Endovascular Cardiac Optical Mapping

血管内心脏光学测绘

• 批准号: 8524784
• 负责人: Christian S Eversull
• 金额: $ 20.15万
• 依托单位: AUST DEVELOPMENT, LLC
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-02 至 2014-09-01
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8524784
• 关键词: Ablation; Address; Adverse effects; Affect; Anatomy; Animal Model; Animals; Arrhythmia; Atrial Fibrillation; Basic Science; Blood; Cardiac; Cardiac ablation; Cardiology; Catheters; Cessation of life; Cicatrix; Clinical; Complex; Computer software; Data; Development; Devices; Disease; Dyes; Edema; Effectiveness; Electrophysiology (science); Failure; Fluorescence; Fluorescent Dyes; Goals; Health Services Accessibility; Heart; Heart Atrium; Hospitalization; Image; Imagery; Imaging technology; Improve Access; Lead; Life; Light; Magnetic Resonance Imaging; Maps; Modality; Modification; Movement; Navigation System; Normal tissue morphology; Optics; Outcome; Patients; Phase; Physicians; Procedures; Pulmonary veins; Reaction Time; Recurrence; Research; Resolution; Resources; Safety; Signal Transduction; Source; Surrogate Endpoint; System; Techniques; Technology; Therapeutic; Time; Tissues; Toxic effect; Treatment outcome; Ventricular Tachycardia; Work; base; cost; design; experience; flexibility; fluorescence imaging; heart rhythm; improved; in vivo; meetings; new technology; novel; public health relevance; ratiometric; spatiotemporal; success; tool; voltage; way finding

DESCRIPTION (provided by applicant): Cardiac arrhythmias affect more than 5 million people nationwide, resulting in more than 1.2 million hospitalizations and 400,000 deaths yearly. The development of cardiac ablation has significantly improved treatment outcomes. Ablation traditionally has relied on electroanatomic mapping which can be tedious and often requires the use of complex navigation systems. Even so, the spatiotemporal resolution of current mapping modalities remains low. These limitations cause ablation to be a highly specialized and costly procedure offered only at select centers. In addition, the effectiveness of ablation is difficult t evaluate during the procedure due to limitations of traditional mapping technologies. The inability to accurately predict ultimate success at the time of initial procedure leads to recurren arrhythmia and repeat ablations. Direct visualization catheters offer simplicity compared to traditional electroanatomic mapping tools in that cardiac anatomy can be directly visualized without the need for complex mapping systems. However, a major limitation of direct visualization catheters is that electrophysiology cannot be directly mapped. For example, in pulmonary vein isolation for atrial fibrillation, although this is largely an anatomically based procedure, direct visualization alone cannot readily facilitate physiologically directed ablation (e.g. ablation based on complex atrial fractionated electrograms or identification of focal rotors) Likewise, when performing substrate modification ablation for ventricular tachycardia, identification of ablation targets visually is problematic at best. Furthermore, as is the case for traditional mapping/ablation systems, ablation efficacy cannot be directly verified, and relies on surrogate endpoints such as electrical block which can be confounded intra-procedurally by tissue edema. Here we propose to combine the simpler approach of a direct visualization catheter with novel, inexpensive, and scalable electrophysiological mapping technology, using voltage sensitive fluorescent dyes to intuitively visualize both anatomy and electrophysiology. In particular, photostable dyes with emissions in the near-infrared spectrum can be optimized for safe in vivo imaging. This system will be applicable to all forms of arrhythmia, including atrial fibrillation, and promises to reduce costs by reducing procedural complexity, procedure time, and arrhythmia recurrence rates. During Phase I the following three specific aims will be addressed: 1. Demonstrate technical feasibility of fluorescence imaging using an affordable light-emitting- diode/single camera system. 2. [Establish preliminary deliverability and safety of optimized near-infrared voltage sensitive dye(s) for clinical use.] 3. Demonstrate the feasibility f a balloon-tipped endovascular visualization catheter to minimally invasively optically map ratiometric voltage in a live animal. In subsequent work, the device and dye designs will be further optimized, dye safety profile will be characterized in more detail, we will refine a clinicl procedural approach in animal models, and the software analysis approach will be expanded, all while pushing toward the ultimate goal of a commercial product.

描述（由申请人提供）：心律失常影响全国500多万人，每年导致120多万人住院治疗和40万人死亡。心脏消融术的发展显著改善了治疗结果。消融传统上依赖于电解剖标测，这可能是繁琐的，并且通常需要使用复杂的导航系统。即便如此，当前标测模式的时空分辨率仍然很低。这些局限性导致消融术是一种高度专业化且昂贵的手术，仅在选定的中心提供。此外，由于传统标测技术的局限性，在手术过程中难以评估消融的有效性。初次手术时无法准确预测最终成功率导致心律失常复发和重复消融。 与传统的电解剖标测工具相比，直接可视化导管提供了简单性，因为心脏解剖结构可以直接可视化，而无需复杂的标测系统。然而，直接可视化导管的主要局限性是不能直接标测电生理学。例如，在用于心房颤动的肺静脉隔离中，尽管这在很大程度上是基于解剖学的过程，但是单独的直接可视化不能容易地促进生理定向消融（例如，基于复杂心房碎裂电描记图的消融或局灶转子的识别）。同样，当执行用于室性心动过速的基底修改消融时，视觉上消融目标的识别充其量是有问题的。此外，正如 在传统的标测/消融系统中，消融功效不能被直接验证，并且依赖于替代终点，诸如电阻滞，其可以在手术中被组织水肿混淆。 在这里，我们建议结合联合收割机的直接可视化导管与新颖的，廉价的，可扩展的电生理标测技术，使用电压敏感的荧光染料直观地可视化解剖和电生理。特别是，具有近红外光谱发射的光稳定染料可以被优化用于安全的体内成像。该系统将适用于所有形式的心律失常，包括房颤，并有望通过降低手术复杂性、手术时间和心律失常复发率来降低成本。 在第一阶段，将实现以下三个具体目标：1.演示使用经济实惠的发光二极管/单摄像头系统进行荧光成像的技术可行性。2. [确定优化的近红外电压敏感染料用于临床的初步可输送性和安全性。] 3.证明球囊头端血管内可视化导管在活体动物中微创光学标测比率电压的可行性。 在后续工作中，将进一步优化器械和染料设计，更详细地描述染料安全性特征，我们将在动物模型中完善临床程序方法，并扩展软件分析方法，同时推动商业产品的最终目标。