Camenzind E, Grossholz M, Urban P, Dorsaz P A, Didier D, Meier B
Department of Cardiology, University Hospital, Geneva, Switzerland.
J Am Coll Cardiol. 1994 Sep;24(3):655-62. doi: 10.1016/0735-1097(94)90011-6.
This study evaluated the safety and efficacy of a newly developed puncture-sealing device consisting of subcutaneous bovine collagen application designed to facilitate local hemostasis after coronary angioplasty.
The most common local hemostatic procedure after coronary angioplasty consists of heparin discontinuation and delayed sheath removal followed by mechanical compression at the puncture site.
Between December 1991 and February 1993, 124 patients undergoing coronary angioplasty with either a 6F guiding catheter followed by a heparin infusion for > 12 h or a 7F or 8F guiding catheter with optional heparin infusion were prospectively randomized to either delayed sheath removal followed by manual compression (n = 62) or sheath removal immediately after angioplasty combined with bovine collagen application for puncture site closure (n = 62). Half of the collagen plugs were delivered using measured and half using estimated skin-artery distance. Clinical and duplex sonographic evaluations of the puncture site were performed 24 h later.
No significant difference in the incidence of local hematomas was observed. Major complications were false aneurysm, venous thrombosis and arterial occlusion. The incidence of false aneurysm was the same in both groups (4 [7%] of 62). Venous thrombosis (2%) and arterial occlusion (2%) were each recorded in one patient, both in the collagen application group.
Sheath removal and collagen application with this new vascular hemostasis device used directly after coronary angioplasty are not superior to delayed sheath removal after heparin discontinuation followed by mechanical compression. Arterial collagen sealing with this device in its current form is associated with a small but worrisome risk of arterial occlusion.
本研究评估一种新开发的穿刺封闭装置的安全性和有效性，该装置由皮下应用牛胶原蛋白组成，旨在促进冠状动脉血管成形术后局部止血。
冠状动脉血管成形术后最常见的局部止血方法包括停用肝素、延迟拔除鞘管，随后在穿刺部位进行机械压迫。
在1991年12月至1993年2月期间，124例行冠状动脉血管成形术的患者被前瞻性随机分组，其中62例使用6F引导导管并肝素输注>12小时，或使用7F或8F引导导管并选择性肝素输注，这些患者被随机分为延迟拔除鞘管后手动压迫组（n = 62）和血管成形术后立即拔除鞘管并应用牛胶原蛋白封闭穿刺部位组（n = 62）。一半的胶原蛋白栓塞剂通过测量皮肤-动脉距离来应用，另一半通过估计皮肤-动脉距离来应用。24小时后对穿刺部位进行临床和双功超声评估。
局部血肿发生率无显著差异。主要并发症为假性动脉瘤、静脉血栓形成和动脉闭塞。两组假性动脉瘤发生率相同（62例中有4例[7%]）。静脉血栓形成（2%）和动脉闭塞（2%）各有1例记录，均在胶原蛋白应用组。
冠状动脉血管成形术后直接使用这种新型血管止血装置拔除鞘管并应用胶原蛋白并不优于停用肝素后延迟拔除鞘管并进行机械压迫。以目前形式使用该装置进行动脉胶原蛋白封闭与动脉闭塞的小但令人担忧的风险相关。
