SA JOURNAL OF DIABETES & VASCULAR DISEASE RESEARCH ARTICLE VOLUME 21 NUMBER 1 • November 2024 13 long-term treatment with oral anticoagulants or in patients with atheromatous vascular wall changes at the site of femoral artery puncture prior to CAG (p = NS for all), as demonstrated in Table 2. Discussion Data from a series of observational and randomised studies show that the implementation of a femoral VCD is safe and has been proven beneficial for selected patient groups, contributing to better haemostasis, early remobilisation, and prompt ambulation and patient comfort, which explains their increasing use after diagnostic CAG or PCI.5,7,11 The primary goal of this study was to assess structural changes on the access femoral site after VCD implantation in patients who had undergone CAG or PCI. It was demonstrated that VCD deployment did not lead to a deteriorating impact on vascular wall properties in the short term, as assessed with wellestablished and broadly used sonographic indices. Moreover, no significant changes were observed regarding the diameter of the RCFA in transverse and longitudinal view, PSV of the RCFA, ratio of the PSV of the RCFA to REILA, and RI of the RCFA. Notably, the degree of atheromatous vascular wall abnormalities at the puncture site remained unchanged in the short-term follow-up time at 30 days after CAG/PCI. Only a few studies have systematically assessed ultrasound indices and intra-, endo- and perivascular complications after the Table 2. Initial and follow-up ultrasonographic findings in selected patient subgroups 24 h after 1 month after Ultrasonographic findings Baseline catheterisation catheterisation p-value Patients on oral anticoagulants (n = 16) End-diastolic diameter of the right common femoral artery, mean ± SD In transverse view (mm) 84.66 ± 4.04 90.33 ± 17.38 86.00 ± 14.93 0.57 In longitudinal view (mm) 74.33 ± 11.02 76.67 ± 11.93 72.33 ± 10.50 0.20 PSV of RCFA (cm/s), mean ± SD 135.57 ± 45.61 104.33 ± 27.14 109.33 ± 1.15 0.37 PSV ratio, mean ± SD* 0.95 ± 0.16 0.80 ± 0.13 0.77 ± 0.10 0.18 Resistive index in RCFA,mean ± SD 0.97 ± 0.02 0.97 ± 0.01 0.96 ± 0.04 0.69 Severity degree of atheromatous vascular wall changes, median (min–max)** 2 (1–3.75) 2 (1–3) 2 (1–3) 0.37 Patients with diabetes mellitus (n = 28) End-diastolic diameter of the right common femoralartery, mean ± SD In transverse view (mm) 87.71 ± 15.43 86.57 ± 10.95 84.00 ± 10.76 0.28 In longitudinal view (mm) 81.21 ± 15.48 78.21 ± 15.02 75.00 ± 12.97 0.16 PSV of RCFA (cm/s), mean ± SD 95.28 ± 32.28 87.79 ± 20.59 81.96 ± 16.64 0.10 PSV ratio, mean ± SD* 0.68 ± 0.19 0.67 ± 0.17 0.68 ± 0.14 0.96 Resistive index in RCFA, mean ± SD 1.05 ± 0.14 1.02 ± 0.13 1.00 ± 0.13 0.24 Severity degree of atheromatous vascular wall changes, median (min–max)** 2 (1–3) 2 (1–3) 2 (1–3) 0.29 Patients with evidence of PAD (n = 66) End-diastolic diameter of the right common femoral artery, mean ± SD In transverse view (mm) 87.08 ± 14.20 86.53 ± 14.20 85.44 ± 12.28 0.71 In longitudinal view (mm) 78.19 ± 14.63 77.10 ± 14.18 75.80 ± 12.81 0.39 PSV of RCFA (cm/s), mean ± SD 92.16 ± 29.69 92.72 ± 28.48 88.07 ± 22.76 0.54 PSV ratio, mean ± SD* 0.73 ± 0.20 0.73 ± 0.21 0.74 ± 0.16 0.99 Resistive index in RCFA, mean ± SD 1.02 ± 0.11 0.97 ± 0.06 0.98 ± 0.08 0.12 Severity degree of atheromatous vascular wall changes, median (min–max)** 2 (1–3) 2 (1–3) 2 (1–3) 0.65 PAD: peripheral artery disease; PSV: peak systolic velocity; RCFA: right common femoral artery; REILA: right external iliac artery. *PSV of the RCFA to PSV of the REILA; **Friedman test. deployment of a VCD. Lee et al. observed no flow abnormalities and no increased incidence of critical peripheral vascular disease after serial ultrasound and clinical assessment of the puncture site compared to the contralateral, non-puncture site in 205 patients treated with Perclose Proglide™ VCD at a one- and 10-year follow up.9,10 It is noticeable that these studies lacked baseline measurements. Data from non-comparative studies showed a 2% incidence of severe vessel stenosis or occlusion. However, this was associated with the inadvertent cannulation of the superficial femoral artery.12 Another study demonstrated a numerical, but not statistically significant, higher incidence of bleeding complications when the puncture site was located lower than the femoral bifurcation, compared to other puncture sites.13 Our study assessed ultrasound markers of vascular function and structure at baseline andwithin a 30-day time range after puncturing the RCFA, which provided better means to ultrasonographically identify the optimal access site to the RCFA and to set a better context for comparisons between baseline and post-cannulation measurements than previous studies. Our study demonstrated that the use of the Perclose Proglide™, a femoral VCD that delivers percutaneous suture to the access site, was safe and not associated with adverse vascular sequelae. This safety profile is in agreement with data in the literature regarding acute vascular complications. Moreover, 4.4% of the patients who
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