Medizinische Klinik I, Medical Faculty, University RWTH Aachen, Pauwelsstr. 30, 52074 Aachen, Germany.
Clin Res Cardiol. 2011 Sep;100(9):789-95. doi: 10.1007/s00392-011-0313-4. Epub 2011 Apr 11.
This study aimed at exploring access site-related vascular complication rates associated with the use of the vascular closure device (VCD) Angio-Seal™ in an unselected patient population undergoing elective as well as emergency coronary angiography or intervention.
The VCD Angio-Seal™ is widely used to achieve hemostasis after diagnostic and interventional cardiac procedures. There are only little data on the frequency of vascular complications after the use of the VCD Angio-Seal™ in patients in non-elective settings.
In-hospital vascular complications were prospectively assessed in 4,653 consecutive cardiac catheterization procedures, which included 2,772 elective diagnostic and 960 elective percutaneous coronary interventions (PCI), and 921 emergency cardiac catheterizations in patients with NSTEMI/STEMI. In 2,077 procedures manual compression (MC) and in 2,576 procedures VCD was applied. Complication rates for manual compression and VCD use were studied and multivariate analyses performed to disclose predictors for access site-related vascular complications.
Vascular complication rates in patients receiving MC to achieve hemostasis were similar to those receiving a VCD (MC 3.4% vs. VCD 3.2%, p = n.s.). Separate analysis of vascular complication rates for subgroups revealed a significant reduction in vascular complications for the PCI group using a VCD (MC 7.7% vs. VCD 3.2%, p = 0.003). In emergencies VCD use lead to a rise in vascular complications (MC 0.9% vs. VCD 6.3%, p < 0.001).
In contrast to elective settings, the risk of access site-related vascular complications is significantly increased after application of the VCD Angio-Seal™ in patients undergoing emergency catheterizations for NSTEMI/STEMI compared with manual compression.
本研究旨在探讨在未经选择的行择期或急诊冠状动脉造影或介入治疗的患者人群中，使用血管闭合装置（VCD）Angio-Seal™相关的血管入路并发症发生率。
VCD Angio-Seal™ 广泛用于在诊断和介入心脏手术后实现止血。在非择期情况下使用 VCD Angio-Seal™ 后血管并发症的频率仅有少量数据。
前瞻性评估了 4653 例连续心脏导管插入术的院内血管并发症，其中包括 2772 例择期诊断和 960 例择期经皮冠状动脉介入治疗（PCI），以及 921 例非 ST 段抬高型心肌梗死/ST 段抬高型心肌梗死患者的急诊心脏导管插入术。在 2077 例中采用手动压迫（MC），在 2576 例中采用 VCD。研究了 MC 和 VCD 应用的并发症发生率，并进行了多变量分析以揭示与血管入路相关的血管并发症的预测因素。
接受 MC 止血的患者的血管并发症发生率与接受 VCD 的患者相似（MC 3.4% vs. VCD 3.2%，p=无统计学意义）。对亚组血管并发症发生率的单独分析显示，使用 VCD 的 PCI 组血管并发症显著减少（MC 7.7% vs. VCD 3.2%，p=0.003）。在急诊中，VCD 的使用导致血管并发症增加（MC 0.9% vs. VCD 6.3%，p<0.001）。
与择期情况相比，在 NSTEMI/STEMI 患者中进行紧急导管插入术时，与手动压迫相比，应用 VCD Angio-Seal™ 显著增加了与血管入路相关的血管并发症的风险。
