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.

项目概要 二尖瓣反流 (MR) 是一种流行且致命的疾病，其特征是二尖瓣关闭不全 瓣膜（MV）小叶正确接合，允许血液从左心室回流到左心室 中庭。 MR 的病因复杂多样，包括粘液性变性 瓣膜组织到心肌梗塞再到非缺血性心肌病。有几种类型的治疗 可用，但这些干预措施的效果仍然不理想且不可预测。其中之一 options 是相对较新的经导管边对边小叶修剪技术，称为 MitraClip 程序（或 TEER）。尽管该手术是安全的，但其在临床试验中的结果，特别是与 与其他手术和治疗方法相比，这些方法一直是高度矛盾的，这主要是由于 MR 的多因素性质。因此，很明显，治疗选择的预测方法 考虑到患者 MV 形状和变形的具体变化对于优化长期治疗是必要的。 术语患者的结果。我们的团队开发了一种基于图像的非侵入性体内 MV 方法 应变估计使我们能够直接根据临床数据量化 MV 形状和变形 成像数据。我们之前也已经证明该技术可用于识别 接受小环的缺血性 MR 患者修复效果的预测性术前因素 瓣环成形术。然而，我们实验室和其他人之前的工作主要集中在 MR 的有限子集上。 患者;为了制定全面的治疗选择指南，必须进行模拟 对各种 MR 病因中改变的 MV 生物力学状态有深入的了解。 此外，MitraClip 的高度非生理性焦点应力对即时效果的影响 MV 小叶的长期形状和变形仍然几乎完全未知。我们将 另外开发了 TEER 程序的完全预测性有限元模拟，以便 术前直接在患者 MV 设备的 3D 模型上测试各种 MitraClip 场景， 利用我们对 MV 功能状态的理解来预测每个患者 12 个月的结果 配置，并选择最佳选项。因此，在本研究中，我们的目标是（1）建立 整个 MR 频谱中 MV 的术前状态以及 (2) 阐明和预测后果 MitraClip 对 MV 传单几何形状、行为和重塑进行解释，并最终 以针对特定患者的定量方式预测这种治疗的结果。