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经皮血管通路大口径动脉封堵器与缝线结扎的对比:观察性与随机研究的协作荟萃分析。

Comparison of plug-based versus suture-based vascular closure for large-bore arterial access: a collaborative meta-analysis of observational and randomized studies.

机构信息

Department of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.

German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Luebeck/Kiel, Hamburg, Germany.

出版信息

Clin Res Cardiol. 2023 May;112(5):614-625. doi: 10.1007/s00392-022-02145-5. Epub 2023 Feb 7.

DOI:10.1007/s00392-022-02145-5
PMID:36749418
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10160216/
Abstract

BACKGROUND

Large-bore arteriotomies can be percutaneously closed with suture-based or plug-based vascular closure device (VCD) strategies. The efficacy of both techniques remains controversial.

AIMS

We conducted a meta-analysis of comparative studies between both VCD strategies, focusing on the most commonly applied VCDs (MANTA and ProGlide).

METHODS

We searched MEDLINE, the Cochrane Central Register of Controlled Trials and Google scholar for observational studies (OS) and randomized controlled trials (RCT) comparing vascular closure with the MANTA-based and the ProGlide-based technique. The principal endpoint of this analysis was access-site related vascular complications. Both study types were analyzed separately.

RESULTS

Access-site related vascular complications were less frequent after vascular closure with the MANTA technique in the analysis of OS (RR 0.61 [95%CI 0.43-0.89], p = 0.01, I = 0%), but more frequent in the analysis of RCT data (RR 1.70 [95%CI 1.16-2.51], p = 0.01, I = 0%). Both data sets provided no significant difference between the VCD techniques in terms of overall bleeding events (OS: RR 0.57 [95%CI 0.32-1.02], p = 0.06, I = 70%; and RCT: RR 1.37 [95%CI 0.82-2.28], p = 0.23, I = 30%). RCT data showed that endovascular stenting or vascular surgery due to VCD failure occurred more often after MANTA application (RR 3.53 [95%CI 1.07-11.33], p = 0.04, I = 0%).

CONCLUSIONS

While OS point to favorable outcomes for large-bore vascular closure with the MANTA-based technique, RCT data show that this strategy is associated with more access-site related vascular complications as well as endovascular stenting or vascular surgery due to device failure compared with the ProGlide-based technique.

摘要

背景

大口径动脉切开术可通过缝线或塞子为基础的血管闭合装置(VCD)策略进行经皮闭合。这两种技术的疗效仍存在争议。

目的

我们对两种 VCD 策略的比较研究进行了荟萃分析,重点是最常用的 VCD(MANTA 和 ProGlide)。

方法

我们在 MEDLINE、Cochrane 对照试验中心注册数据库和 Google 学术上搜索了比较 MANTA 基和 ProGlide 基血管闭合技术的观察性研究(OS)和随机对照试验(RCT)。该分析的主要终点是与血管入路相关的血管并发症。两种研究类型分别进行了分析。

结果

在 OS 分析中,使用 MANTA 技术进行血管闭合后,与血管入路相关的血管并发症发生率较低(RR 0.61 [95%CI 0.43-0.89],p=0.01,I=0%),但在 RCT 数据的分析中,发生率较高(RR 1.70 [95%CI 1.16-2.51],p=0.01,I=0%)。两组数据在总体出血事件方面均未显示 VCD 技术之间有显著差异(OS:RR 0.57 [95%CI 0.32-1.02],p=0.06,I=70%;RCT:RR 1.37 [95%CI 0.82-2.28],p=0.23,I=30%)。RCT 数据显示,由于 MANTA 应用导致 VCD 失败后,需要进行血管内支架或血管手术的情况更为常见(RR 3.53 [95%CI 1.07-11.33],p=0.04,I=0%)。

结论

虽然 OS 指向使用 MANTA 基技术进行大口径血管闭合的有利结果,但 RCT 数据表明,与 ProGlide 基技术相比,该策略与更多的血管入路相关血管并发症以及由于器械失败导致的血管内支架或血管手术相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3ec/10160216/28b48db3ed57/392_2022_2145_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3ec/10160216/7c981888bf7f/392_2022_2145_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3ec/10160216/16eba00abb02/392_2022_2145_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3ec/10160216/487965297aad/392_2022_2145_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3ec/10160216/28b48db3ed57/392_2022_2145_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3ec/10160216/7c981888bf7f/392_2022_2145_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3ec/10160216/16eba00abb02/392_2022_2145_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3ec/10160216/487965297aad/392_2022_2145_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3ec/10160216/28b48db3ed57/392_2022_2145_Fig4_HTML.jpg

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