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来自法国单中心回顾性登记研究,比较使用MANTA(基于胶原塞)与PROSTAR(基于缝线)行经导管主动脉瓣植入术后的血管并发症

Vascular Complications Following Transcatheter Aortic Valve Implantation, Using MANTA (Collagen Plug-Based) versus PROSTAR (Suture-Based), from a French Single-Center Retrospective Registry.

作者信息

Benic Clément, Nicol Pierre Philippe, Hannachi Sinda, Gilard Martine, Didier Romain, Nasr Bahaa

机构信息

Department of Cardiology, University Hospital of Brest, 29200 Brest, France.

Department of Vascular Surgery, University Hospital of Brest, 29200 Brest, France.

出版信息

J Clin Med. 2023 Oct 23;12(20):6697. doi: 10.3390/jcm12206697.

DOI:10.3390/jcm12206697
PMID:37892835
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10607530/
Abstract

TAVI requires a large-bore arteriotomy. Closure is usually performed by the suture system. Some studies report a vascular complication rate of up to 21%. MANTA is a recently developed percutaneous closure system dedicated to large caliber vessels based on an anchoring system. Early studies report a lower rate of vascular complications with MANTA devices. This single-center retrospective study included all patients who underwent femoral TAVI at the Brest University Hospital from 20 November 2019 to 31 March 2021. The primary endpoint is the rate of vascular complications (major and minor) pre and post-TAVI procedure. In total, 264 patients were included. There were no significant differences in vascular complications (major and minor) between the two groups (13.6% in the MANTA group versus 21.2% in the PROSTAR group; = 0.105), although there was a tendency to have fewer minor vascular complications in the Manta group (12.1% versus 20.5%; = 0.067). Manta was associated with a lower rate of bleeding complications (3.8% versus 15.2%; = 0.002), predominantly minor complications with fewer closure failures (4.5% versus 13.6%; = 0.01), less use of covered stents (4.5% versus 12.9%; = 0.016), and with no difference in the need for vascular surgery compared to the Prostar group (1.5% versus 2.3%; = 0.652). On the other hand, Manta was associated with a higher rate of femoral stenosis (4.5% versus 0%; = 0.013) without clinical significance (1.5% versus 0%; = 0.156). The Manta and Prostar devices are equivalent in terms of vascular complications. The Manta, compared to the Prostar, is associated with fewer bleeding complications.

摘要

经导管主动脉瓣植入术(TAVI)需要做大口径动脉切开术。通常通过缝合系统进行闭合。一些研究报告血管并发症发生率高达21%。MANTA是一种最近开发的基于锚定系统的用于大口径血管的经皮闭合系统。早期研究报告使用MANTA装置时血管并发症发生率较低。这项单中心回顾性研究纳入了2019年11月20日至2021年3月31日在布雷斯特大学医院接受股动脉TAVI的所有患者。主要终点是TAVI手术前后血管并发症(主要和次要)的发生率。总共纳入了264例患者。两组之间在血管并发症(主要和次要)方面没有显著差异(MANTA组为13.6%,PROSTAR组为21.2%;P = 0.105),尽管MANTA组有较少次要血管并发症的趋势(12.1%对20.5%;P = 0.067)。MANTA与较低的出血并发症发生率相关(3.8%对15.2%;P = 0.002),主要是次要并发症,闭合失败较少(4.5%对13.6%;P = 0.01),覆膜支架使用较少(4.5%对12.9%;P = 0.016),与Prostar组相比,血管手术需求无差异(1.5%对2.3%;P = 0.652)。另一方面,MANTA与较高的股动脉狭窄发生率相关(4.5%对0%;P = 0.013),但无临床意义(1.5%对0%;P = 0.156)。MANTA和Prostar装置在血管并发症方面相当。与Prostar相比,MANTA与较少的出血并发症相关。

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