Left Atrial Appendage Isolation Device to Reduce Stroke

描述(由申请人提供)： 房颤是最常见的心律失常，目前影响着200多万美国人。左心房(LA)血栓形成的栓塞物已被证明是中风的主要原因，尤其是在老年人中。90%以上的左心耳血栓位于左心耳。据估计，20%的中风患者患有房颤，美国心脏协会最近估计，与中风相关的总成本每年超过430亿美元。目前，最广泛用于房颤患者的治疗方法是口服华法林以增加凝血时间。然而，据报道，虽然华法林可以显著降低风险，但它仍然没有得到充分利用(在一项研究中，只有34.7%的合格患者)和被滥用(在另一项研究中，超过50%的患者凝血时间超出范围)。最近，分离左心耳已成为房颤相关卒中的一种可能的预防性治疗方法。Ension已经开始开发一种设备，最终目的是操纵LAA，并在功能上将其与循环隔离。这种装置足够紧凑，可以在内窥镜下作为独立的手术程序使用，但也可以用于心内直视手术，在心内直视手术中，分离左心耳是整个手术的一部分。开发工作分三个阶段进行。目前的设备迭代只能抓住左心耳，而且太大了，不能在内窥镜下使用。在这个第一阶段的提案中，我们打算缩小设备尺寸，提高其能力和灵活性，并在猪身上进行急性和慢性体内实验，以显示LAA功能隔离的效果。我们在第二阶段的具体目标之一是加入订书机组件，这样只需要一个工具就可以抓住、操纵和从功能上隔离LAA。

DESCRIPTION (provided by applicant): Atrial fibrillation (AF) is the most common cardiac dysarrhythmia, currently affecting over 2 million Americans. Embolic material from thrombus in the fibrillating left atrium (LA) has been documented as a major cause of stroke, especially in the elderly. Over 90 percent of LA thrombus lies within the left atrial appendage (LAA). It has been estimated that 20 % of stroke victims were afflicted with AF and the American Heart Association has recently estimated that the overall cost associated with stroke exceeds $43 billion per year. Currently, the most widely used therapy for patients with AF is oral warfarin to increase blood clotting times. However it has been reported that while warfarin can significantly reduce risk, it remains both underutilized (only 34.7% of eligible patients in one study) and misutilized (over 50% of patients with clotting times out of range in another study). Recently, isolation of the LAA has surfaced as a possible preventive therapy for AF related stroke. Ension has begun development of a device ultimately intended to manipulate the LAA and functionally isolate it from the circulation. This device would be compact enough to use endoscopically as a standalone procedure, but could also be used during open-heart operations where isolation of the LAA would be part of the overall operation. Development is proceeding in three phases. Current device iterations only have the capability to grasp the LAA and are too large for endoscopic use. In this Phase I proposal we intend to decrease device size, improve its capabilities and flexibility, and perform both acute and chronic in vivo experiments in pigs to show the effects of LAA functional isolation. Among our specific aims in Phase II would be the incorporation of a stapling component so that only one tool would be required to grasp, manipulate, and functionally isolate the LAA.