Stabilization Device for Transseptal Access

描述（由申请人提供）：左心手术的经间隔（TS）通道是诊断和治疗传递的一个重要且快速增长的领域，预计美国患者总数超过1000万。在美国和/或欧洲，TS进入程序用于房颤（AF）消融、左房耳（LAA）闭合、卵圆孔未闭（PFO）闭合和二尖瓣返流（MR）治疗。对于后者，严重MR的治疗可以通过TS通路和在二尖瓣上放置夹（MitraClip或MC）来完成。即使对于最有经验的介入心脏病专家（ICs）来说，MC放置的导管定位也具有挑战性，并且导致长时间的手术时间和大量的x射线暴露。进入心脏左侧的起始TS通道入口点是MC放置的关键因素。自1959年Ross的早期报道（“拖放”技术）以来，TS通路的程序并没有明显改变，但这种方法仍然存在许多挑战，包括导管定位困难、导管稳定困难以及心房壁或主动脉穿刺风险。虽然“拖放”技术为消融手术提供了最佳的下间隔进入点，但由于导管在最终夹放置时需要多次转弯，因此MC手术需要更优越/后方的穿刺位置。虽然这个上/后位置可以通过超声心动图定位，但心脏的持续运动和卵圆窝（FO）的薄滑特性使得标准的TS通路穿刺难以预测。相对于二尖瓣过高或过低的通道会使MC植入几乎不可能，因此需要移除装置、TS重新穿刺和装置重新推进。因此，在TS入路之前和期间，FO的初始定位和随后的稳定对于MC手术至关重要，以限制植入时间和x射线暴露。在本提案中，我们将验证一种新型的、可偏转的经间隔导管（TSAC）的能力，该导管利用真空吸引技术提供更好的导管定位和稳定，更容易穿刺FO，从而减少TS和MC手术和x射线暴露时间。为了实现这一目标，我们将评估TSAC的安全性和能力，以减少在心力衰竭的人类尸体和患有mr的慢性心力衰竭猪中使用TS的传统方法提供MC的程序和x射线暴露时间

DESCRIPTION (provided by applicant): Transseptal (TS) access for left heart procedures is an important and rapidly growing space for diagnostics and therapy delivery with an expected total of over 10 million U.S. patients. In the U.S. and/or Europe, TS access procedures are used for atrial fibrillation (AF) ablation, left atrial appendage (LAA) closure, patent foramen ovale (PFO) closure, and treatment of mitral valve regurgitation (MR). For the latter, treatment of severe MR can be accomplished through TS access and the placement of a clip (MitraClip or MC) on the mitral valve. Catheter positioning for MC placement has been challenging even for the most experienced interventionalist cardiologists (ICs) and has led to long procedure times with significant x-ray exposure. The initial TS access entry point into the left side of the heart s the key factor for MC placement. TS access procedures have not significantly changed since early reports by Ross in 1959 ("drag and drop" technique) and many challenges still exist with this method including difficulty with: catheter localization, catheter stabilization, and the risk f atrial wall or aortic puncture. While the "drag and drop" technique provides an optimal inferior septal access point for ablation procedures, the MC procedure requires a more superior/posterior puncture site due to the multiple turns required by the catheter for final clip placement. While this superior/posterior position can be located with echocardiography, the constant movement of the heart and the thin and slippery nature of the fossa ovalis (FO) make standard TS access punctures unpredictable. Access that is too high or too low relative to the mitral valve can make implantation of the MC virtually impossible thus requiring device removal, TS re-puncture, and device re-advancement. Thus, initial localization on the FO with subsequent stabilization prior to and during TS access is critical for MC procedures to limit implant times and x-ray exposure. In this proposal, we will validate the ability of a novel, deflectable transseptal access catheter (TSAC) that utilizes vacuum suction technology to provide improved catheter localization and stabilization, easier puncture of the FO, and thus leading to decreased TS and MC procedural and x-ray exposure times. To accomplish this goal, we will assess both the safety and the ability of the TSAC to reduce procedure and x-ray exposure times for delivery of MC relative to traditional means for TS access in human cadavers with heart failure and in chronic heart failure swine with MR. This proposal addresses a clinically significant problem with applications that can reach beyond treatment of MR to multiple TS left heart procedures.