Collagen plug-based vascular closure devices do not decrease vascular and bleeding complications occurring after balloon aortic valvuloplasty

Abstract

Background: The benefits of vascular closure devices (VCDs) in the prevention of vascular complications after femoral intervention remain controversial.

Aim: To evaluate the efficiency of collagen plug-based VCDs in the prevention of femoral access complications after balloon aortic valvuloplasty.

Methods: We conducted a prospective analysis of consecutive patients who underwent balloon aortic valvuloplasty by femoral retrograde technique in our centre between 2009 and 2012. Group 1 included 75 patients in whom femoral puncture haemostasis was obtained with the use of an 8F collagen plug-based VCD (Angio-Seal™; Saint-Jude Medical, Inc.); group 2 included 105 patients who had manual or mechanical groin compression (FemoStop™; RADI Medical Systems, Inc.). We did not use heparin during the procedure. We collected data on major in-hospital adverse events, major bleeding (Bleeding Academic Research Consortium classification≥3) and vascular access complications.

Results: We included 180 patients with severe and symptomatic aortic stenosis. Indications for valvuloplasty were mainly bridge to transcatheter aortic valve implantation or palliative therapy (72%). The groups were similar in terms of median age, lower limb artery disease and body mass index. Vascular and bleeding complications occurred in 11.1% of patients and were not decreased with the use of VCDs (relative risk 2.60, 95% confidence interval 1.10-3.09; P=0.05). These findings were consistent across all prespecified subgroups. Duration of hospital stay was not reduced by VCDs.

Conclusions: Based on the results of this study, performed with small-size sheaths and without heparin, collagen plug-based VCDs increase femoral access complications following aortic valvuloplasty. Systematic use of VCDs in elderly patients, with probable advanced limb atherosclerosis, is questionable.

Keywords: Balloon aortic valvuloplasty; Complications vasculaires; Fermeture vasculaire percutanée; Valvuloplastie aortique au ballon; Vascular closure devices; Vascular complications.