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ProGlide 与 MANTA 血管闭合装置在大口径入路管理中的荟萃分析。

Meta-analysis of ProGlide versus MANTA vascular closure devices for large-bore access site management.

机构信息

Department of Internal Medicine, Cleveland Clinic Akron General, Akron, OH, USA.

Department of Surgery, Mayo Clinic, Rochester, MN, USA.

出版信息

Indian Heart J. 2022 May-Jun;74(3):251-255. doi: 10.1016/j.ihj.2022.03.003. Epub 2022 Mar 31.

Abstract

INTRODUCTION

The comparative effectiveness of ProGlide® compared with MANTA® vascular closure devices (VCDs) in large-bore access site management is not entirely certain, and has only been evaluated in underpowered studies. This meta-analysis aimed to evaluate the outcomes of ProGlide® compared with MANTA® VCDs.

METHODS

PubMed, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched systematically for relevant articles from the inception of the database until August 27, 2021. The outcomes of interest were all bleeding events, major bleeding, major and minor vascular complications, pseudoaneurysm, stenosis or dissection, and VCD failure. Risk ratios were used as point estimates of endpoints. All statistical analyses were carried out using R version 4.0.3.

RESULTS

Four observational studies and 1 pilot randomized controlled trial (RCT) were included in the final analysis. There was no significant difference between the ProGlide® and MANTA® groups in the risk of all bleeding events, major/life-threatening bleeding, major vascular complications, minor vascular complications, pseudoaneurysms, and/or stenosis or dissection of the entry site vessel. However, the incidence of VCD failure was higher in the ProGlide® group compared with the MANTA® group (RR 1.94; 95% CI 1.31-2.84; I = 0%).

CONCLUSION

In conclusion, both VCDs (ProGlide® and MANTA®) have comparable outcomes with regard to risk of bleeding, vascular complications, pseudoaneurysms, and/or stenosis or dissection of entry vessel. ProGlide® was however associated with higher device failure.

摘要

简介

在大口径入路管理中,ProGlide®与 MANTA®血管闭合装置(VCD)的比较效果尚不完全明确,且仅在研究力度不足的研究中进行了评估。本荟萃分析旨在评估 ProGlide®与 MANTA® VCD 的结果。

方法

系统地检索了 PubMed、EMBASE 和 Cochrane 对照试验中心注册库(CENTRAL),以获取自数据库创建以来至 2021 年 8 月 27 日的相关文章。主要结局为所有出血事件、大出血、主要和次要血管并发症、假性动脉瘤、狭窄或夹层以及 VCD 失败。风险比用作终点的点估计。所有统计分析均使用 R 版本 4.0.3 进行。

结果

最终分析纳入了 4 项观察性研究和 1 项先导性随机对照试验(RCT)。ProGlide®组和 MANTA®组在所有出血事件、主要/危及生命的出血、主要血管并发症、次要血管并发症、假性动脉瘤以及/或入路血管狭窄或夹层的风险方面无显著差异。然而,ProGlide®组的 VCD 失败发生率高于 MANTA®组(RR 1.94;95%CI 1.31-2.84;I = 0%)。

结论

总之,两种 VCD(ProGlide®和 MANTA®)在出血、血管并发症、假性动脉瘤以及/或入路血管狭窄或夹层的风险方面具有相似的结果。然而,ProGlide®与更高的设备故障相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b4c8/9243605/284a2ffbb372/gr1.jpg

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