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使用新型血管闭合装置胶原塞基 MANTA 经股动脉经导管瓣膜植入术后经皮闭合入路的早期结果。

Early Outcomes After Percutaneous Closure of Access Site in Transfemoral Transcatheter Valve Implantation Using the Novel Vascular Closure Device Collagen Plug-Based MANTA.

机构信息

Interventional Cardiology Unit, Sint Antonius Ziekenhuis, Nieuwegein, The Netherlands; Interventional Cardiology Unit, Puerta del Mar Hospital, Cadiz, Spain.

Interventional Cardiology Unit, Sint Antonius Ziekenhuis, Nieuwegein, The Netherlands.

出版信息

Am J Cardiol. 2019 Oct 15;124(8):1265-1271. doi: 10.1016/j.amjcard.2019.07.030. Epub 2019 Jul 29.

Abstract

A new collagen-based MANTA vascular closure device (VCD) was developed for closing large-bore arteriotomies after transfemoral transcatheter aortic valve implantation (TAVI). We evaluated safety and feasibility at 30-day follow-up in terms of vascular and bleeding complications and mortality of the collagen-based MANTA VCD compared with the suture-based Prostar XL VCD in a cohort of 366 patients who underwent transfemoral TAVI between January 2015 and April 2018. The MANTA VCD was used in 168 patients and the Prostar XL VCD in 198 patients, with successful closure of 98.8% and 98.5%, respectively. VARC-2 defined as major vascular and bleeding complications was similar in both groups (MANTA vs Prostar XL): 0.6% versus 1.0% (p = 0.661) and 0.6% versus 1.5% (p = 0.102). Minor vascular and bleeding complications, were significantly more frequent (10.7 vs 18.8 %, p = 0.003 and 13.7 vs 19.7%, p = 0.080, respectively) in the Prostar XL cohort. Thirty-day all-cause mortality was 2.7%, without significant difference between the groups (p = 0.278). The MANTA device is a safe and feasible option for vascular access closure in patients undergoing transfemoral TAVI.

摘要

一种新型基于胶原蛋白的 MANTA 血管闭合装置(VCD)已被开发用于经股动脉经导管主动脉瓣置换术(TAVI)后闭合大口径动脉切开部位。我们在 366 例 2015 年 1 月至 2018 年 4 月期间接受经股动脉 TAVI 的患者中,评估了 30 天随访时基于胶原蛋白的 MANTA VCD 与基于缝线的 Prostar XL VCD 在血管和出血并发症以及死亡率方面的安全性和可行性。MANTA VCD 在 168 例患者中使用,Prostar XL VCD 在 198 例患者中使用,分别成功闭合 98.8%和 98.5%。VARC-2 定义的主要血管和出血并发症在两组中相似(MANTA 与 Prostar XL):0.6%与 1.0%(p=0.661)和 0.6%与 1.5%(p=0.102)。较小的血管和出血并发症在 Prostar XL 组中更为常见(10.7%比 18.8%,p=0.003 和 13.7%比 19.7%,p=0.080)。30 天全因死亡率为 2.7%,两组间无显著差异(p=0.278)。MANTA 装置是经股动脉 TAVI 患者血管入路闭合的安全可行选择。

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