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Ultrasound-Guided Femoral Hemostasis in Peripheral Angioplasty: Real-World Outcomes with Vascular Closure Devices
Ioannis Skalidis1,2, Livio D'Angelo2, Mariama Akodad2
1Department of Cardiology, HFR Fribourg-Cantonal Hospital, University of Fribourg, 1700 Fribourg, Switzerland.
Insights
Vascular closure devices (VCDs) show lower access-site complication rates compared to manual compression in peripheral endovascular procedures. This real-world study highlights VCDs as a potentially safer option for femoral access closure.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Device Technology
Background:
- Access-site complications (ASCs) are a significant concern in peripheral endovascular procedures, especially with large sheaths and complex anatomy.
- Existing randomized coronary trials suggest vascular closure devices (VCDs) are non-inferior to manual compression (MC), but real-world peripheral data under ultrasound guidance is limited.
Purpose of the Study:
- To evaluate the safety and efficacy of VCDs versus MC for achieving hemostasis in peripheral endovascular interventions.
- To identify factors associated with access-site complications in ultrasound-guided femoral access.
Main Methods:
- Retrospective analysis of 231 consecutive peripheral arterial revascularizations (2010-2023) using common femoral access under real-time ultrasound guidance.
- Hemostasis achieved via manual compression (MC) or VCDs (collagen plug-based, suture-mediated, clip-based).
- Primary endpoint: 30-day ASCs. Secondary endpoint: VCD failure. Multivariable logistic regression adjusted for sheath size > 6 Fr and calcification.
Main Results:
- ASCs occurred in 12.1% of procedures, with significantly higher rates in the MC group (18.5%) compared to VCDs (9-14%, p=0.044).
- Adjusted analysis revealed MC (OR 2.41), sheath size > 6 Fr, and puncture-site calcification were independently associated with ASCs.
- VCD failure occurred in 3.6% of cases, with no failures reported for collagen plug-based devices.
Conclusions:
- In this real-world, ultrasound-guided peripheral cohort, VCD use was associated with reduced 30-day ASC rates compared to MC.
- VCDs demonstrated low failure rates, particularly collagen plug-based devices.
- Findings suggest individualized, imaging-guided strategies for femoral closure in peripheral interventions.
Abstract:
Background and Objectives: Access-site complications (ASCs) remain clinically relevant after peripheral endovascular procedures, particularly with large femoral sheaths and complex anatomy. While randomized coronary trials show non-inferiority of vascular closure devices (VCDs) versus manual compression (MC), real-world data in peripheral interventions performed under systematic ultrasound-guided access are limited. Materials and Methods: This retrospective single-center cohort included consecutive peripheral arterial revascularizations (2010-2023) performed via common femoral access under real-time ultrasound guidance. Hemostasis was achieved using MC or VCDs, categorized as collagen plug-based, suture-mediated, or clip-based systems. The primary endpoint was 30-day ASCs, defined as hematoma requiring management, pseudoaneurysm, bleeding requiring transfusion, access-site thrombosis/occlusion, arteriovenous fistula, or infection. The secondary endpoint was VCD failure, defined as unsuccessful hemostasis requiring adjunctive measures. Multivariable logistic regression adjusted for prespecified anatomical and procedural covariates, including sheath size > 6 Fr and puncture-site calcification. Results: Among 231 procedures, VCDs were used in 139 (60.2%) and MC in 92 (39.8%). ASC occurred in 28 cases (12.1%), with higher rates in the MC group compared with VCDs (18.5% vs. 9-14% across device types; p = 0.044). In adjusted analyses, MC (vs any VCD) (odds ratio [OR] 2.41, 95% confidence interval [CI] 1.06-5.47; p = 0.035), sheath size > 6 Fr, and puncture-site calcification were independently associated with ASCs. VCD failure occurred in 5 cases (3.6%) and was not observed with collagen plug-based devices. Conclusions: In this ultrasound-guided real-world peripheral cohort, VCD use was associated with lower 30-day ASC rates and low device failure rates compared with MC. Given the retrospective and non-randomized design, these findings should be considered hypothesis-generating and support individualized, imaging-guided strategies for femoral closure in peripheral interventions.
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