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目的:Angio—Seal血管闭合装置是一种新型的止血装置。本研究旨在探讨在冠状动脉造影和介入治疗术后,使用Angio-Seal血管闭合装置对股动脉穿刺部位进行止血的有效性、安全性及并发症发生情况。方法:2003年5月-2004年2月期间,我院心内科共对129例(男性99例,女性30例,平均年龄63.2±11.5岁)行冠脉造影或介入治疗的患者使用了Angio-Seal血管闭合装置进行股动脉穿刺部位的止血,观察使用该装置所需的止血时间、患者的下肢制动时问以及止血即刻至术后7d内局部并发症的发生情况。结果:129例患者中,128例即刻止血成功,成功率为99.2%。失败的1例为胶原栓经鞘管送入后未能充分打开,撤出输送鞘管时被一并拉出。成功止血的128例患者的止血时间为0.5-3min(平均1.1±0.6min);术后下肢平均制动时间为7.1±3.4h,其中112例患者在4-6h可以下床活动,16例患者因局部渗血而延长下肢制动时间至10-24h;止血过程中和止血后无1例患者发生显著迷走反应;术后随访7d,发生皮下血肿(直径≥3cm)5例,假性动脉瘤1例,局部并发症的总发生率为4.69%,无1例需行外科血管修复术。结论:在冠状动脉造影和介入治疗术后,Angio-Seal血管闭合装置是一种安全、有效的动脉止血装置,它可以缩短止血时间和术后肢体制动时间,并有助于减少局部并发症的发生。
Objective: Angio-Seal vascular closure device is a new type of hemostasis device. The purpose of this study was to investigate the efficacy, safety and complication of hemostasis of femoral artery puncture site using Angio-Seal vascular closure device after coronary angiography and interventional therapy. Methods: From May 2003 to February 2004, 129 patients (99 males and 30 females, mean age 63.2 ± 11.5 years) undergoing coronary angiography or interventional therapy were treated with Angio- Seal vessel closure device for the femoral artery puncture site to stop bleeding, observe the device using the required time to stop bleeding, the patient’s lower limbs when asked to brake and hemostasis immediately to 7d after surgery, the occurrence of local complications. Results: Among the 129 patients, 128 cases were successfully stopped bleeding immediately, with a success rate of 99.2%. One case of failure failed to fully open after the collagen plug was delivered through the sheath, and was pulled out when it was withdrawn from the delivery sheath. 128 cases of successful hemostasis stop bleeding time 0.5-3min (average 1.1 ± 0.6min); average postoperative lower limb brake time was 7.1 ± 3.4h, of which 112 patients can be out of bed in 4-6h activity, 16 patients Due to local bleeding lengthening the lower limbs braking time to 10-24h; hemostasis during and after the hemostasis in 1 patient did not produce significant vagal reaction; 7d after follow-up, subcutaneous hematoma (diameter ≥ 3cm) in 5 cases, pseudoaneurysm In 1 case, the overall incidence of local complications was 4.69%. No patient required surgical vascular repair. CONCLUSIONS: Angio-Seal vascular closure device is a safe and effective arterial hemostasis device after coronary angiography and interventional therapy. It can shorten the time of hemostasis and postoperative limb immobilization, and help to reduce local complications happened.