MR. Therefore, it is clear that a predictive approach to treatment selection that accounts for patient specific variations in MV shape and deformation is necessary to optimize long- term patient outcomes. Our group has developed a noninvasive, image-based method for in vivo MV strain estimation which allows us to quantify MV shape and deformation directly from clinically available imaging data. We have also previously demonstrated that this technique can be used to identify predictive, presurgical factors of repair efficacy for ischemic MR patients undergoing undersized ring annuloplasty. However, previous work by our lab and others has focused on limited subsets of MR patients; in order to develop a comprehensive treatment selection guide, simulations must be grounded in a robust understanding of the altered MV biomechanical state in the full range of MR etiologies. Furthermore, the effects of the highly non-physiological focal stress of the MitraClip on the immediate and long-term shape and deformation of the MV leaflets remains almost completely unknown. We will additionally develop a fully predictive finite element simulation of the TEER procedure in order to preoperatively test various MitraClip scenarios directly on a 3D model of the patient's MV apparatus, use our understanding of the MV functional state to predict the 12-month outcomes of each configuration, and select the most optimal option. Therefore, in this study, we aim to (1) establish the pre-operative state of the MV across the MR spectrum and (2) elucidate and predict the consequences of the MitraClip on MV leaflet geometry, behavior, and remodeling in order to explain and ultimately predict the outcomes of this treatment in a patient-specific and quantitative manner.

项目摘要 二尖瓣反流（MR）是一种普遍的致命疾病，其特征是二尖瓣 瓣膜（MV）传单正确地co仪，允许血液从左心室的回流向左 中庭。 MR的病因是复杂而多样的，范围从 瓣膜组织到心肌梗死至非缺血性心肌病。几种类型的治疗是 可用，但是这些干预措施的功效仍然是最佳和不可预测的。其中之一 选项是相对较新的经导管边缘到边缘传单剪切技术，称为Mitraclip 程序（或TEER）。尽管该程序是安全的，但其在临床试验中的结果，尤其是比较 对于其他外科手术和治疗性治疗，这是高度矛盾的，主要是由于 MR的多因素性质。因此，很明显，一种预测的治疗方法 为了优化长期，需要计算患者特定于MV形状和变形的变化 术语患者的结果。我们的小组开发了一种基于图像的无创的方法，用于体内MV 应变估计，使我们可以直接从临床上量化MV形状和变形 成像数据。我们以前还证明，该技术可用于识别 缺血性MR患者的预测性修复疗效的预性因素 环形成形术。但是，我们的实验室和其他人的先前工作重点是MR的有限亚集 患者;为了制定全面的治疗选择指南，必须将模拟接地 在整个MR病因范围内，对MV生物力学状态改变的强烈理解。 此外，mitraclip高度非生理局灶性应力对立即的影响 MV小叶的长期形状和变形几乎完全未知。我们将 另外，为TEER程序开发了完全预测的有限元模拟，以便 术前直接在患者MV设备的3D模型上测试各种Mitraclip方案， 利用我们对MV功能状态的理解来预测每个功能的12个月结果 配置，然后选择最佳选项。因此，在这项研究中，我们的目标是（1）建立 MV跨MR光谱的术前状态，（2）阐明并预测后果 MV传单几何形状，行为和重塑的MITraclip，以解释并最终 以患者特异性和定量方式预测这种治疗的结果。