Low-Dose Tomosynthetic Interventional System For Quantitative Cardiac Imaging

描述(申请人提供)：X射线透视提供实时成像、高空间分辨率、易用性和设备兼容性的组合，这对于在透视引导的介入(FGI)过程中快速诊断冠状动脉疾病和导管引导至关重要。尽管美国每年进行的数百万次FGI手术无可否认地改善和挽救了生命，但这些手术给患者和实施手术的医务人员带来了辐射负担。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射线系统在剂量效率方面的改进空间有限。传统透视的2D投影格式也不能提供现代导管消融程序所需的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，该系统将显著减少患者和工作人员的X射线剂量，同时提供实时3D导管指导。扫描束数字X射线(SBDX)系统是一种低剂量透视/透视系统，使用低散射逆几何扫描执行30帧/秒的成像。之前由美国国立卫生研究院资助的研究使一种先进的SBDX系统得以构建，该系统能够将患者入院皮肤剂量减少到常规剂量的15%，同时保持100%的常规图像信噪比。这项研究还产生了两种新的介入技术，它们利用了独特的SBDX实时、多平面、断层合成重建器：逐帧3D导管尖端跟踪和用于设备尺寸确定的免校准3D血管分析。这一新提议将通过三个项目将SBDX推进到介入实验室。首先，将进行一项人体研究，以比较SBDX和传统X射线剂量、图像质量和介入设备大小调整的准确性。其次，将构建一个用于3D导管跟踪和心脏可视化的程序室系统，并在左心房消融的动物模型中进行验证。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心动图，而不需要单独的术前CT扫描。减少心脏导管实验室中的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。许多现代介入手术都需要实时三维成像能力。这项研究的成功结论将是一个低剂量的X射线透视系统，它在单一的介入实验室中提供临床图像质量、新的治疗工具和3D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。在我国，每年有超过100万例冠状动脉成形术和20万例导管消融术用于治疗心房颤动，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，同时显著减少对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.