经股动脉心导管术后应用Angio-Seal血管封堵器与徒手压迫两种止血方法的随机对比分析

A Randomized Comparison for Two Hemostasis after Cardiac Catheterization Via Femoral Artery

目的 :随机对比研究经股动脉心导管术后应用 Angio- Seal血管封堵装置 (VCD)与徒手压迫止血方法(MC)的优弱。方法 :将 2 0 0例患者随机分为 A、B两组 ,A组应用 VCD,B组为 MC,观察 :止血成功率、止血时间、加压包扎时间和肢体制动时间 ,以及穿刺部位并发症和全身并发症 (血管迷走神经反射、腰背不适等 )。结果 :两组止血成功率(A组 95 % ,B组 87% )、止血时间 (A组 3.19min± 1.6 4 min,B组 18.71min± 6 .87min)、加压包扎时间 (A组 0 h,B组6 .0 8h± 2 .4 3h)和肢体制动时间 (A组 2 .92 h± 1.4 2 h,B组 2 1.4 h± 2 .5 h)均有显著差异 (P<0 .0 0 1)。并发症的发生率 A组明显低于 B组。结论 :应用 VCD可以明显降低术后患者的不适程度和并发症的发生率 ,减轻医护人员的负担 ,尤其适于一些穿刺处并发症高危患者或不能耐受长时间制动的患者。

Objective:To compare the safety and efficacy of vascular closure device (VCD) with manual compression (MC) in achieving hemostasis after femoral cardiac catheterization patients and to determine the ability of these two techniques to reduce groin complications and discomfort.Methods:A total of 200 patients were randomly divided into VCD (group A,n=100) versus MC (group B,n=100). The success rate of hemostasis, the time of hemostasis, of bandaging with compression, of immobilization and the complication rates were observed.Results:Technical success rate (group A 95% vs.87%), the time of hemostasis (group A 3.19 min±1.64 min vs. 18.71 min±6.87 min), of bandaging with compression (group A 0h vs. 6.08 h±2.43 h), of immobilization (group A 2.92 h±1.42 h vs.21.4 h±2.5 h) all were significantly different between the two groups (P<0.001). There were low rate of complication including merely 5% (vs.11%) of the hematomas, 2% (vs.8%) of vasovagal reflex in the group A. There were 5% of pseudoaneurysm, of and 92% of distress on the waist and lower limb.Conclusion:This vascular closure device provideed a safe and effective means of obtaining rapid arterial hemostasis after cardiac catheterizatio. It appeared to be particularly useful in patients most at risk for access site complications or patients unable to tolerate laying for a long time.