The purpose of the present study was to analyze complications following antegrade puncture of the common femoral artery (CFA) and the superficial femoral artery (SFA) using vascular closure systems (VCS). A single-center, retrospective study was performed after obtaining approval from the institutional review board and informed consent from all patients. At our center, the CFA or SFA are used for arterial access. All patients were evaluated clinically on the same day. If there was any suspicion of an access site problem, Duplex ultrasound was performed. Access location was the CFA in 50 patients and the SFA in 130 patients. The sheath size ranged from 4F to 10F. Two patients had to be excluded because of lack of follow-up. Successful hemostasis was achieved in 162 of 178 cases (91 %). The following complications were observed in 16 patients (8.9 %): 4 pseudoaneurysms (2.2 %), 11 hematomas (6.2 %), and 1 vascular occlusion (0.5 %). The two pseudoaneurysms healed spontaneously, in one case an ultrasound-guided thrombin injection was performed, and one aneurysm was compressed manually. No further medical therapy was needed for the hematomas. The one vascular occlusion was treated immediately with angioplasty using a contralateral approach. No significant difference was noted between the CFA and the SFA group with respect to complications (p = 1.000). The use of closure devices for an antegrade approach up to 10F is feasible and safe. No differences in low complication rates were observed between CFA and SFA.

Feasibility and Safety of Vascular Closure Devices in an Antegrade Approach to Either the Common Femoral Artery or the Superficial Femoral Artery

Introduction Although recently published evidence favours transradial access (TRA) when using large-bore guiding catheters for percutaneous coronary intervention (PCI) of complex coronary lesions, the femoral artery will still be used in a considerate proportion of patients undergoing complex PCI, especially in PCI of chronic total occlusions (CTO). Ultrasound-guided puncture of the femoral artery may reduce clinically relevant access site complications, but robust evidence is lacking up to date. Methods and analysis A total of 542 patients undergoing complex PCI, defined as PCI of CTO, complex bifurcation, heavy calcified lesion or left main, in which the 7-F or 8-F transfemoral access is required, will be randomised to ultrasound-guided puncture or fluoroscopy-guided puncture. The primary outcome is the incidence of the composite end-point of clinically relevant access site related bleeding and/or vascular complications requiring intervention. Access site complications and major adverse cardiovascular events up to 1 month will also be compared between both groups. Ethics and dissemination Ethical approval for the study was granted by the local Ethics Committee (‘Medisch Ethische Toetsing Commissie Isala Zwolle’) for all Dutch sites, ‘Comité Medische Ethiek Ziekenhuis Oost-Limburg’ for Hospital Oost-Limburg, ‘Comité d’éthique CHU-Charleroi—ISPPC’ for Centre Hospilatier Universitaire de Charleroi and ‘Ethik Kommission de Ärztekammer Nordrhein’ for Elisabeth-Krankenhaus). The trial outcomes will be published in peer-reviewed journals of the concerned literature. The ultrasound guided transfemoral access in complex large bore PCI trial has been administered in the ClinicalTrials.gov database, reference number: NCT03846752. Registration details ClinicalTrials.gov identifier: NCT03846752.

https://bmjopen.bmj.com/content/bmjopen/12/12/e065693.full.pdf

ULTrasound-guided TRAnsfemoral puncture in COmplex Large bORe PCI: study protocol of the UltraCOLOR trial

A variety of contemporary closure technologies expand the strategies available to the endovascular interventionalist for vascular access management. The currently available devices have consistently demonstrated the ability to shorten time to hemostasis and ambulation; decrease in access-site-related bleeding complications has not yet been convincingly shown. Careful observation of users’ instructions of individual devices and operators’ expertise in their use are likely the most critical determinants of clinical success in on-label indications. Further studies are needed to define clinical benefits in specific subsets and to clarify the cost-effectiveness of VCDs in real-life settings.

Closure of Percutaneous Vascular Access

The outcomes of chronic total occlusion percutaneous coronary intervention have considerably improved during the last decade with continued emphasis on improving procedural safety. Vascular access site bleeding remains one of the most frequent complications. Several procedural strategies have been implemented to reduce the rate of vascular access site complications. This state-of-the-art review summarizes and describes the current evidence on optimal vascular access strategies for chronic total occlusion percutaneous coronary intervention.

Vascular Access in Percutaneous Coronary Intervention of Chronic Total Occlusions: A State-of-the-Art Review.

Purpose: To report the 1-year results of a prospective multicenter trial to evaluate the safety and efficacy of treating symptomatic femoropopliteal occlusive disease using 4-F–compatible materials...

4-French–Compatible Endovascular Material Is Safe and Effective in the Treatment of Femoropopliteal Occlusive Disease: Results of the 4-EVER Trial

Background. Currently approved vascular closure devices (VCDs) are not recommended for use in arterial puncture sites distal to the common femoral artery (CFA) bifurcation. The StarClose™ vascular system (SC) is a unique VCD that does not contain intravascular components, a feature that may allow safe use in smaller vessels. Objective. We sought to determine the efficacy and long-term safety of the SC for hemostasis of arterial punctures distal to the CFA bifurcation. Methods. Consecutive patients with arterial puncture sites located distal to the CFA bifurcation received SC after percutaneous coronary intervention (PCI). Patients were ambulated 4-6 hours later, and the presence of vascular complications was determined clinically before hospital discharge. Clinical and Doppler ultrasound examinations were performed at 8—9 months to assess long-term safety. Results. A total of 106 patients undergoing PCI were included in the study. Mean age was 66 ± 12 years and 63% were male. The arterial puncture site was located in the superficial femoral artery (SFA) in 76 (72%), the profunda femoris artery (PFA) in 22 (21%) and undetermined in 8 (7%) patients. The mean diameter of the CFA was significantly greater than the SFA or the PFA branch with the SC (6.2 ± 1.5 vs. 4.5 ± 1.0 mm for the CFA and branch with SC, respectively; p < 0.0001). Device success was achieved in 102 (96%) patients. At 24 hours, a hematoma ≥ 5 cm was reported in 13 (12%) patients. No other vascular complications occurred. At a mean follow up of 9 ± 2.5 months, there was no clinical or Doppler evidence of arterial insufficiency or vascular complications. Conclusion. The SC can be used for hemostasis after PCI in select cases where the arterial puncture site is located distal to the CFA bifurcation without adverse clinical outcomes.

Efficacy and long-term safety of StarClose™ for hemostasis of arterial puncture sites distal to common femoral artery bifurcation after percutaneous coronary interventions.

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Efficacy and long-term safety of StarClose™ for hemostasis of arterial puncture sites distal to common femoral artery bifurcation after percutaneous coronary interventions.