Ultrasound Evaluation of Puncture Sites After Deployment of Two Different Types of Vascular Closure Devices: A Prospective Comparative Study
The aim of this study was to compare the ultrasonographic findings of femoral puncture sites and the complications of Perclose ProGlide® and FemoSeal™ after neurointerventional procedures.
In this prospective, single-center study, we randomly assigned 155 femoral puncture sites to treatment with Perclose ProGlide® or FemoSeal™. We hypothesized that the two different types of VCD cause different vascular changes. Ultrasonography of the femoral puncture sites was performed 24 h after the procedure and at an outpatient visit after 6 months. The intima–media thickness (IMT), vessel diameter, and minimal luminal diameter of the common femoral artery were measured; the perivascular soft tissue change and absorption of the hemostatic material were observed. The device failure rate and vascular complications associated with each device were also evaluated.
Follow-up ultrasonography was performed at a median follow-up time of 187.0 days (range 147–240 days) after the initial ultrasonography. The IMT on follow-up ultrasonography was significantly higher in patients who received FemoSeal™ (P = 0.0000). Intimal hyperplasia and partial absorption of the hemostatic material were significantly more frequent in patients who received FemoSeal™. The vessel diameters on initial and follow-up ultrasonography were not significantly different, but the minimal diameter on follow-up ultrasonography was significantly lower in patients who received FemoSeal™. Device failure and pseudoaneurysms occurred at 9 and 3 puncture sites in patients who received Perclose ProGlide®, respectively.
Intimal hyperplasia was more frequently observed in patients who received FemoSeal™. However, more device failures and pseudoaneurysms occurred in patients who received Perclose ProGlide®.
Level of Evidence
Step 2 (level 2).
KeywordsVascular closure device FemoSeal Perclose ProGlide Ultrasonography Intima–media thickness Intimal hyperplasia
This study was funded by Abbott Vascular Korea.
Compliance with Ethical Standards
Conflict of interest
The authors do not have any conflicts of interest to declare.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in this study.
- 6.Michalis LK, Rees MR, Patsouras D, Katsouras CS, Goudevenos J, Pappas S, Sourla E, Kolettis T, Sioros L, Zotou P. A prospective randomized trial comparing the safety and efficacy of three commercially available closure devices (Angioseal, Vasoseal and Duett). Cardiovasc Intervent Radiol. 2002;25:423–9.CrossRefGoogle Scholar
- 18.Sanghi P, Virmani R, Do D, Erikson J, Elliott J, Cilingiroglu M, Matthews H, Kazi M, Ricker R, Bailey SR. A comparative evaluation of arterial blood flow and the healing response after femoral artery closure using angio-seal STS plus and StarClose in a porcine model. J Int Cardiol. 2008;21:329–36.CrossRefGoogle Scholar
- 23.Fujihara M, Haramitsu Y, Ohshimo K, Yazu Y, Izumi E, Higashimori A, Yokoi Y. Appropriate hemostasis by routine use of ultrasound echo-guided transfemoral access and vascular closure devices after lower extremity percutaneous revascularization. Cardiovasc Interv Ther. 2017;32:233–40.CrossRefGoogle Scholar
- 24.Vidi VD, Matheny ME, Govindarajulu US, Normand S-LT, Robbins SL, Agarwal VV, Bangalore S, Resnic FS. Vascular closure device failure in contemporary practice. JACC: Cardiovasc Interv. 2012;5:837–44.Google Scholar
- 28.Martin JL, Pratsos A, Magargee E, Mayhew K, Pensyl C, Nunn M, Day F, Shapiro T. A randomized trial comparing compression, perclose proglide™ and Angio-Seal VIP™ for arterial closure following percutaneous coronary intervention: the cap trial. Catheter Cardiovasc Interv. 2008;71:1–5.CrossRefGoogle Scholar