Bangalore Sripal, Vidi Venkatesan D, Liu Christopher B, Shah Pinak B, Resnic Frederic S
New York University School of Medicine, New York, USA.
J Invasive Cardiol. 2011 May;23(5):194-9.
To evaluate the efficacy and safety of the nitinol clip-based closure device (Starclose®, Abbott Vascular, Santa Clara, California) in patients with femoral arterial cannulation at the common femoral artery bifurcation.
Femoral artery puncture at the bifurcation of common femoral artery is a relative contraindication for the use of vascular closure devices with intravascular components, and patients with bifurcation cannulation were excluded from the pivotal trials of these devices. The nitinol clip-based closure device (Starclose) is extravascular and is sometimes used in such patients; however, the efficacy and safety of this approach is unknown.
We evaluated consecutive patients undergoing deployment of a Starclose device following a coronary procedure via the femoral artery approach. Quantitative femoral angiographic analyses were performed using a hand caliper. The distance of the artery puncture site from the bifurcation was recorded in each patient. Any arterial cannulation ≤ 3 mm from the bifurcation was categorized as a bifurcation cannulation (as the outer diameter of the nitinol clip of Starclose is 4 mm).
Among 1096 patients who underwent deployment of a Starclose device, 217 (20%) were within 3 mm of the bifurcation. Starclose deployment at the bifurcation was not associated with a significant increase in the risk of any (0.9% vs. 1.0%; p = 0.892) major (0.0% vs. 0.3%; p = 0.389) or minor vascular complications (0.9% vs. 0.7%; p = 0.711) compared to deployment for non-bifurcation cannulations (both for diagnostic and percutaneous coronary interventional procedures). The results were unchanged in both a regression model adjusted for a propensity score (41 baseline covariates) as well as a propensity score-matched cohort (217 bifurcation cannulations vs. 217 non-bifurcation cannulations).
In a select group of patients, vascular closure using a extravascular closure device (Starclose) appears to be safe for arterial cannulations at or near the bifurcation.
评估基于镍钛合金夹的闭合装置（Starclose®，雅培血管，加利福尼亚州圣克拉拉）在股总动脉分叉处进行股动脉插管患者中的有效性和安全性。
在股总动脉分叉处进行股动脉穿刺是使用带有血管内组件的血管闭合装置的相对禁忌证，并且分叉处插管的患者被排除在这些装置的关键试验之外。基于镍钛合金夹的闭合装置（Starclose）是血管外的，有时用于此类患者；然而，这种方法的有效性和安全性尚不清楚。
我们评估了通过股动脉途径进行冠状动脉手术后连续接受Starclose装置植入的患者。使用手动卡尺进行定量股动脉血管造影分析。记录每位患者动脉穿刺部位距分叉处的距离。任何距分叉处≤3 mm的动脉插管被归类为分叉处插管（因为Starclose的镍钛合金夹外径为4 mm）。
在1096例接受Starclose装置植入的患者中，217例（20%）位于距分叉处3 mm以内。与非分叉处插管（用于诊断和经皮冠状动脉介入手术）相比，在分叉处植入Starclose与任何主要（0.9%对1.0%；p = 0.892）、主要（0.0%对0.3%；p = 0.389）或次要血管并发症（0.9%对0.7%；p = 0.711）风险的显著增加无关。在针对倾向评分（41个基线协变量）进行调整的回归模型以及倾向评分匹配队列（217例分叉处插管与217例非分叉处插管）中，结果均未改变。
在一组特定患者中，使用血管外闭合装置（Starclose）进行血管闭合对于分叉处或其附近的动脉插管似乎是安全的。
