RESEARCH ARTICLE SA JOURNAL OF DIABETES & VASCULAR DISEASE 14 VOLUME 21 NUMBER 1 • November 2024 eventually received Perclose Proglide™ experienced acute vascular complications, and 2.2% developed a large groin haematoma. This is in comparison to 6.9 and 4.8%, respectively, in the Instrumental Sealing of ARterial Puncture Site – CLOSURE Device vs Manual Compression (ISARCLOSURE) trial,7 which is the largest randomised trial on the matter. Data from randomised studies have demonstrated that the use of a VCD was not inferior to manual compression in terms of the incidence of pseudo-aneurysms and arteriovenous fistulae (2.2%), while it was associated with a reduced incidence in large groin haematomas (ranging from 2.2 to 4.8%).7,14 Findings from two network meta-analyses of femoral VCDs revealed a relatively similar safety profile among various VCDs compared to manual compression. One of the meta-analyses found that Angio-Seal™ and FemoSeal™ were advantageous over other VCDs in terms of major adverse vascular complications and haematomas,15 while a more recent meta-analysis demonstrated that StarClose™ outperformed other VCDs regarding the occurrence of major complications.16 It should be noted that the implementation of a VCD provides the opportunity for prompt remobilisation and ambulation with safety, which can be particularly beneficial for selected patient groups, such as those on oral anticoagulation, who have a higher bleeding risk after femoral artery puncture. Our subgroup analysis revealed no differences in sonographic indices in patients on oral anticoagulation, with type 2 diabetes or with subclinical PAD during the study follow-up period. Notably, patientswith diabetesmellitus demonstrated a trend for a decreasing PSV of the RCFA, and patients with evidence of PAD displayed a trend towards a lower RI in the RCFA throughout the study. However, these observations did not reach statistical significance at the level of ≤ 10%. This suggests the potential advantageous use of a VCD in high-risk patients, not only concerning vascular and bleeding complications, allowing for a shorter time to haemostasis and early discharge, as observed in other studies,17 but also for better functional vascular properties. Participants in the current study were treated exclusively with Perclose Proglide™, which is a suture-mediated closure system. The suture appeared as a subtle perivascular hyper-echogenicity in ultrasonography just after deployment, but this finding did not persist in the short-term follow up. In line with previous findings, the deployed suture was visible in only 12% of the participants at the 30-day follow up. Other VCD types correlate with partial absorption, perivascular and intravascular changes.18 These changes could be attributed to traumatic and inflammatory triggers resulting from the intra-arterial anchor plate, a characteristic feature of other VCDs.19,20 However, the characteristic feature of Perclose Proglide™ was reflected on the sustained integrity of the arterial wall and unobstructed deployment site observed in the current study and may explain the low incidence of intra- and perivascular adverse changes, found in only one case of minimal atheromatous changes at the 30-day follow up. Recent guidelines recommend the transradial approach regardless of the clinical setting (acute or chronic disease) due to the lower rate of complications at the access site, quicker ambulation and comparable clinical outcomes.21,22 However, femoral access remains an option in patients with anatomical limitations or in cases in which a coronary artery bypass graft surgery is highly likely, and the radial artery needs to be preserved as a bypass conduit vessel.21,22 Our findings suggest that the use of a VCD in patients ineligible for transradial access does not result in femoral arterial wall alterations and is safe. The deployment of Perclose Proglide™ is known to be technically demanding. Data from a large single-centre registry reported a 6.1% rate of device failure in 2 996 patients treated with a suture-type VCD after CAG.23 Four device failures (4.3%) were observed in our study, which were associated with repeated femoral artery puncture in the recent past. Other investigators reported higher rates of Perclose Proglide™ device failure, suggesting the association with a learning curve and familiarity with the device usage.24 It is important to note that interventionalists must be familiar with a VCD, its limitations and deployment specifics to effectively use it and prevent postprocedural complications. Limitations This study has limitations. First, this was a two-centre, onearm, open-label study with a prospective, short-term follow-up design. Implementing ultrasonographic assessment prior to femoral puncture excluded patients with PAD or abnormalities that could result in vascular complications. However, it may have improved femoral artery localisation and optimised cannulation by preventing higher or lower punctures or punctures at bifurcation. The participants in the current study underwent CAG and PCI with the use of 6F sheaths. Our results should not be extrapolated in subjects with femoral cannulation in other conditions, such as transcatheter aortic valve replacement. The power of the study was limited by the sample size, although most studies on clinical outcomes after the implantation of the suture-mediated VCD, used in our study, included similar numbers of participants.16,24 Previous investigations regarding ultrasonographic assessment of femoral access site included more patients and followed up patients for a longer duration, but they did not obtain baseline values.9 Our findings should, therefore, be confirmed in prospective studies with longterm follow up, conducted in a randomised manner, with a comparative arm of patients treated with manual compression. Conclusion The use of a suture-mediated VCD was safe and was not associated with adverse vascular complications or structural vascular wall changes at the femoral access site 30 days after deployment in patients undergoing percutaneous CAG and/or PCI. Acknowledgement The first two authors (DP and KM) contributed equally to the study. References 1. Agostoni P, Biondi-Zoccai GG, de Benedictis ML, et al. Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures; Systematic overview and meta-analysis of randomized trials. J Am Coll Cardiol 2004; 44(2): 349–556. 2. Omede P, Bertaina M, Cerrato E, et al. Radial and femoral access for interventional fellows performing diagnostic coronary angiographies: the LEARN-Cardiogroup II, a prospective multicenter study. J Cardiovasc Med 2018; 19(11): 650–654. 3. Waldo SW, Gokhale M, O’Donnell CI, et al. Temporal trends in coronary angiography and percutaneous coronary intervention: insights from the VA Clinical Assessment, Reporting, and Tracking Program. J Am Coll Cardiol Cardiovasc Interven 2018; 11(9): 879–888.
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