Hemostasis success rates and local complications with collagen after femoral access for cardiac catheterization: analysis of 6007 published patients

Abstract

Since the first clinical studies regarding sealing of arterial puncture sites with collagen with the use of the vascular hemostatic device (VHD) and the hemostatic puncture closing device (HPCD) in the early 1990s were performed, no analysis summarizing the published patients has been reported. Therefore we performed a Medline search of data as far back as 1990 and included abstracts presented at the major scientific meetings in the United States (American Heart Association, American College of Cardiology), Europe (European Society of Cardiology), and Germany (German Society of Cardiology). A total of 6007 patients were found to have been enrolled in studies with VHD (4448 patients) or with HPCD (1559 patients). Parameters analyzed in this review were hemostasis success rates and local complications. To assess the impact of the sealing devices on local complications, studies without control groups were excluded. The hemostasis success rates immediately after deployment seemed to be higher for HPCD, but at 2' to 5' after sheath removal, they were in the same range for VHD and HPCD. In controlled studies minor local complications occurred at a rate of 7.6% in the VHD group and in 6.7% of the HPCD group. Because the control group in the HPCD studies showed a considerably higher rate of minor complications than the VHD group (11.7% vs 5.7%), the reduction in minor complications was statistically significant for HPCD, whereas VHD did not reduce minor local complications. Major local complications were reported in 3.8% of the VHD group but in only 1.8% of the HPCD group. The increase of major local complications was statistically significant with VHD (control, 1.7%) but not with HPCD (control, 1.4%). Our analysis shows that some differences between collagen devices may exist, but neither device has been proven to reduce major local complications.