Ward S R, Casale P, Raymond R, Kussmaul W G, Simpfendorfer C
Cleveland Clinic Foundation, Ohio 44195, USA.
Am J Cardiol. 1998 Mar 1;81(5):569-72. doi: 10.1016/s0002-9149(97)00970-3.
A collagen hemostatic puncture closure device has been developed as an alternative to traditional manual pressure techniques for achieving effective femoral arterial hemostasis after coronary angiography. The purpose of the current study was to determine if patients receiving this device can ambulate safely at 1 hour compared with patients receiving traditional manual pressure and bed rest after sheath removal for diagnostic cardiac catheterization. Patients (n = 304) were randomized to either the device group (n = 202) with ambulation at 1 hour after sheath removal or to the manual pressure control group (n = 102) with ambulation at 4 to 6 hours after sheath removal. The device group achieved earlier time to hemostasis (0.9 +/- 3 vs 17.0 +/- 8 minutes, p = 0.0001) and faster time to outpatient discharge (5.0 +/- 4 vs 7.7 +/- 4 hours, p = 0.0001) compared with the control group. There were bleeding or vascular complications in 19 patients (9%) in the device group and in 6 patients (6%) in the manual pressure group (p = 0.397). In patients undergoing diagnostic coronary angiography, this device, compared with traditional techniques for achieving hemostasis after sheath removal, allows for faster time to effective hemostasis with resultant earlier discharge from the hospital.
一种胶原蛋白止血穿刺闭合装置已被开发出来，作为冠状动脉造影后实现有效股动脉止血的传统手动压迫技术的替代方法。本研究的目的是确定与接受传统手动压迫并在拔除鞘管后卧床休息的患者相比，接受该装置的患者在1小时后能否安全行走。患者（n = 304）被随机分为装置组（n = 202），在拔除鞘管后1小时行走，或手动压迫对照组（n = 102），在拔除鞘管后4至6小时行走。与对照组相比，装置组实现止血的时间更早（0.9±3对17.0±8分钟，p = 0.0001），出院时间更快（5.0±4对7.7±4小时，p = 0.0001）。装置组有19例患者（9%）出现出血或血管并发症，手动压迫组有6例患者（6%）出现此类并发症（p = 0.397）。在接受诊断性冠状动脉造影的患者中，与拔除鞘管后实现止血的传统技术相比，该装置能更快实现有效止血，从而使患者更早出院。
