Miyashita Hirokazu, Moriyama Noriaki, Dahlbacka Sebastian, Vähäsilta Tommi, Vainikka Tiina, Jalanko Mikko, Viikilä Juho, Laine Mika
Heart and Lung Center, Helsinki University and Helsinki University Central Hospital, Helsinki, Finland; Department of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Kamakura, Japan.
Department of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Kamakura, Japan.
Am J Cardiol. 2022 Oct 1;180:116-123. doi: 10.1016/j.amjcard.2022.06.046. Epub 2022 Aug 4.
Despite the development of device technology and operators' experience, access site vascular complications (VCs) remain one of the major concerns after transcatheter aortic valve implantation (TAVI). MANTA (Teleflex, Wayne, Pennsylvania) is a large-bore vascular closure device (VCD) with promising incidence of VC. Previously, we demonstrated that the ultrasound-guided MANTA (US-MANTA) technique further improved the outcomes compared with conventional MANTA (C-MANTA) without ultrasound guidance. The present study was established to prove the effectiveness of the technique in a larger population. In this study, we included 1,150 patients (335 patients with C-MANTA and 815 with US-MANTA) who received MANTA after TAVI from April 2017 to September 2021. The primary endpoint was MANTA-related VC. Overall VC, VCD failure, and bleeding complications were also assessed based on the Valve Academic Research Consortium 3 criteria. MANTA-related VC occurred in 12.5% in the C-MANTA group and 6.8% in the US-MANTA group (p = 0.001). VCD failure rate were 7.5% and 3.9%, respectively (p = 0.012). Valve Academic Research Consortium 3 major and minor VC were more frequent in C-MANTA group (major: 7.8% vs 4.4%, p = 0.023; minor: 8.1% vs 4.4%, p = 0.022). Multivariate analysis revealed US-MANTA as the negative predictor of MANTA-related VC (odds ratio 0.57, 95% confidence interval 0.36 to 0.89, p = 0.013). However, subgroup analysis showed the efficacy of the US-MANTA technique was limited to the patients without severely calcified puncture site (P = 0.048). In conclusion, the US-MANTA technique was an effective strategy to reduce VC after transfemoral TAVI compared with C-MANTA.
尽管设备技术有所发展且操作人员经验日益丰富，但穿刺部位血管并发症（VCs）仍是经导管主动脉瓣植入术（TAVI）后主要关注的问题之一。MANTA（泰利福公司，宾夕法尼亚州韦恩）是一种大口径血管闭合装置（VCD），其VC发生率有望降低。此前，我们证明与无超声引导的传统MANTA（C-MANTA）相比，超声引导下的MANTA（US-MANTA）技术进一步改善了治疗效果。本研究旨在证实该技术在更大规模人群中的有效性。在本研究中，我们纳入了2017年4月至2021年9月期间接受TAVI后使用MANTA的1150例患者（335例使用C-MANTA，815例使用US-MANTA）。主要终点是与MANTA相关的VC。还根据瓣膜学术研究联盟3标准评估了总体VC、VCD失败和出血并发症。C-MANTA组中与MANTA相关的VC发生率为12.5%，US-MANTA组为6.8%（p = 0.001）。VCD失败率分别为7.5%和3.9%（p = 0.012）。瓣膜学术研究联盟3标准的主要和次要VC在C-MANTA组中更常见（主要：7.8%对4.4%，p = 0.023；次要：8.1%对4.4%，p = 0.022）。多变量分析显示US-MANTA是与MANTA相关VC的负性预测因素（比值比0.57，95%置信区间0.36至0.89，p = 0.013）。然而，亚组分析显示US-MANTA技术的疗效仅限于穿刺部位无严重钙化的患者（P = 0.048）。总之，与C-MANTA相比，US-MANTA技术是降低经股动脉TAVI后VC的有效策略。
