Complications with Angio-Seal™ vascular closure devices compared with manual compression after diagnostic cardiac catheterization and percutaneous coronary intervention.

OBJECTIVES

This study assessed and compared vascular complications in CATHs and PCIs using an Angio-Seal™ vascular closure device (VCD) versus manual compression (MC).

METHODS

Secondary data analysis of a population-based multiyear cohort database was conducted to compare femoral access-related vascular outcomes in cardiac procedures using VCD and MC between May 1, 2006 and December 31, 2010. The primary outcome was any vascular complication. Propensity score adjusted analysis was conducted to reduce bias associated with covariate imbalance between the groups compared.

RESULTS

Of the 11,897 procedures, 7,063 (59.4%) used a VCD. Vascular complications occurred in 174/8,796 (2.0%) of CATHs and 82/3,004 (2.7%) of PCIs. In the CATH sample, the odds of vascular complication were 57% lower if a VCD was used (OR = 0.43, 95% CI 0.31-0.60). For the PCI sample, the risk was 49% lower if a VCD was used (OR = 0.51, 95% CI 0.31-0.81).

CONCLUSIONS

A low incidence of vascular complications was observed with the use of an Angio-Seal VCD relative to MC for both procedures.