Stabilization Device for Transseptal Access

用于房间隔接入的稳定装置

• 批准号: 8591527
• 负责人: GHASSAN S KASSAB
• 金额: $ 26.93万
• 依托单位: 3DT HOLDINGS, LLC
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-01 至 2015-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8591527
• 关键词: Ablation; Address; Age; Application procedure; Atrial Fibrillation; Autopsy; Blood Vessels; Cadaver; Cardiac; Catheters; Chronic; Clip; Comorbidity; Device Removal; Devices; Diagnostic; Distal; Drops; Echocardiography; Esophageal; Europe; Family suidae; Flare; Fluoroscopy; Fossa; Goals; Grant; Heart; Heart Atrium; Heart failure; Human; Implant; Implantation procedure; Inferior; Learning; Left; Left Ventricular Function; Left atrial structure; Left ventricular structure; Location; Measurement; Methods; Mitral Valve; Mitral Valve Insufficiency; Movement; Nature; Operative Surgical Procedures; Patent Foramen Ovale; Patients; Pericardial effusion; Phase; Physicians; Pliability; Positioning Attribute; Procedures; Pulmonary veins; Puncture procedure; Relative (related person); Reporting; Risk; Safety; Saline; Side; Site; Slide; Small Business Innovation Research Grant; Suction; Surface; Surgeon; Techniques; Technology; Therapeutic; Thick; Time; Vacuum; Validation; auricular appendage; clinically significant; experience; imaging modality; implantation; improved; novel; pressure; public health relevance; radiologist; repaired; tool

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.

描述（由申请人提供）：用于左心手术的经房间隔（TS）入路是一个重要且快速增长的诊断和治疗领域，预计美国患者总数超过1000万。在美国和/或欧洲，TS入路手术用于房颤（AF）消融、左心耳（LAA）闭合、卵圆孔未闭（PFO）闭合和二尖瓣返流（MR）治疗。对于后者，可通过TS入路和二尖瓣上的二尖瓣夹（MitraClip或MC）置入完成重度二尖瓣返流的治疗。即使对于最有经验的介入心脏病学家（IC）来说，MC放置的导管定位也具有挑战性，并导致手术时间长，X射线暴露严重。进入心脏左侧的初始TS进入点是MC放置的关键因素。自1959年Ross的早期报告（“拖放”技术）以来，TS入路手术未发生显著变化，该方法仍存在许多挑战，包括导管定位、导管稳定以及心房壁或主动脉穿刺风险方面的困难。虽然“拖放”技术为消融术提供了最佳的下间隔入路点，但MC手术需要更高的上级/后部穿刺部位，因为导管需要多次旋转才能最终放置金属夹。虽然这种上级/后部位置可以通过超声心动图定位，但是心脏的持续运动和卵圆窝（FO）的薄而滑的性质使得标准TS通路穿刺不可预测。相对于二尖瓣过高或过低的入路可能使MC植入几乎不可能，因此需要取出器械、TS重新穿刺和器械重新推进。因此，在TS入路之前和期间，FO上的初始定位以及随后的稳定对于MC手术限制植入时间和X射线暴露至关重要。在本提案中，我们将验证一种新型可偏转经房间隔通路导管（TSAC）的能力，该导管利用真空抽吸技术来改善导管定位和稳定性，更容易刺穿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，以减少在患有心力衰竭的人类尸体和患有MR的慢性心力衰竭猪中相对于传统TS入路方法输送MC的手术和X射线暴露时间。 应用程序的显著问题可能超出MR治疗，涉及多个TS左心手术。