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用于较大尺动脉切开术的CELT血管闭合装置:单中心回顾性分析。

CELT vascular closure device for larger NES arteriotomies: A single-center retrospective analysis.

作者信息

Johnston Philip, Pitiranggon Chada, Wheibe Elias, Kinnitt Jordan, Shah Manav, Chaudry Imran, McDermott Sean, Turner Ray, Turk Aquilla S, Vargas Jan

机构信息

Department of Neuroendovascular Surgery, University of South Carolina School of Medicine - Greenville, Greenville, SC, USA.

Department of General Surgery, UT Southwestern, Dallas, TX, USA.

出版信息

Interv Neuroradiol. 2025 Jul 23:15910199251360140. doi: 10.1177/15910199251360140.

Abstract

Introduction/PurposeThe shift from transfemoral to transradial access in interventional cardiology has gained momentum due to fewer access site complications, earlier ambulation, and improved patient comfort. Adoption in neuroendovascular procedures has been slower due to anatomical challenges, a steeper learning curve, and reliance on transfemoral devices. Shapiro et al. reported a 4.6% total and 1.6% major complication rate with transfemoral mechanical thrombectomy (MT). While transradial MT aims to reduce such risks, small radial arteries pose concerns such as vasospasm and catheter entrapment. For large-bore access sites (>8F), available percutaneous closure options are limited. Vascular closure devices offer immediate hemostasis-even in anticoagulated patients-but data are limited on off-label use in oversized arteriotomies. We present a single-center retrospective experience using a 7F CELT closure device on 9F arteriotomies in MT.Materials/MethodsWe retrospectively reviewed patients from January 2021 to 2023 who underwent endovascular procedures using 9F femoral sheaths closed with a 7F CELT device. Data included demographics, procedural details, antithrombotic use, hemostasis efficacy, and closure-related complications.ResultsMost patients (96.3%) underwent MT. The CELT device achieved hemostasis in line with the primary outcome definition in 93.2% (95% CI [90.3, 96.0]). Major complications included two cases (0.5%) of lower limb ischemia requiring surgical repair. No retroperitoneal hematomas or transfusions occurred.ConclusionThe 7F CELT closure device demonstrated a 93.2% efficacy rate and a 95% complication-free rate when used off-label for 9F arteriotomies, supporting its potential viability in high-acuity neuroendovascular procedures.

摘要

引言/目的

由于穿刺部位并发症较少、能更早下床活动以及患者舒适度提高,介入心脏病学中从经股动脉入路向经桡动脉入路的转变势头渐强。由于解剖学挑战、学习曲线更陡以及对经股动脉器械的依赖,神经血管内介入手术中这种转变的采用速度较慢。夏皮罗等人报告经股动脉机械取栓术(MT)的总并发症发生率为4.6%,主要并发症发生率为1.6%。虽然经桡动脉MT旨在降低此类风险,但桡动脉较细会引发诸如血管痉挛和导管嵌顿等问题。对于大口径穿刺部位(>8F),可用的经皮闭合选择有限。血管闭合装置可实现即时止血——即使是对抗凝患者也是如此——但关于其在超大动脉切开术中的超说明书使用的数据有限。我们展示了在MT的9F动脉切开术中使用7F CELT闭合装置的单中心回顾性经验。

材料/方法

我们回顾性分析了2021年1月至2023年期间接受血管内手术的患者,这些患者使用9F股动脉鞘并通过7F CELT装置进行闭合。数据包括人口统计学信息、手术细节、抗栓药物使用情况、止血效果以及与闭合相关的并发症。

结果

大多数患者(96.3%)接受了MT。CELT装置在93.2%(95%CI[90.3,96.0])的患者中实现了符合主要结局定义的止血。主要并发症包括两例(0.5%)需要手术修复的下肢缺血。未发生腹膜后血肿或输血情况。

结论

7F CELT闭合装置在用于9F动脉切开术的超说明书使用时,显示出93.2%的有效率和95%的无并发症率,支持其在高急症神经血管内手术中的潜在可行性。

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