Cardioscopically-guided Valve Repair in the Beating Heart

心镜引导下跳动心脏瓣膜修复

• 批准号: 10211326
• 负责人: Pierre E Dupont
• 金额: $ 76.06万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-22 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10211326
• 关键词: Address; Adoption; Affect; Algorithm Design; Animal Experiments; Articular Range of Motion; Blood; Blood Vessels; Cardiopulmonary Bypass; Cardioscopes; Catheters; Clinical; Complex; Data; Device Designs; Devices; Disease; Effectiveness; Excision; Femoral vein; Funding; Goals; Gold; Health; Heart; Heart Valve Diseases; Heart Ventricle; Heart failure; Hospitalization; Hour; Image; Imaging technology; Intervention; Intuition; Joystick; Left ventricular structure; Length; Length of Stay; Manuals; Medical; Mitral Valve; Mitral Valve Insufficiency; Morphologic artifacts; Motion; Operative Surgical Procedures; Optics; Outcome; Patient Care; Patient risk; Patients; Population; Procedures; Process; Recurrence; Residual state; Risk; Robotics; Shapes; Standardization; System; Techniques; Technology; Time; Tissues; Tricuspid valve structure; Ultrasonography; Visualization; alternative treatment; aortic valve; base; design; dexterity; experimental study; follow-up; imaging system; implantation; improved; in vivo; in vivo evaluation; meetings; mortality; mortality risk; operation; optical imaging; papillary muscle; reconstruction; repaired

Project Summary Valvular heart disease is an important health problem afflicting over 2.5% of the US population and, while surgical repair of native tissue remains the gold standard, the reduced risk of catheter-based interventions has provided the capability to intervene earlier in the disease process as well as in the sickest patients while avoiding the risks of cardiopulmonary bypass. The outcomes of transcatheter procedures are not, however, consistently superior to alternative treatments. For example, those patients receiving transcatheter edge-to- edge repair of mitral regurgitation benefit from a significantly shorter hospital stay but require follow-up surgery for recurrent mitral regurgitation substantially more often than those undergoing initial surgical repair. As a second example, when transcatheter tricuspid valve repair devices are successfully deployed, they substantially reduce the risk of death compared to medical therapy, but device implantation is successful less than 3/4 of the time. Optimal patient care should combine the benefits of beating-heart interventions with the effectiveness and patient-specific tailoring of surgical repair. We hypothesize that the fundamental limitation is that catheter-based delivery greatly reduces the interventionalist's capability to visualize and to intuitively control device delivery. To address these issues, in the prior funding period, we created the first cardioscopic imaging systems for performing valve repair inside the blood-filled beating heart. We demonstrated that cardioscopy can improve local visualization to such a degree that certain procedures can be accomplished in minutes rather than hours. We also created a joystick-controlled robotic catheter that provided an intuitive control interface and a standardized platform for performing valve repairs. These results were achieved using transapical access to the left ventricle of the heart. For broad adoption, we need to further develop this technology to enable its percutaneous delivery via the femoral vein. Percutaneous delivery presents significant new challenges since the cardioscopes must be compact during vascular navigation and then enlarge for valvular imaging. Furthermore, to enable broad adoption of transcatheter valve repairs and to make those repairs as effective as surgical repairs, the robotic catheter should not just make a single repair technique easy to perform, but instead should allow a clinician to easily perform a sequence of complementary repairs as is now done in surgery. In Aim 1, we will overcome the challenges of percutaneous cardioscope delivery by creating balloon-based cardioscope designs and demonstrating this technology for the specific repair of mitral chordae implantation through ex vivo and in vivo testing. In Aim 2, we will design a modular robotic catheter platform to create the capability for a single delivery system to be used to perform two important complementary mitral valve repairs, chordae implantation and annuloplasty, through a standardized joystick-based interface. We will evaluate this system using ex vivo and in vivo experiments.

项目摘要 瓣膜心脏病是一个重要的健康问题，遭受了美国人口2.5％以上的折磨，而 天然组织的手术修复仍然是黄金标准，是基于导管的干预措施的风险降低 已经提供了在疾病过程和最病患者中进行较早干预的能力 避免心肺旁路的风险。但是，经导管程序的结果不是 始终优于替代治疗。例如，那些接受经导管边缘至边缘的患者 二尖瓣反流的边缘维修受益于医院较短的住院，但需要随访手术 对于二尖瓣重复反流的频率要比进行初始手术修复的二尖瓣反流。作为 第二个示例，当经过经导管三尖瓣维修设备成功部署时 与医疗疗法相比，大大降低了死亡的风险，但设备植入成功率较低 超过3/4的时间。最佳患者护理应结合殴打心脏干预的好处 手术修复的有效性和特定于患者的剪裁。我们假设基本限制 是基于导管的交付大大降低了干预主义者的可视化和直观的能力 控制设备交付。为了解决这些问题，在以前的资金期间，我们创建了第一个心脏镜检查 用于在充满血液的心脏内部进行瓣膜修复的成像系统。我们证明了这一点 心脏镜检查可以改善本地可视化，以至于可以在某些过程中完成某些过程 分钟而不是数小时。我们还创建了一个操纵杆控制的机器人导管，该导管提供了直观的 控制界面和用于执行阀维修的标准化平台。这些结果是使用 转移到心脏的左心室。为了广泛采用，我们需要进一步发展 通过股骨静脉递送经皮的技术。经皮递送礼物 重大的新挑战，因为在血管导航期间必须紧凑，然后 扩大瓣膜成像。此外，为了广泛采用经导管阀维修和 使这些维修与手术维修一样有效，机器人导管不应仅进行一次维修 易于执行的技术，但应允许临床医生轻松执行一系列补充 现在的维修工作。在AIM 1中，我们将克服经皮心镜的挑战 通过创建基于气球的心镜设计并为特定的特定进行交付 通过体内和体内测试修复二尖瓣静脉植入。在AIM 2中，我们将设计一个模块化 机器人导管平台可创建用于执行两个传递系统的功能 通过标准化 基于操纵杆的界面。我们将使用离体和体内实验评估该系统。