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随机试验:使用聚焦压迫与球囊压迫设备进行桡动脉止血。

Randomized Trial of Radial Hemostasis Using Focused vs Balloon Compression Devices.

机构信息

Gagnon Cardiovascular Institute, Morristown Medical Center, 100 Madison Ave, Morristown, NJ 07960 USA.

出版信息

J Invasive Cardiol. 2020 May;32(5):169-174. doi: 10.25270/jic/19.00407. Epub 2020 Apr 24.

DOI:10.25270/jic/19.00407
PMID:32330117
Abstract

BACKGROUND

Radial artery hemostasis devices differ in compression mechanisms, which may influence time to hemostasis and hand perfusion.

METHODS

Subjects (n = 52) undergoing transradial diagnostic coronary catheterization or percutaneous coronary intervention (PCI) were randomized 1:1 to either focused compression (VasoStat; Forge Medical) or balloon compression device (TR Band; Terumo Medical) for radial artery hemostasis. Time to complete hemostasis enabling device removal was measured in each subject. Hand perfusion was quantitated using the perfusion index (PI) with oximetry (1) before; (2) during device use; (3) during device use with ulnar artery compression; and (4) following device removal.

RESULTS

Focused compression resulted in a significantly shorter time to complete hemostasis vs balloon compression (208 min [IQR, 115-320 min] vs 242 min [IQR, 120-439 min], respectively; P=.04). This difference was greatest among the subset undergoing PCI, where the VasoStat resulted in a 43-minute reduction until complete hemostasis (P=.04). Baseline PI was similar between the focused and balloon compression groups (4.9 vs 3.9, respectively; P=.09). Focused compression resulted in a similar reduction in median PI from baseline to during device use compared with balloon compression (-27% vs -18%, respectively; P=.26). Both devices decreased PI over 50% from baseline during simultaneous ulnar artery compression (P<.01), and increased PI over 50% from baseline following device removal (P=.02). No radial artery occlusion occurred, and rates of device manipulation and access-site bleeds were low in both groups.

CONCLUSION

Complete hemostasis was achieved earlier with the VasoStat focused compression device compared with the TR Band balloon compression device. Both devices transiently reduced hand perfusion, particularly during ulnar compression, which increased from baseline following device removal. Larger trials comparing these radial hemostasis devices and outcomes are warranted.

摘要

背景

桡动脉止血装置在压迫机制上有所不同,这可能会影响止血时间和手部灌注。

方法

接受经桡动脉诊断性冠状动脉造影或经皮冠状动脉介入治疗(PCI)的受试者(n=52)按 1:1 随机分为聚焦压迫(VasoStat;Forge Medical)或球囊压迫装置(TR Band;Terumo Medical)进行桡动脉止血。测量每位受试者完成止血以移除设备的时间。使用血氧饱和度计(1)在设备使用前;(2)在设备使用期间;(3)在设备使用期间同时压迫尺动脉;以及(4)在设备移除后,对手部灌注进行定量评估。

结果

与球囊压迫相比,聚焦压迫可显著缩短止血完成时间(208 分钟[IQR,115-320 分钟] vs 242 分钟[IQR,120-439 分钟];P=.04)。在接受 PCI 的亚组中,这种差异最大,VasoStat 使完全止血的时间缩短了 43 分钟(P=.04)。在聚焦和球囊压迫组之间,基线灌注指数相似(分别为 4.9 和 3.9;P=.09)。与球囊压迫相比,聚焦压迫导致从中线到设备使用期间的中位灌注指数相似的降低(-27%对-18%;P=.26)。两种装置在同时压迫尺动脉时,PI 从基线降低超过 50%(P<.01),在移除装置后,PI 从基线增加超过 50%(P=.02)。两种装置均未发生桡动脉闭塞,且两组的装置操作和穿刺部位出血发生率均较低。

结论

与 TR Band 球囊压迫装置相比,VasoStat 聚焦压迫装置更早地实现完全止血。两种装置均短暂降低手部灌注,尤其是在压迫尺动脉时,移除装置后,PI 从基线增加。需要进行更大规模的试验来比较这些桡动脉止血装置和结局。

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