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

摘要 房颤是最常见的心律失常形式，估计#年患病率为520万。 2010年，预计到2030年将增加到1210万。心房颤动是血栓形成的主要危险因素 中风，在所有年龄段中，中风风险独立增加4-5倍。因此，绝大多数 房颤患者需要某种形式的中风预防治疗。当前的一线卒中预防 对房颤患者的治疗是终生使用口服抗凝药物，这些药物与 由于出血风险增加了大约2到2.5倍，包括颅内出血，这可能导致 到住院、输血、手术和死亡。 本研究的目的是改善非瓣膜性心房颤动的卒中预防治疗。 将左心耳闭塞(LAAO)手术转变为较大节段的一线治疗 患者群体，特别是预期寿命20年以上的年轻患者，他们可能 在他们的一生中经历出血问题。LAAO是一种微创手术，植入物 使用血管内导管输送，用于机械地永久封闭左心耳 以降低血栓的风险。阻碍LAAO成为一线疗法的障碍主要是 安全和成本。研究人员的目标是克服这些障碍，将LAAO转变为一线疗法 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 通过协同结合新的医学成像、机器人导管控制和 先进的可视化技术，可提高LAAO程序的安全性、成本和工作流程。 拟议的技术扩展了调查人员在该领域早期工作中提出的新方法 在实时MRI图像采集和重建方面，机器人导管使用 核磁共振扫描仪，先进的可视化和LAAO的体积规划。这个项目被组织成三个部分 具体目标，每个目标都侧重于程序工作流程的一个关键方面，即程序规划； 经鼻中隔穿刺术和LAAO植入物植入术。这些具体目标建立在横切技术研究的基础上 在核磁共振、机器人和人机界面技术方面，研究人员将在这些领域开发新的 快速灵活的2D/3D心脏MRI成像技术，与机器人控制的MRI兼容的Dexterous 心导管，以及具有高级可视化的人机界面。 这项提议的最终结果将是MRI引导的机器人导管系统的完整原型 实施LAAO手术，结合术中实时核磁共振、机器人导管控制和高级 可视化技术，以促进更安全、更高效和更具成本效益的LAAO程序。已开发的 系统和基础技术将得到脊椎动物介入心脏病学专家的验证 动物和非临床人体研究。

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.