Low-Dose Tomosynthetic Interventional System For Quantitative Cardiac Imaging

描述（由申请人提供）：X射线荧光透视提供了实时成像、高空间分辨率、易用性和器械兼容性的组合，这对于在荧光透视引导介入（FGI）手术期间快速诊断冠状动脉疾病和导管引导至关重要。尽管每年在美国进行的数百万次FGI手术无疑改善和挽救了生命，但这些手术对患者和执行这些手术的医务人员都造成了辐射负担。辐射风险包括严重的皮肤损伤、白内障和癌症。不幸的是，传统X射线系统的剂量效率的改进空间有限。传统荧光透视的2D投影格式也不能提供现代导管消融手术所需的3D设备和解剖信息。该项目的目标是开发一种新型的逆几何X射线透视系统，该系统将大大减少患者和工作人员的X射线剂量，同时提供实时3D导管引导。扫描束数字X射线（SBDX）系统是一种低剂量荧光透视/荧光摄影系统，使用低散射反向几何扫描执行30帧/秒成像。先前NIH资助的研究使得能够构建先进的SBDX系统，该系统能够将患者入射皮肤剂量降低到传统剂量的15%，同时保持100%的传统图像信噪比。这项研究还产生了两种新的介入技术，利用独特的SBDX实时、多平面、断层合成重建器：逐帧3D导管头端跟踪和免校准3D血管分析，以确定器械尺寸。这项新提案将通过三个项目将SBDX推进到介入实验室。首先，将进行一项人类受试者研究，以比较SBDX和传统X射线剂量、图像质量和介入器械尺寸准确性。其次，将在左心房消融动物模型中构建并验证用于3D导管跟踪和心脏可视化的手术室系统。第三，将开发在介入室进行SBDX计算机断层扫描的能力，以便为消融手术提供3D心脏标测图，而无需单独的术前CT扫描。减少心脏导管室的X射线剂量对于最大限度地提高患者和工作人员的安全至关重要。许多现代介入手术需要实时三维成像能力。本研究的成功结论将是一个低剂量X射线透视系统，提供临床图像质量，新的治疗工具，并在一个单一的介入实验室三维成像能力。 公共卫生相关性：冠状动脉疾病和心律失常是我们社会发病率和死亡率的重要原因。我国每年进行100多万例冠状动脉血管成形术和20万例导管消融术治疗房颤，挽救了许多人的生命，提高了更多人的质量。这项工作的成功完成将提供治疗工具，改善这些程序的结果，同时大大降低患者和医务人员的辐射暴露。

DESCRIPTION (provided by applicant): X-ray fluoroscopy provides a combination of real-time imaging, high spatial resolution, ease of use, and device compatibility that is essential for rapid diagnosis of coronary artery disease and catheter guidance during fluoroscopically-guided interventional (FGI) procedures. Although the millions of FGI procedures performed in the U.S. each year undeniably improve and save lives, these procedures entail a radiation burden on both the patient and the medical staff who perform them. Radiation risks include serious skin injury, cataracts, and cancer. Unfortunately, there is limited room for improvement in the dose efficiency of conventional x-ray systems. The 2D projection format of conventional fluoroscopy also fails to provide the 3D device and anatomic information needed for modern catheter ablation procedures. The goal of this project is to develop a novel inverse-geometry x-ray fluoroscopic system that will dramatically reduce x-ray dose to patient and staff, while simultaneously providing real-time 3D catheter guidance. The Scanning-Beam Digital X-ray (SBDX) system is a low-dose fluoroscopic/fluorographic system that performs 30 frame/sec imaging using low-scatter inverse-geometry scanning. Previous NIH-funded research enabled the construction of an advanced SBDX system capable of reducing patient entrance skin dose to 15% of a conventional dose while maintaining 100% of conventional image signal-to-noise ratio. This research also yielded two new interventional techniques that exploit the unique SBDX real-time, multiplane, tomosynthetic reconstructor: frame-by-frame 3D catheter tip tracking and calibration-free 3D vessel analysis for device sizing. This new proposal will advance SBDX into the interventional laboratory through three projects. First, a human subjects study will be performed to compare SBDX and conventional x-ray dose, image quality, and interventional device sizing accuracy. Second, a procedure-room system for 3D catheter tracking and cardiac visualization will be constructed and validated in an animal model of ablation in the left atrium. Third, the ability to perform SBDX computed tomography in the interventional room will be developed, in order to provide 3D cardiac maps for ablation procedures without the need for a separate, pre-procedure CT scan. Reducing x-ray dose in the cardiac cath lab is critical to maximizing the safety of patient and staff. Real-time three-dimensional imaging capability is needed for many modern interventional procedures. The successful conclusion of this research will be a low dose x-ray fluoroscopic system which provides clinical image quality, novel therapeutic tools, and 3D imaging capability in a single interventional laboratory. PUBLIC HEALTH RELEVANCE: Coronary artery disease and cardiac arrhythmia are significant causes of morbidity and mortality in our society. Over 1,000,000 coronary angioplasties and 200,000 catheter ablation procedures for the treatment of atrial fibrillation are performed annually in our country, saving many lives and improving the quality of many more. Successful completion of this work will provide therapeutic tools which improve the outcomes of these procedures, while dramatically lowering the radiation exposure to the patient and medical staff.