经皮血管缝合器的临床安全性评价

Clinical evaluation about safety of arteriotomy closure device

目的:评价冠状动脉造影和介入治疗后Perclose血管缝合器止血的临床安全性。方法:对264例接受冠状动脉造影或支架术患者,在术后使用血管缝合器Perclose 132例(Perclose组)或人工压迫止血132例(人工组)作股动脉穿刺部位止血。比较2组的止血时间、制动时间和血管并发症发生率。结果:Perclose组显著缩短止血时间和制动时间(P<0.01),但其与人工组的血管并发症发生率差异无统计学意义(5.3%∶6.1%,P>0.05)。结论:使用Perclose血管缝合器能显著缩短止血时间和制动时间,但不减少股动脉穿刺并发症的发生。

Objective：To assess the safety ot arteriotomy closure device （ Perclose ） in patients undergoing coronary angiography or percutaneous coronary interventions, Method：Two hundred and sixty four patients were randomly allocated to hemostatic treatment with Perelose device （ Perclose group, n = 132 ） or by manual compression （manual group, n = 132 ） after coronary angiography or percutaneous coronary interventions. Time to achievement of hemostasis, braking time and vascular complications were compared between the two groups. Resuit：Both time to achievement of hemostasis and braking time were significantly reduced in the Perclose group （ P〈0. 01）, but the incidence of vascular complications was similar between Perclose group and manual group （5.3 % ： 6.1%, P〉0.05）. Conclusion： Arteriotomy closure device Perclose can achieve hemostasis and ambulation faster than manual compression, but it may not decrease vascular complications at the access site.