Ultrasound Evaluation of Puncture Sites After Deployment of Two Different Types of Vascular Closure Devices: A Prospective Comparative Study.

PURPOSE: 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.

METHODS: 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.

RESULTS: 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.

CONCLUSIONS: 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).