Comparison of Vascular Closure Devices Versus Manual Compression After Femoral Artery Puncture in Women

Abstract

Background: The value of vascular closure devices (VCD) in women undergoing transfemoral catheterization has not been sufficiently investigated. Methods and Results: This is a sex-specific analysis of 1395 women enrolled in a large-scale, randomized, multicenter trial, in which patients undergoing transfemoral diagnostic coronary angiography were randomly assigned in a 1:1:1 ratio to arteriotomy closure with an intravascular VCD, extravascular VCD, or manual compression (MC). Primary objective was to assess the safety and efficacy of 2 different VCD compared with MC regarding vascular access-site complications at 30 days. A secondary comparison was between 2 different types of contemporary VCD. Overall, women were at higher risk for vascular access-site complications compared with men (9.0% versus 6.4%; P =0.002). Vascular access-site complications were comparable in women assigned to VCD and MC (8.6% versus 9.8%; P =0.451). There was no interaction of treatment effect and sex ( P interaction =0.970). Time to hemostasis was significantly shortened with VCD compared with MC (1 [interquartile range, 0.5–2.0] minutes) versus 11 [interquartile range, 10–15] minutes; P <0.001); however, more women with VCD required repeat MC (2.4% versus 0.6%; P =0.018). The use of the intravascular compared with the extravascular VCD was associated with a numerical reduction in vascular access-site complications (6.6% versus 10.7%; P =0.027) and significant reductions in time to hemostasis and VCD failure. Conclusions: In women undergoing diagnostic coronary angiography via the common femoral artery, VCD and MC provided comparable safety, while time to hemostasis was reduced with VCD. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01389375.

Ultrasound-guided puncture reduces bleeding-associated complications, regardless of calcified plaque, after endovascular treatment of femoropopliteal lesions, especially using the antegrade procedure: A single-center study

“…The predictors of bleeding-associated complications such as the female sex, anticoagulant use, a large sheath size, and manual compression, identified in previous studies [12][13][14][15][16][17][18], were not significant in this study. The implication is that the increased risk due to these factors is offset by performing an "optimal puncture" with the ultrasound-guided puncture of the CFA.…”

“…Previous studies have reported that patient predictors of bleeding-associated complications were increasing age and the female sex [12,17]. Applegate RJ revealed that increasing age was associated with bleeding-associated complications (OR = 1.02, 95% CI 1.01-1.03, p<0.001) in 34,556 patients who underwent percutaneous cardiac catheterization via the CFA [24].…”

“…One of the most common complications of EVT is bleeding complications at the vascular access site, with an incidence of 1-10% [9][10][11]. Identified risk factors include increasing age, the female sex, anticoagulant use, puncture without ultrasonographic guidance, a large sheath size, and manual compression [12][13][14][15][16][17][18]. Although various studies have reported on the risk factors, the results are inconclusive.…”

Access Site Complications of Peripheral Endovascular Procedures: A Large, Prospective Registry on Predictors and Consequences

“…In addition, due to a lower bodyweight compared with men, periprocedural heparin dose might have been relatively high. In accordance with Gewalt et al, 12 there was no interaction of VCD treatment effect with sex.…”

SCAI Expert Consensus Statement on Sex-Specific Considerations in Myocardial Revascularization

“…With respect to femoral catheterization, vascular complication rates with vascular closure devices (VCDs) in women are inconsistent across studies. 133,134 The Instrumental Sealing of Arterial Puncture Site -CLOSURE Device versus Manual Compression (ISAR-CLOSURE) trial reported similar rates of vascular access-site complications in women receiving a VCD compared with those receiving manual compression (8.6% vs. 9.8%; p¼0.451), 133 whereas other studies have reported reduced or even higher vascular complications with VCD in women. [135][136][137] As such, the optimal manner of achieving hemostasis at the access site in women undergoing transfemoral cardiac catheterization is not defined.…”