Ultrasonographic assessment and clinical outcomes after deployment of a suture-mediated femoral vascular closure device.

Abstract

Introduction: Data regarding changes in the arterial vascular wall after the deployment of suture-mediated vascular closure devices (VCD) at the femoral site in patients undergoing percutaneous coronary angiography (CAG) or percutaneous coronary intervention (PCI) are sparse. This study investigated the occurrence of structural vascular changes or adverse vascular complications at the access site in the short term after the deployment of a suture-mediated intravascular VCD.

Methods: Ninety-three patients (72% males) with a mean age of 62 ± 11 years were enrolled. Duplex sonography was conducted at the access site at baseline, 24 hours and 30 days after femoral puncture in patients with successful VCD deployment. Vessel diameter, flow velocities, the severity of atherosclerosis, and the intravascular or perivascular tissue alterations in both the right common femoral artery (RCFA) and right external iliac artery (REILA) were assessed. Vascular complications were documented.

Results: There were no significant changes regarding the diameter of the RCFA in the transverse and longitudinal view, peak systolic velocity (PSV) of the RCFA, PSV ratio of the RCFA to REILA, the resistive index of the RFCA and the severity of arterial wall abnormalities before femoral puncture, the day following VCD deployment and 30 days after (p = NS for all) in the general population and in patients with diabetes mellitus, on oral anticoagulants or with mild peripheral artery disease (p = NS for all markers). Device failure was observed in four cases. Few (4.4%) patients had vascular complications, which included exclusively major or minor haematomas, most of which did not persist at the 30-day follow up.

Conclusion: The use of a suture-mediated VCD was safe and was not associated with adverse vascular wall changes at the femoral access site 30 days after deployment in patients undergoing CAG and/or PCI.