Halim J, Missault L, Lycke M, Van der Heyden J
Department of Cardiology, Sint-Jan Hospital, Bruges, Belgium.
Neth Heart J. 2020 Dec;28(12):639-644. doi: 10.1007/s12471-020-01465-3.
The present study aims to evaluate the efficacy and safety of the MANTA vascular closure device (VCD) (Teleflex, Morrisville, NC, USA) in transfemoral transcatheter aortic valve replacement (TF-TAVR).
To close the femoral artery in TF-TAVR a VCD is the treatment of choice. Data involving suture-based VCDs have been extensive. Although scarce, results on the MANTA device are promising. There is no consensus yet as to whether the MANTA device is associated with fewer access-site-related vascular/bleeding complications when compared to suture-based VCDs.
In this prospective single-arm study, performed at a single centre, a total of 73 patients eligible for TF-TAVR were included and consecutively treated with the MANTA device.
Access-site-related vascular complications were seen in 13.7% of patients treated with the MANTA device. In this group of patients only minor vascular complications were observed. Access-site-related bleeding complications were rare (6.8%), and device failure was seen in 13.7% of the patients.
This single-centre study confirms that use of the MANTA device in TF-TAVR is feasible with an acceptable rate of access-site-related complications and no major vascular complications.
本研究旨在评估MANTA血管闭合装置（VCD）（美国北卡罗来纳州莫里斯维尔市泰利福公司生产）在经股动脉经导管主动脉瓣置换术（TF-TAVR）中的有效性和安全性。
在TF-TAVR中，VCD是闭合股动脉的首选治疗方法。关于基于缝线的VCD的数据已经很广泛。虽然关于MANTA装置的数据很少，但结果很有前景。与基于缝线的VCD相比，MANTA装置是否与较少的与穿刺部位相关的血管/出血并发症相关，目前尚无共识。
在单中心进行的这项前瞻性单臂研究中，共纳入73例符合TF-TAVR条件的患者，并连续使用MANTA装置进行治疗。
使用MANTA装置治疗的患者中，13.7%出现了与穿刺部位相关的血管并发症。在这组患者中，仅观察到轻微的血管并发症。与穿刺部位相关的出血并发症很少见（6.8%），13.7%的患者出现了装置故障。
这项单中心研究证实，在TF-TAVR中使用MANTA装置是可行的，与穿刺部位相关的并发症发生率可接受，且无重大血管并发症。
