SITE OPTIMIZATION SYSTEM FOR LV EPICARDIAL STIMULATION

描述(由申请人提供)： 心脏再同步化治疗(CRT)作为充血性心力衰竭的有效治疗手段的出现，是心律管理的革命性一步。这种治疗方法已被证明能显著改善美国500多万重病患者的发病率和死亡率。研究表明，每个心腔之间和内部的时序以及刺激部位的位置是恢复同步性和正确血流动力学的关键因素。另一个明显的结论是，患者之间在心力衰竭状况和病因上的差异需要针对个人的专门治疗。对CRT无反应的受试者群体中一致且令人失望的部分(20%-30%)可能部分是由于不太理想的患者治疗。目前的左心室(LV)血管内起搏有一些局限性，尤其是起搏部位的选择受冠状静脉分支的限制。这种疗法的发展现在必须着眼于最大化每个CRT患者的结局，然而临床实践并没有利用起搏位置来实现CRT的最大益处。这项拟议的工作概述了用于优化CRT相关的左室心外膜刺激部位的系统的设计、开发和测试。该设备将能够记录和分析固有窦性心律时左室的机电反应，以确定提供最大血流动力学改善的起搏部位。这种亟需的优化设备将利用心外膜起搏的无限制定位潜力和微创进入心脏外膜表面的优势。可行性研究将证明存在一个最佳的LV刺激部位，以及原型装置是否能准确定位该部位。建议的起搏部位优化研究也将为科学理解CRT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.