Biomechanical Optimization of Mitral Valve Repair Operations and Annuloplasty Rings for Primary Mitral Valve Regurgitation

原发性二尖瓣反流二尖瓣修复手术和瓣环成形术环的生物力学优化

• 批准号: 10597517
• 负责人: Yuanjia Zhu
• 金额: $ 7.39万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10597517
• 关键词: 3D Print; Adopted; Advocate; Anatomy; Animal Model; Animals; Appearance; Arrhythmia; Biomechanics; Cardiac Surgery procedures; Chronic; Clinical; Complex; Custom; Data; Development; Echocardiography; Engineering; Excision; Failure; Fatigue; Geometry; Goals; Guidelines; Heart; Heart Valve Diseases; Heart failure; Human; Imaging Device; Imaging technology; Individual; Intervention; Lead; Left; Lesion; Mitral Valve; Mitral Valve Insufficiency; Mitral Valve Prolapse; Modeling; Morbidity - disease rate; Motion; Operating Rooms; Operative Surgical Procedures; Outcome; Pathologic Processes; Patient Care; Pattern; Phenotype; Ptosis; Pulmonary Hypertension; Series; Solid; Surgeon; Techniques; Test Result; Testing; Translating; United States; Validation; Ventricular; Visual; base; biomechanical engineering; cardiac magnetic resonance imaging; clinical application; clinically relevant; design; experimental study; flexibility; heart function; heart imaging; hemodynamics; improved; in vivo; innovation; mortality; novel; operation; pre-clinical; preference; preservation; prototype; reconstruction; repair strategy; repaired; sensor; sheep model; standard of care

PROJECT SUMMARY Mitral valve regurgitation is one of the most prevalent valvular heart diseases worldwide and is a significant cause of global morbidity and mortality. Although mitral repair operations were first described several decades ago, numerous new repair techniques have been developed in recent years. However, these techniques were described primarily based on anatomic principles and guided by valvular appearance and function, mostly via visual assessment and echocardiography. The biomechanical engineering principles and fundamentals underlying various mitral valve repair techniques have rarely been investigated, and repair strategy remains largely based on surgeon’s preference. With evolving guidelines advocating earlier, more aggressive intervention with mitral valve repair whenever possible, especially for regurgitant lesions, the goal of this proposal is to establish a solid understanding of mitral valve repair biomechanics for primary mitral regurgitation. This is essential for optimizing these complex mitral valve repair operations to enhance valve repairability, expand valve repair technique adoptability, and improve repair durability. Aim 1 will characterize and optimize our novel 3D- printed mitral annuloplasty ring prototype with selective flexibility. Using healthy human cardiac MRI marker tracking and fatigue testing results, the annuloplasty ring design will be perfected to facilitate the native mitral annular motion and enhance durability. Next, primary mitral regurgitation models with leaflet prolapse and annular dilation will be created and assessed. Current clinically employed repair operations, namely triangular resection, neochordal reconstruction, and ring annuloplasty using our novel design and other annuloplasty rings with varying flexibility, will be tested on these primary mitral regurgitation models. Innovative biomechanical sensors and advanced cardiac imaging technologies will facilitate the detailed analysis of the engineering principles underlying these operations and annuloplasty ring designs. Aim 2 will validate findings from the ex vivo experiments in pre-clinical ovine models. The effect of annuloplasty rings’ flexibility on natural mitral annular motion and left ventricular vortex flow pattern after ring annuloplasty will be investigated in healthy ovine models without mitral regurgitation. The mitral valve repair operations will be evaluated on the ovine models with chronic primary mitral regurgitation generated by posterior leaflet chordal transection. The results will be compared to the ex vivo studies. The experiments proposed herein have great clinical applicability. Findings from this study can help surgeons gain substantial understanding of mitral valve repair biomechanics thereby translating directly to patient care in the operating room.

项目摘要 二尖瓣反流是全球最普遍的瓣膜心脏病之一，是一个重要的 全球发病率和死亡率的原因。尽管首先描述了二尖瓣维修操作几十年 以前，近年来已经开发了许多新的维修技术。但是，这些技术是 主要基于解剖学原理，并以瓣膜外观和功能为指导，主要是通过 视觉评估和超声心动图。生物力学工程原理和基本面 几乎没有研究过各种二尖瓣维修技术，并且维修策略仍然存在 主要基于外科医生的偏爱。随着不断发展的指南提倡，更具侵略性的干预措施 尽可能进行二尖瓣维修，尤其是对于反流病变，该提案的目标是 对二尖瓣修复生物力学建立可靠的理解，用于原发性二尖瓣反流。这是 优化这些复杂的二尖瓣维修操作以增强阀门维修性，扩展阀门至关重要 维修技术可采用，并提高维修耐用性。 AIM 1将表征和优化我们的小说3D- 具有选择性柔韧性的印刷二尖瓣环形成形术环原型。使用健康的人类心脏MRI标记 跟踪和疲劳测试结果，环形成形术环设计将非常适合促进本地二尖瓣 环形运动并提高耐用性。接下来，带有传单脱垂和 将创建和评估环形字典。当前的临床雇用维修操作，即三角形 使用我们的新型设计和其他环形成形术环，切除，新纹理重建和环形整形术 具有不同的灵活性，将在这些主要二尖瓣反流模型上进行测试。创新的生物力学 传感器和高级心脏成像技术将促进工程的详细分析 这些操作和环形成形术环设计的原则。 AIM 2将验证EX的发现 临床前卵巢模型中的体内实验。环形成形术环的灵活性对天然二尖瓣环形的影响 在健康的卵巢模型中，将研究环形环形成形术后运动和左心室涡流流量模式 没有二尖瓣反流。二尖瓣维修操作将在具有慢性的卵巢模型上进行评估 由后叶弦翻译产生的原发性二尖瓣反流。结果将与 离体研究。本文提出的实验具有良好的临床适用性。这项研究的结果 可以帮助外科医生对二尖瓣修复生物力学有实质性的了解，从而直接翻译 在手术室的患者护理。