Kussmaul W G, Buchbinder M, Whitlow P L, Aker U T, Heuser R R, King S B, Kent K M, Leon M B, Kolansky D M, Sandza J G
Pennsylvania Hospital, Philadelphia, USA.
J Am Coll Cardiol. 1995 Jun;25(7):1685-92. doi: 10.1016/0735-1097(95)00101-9.
This study was performed to test the safety and efficacy of a novel bioabsorbable hemostatic puncture closure device deployed through an arterial sheath.
Cardiac catheterization procedures are associated with a risk of complications at the arterial access site. Increasing numbers of interventional procedures requiring large sheaths or intense anticoagulation underline the need for secure, rapid methods of obtaining hemostasis at the time of sheath removal.
We conducted a randomized, multicenter trial in 435 patients undergoing cardiac catheterization or angioplasty at eight participating centers. In 218 patients, hemostasis was achieved using the device (group I); 217 patients were assigned to the manual pressure control group (group II).
There were no significant differences in baseline characteristics. Time to hemostasis was considerably shorter in group I (2.5 +/- 15.2 vs. 15.3 +/- 11.7 min [mean +/- SD], p < 0.0001). The deployment success rate for the device was 96%, and 76% of group I patients experienced immediate (within 1 min) hemostasis. Complication rates were lower in group I for bleeding, hematoma and occurrence of any complication. There was no difference in the small incidence of pseudoaneurysm formation. There was no change in either group in the ankle/brachial systolic blood pressure index. Ultrasound follow-up studies 60 days after device deployment revealed complete absorption of the device in all cases. Subgroup analysis revealed particular benefit in patients undergoing interventional procedures. The administration of heparin was associated with a significantly higher complication rate in the manual pressure control group, whereas heparin had no effect on hemostasis time or complication rates in the device group.
This sheath-deployed, bioabsorbable device provides a safe and effective means of obtaining rapid arterial hemostasis after cardiac catheterization procedures. It appears to be particularly useful in those patients most at risk for access site complications.
本研究旨在测试一种通过动脉鞘管置入的新型生物可吸收止血穿刺闭合装置的安全性和有效性。
心脏导管插入术在动脉穿刺部位存在并发症风险。越来越多的介入手术需要使用大鞘管或强化抗凝，这凸显了在拔除鞘管时采用安全、快速止血方法的必要性。
我们在八个参与中心对435例接受心脏导管插入术或血管成形术的患者进行了一项随机、多中心试验。218例患者使用该装置实现止血（第一组）；217例患者被分配至手动压迫对照组（第二组）。
两组患者的基线特征无显著差异。第一组的止血时间明显更短（2.5±15.2分钟对15.3±11.7分钟[平均值±标准差]，p<0.0001）。该装置的置入成功率为96%，第一组76%的患者实现了即刻（1分钟内）止血。第一组在出血、血肿及任何并发症的发生率方面较低。假性动脉瘤形成的发生率较低，两组之间无差异。两组的踝/臂收缩压指数均无变化。装置置入60天后的超声随访研究显示，所有病例中该装置均完全吸收。亚组分析显示，在接受介入手术的患者中该装置具有特别的益处。在手动压迫对照组中，肝素的使用与显著更高的并发症发生率相关，而肝素对装置组的止血时间或并发症发生率无影响。
这种通过鞘管置入的生物可吸收装置为心脏导管插入术后快速实现动脉止血提供了一种安全有效的方法。它似乎对那些发生穿刺部位并发症风险最高的患者特别有用。
