Impact of Gender on Femoral Access Complications Secondary to Application of a Collagen-based Vascular Closure Device

Volume 16 - Issue 5 - May, 2004
Posted on: 8/1/08
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Author(s):

Holger Eggebrecht, MD, Clemens von Birgelen, MD, PhD, Christoph Naber, MD, Knut Kröger, MD* Axel Schmermund, MD, Heinrich Wieneke, MD, Thomas Bartel, MD, Uta Wörtgen, MD, Dietrich Baumgart, MD, Michael Haude, MD, Raimund Erbel, MD

ABSTRACT: Background: Vascular complications at the femoral access site continue to be a significant problem after cardiac catheterization procedures. It was the aim of the present study to assess the impact of gender on the incidence of severe femoral access complications following the application of a collagen-based vascular closure device after transfemoral catheterization procedures. Methods: A total of 1294 consecutive patients (977 male, 317 female) underwent closure of femoral access sites with 8F collagen-based vascular closure devices (Angioseal™) immediately after diagnostic or interventional coronary catheterization procedures, independently of the coagulation status. All patients were closely monitored for the occurrence of complications during the following 24 hours. Results: Between male and female patients, there was no difference in the technical performance of the device with successful deployment being achieved in 96.7% and 95.9%, respectively (p=0.60). Severe access complications were found to be significantly higher in female versus male patients (1.6% vs. 0.2%; Odds ratio 7.7, 95% confidence interval 1.5–40.1; p = 0.015), although similar accomplishment of an immediate hemostasis was seen in 92.8% and 92.4% of male and female patients (p=0.98). Conclusion: Women show a significantly increased risk of developing severe femoral access complications secondary to the application of a collagen-based vascular closure device, although the overall incidence of these complications is relatively low. We speculate that the increased risk in women may be related to smaller arterial dimensions, which could be evaluated by femoral angiography prior to deployment of a closure device. J INVAS CARDIOL 2004;16:247–250

Keywords: vascular access complications,catheterization, closure device, femoral, bleeding, female, gender

Vascular complications at the femoral access site continue to be a significant problem after cardiac catheterization procedures.^1,2 Previous studies identified procedural and patient-related predictors of local vascular complications, such as the size of the introducer sheath and the intensity and duration of anticoagulant or antiplatelet therapy during and after the procedure.³ Patient-related risk factors include advanced age, presence of peripheral vascular disease, and marked obesity;^3,4 few studies also suggested an increased risk of access complications in women.^4,5

Recently, a variety of suture-based and collagen-based vascular closure devices has been introduced to facilitate management of the femoral access site, to achieve an earlier ambulation and discharge, and to reduce access site complications;^1–3 it remains, however, controversial whether the use of closure devices actually reduces the incidence of local vascular complications. The Angio-Seal™ (St. Jude Medical Inc., St. Paul, Minn.) vascular closure device is a well-established closure device, which uses an intravascular biodegradable anchor and an extra-arterial resorbable collagen plug to achieve local hemostasis after transfemoral catheterization procedures.⁶

In the present analysis, we evaluated the impact of male and female gender on the occurrence of vascular access complications secondary to the application of the Angio-Seal vascular closure device in patients undergoing both, diagnostic and therapeutic cardiac catheterization procedures.