SA JOURNAL OF DIABETES & VASCULAR DISEASE RESEARCH ARTICLE VOLUME 21 NUMBER 1 • November 2024 11 This study aimed to investigate whether the deployment of a suture-mediated intravascular VCD might result in adverse vascular complications or vascular structural changes at the vascular access site in the short term, as assessed by broadly used sonographic markers, in patients who underwent CAG and/or PCI via transfemoral access. Methods This study was a two-centre, one-arm, open-label, prospective cohort study. It included patients who had undergone a diagnostic percutaneous CAG or PCI with transfemoral access because of noneligibility for a transradial access, based on the physician’s decision and who had consented to the implementation of a VCD instead of manual compression. The participants were patients of the First Cardiology Clinic at Hippokration Hospital (65.70%) and the Second Cardiology Clinic at Attikon Hospital of the National and Kapodistrian University of Athens. Recruitment occurred between March 2014 and July 2017. Patients under the age of 18 years, those with a history of peripheral artery disease (PAD) involving interventional or surgical treatment at the access site or reported claudication, those with ultrasonographically severe PAD and/or severe calcification of the right femoral common artery (RCFA) (n = 6), patients who had previously received an ipsilateral VCD deployment (n = 6), and those with symptoms of infection or a large haematoma (n = 1) at the end of the PCI/CAG were excluded from the study. The study protocol conformed to the ethical guidelines of the 1975 Declaration of Helsinki and received prior approval by the Human Research Committee of Hippokration General Hospital (15/2011 as part of a greater study protocol on patients who received coronary artery angiography). All participants provided written, informed consent before entering the study. Medical history, and clinical and laboratory results were obtained from hospital records. Arterial duplex ultrasonography was used to assess for contra-indications, as stated above, and to guide the arteriotomy of the RCFA. The RCFA was accessed with an 18-gauge needle and cannulated by means of an Arrow 6F × 11-cm introducer sheath (Medtronic, Minneapolis, MN, USA). Ninety-three patients who received the Perclose Proglide™ closure device (Abbott Labs, Redwood City, CA, USA) were included in the study. Perclose Proglide™ is a suture-mediated VCD that delivers a non-absorbable polyester suture through the arterial wall, which is tightened to achieve haemostasis. All procedures were performed by three experienced interventional cardiologists, according to the recommendations of the manufacturer. Device failure was defined as unsuccessful VCD deployment and led to manual compression. Complications included bleeding requiring transfusion, pseudo-aneurysms, arteriovenous fistula, access site infections, haematomas and the need for surgical or interventional vascular treatment. Haematomas were distinguished between major (≥ 5 cm) and minor (< 5 cm) with ultrasonography. Deployment of the VCD was not successful in four patients, who were consequently excluded from the follow up. Patients were mobilised after six to eight hours, according to standard hospital protocols. Detailed information regarding mobilisation or ambulation was not recorded. Symptoms including claudication, tenderness or pain at the access site, groin infections and haematomas were clinically assessed the day after and 30 days following femoral artery cannulation. Arterial duplex ultrasonography was performed at baseline, on the day after and 30 days after VCD deployment with an 8L-RS 4–13MHz linear transducer (General Electric, Milwaukee, Wisconsin, USA) to assess established ultrasound markers of vascular function and structure. At baseline, ultrasound assessment was also used to obtain the appropriate access site after screening for severe PAD. The RCFA was examined approximately 1 cm proximal to the bifurcation. At this point, vessel diameter was assessed at three sites within 1 cm in both longitudinal and transverse views at enddiastole, and mean values were estimated. In cases where a plaque was present, the thickest part of the plaque in the longitudinal view was measured. We defined evidence of PAD as the presence of plaques or localised vascular wall thickening with a thickness ≥ 1.5 mm and characterised them as atheromas from grade 1 to 4 (grade 1 for thickness ≤ 1.5 mm, grade 2 for 1.6–2.9 mm, grade 3 for 3–4.5 mm and grade 4 for 4.6–6 mm). Changes exceeding 6 mm were considered indicative of severe PAD, leading to exclusion from the study and/or receiving VCD treatment. Pulsed-wave Doppler was utilised to determine the peak systolic velocity (PSV) and end-diastolic velocity (EDV) at the RCFA and at the right external iliac artery (REILA). The PSV ratio was calculated by dividing the PSV of the RCFA by the PSV of the REILA to distinguish significant vascular stenosis of > 50%. The resistive index (RI) was assessed using the formula RI = (PSV – EDV) / PSV. Additionally, hypoechogenic changes of the arterial wall tissue and at the external side of the adventitia, such as the perivascular soft tissue of the vessels at the access site were also assessed with ultrasonography. Statistical analysis All continuous variables were tested for normal distribution before any further analysis was carried out by means of visual inspection of histograms for normal distribution, and the use of the Kolmogorov–Smirnov test for non-normal distribution. Continuous variables with a normal distribution are presented as mean ± one standard deviation (SD), whereas skewed variables are reported as median with first and third quartiles. Repeated measures analysis of variance (ANOVA) and the Student’s t-test or Friedman test and the Wilcoxon–Mann–Whitney test were applied for continuous variables, as appropriate. Categorical variables are reported as counts and percentages. Statistical significance was set at a p-value < 0.05. All statistical analyses were performed using SPSS Statistics 26 (IBM, Chicago, Illinois, USA). Results We enrolled 93 consecutive patients (72% males) with a mean age of 62 ± 11 years who underwent percutaneous CAG via a right femoral route and received femoral artery closure with a Perclose Proglide™ VCD. Median follow-up time was 31 (28–35) days after recruitment. In four cases, a VCD could not be delivered due to difficulties encountered during puncture, attributed to hardened tissue resulting from repeated femoral artery punctures for recent CAG procedures. The baseline demographic and clinical characteristics of the study participants are summarised in Table 1. One asymptomatic minor dissection of the right superficial femoral artery, two cases of major local haematomas and two cases of minor local haematomas were observed on the day following the CAG, all of which were treated conservatively. At the one-month follow up after CAG, only one patient with an extensive postinterventional local haematoma was still experiencing a persistant, albeit smaller, local haematoma. No pseudo-aneurysms and no arteriovenous fistulae were observed throughout the study and
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