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VASCADE® MVP 静脉血管闭合装置在接受经皮左心耳封堵术与 WATCHMAN 治疗的患者中的疗效和安全性。

Efficacy and safety of the VASCADE® MVP venous vascular closure device in patients undergoing percutaneous left atrial appendage occlusion with WATCHMAN.

机构信息

Internal Medicine Residency Program, Mercy Health-St. Rita's Medical Center, Lima, Ohio, USA.

Department of Cardiovascular Disease, HCA Houston Healthcare - Kingwood/University of Houston College of Medicine, Houston, Texas, USA.

出版信息

Catheter Cardiovasc Interv. 2024 Nov;104(6):1260-1266. doi: 10.1002/ccd.31209. Epub 2024 Sep 15.

Abstract

BACKGROUND

The VASCADE MVP venous vascular closure system is commonly used for percutaneous venotomy closure in catheter-based procedures utilizing sheath sizes 6-12 French. However, its application with larger sheaths such as ones required in left atrial appendage occlusion (LAAO) has yet to be explored.

AIMS

This study compared the efficacy and safety of VASCADE MVP versus conventional Figure-of-8 sutures (Fo8) for femoral venotomy closure in patients undergoing Watchman LAAO.

METHODS

This single-center retrospective analysis included patients who underwent post-LAAO femoral venotomy closure with either VASCADE MVP or Fo8 sutures. The primary efficacy endpoint was time to hemostasis (TTH). Primary safety endpoints were 30-day access site-related readmissions and major complications. Minor access-site-related complications were also assessed.

RESULTS

107 patients underwent post-LAAO femoral venotomy closure with VASCADE MVP, of which 101 were successful (94.4%). 99 patients underwent conventional closure with Fo8 sutures and supplemental manual pressure. Baseline characteristics were similar between groups. TTH was significantly shorter with VASCADE MVP (152.9 vs. 335.8 s, p = 0.001). Major safety outcomes were comparable. However, the conventional group experienced a higher incidence of ecchymosis (16.2% vs 4.7%, p = 0.007) and 30-day all-cause readmission (18.2% vs 8.4%, p = 0.038).

CONCLUSIONS

VASCADE MVP significantly reduced TTH compared to Fo8 sutures after LAAO. While demonstrating a similar safety profile, VASCADE MVP may offer a more efficient approach to femoral vein closure in this patient population.

摘要

背景

VASCADE MVP 静脉血管闭合系统常用于经皮血管切开术闭合,所用鞘管尺寸为 6-12 French。然而,其在较大鞘管(如左心耳封堵术 [LAAO] 所需鞘管)中的应用尚未得到探索。

目的

本研究比较了 VASCADE MVP 与传统的 8 字缝合(Fo8)在接受 Watchman LAAO 的患者中行股静脉切开闭合术的疗效和安全性。

方法

这项单中心回顾性分析纳入了接受 LAAO 后行股静脉切开闭合术的患者,这些患者使用 VASCADE MVP 或 Fo8 缝线。主要疗效终点是止血时间(TTH)。主要安全性终点为 30 天内与入路相关的再入院和主要并发症。还评估了次要与入路相关的并发症。

结果

107 例患者接受了 LAAO 后行股静脉切开闭合术,其中 101 例(94.4%)成功使用了 VASCADE MVP。99 例患者接受了 Fo8 缝线和补充手动按压的传统闭合。两组的基线特征相似。VASCADE MVP 的 TTH 显著缩短(152.9 秒比 335.8 秒,p=0.001)。主要安全性结果相似。然而,传统组的瘀斑发生率(16.2%比 4.7%,p=0.007)和 30 天全因再入院率(18.2%比 8.4%,p=0.038)更高。

结论

与 Fo8 缝线相比,LAAO 后 VASCADE MVP 显著缩短 TTH。虽然显示出相似的安全性特征,但 VASCADE MVP 可能为该患者人群提供更有效的股静脉闭合方法。

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