Stabilization Device for Transseptal Access

描述(由申请人提供)：左心手术的经间隔(TS)通路是诊断和治疗提供的一个重要且快速增长的空间，预计美国患者总数将超过1000万。在美国和/或欧洲，TS入路程序用于房颤(AF)消融、左心耳(LAA)关闭、卵圆孔未闭(PFO)关闭和二尖瓣返流(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子(MitraClip或MC)来完成。即使对于最有经验的介入心脏病学家(IC)来说，MC放置的导管定位也是具有挑战性的，这导致了长时间的手术时间和大量的X射线暴露。最初的TS入门切入点进入左侧心脏，关键因素是S的MC位置。自Ross于1959年报道后，TS的操作程序没有明显的改变(“拖放”技术)，这种方法仍然存在许多挑战，包括导管定位困难，导管稳定，以及房壁或主动脉被刺穿的风险。“拖放”技术为消融手术提供了最佳的下间隔切入点，而MC手术则需要更高的穿刺点/后穿刺点，因为导管需要多次旋转才能放置最终的夹子。虽然这一上/后位置可以通过超声心动图来定位，但心脏的持续运动和卵圆窝(FO)的薄而滑的性质使得标准的TS入路穿刺术变得不可预测。相对于二尖瓣过高或过低的入路可能会使MC几乎不可能植入，因此需要取出装置、TS重新穿刺术和重新推进装置。因此，对于MC手术限制植入次数和X光暴露来说，在FO上的初始定位并在TS前和期间随后的稳定是至关重要的。在这项提案中，我们将验证一种新型的、可偏转的跨间隔通路导管(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性，更容易穿透FO，从而减少TS和MC程序性和X光暴露时间。为了实现这一目标，我们将评估TSAC在减少MC交付程序和X光暴露时间方面的安全性和能力，相对于传统方法在患有心力衰竭的人类身体和患有MR的慢性心力衰竭猪身上进行TS治疗。这项建议针对临床 从MR治疗延伸到多个TS左心手术的应用程序存在重大问题。

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.