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一种用于即时封闭动脉穿刺部位的新型止血穿刺闭合装置。

A new hemostatic puncture closure device for the immediate sealing of arterial puncture sites.

作者信息

de Swart H, Dijkman L, Hofstra L, Bär F W, Van Ommen V, Tordoir J, Wellens H J

机构信息

Department of Cardiology, Academic Hospital Maastricht, The Netherlands.

出版信息

Am J Cardiol. 1993 Aug 15;72(5):445-9. doi: 10.1016/0002-9149(93)91138-8.

DOI:10.1016/0002-9149(93)91138-8
PMID:8352188
Abstract

After angiography, 6 to 24 hours of bedrest is indicated to assure that adequate hemostasis of the femoral artery has been achieved. Recently, a new hemostatic puncture closure device (HPCD) has been developed, which consists of a resorbable polymer anchor, a resorbable suture, a small collagen plug and an 8Fr delivery device. The device is delivered into the femoral artery through the introducer sheath, the anchor is secured against the intraluminal artery wall, and the collagen plug is deployed on the arterial wall. The prototype of the HPCD was used in 20 patients administered heparin. After insertion of the HPCD, hemostasis was achieved in 1.2 +/- 2.1 minutes; in 2 patients a light pressure dressing was applied for 4 hours to stop oozing. No late bleeding occurred. In 1 patient the positioning suture broke, requiring the application of a pressure bandage. Patients were uneventfully mobilized after 6.7 +/- 3.5 hours. In all patients serial duplex scanning of the femoral artery was performed before and after 1, 7, 30 and 90 days after HPCD placement. In 5 patients a small subcutaneous hematoma close to the site of introduction could be detected by ultrasound 1 day after catheterization. All but 1 patient had normalization of the flow patterns in the femoral artery. It is concluded that: (1) the HPCD is an effective device to achieve immediate hemostasis after arterial catheterization despite antithrombotic therapy, (2) early mobilization was uneventful, (3) duplex ultrasound studies demonstrated only transient changes in the punctured femoral artery, and (4) further investigations are needed to establish the efficacy and safety of the device.

摘要

血管造影术后,建议卧床休息6至24小时,以确保股动脉充分止血。最近,一种新型止血穿刺闭合装置(HPCD)已被研发出来,它由一个可吸收聚合物锚、一根可吸收缝线、一个小胶原蛋白塞和一个8Fr输送装置组成。该装置通过导入鞘管送入股动脉,将锚固定在动脉腔内的血管壁上,并将胶原蛋白塞部署在动脉壁上。HPCD的原型在20例接受肝素治疗的患者中使用。插入HPCD后,1.2±2.1分钟内实现止血;2例患者应用轻压敷料4小时以止血。未发生迟发性出血。1例患者定位缝线断裂,需要应用加压绷带。患者在6.7±3.5小时后顺利活动。对所有患者在放置HPCD前以及放置后1、7、30和90天进行股动脉系列双功扫描。5例患者在插管后1天通过超声检测到靠近穿刺部位有小的皮下血肿。除1例患者外,所有患者股动脉血流模式均恢复正常。得出以下结论:(1)尽管进行了抗血栓治疗,HPCD仍是动脉插管后实现即时止血的有效装置;(2)早期活动顺利;(3)双功超声研究仅显示穿刺股动脉有短暂变化;(4)需要进一步研究以确定该装置的有效性和安全性。

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