Magnetic Resonance Imaging Guided Robotic Catheter System for Left Atrial Appendage Occlusion Procedures

用于左心耳封堵手术的磁共振成像引导机器人导管系统

• 批准号: 10666474
• 负责人: Hiram Bezerra
• 金额: $ 84.61万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-15 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10666474
• 关键词: 3-Dimensional; Age; Algorithms; Anatomy; Animals; Anticoagulation; Area; Arrhythmia; Atrial Fibrillation; Blood coagulation; Cardiac; Cardiology; Catheters; Cessation of life; Chronic; Clinical; Clinical Research; Data; Data Collection; Detection; Development; Devices; Exposure to; Fluoroscopy; Goals; Hemorrhage; Hospitalization; Human; Human Resources; Image; Implant; Implantation procedure; Intervention; Intracranial Hemorrhages; Ionizing radiation; Left; Life Expectancy; Location; Magnetic Resonance Imaging; Mechanics; Medical Imaging; Methods; Operative Surgical Procedures; Oral; Patients; Performance; Pharmaceutical Preparations; Physicians; Positioning Attribute; Prevalence; Prevention therapy; Probability; Procedures; Puncture procedure; Research; Research Personnel; Resolution; Risk; Risk Factors; Risk Reduction; Robotics; Safety; Schedule; Scheme; Speed; Stroke; Stroke prevention; Study Subject; System; Technology; Thrombus; Time; Transesophageal Echocardiography; Transfusion; Ultrasonography; United States; User-Computer Interface; Validation; Vertebrates; Visualization; Work; anatomic imaging; auricular appendage; cardiac magnetic resonance imaging; comparative efficacy; cost; cost effective; design and construction; efficacy study; experience; experimental study; flexibility; heart imaging; human subject; image guided; improved; in vivo; magnetic field; minimally invasive; new technology; novel; novel strategies; patient population; pre-clinical; prevent; prototype; reconstruction; research study; robot control; screening; seal; soft tissue; stroke risk; success; technology development; therapy development; three-dimensional visualization

Abstract Atrial fibrillation is the most common form of cardiac arrhythmia, with prevalence estimated to be 5.2 million in 2010 and predicted to increase to 12.1 million in 2030. Atrial fibrillation is a major risk factor for blood clots and stroke, independently increasing stroke risk 4- to 5-fold throughout all ages. Therefore, the vast majority of patients with atrial fibrillation require some form of stroke prevention therapy. Current first line stroke prevention therapy for atrial fibrillation patients is life-long use of oral anti-coagulation medications, which are associated with increase in bleeding risk by approximately 2- to 2.5-fold, including intracranial hemorrhage, that may lead to hospitalization, transfusion, surgery, and death. The purpose of the present study is to improve stroke prevention treatment for non-valvular atrial fibrillation by transforming the Left Atrial Appendage Occlusion (LAAO) procedure into a first line therapy for a larger segment of patient populations, especially for younger patients with 20+ year of life expectancy who are likely to experience bleeding problems in their lifetimes. LAAO is a minimally invasive procedure where an implant delivered using an intravascular catheter is used to permanently seal off the left atrial appendage mechanically to reduce the risk of blood clots. The barriers preventing LAAO from becoming a first line therapy are primarily safety and cost. The investigators aim to overcome these barriers and transform LAAO into a first line therapy by developing a real-time Magnetic Resonance Imaging (MRI)-guided robotic intravascular catheter system for performing LAAO procedures by synergistically combining novel medical imaging, robotic catheter control, and advanced visualization technologies to improve the safety, cost, and workflow of LAAO procedures. The proposed technology expands on novel approaches initiated by the investigators in earlier work in the areas of real-time MRI image acquisition and reconstruction, robotic catheters actuated using the magnetic field of the MRI scanner, advanced visualization, and volumetric planning of LAAO. The project is organized into three Specific Aims, each focusing on one key aspect of the procedure workflow, namely, procedure planning, transseptal puncture, and LAAO implant delivery. These Specific Aims build on crosscutting technical research on MRI, robotics, and human-machine interface technologies, where the investigators will develop novel technologies for rapid and flexible 2D/3D cardiac MRI imaging, robotically controlled MRI-compatible dexterous cardiac catheters, and human-machine interfaces with advanced visualization. The end result of this proposal will be the complete prototype of an MRI-guided robotic catheter system for performing LAAO procedures combining real-time intraoperative MRI, robotic catheter control, and advanced visualization technologies to facilitate safer, more efficient, and cost-effective LAAO procedures. The developed system and the underlying technologies will be validated by experts in interventional cardiology in vertebrate animal and non-clinical human studies.

摘要 心房颤动是最常见的心律失常形式， 预计到2030年将增加到1210万。房颤是血栓形成的主要危险因素， 中风，独立增加中风风险4至5倍，在所有年龄段。因此，绝大多数 患有心房纤维性颤动的患者需要某种形式的中风预防治疗。当前一线中风预防 房颤患者的治疗是终身使用口服抗凝药物， 出血风险增加约2- 2.5倍，包括颅内出血，可能导致 住院输血手术和死亡 本研究的目的是通过以下措施改善非瓣膜性房颤的中风预防治疗 将左心房封堵术（LAAO）转变为较大节段的一线治疗 患者人群，尤其是预期寿命超过20年的年轻患者， 在他们的一生中经历出血问题。LAAO是一种微创手术， 使用血管内导管输送的药物用于机械地永久密封左心房附件 以减少血栓的风险。阻止LAAO成为一线治疗的障碍主要是 安全和成本。研究者的目标是克服这些障碍，将LAAO转化为一线治疗 通过开发实时磁共振成像（MRI）引导的机器人血管内导管系统， 通过协同组合新型医学成像、机器人导管控制和 先进的可视化技术，以改善LAAO手术的安全性、成本和工作流程。 所提出的技术扩展了研究人员在该领域早期工作中提出的新方法 实时MRI图像采集和重建，机器人导管使用磁场驱动， MRI扫描仪、高级可视化和LAAO体积规划。该项目分为三个部分 具体目标，每个目标都侧重于手术工作流程的一个关键方面，即手术规划， 经中隔穿刺和LAAO植入物输送。这些具体目标建立在跨领域技术研究的基础上 在MRI，机器人和人机界面技术，研究人员将开发新的 快速灵活的2D/3D心脏MRI成像技术，机器人控制的MRI兼容灵巧 心脏导管和具有高级可视化的人机界面。 该提案的最终结果将是MRI引导机器人导管系统的完整原型， 进行LAAO手术，结合实时术中MRI、机器人导管控制和先进的 可视化技术，以促进更安全、更高效和更具成本效益的LAAO手术。发达 系统和基础技术将由脊椎动物介入心脏病学专家进行验证 动物和非临床人体研究。