Silber S
Dr. Müller Hospital, Munich, Germany.
Clin Cardiol. 1997 Dec;20(12):981-92. doi: 10.1002/clc.4960201203.
Despite the continuous reduction of sheath sizes in diagnostic and interventional cardiac catheterizations and the discontinuation of coumadin use after coronary stent implantation, a challenging role remains for hemostatic devices in the sealing femoral puncture sites. Since the introduction of the vascular hemostatic device (VHD) in 1991 and the hemostatic puncture closing device (HPCD) in 1992, numerous studies investigating these devices have been published. The deployment success rates reported in 2,292 patients for VHD is 97%, ranging from 88 to 100%. For HPCD, the mean deployment success rate resulting from 622 published patients leads to an identical result of 97%, ranging between 91 and 100%. For time to hemostasis, data have been analyzed according to the four different clinical situations, depending on level of anticoagulation (none or full) and the time of sheath removal (immediate or delayed). In randomized studies, when compared with the manual control groups, both devices revealed a statistically significant reduction in time to hemostasis: 12 to 16 minutes less for diagnostic catheterization and 14 to 30 minutes less for PTCA. As for minor local complications, no clinically relevant differences seem to exist. None of these devices has been proven to reduce major local complications. Prospective trials addressing early mobilization after percutaneous transluminal coronary angioplasty and the cost effectiveness of arterial closure devices in defined subgroups are warranted.
尽管诊断性和介入性心脏导管插入术中鞘管尺寸不断减小,且冠状动脉支架植入术后停用了华法林,但止血装置在封闭股动脉穿刺部位方面仍发挥着挑战性作用。自1991年引入血管止血装置(VHD)和1992年引入止血穿刺闭合装置(HPCD)以来,已有大量关于这些装置的研究发表。2292例患者使用VHD的部署成功率为97%,范围在88%至100%之间。对于HPCD,622例已发表患者的平均部署成功率同样为97%,范围在91%至100%之间。对于止血时间,已根据四种不同临床情况进行数据分析,这取决于抗凝水平(无或充分)以及鞘管移除时间(立即或延迟)。在随机研究中,与手动对照组相比,两种装置均显示止血时间在统计学上显著缩短:诊断性导管插入术减少12至16分钟,经皮冠状动脉腔内血管成形术(PTCA)减少14至30分钟。至于轻微局部并发症,似乎不存在临床相关差异。这些装置均未被证明能减少严重局部并发症。有必要进行前瞻性试验,探讨经皮腔内冠状动脉成形术后的早期活动情况以及特定亚组中动脉闭合装置的成本效益。