SITE OPTIMIZATION SYSTEM FOR LV EPICARDIAL STIMULATION

描述（由申请人提供）： 心脏起搏治疗（CRT）作为一种有效的治疗充血性心力衰竭的方法的出现是心脏节律管理的一个革命性步骤。这种治疗已被证明可以显著改善美国超过500万的重病患者人群的发病率和死亡率。研究表明，每个心腔之间和内部的时序以及刺激部位位置是恢复同步性和适当血流动力学的关键因素。另一个明显的结论是，心力衰竭病情和病因的患者间差异需要针对个体的治疗。CRT无效的受试者人群的一致性和令人失望的部分（20-30%）可能部分归因于次优患者治疗。当前左心室（LV）的血管内起搏有几个局限性，特别是在冠状静脉分支的限制内的起搏部位选择的限制。这种治疗的发展现在必须集中在最大限度地提高每名CRT患者的结局，然而，临床实践尚未利用起搏位置来实现CRT的最大受益。拟议的工作概述了一个系统的设计，开发和测试，用于优化与CRT相关的左心室心外膜刺激的网站。该器械将能够记录和分析固有窦性心律期间LV的机电反应，以识别提供最大血流动力学改善的起搏部位。这种急需的优化装置将利用心外膜起搏的无约束定位潜力和对心脏心外膜表面的微创进入。可行性研究将证明存在最佳LV刺激部位，以及原型器械是否可以准确定位该部位。拟议的起搏部位优化研究也将为CRT的科学理解提供有价值的见解。

DESCRIPTION (provided by applicant): The advent of cardiac resynchronization therapy (CRT) as an effectual treatment of congestive heart failure has been a revolutionary step in cardiac rhythm management. This treatment has been proven to significantly improve the morbidity and mortality of this very sick patient population of over 5 million in the US. Research indicates that the timing sequence between and within each cardiac chamber and stimulation site location are critical factors for the restoration of synchrony and proper hemodynamics. Another evident conclusion is that the inter-patient variation in heart failure condition and etiology requires therapy specialized to the individual. The consistent and disappointing portion (20-30%) of the subject population that do not respond to CRT may be due in part to suboptimal patient therapy. Current endovascular pacing of the left ventricle (LV) has several limitations, especially the restriction of pacing site options within the constraints of the coronary venous branches. The evolution of this therapy must now focus on maximizing the outcome of every CRT patient, however clinical practice has not made use of pacing location to realize the maximum benefit available with CRT. The proposed work outlines the design, development, and testing of a system for optimizing the site of left ventricular epicardial stimulation associated with CRT. The device will be capable of recording and analyzing the electromechanical response of the LV during intrinsic sinus rhythm in order to identify the pacing site that provides the maximum hemodynamic improvement. This much needed optimization device will take advantage of the unconstrained location potential of epicardial pacing and the minimally invasive access to the epicardial surface of the heart. A feasibility study will demonstrate that an optimum LV site of stimulation exists and if the prototype device can accurately locate that site. The proposed pacing site optimization study will also add valuable insights to the scientific understanding of CRT.