RESEARCH ARTICLE SA JOURNAL OF DIABETES & VASCULAR DISEASE 10 VOLUME 21 NUMBER 1 • November 2024 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. Keywords: vascular closure device, suture-mediated, duplex ultrasound, complications, femoral artery The performance of percutaneous coronary angiography (CAG) and percutaneous coronary intervention (PCI) requires artery cannulation. Although transradial cardiac catheterisation is increasingly being adopted due to lower vascular and bleeding complications,1,2 many interventional cardiologists persist in using the femoral approach. This preference may be partly attributed to the greater familiarity that many interventional cardiologists have with the method.3 Importantly, observational studies show that the use of femoral vascular closure devices (VCDs) allows for comparable major bleeding rates between transradial and transfemoral arterial access in patients who underwent CAG or PCI.4 VCDs enable arteriotomy closure, reducing the time to achieve haemostasis, and assuring early remobilisation, ambulation and patient comfort in a safe and cost-efficient manner.5-7 On the other hand, there is a lack of evidence regarding the superiority of VCD implementation over manual compression in terms of adverse vascular complications, such as arteriovenous fistula, pseudoaneurysms, haematomas, occlusion, thrombosis and the incidence of major bleedings, in an all-comers population. However, VCD implementation may particularly benefit selected patient groups who receive CAG.5,8 The effect of VCD deployment on the properties of the vasculature at the femoral access site has been investigated by only a few researchers, who demonstrated that there was no association between VCD implantation and severe adverse vascular complications in a one- and 10-year term.9,10 The use of Perclose Proglide™, a suture-mediated VCD, resulted in better sonographic findings than the Angio-Seal™, a VCD that delivers a suturetethered extravascular collagen plug. However, the lack of baseline measurements prevented the precise evaluation of the VCD effect on the vascular wall, accompanied by the paradoxical observation of an increased vessel lumen on the access site compared to the non-accessed femoral artery.9,10 Dimitrios Papoutsis, Konstantinos Mourouzis, Nikoleta Bozini, Konstantinos Aznaouridis, Evangelos Oikonomou, Katerina Chatzimichael, Elias Brountzos, Manolis Vavuranakis, Costas Tsioufis, John Lekakis, Gerasimos Siasos, Dimitris Tousoulis Correspondence to: Konstantinos Mourouzis Dimitrios Papoutsis, Nikoleta Bozini, Konstantinos Aznaouridis, Evangelos Oikonomou, Manolis Vavuranakis, Costas Tsioufis, Gerasimos Siasos, Dimitris Tousoulis First Department of Cardiology, Medical School, National and Kapodistrian University of Athens, Hippokration Hospital, Athens, Greece e-mail: konstantinos.mourouzis@med.uni-muenchen.de John Lekakis Second Department of Cardiology, Medical School, Attikon Hospital, National and Kapodistrian University of Athens, Athens, Greece Katerina Chatzimichael, Elias Brountzos Second Department of Radiology, Medical School, University General Hospital, ATTIKON, National and Kapodistrian University of Athens, Athens, Greece Previously published online in Cardiovasc J Afr November 2023 S Afr J Diabetes Vasc Dis 2024; 21: 10–15
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