Comparison of the Novel Angio-Seal Evolution With Angio-Seal STS Closure Device

Abstract

Background. Angio-Seal Evolution (ASE) is a novel vascular closure device (VCD) engineered to reduce deployment skills. It is unknown if these changes translated into better clinical results. Methods and Results. Early VCD failure and major and minor vascular complications were prospectively assessed in 584 consecutive patients treated by ASE (ASE group) and in 633 consecutive patients treated by the older Angio-Seal STS (AS-STS group). Early VCD failure was rare (ASE 1.7% vs AS-STS 1.3%, P = .52). Major vascular complication risk was similar (odds ratio [OR] = 1.76, 95% confidence interval [CI] = 0.79-3.90, P = .17), but minor vascular complication rate was significantly higher in the ASE group (OR = 3.36, 95% CI = 1.57-7.21, P = .002). At logistic regression ASE was an independent predictor of vascular complications. Early VCD failure was associated with the highest risk for vascular complications. Conclusions. In a large unselected population, ASE-treated patients showed increased risk for minor vascular complications. Early VCD failure negatively affected short-term vascular prognosis.