Dehghani Payam, Mohammad Atif, Marcuzzi Danny, Hong Tony, Holmes Kate, Evangelista Melma Jean S, Boutin Adrien, Leong-Poi Howard, Cheema Asim N
Terrence Donnelly Heart Center, St. Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada.
J Invasive Cardiol. 2010 Nov;22(11):505-10.
Currently approved vascular closure devices (VCDs) are not recommended for use in arterial puncture sites distal to the common femoral artery (CFA) bifurcation. The StarClose™ vascular system (SC) is a unique VCD that does not contain intravascular components, a feature that may allow safe use in smaller vessels.
We sought to determine the efficacy and long-term safety of the SC for hemostasis of arterial punctures distal to the CFA bifurcation.
Consecutive patients with arterial puncture sites located distal to the CFA bifurcation received SC after percutaneous coronary intervention (PCI). Patients were ambulated 4-6 hours later, and the presence of vascular complications was determined clinically before hospital discharge. Clinical and Doppler ultrasound examinations were performed at 8-9 months to assess long-term safety.
A total of 106 patients undergoing PCI were included in the study. Mean age was 66 ± 12 years and 63% were male. The arterial puncture site was located in the superficial femoral artery (SFA) in 76 (72%), the profunda femoris artery (PFA) in 22 (21%) and undetermined in 8 (7%) patients. The mean diameter of the CFA was significantly greater than the SFA or the PFA branch with the SC (6.2 ± 1.5 vs. 4.5 ± 1.0 mm for the CFA and branch with SC, respectively; p < 0.0001). Device success was achieved in 102 (96%) patients. At 24 hours, a hematoma ≥ 5 cm was reported in 13 (12%) patients. No other vascular complications occurred. At a mean follow up of 9 ± 2.5 months, there was no clinical or Doppler evidence of arterial insufficiency or vascular complications.
The SC can be used for hemostasis after PCI in select cases where the arterial puncture site is located distal to the CFA bifurcation without adverse clinical outcomes.
目前批准使用的血管闭合装置（VCDs）不推荐用于股总动脉（CFA）分叉远端的动脉穿刺部位。StarClose™血管系统（SC）是一种独特的VCD，不包含血管内组件，这一特性可能使其能够安全用于较小血管。
我们试图确定SC用于CFA分叉远端动脉穿刺止血的有效性和长期安全性。
连续的CFA分叉远端动脉穿刺部位的患者在经皮冠状动脉介入治疗（PCI）后接受SC。4 - 6小时后让患者下床活动，并在出院前临床确定是否存在血管并发症。在8 - 9个月时进行临床和多普勒超声检查以评估长期安全性。
共有106例接受PCI的患者纳入研究。平均年龄为66±12岁，63%为男性。76例（72%）患者的动脉穿刺部位位于股浅动脉（SFA），22例（21%）位于股深动脉（PFA），8例（7%）患者未明确。CFA的平均直径显著大于使用SC时的SFA或PFA分支（CFA和使用SC的分支分别为6.2±1.5 vs. 4.5±1.0 mm；p < 0.0001）。102例（96%）患者实现了装置成功。24小时时，13例（12%）患者报告有≥5 cm的血肿。未发生其他血管并发症。平均随访9±2.5个月时，没有临床或多普勒证据表明存在动脉供血不足或血管并发症。
在动脉穿刺部位位于CFA分叉远端的特定情况下，SC可用于PCI后的止血，且无不良临床结局。
