Robert L Minor1, Thomas Maley, Diana Jenkins, Ya-Huei Li. 1. Billings Clinic Heart and Vascular at Community Medical Center, 2827 Fort Missoula Road, Missoula, MT 59804-7408 USA. RMinor@BillingsClinic.org.
Abstract
PURPOSE: 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. METHODS: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. RESULTS: 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). CONCLUSION: Both RCDs achieved hemostasis enabling same-day discharge. VS had significantly shorter time to hemostasis with fewer device manipulations and increased patient-reported comfort.
RCT Entities:
PURPOSE: 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. METHODS: 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. RESULTS: 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). CONCLUSION: Both RCDs achieved hemostasis enabling same-day discharge. VS had significantly shorter time to hemostasis with fewer device manipulations and increased patient-reported comfort.