Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
Department of Interventional Cardiology, San Raffaele Scientific Institute, Milan, Italy; Department of Interventional Cardiology, EMO-GVM Centro Cuore, Milan, Italy.
JACC Cardiovasc Interv. 2017 Mar 27;10(6):613-619. doi: 10.1016/j.jcin.2016.12.277.
The authors sought to study the safety and efficacy of the MANTA Vascular Closure Device (VCD), a novel collagen-based technology dedicated to closure of large-bore arteriotomies.
Novel transfemoral therapeutic interventions requiring large-bore catheters have become valid minimally invasive options but have inherent access management challenges. To date, no dedicated vascular closure devices exist for large arteriotomies.
A prospective, single-arm clinical investigation enrolling patients who underwent elective percutaneous interventions with large-bore catheters and planned percutaneous arteriotomy closure in 3 European institutions.
A total of 50 patients with a mean age of 79.5 ± 8.3 years underwent high-risk percutaneous coronary intervention, balloon aortic valvuloplasty, or transcatheter aortic valve replacement with large-bore catheters sized 12-F to 19-F. MANTA closure was performed by 9 different operators. The 14-F MANTA VCD was deployed in one-third of the overall cohort (16 of 50, 32%), and the 18-F MANTA VCD in the remainder. The MANTA VCD was deployed successfully in all patients. The mean time to hemostasis was 2 min, 23 s. One patient had a major vascular and major bleeding complication with prolonged femoral bleeding that was successfully treated with a covered stent and eventual surgical repair. There were no other access site-related complications.
This first multicenter experience demonstrates rapid and reliable hemostasis and low complication rates with the use of the plug-based MANTA VCD for large-bore arteriotomy closure.
作者旨在研究 MANTA 血管闭合装置（VCD）的安全性和有效性，该设备是一种新型的胶原基技术，专门用于闭合大口径动脉切口。
需要大口径导管的新型经股治疗干预已成为有效的微创选择，但存在固有的入路管理挑战。迄今为止，尚无专门用于大动脉切开术的血管闭合装置。
这是一项在欧洲 3 家机构进行的前瞻性、单臂临床研究，共纳入了 50 名接受大口径导管择期经皮介入治疗且计划行经皮动脉切开术闭合的患者。
共有 50 名平均年龄为 79.5±8.3 岁的患者接受了高危经皮冠状动脉介入治疗、球囊主动脉瓣成形术或经导管主动脉瓣置换术，使用的导管尺寸为 12-F 至 19-F。由 9 名不同的操作人员进行 MANTA 闭合。三分之一（16/50，32%）的患者使用了 14-F MANTA VCD，其余患者使用了 18-F MANTA VCD。所有患者均成功地部署了 MANTA VCD。平均止血时间为 2 分 23 秒。1 名患者出现了主要血管和大出血并发症，股动脉出血延长，采用带膜支架成功治疗，并最终进行了手术修复。没有其他与入路相关的并发症。
这项多中心的首次经验表明，使用基于塞子的 MANTA VCD 闭合大口径动脉切开术可快速、可靠地止血，并发症发生率低。
