Billings Clinic Heart and Vascular at Community Medical Center, 2827 Fort Missoula Road, Missoula, MT 59804-7408 USA.
J Invasive Cardiol. 2021 Feb;33(2):E84-E90. Epub 2021 Jan 21.
VasoStat (VS; Forge Medical) is a recently developed radial artery compression device (RCD) producing focused puncture-site pressure. We compared time to hemostasis and patient experience with VS vs balloon compression with the TR Band (Terumo) in a randomized, prospective trial among subjects undergoing radial catheterization procedures with same-day discharge.
Forty subjects without prior radial access undergoing elective coronary and/or endovascular diagnostic or interventional procedures were randomized to VS or TR Band. Primary outcome was time to hemostasis enabling RCD removal. Secondary outcomes included patient satisfaction measuring subject-reported domains of pain, paresthesia, and swelling, number of device manipulations, and radial patency at follow-up duplex assessment. Hand perfusion index (PI) was also measured prior to radial access, during RCD use, during RCD use with ulnar compression, and after 30 days.
VS reduced time to complete hemostasis by 54 ± 20 minutes compared with TR Band (P=.01). Time from RCD application to discharge trended shorter among the VasoStat patients vs TR Band patients (209 ± 13 minutes vs 254 ± 22 minutes, respectively; P=.09). VS required fewer RCD manipulations (P=.04). Mean patient discomfort score was 2.7 with VS and 6.1 with TR (P=.04). Change from baseline in hand PI was similar at all time points. After 30 days, ultrasound detected no radial artery occlusion and no difference in radial artery peak systolic velocities (57 cm/s with VS vs 50 cm/s with TR; P=.85).
Both RCDs achieved hemostasis enabling same-day discharge. VS had significantly shorter time to hemostasis with fewer device manipulations and increased patient-reported comfort.
VasoStat（VS；Forge Medical）是一种新开发的桡动脉压迫装置（RCD），可产生集中的穿刺部位压力。我们在一项随机、前瞻性试验中比较了 VS 与 TR 带（Terumo）在具有当日出院适应证的接受桡动脉导管插入术的患者中的止血时间和患者体验。
40 例无既往桡动脉入路的患者，行择期冠状动脉和/或血管内诊断或介入治疗，随机分为 VS 或 TR 带组。主要结局是能够移除 RCD 的止血时间。次要结局包括患者满意度，通过患者报告的疼痛、感觉异常和肿胀的领域来衡量，设备操作次数，以及在后续的超声双功能检查中桡动脉通畅性。在桡动脉入路前、RCD 使用期间、RCD 使用时伴尺侧压迫以及 30 天后，还测量了手部灌注指数（PI）。
与 TR 带相比，VS 可将完全止血时间缩短 54±20 分钟（P=.01）。从 RCD 应用到出院的时间，VasoStat 患者比 TR 带患者更短（分别为 209±13 分钟和 254±22 分钟，P=.09）。VS 所需的 RCD 操作次数更少（P=.04）。VS 的平均患者不适评分是 2.7，TR 是 6.1（P=.04）。所有时间点的手部 PI 从基线的变化相似。30 天后，超声检查未发现桡动脉闭塞，桡动脉峰值收缩速度无差异（VS 为 57cm/s，TR 为 50cm/s，P=.85）。
两种 RCD 均能达到止血效果，实现当日出院。VS 达到止血的时间更短，设备操作次数更少，患者报告的舒适度更高。
