BACKGROUND: The Angio-Seal Evolution (ASE) is a novel vascular closure device (VCD) engineered to reduce the individual skills needed for deployment. A clinical comparison of ASE with manual femoral compression (MC) has never been reported. METHODS AND RESULTS: A total of 451 consecutive patients treated by ASE following cardiac catheterization were compared with 451 propensity-score matched controls treated by MC. Early failure of ASE and in-hospital major vascular complications (any retroperitoneal hemorrhage, limb-threatening ischemia or surgical repair) and minor vascular complications (any groin hematoma ≥ 5 cm or pseudoaneurysm) following ASE deployment were prospectively assessed. Early failure of ASE was rare (1.8%). In the two groups, the major vascular complication rate was similar [odds ratio (OR), 2.5; 95% confidence interval (CI), 0.5-13.0; p = NS]. However, patients treated by ASE showed a significantly higher risk for minor vascular complications (OR, 2.2; 95% CI, 1.1-4.3; p = 0.029). In comparison to successful deployment, early ASE failure was associated with a very high risk for both major (OR, 15.7; 95% CI, 1.56-158.7; p = 0.002) and minor (OR, 6.1; 95% CI, 1.2-31.8; p = 0.015) vascular complications. CONCLUSION: In a large, single-center experience, early ASE failure was rare and the rate of major vascular complications following ASE deployment was similar to controls. However, an excess of minor vascular complications (generally large groin hematomas) was observed in patients treated by ASE. Our study confirms that early ASE failure is an important risk factor for severe vascular complications.
BACKGROUND: The Angio-Seal Evolution (ASE) is a novel vascular closure device (VCD) engineered to reduce the individual skills needed for deployment. A clinical comparison of ASE with manual femoral compression (MC) has never been reported. METHODS AND RESULTS: A total of 451 consecutive patients treated by ASE following cardiac catheterization were compared with 451 propensity-score matched controls treated by MC. Early failure of ASE and in-hospital major vascular complications (any retroperitoneal hemorrhage, limb-threatening ischemia or surgical repair) and minor vascular complications (any groin hematoma ≥ 5 cm or pseudoaneurysm) following ASE deployment were prospectively assessed. Early failure of ASE was rare (1.8%). In the two groups, the major vascular complication rate was similar [odds ratio (OR), 2.5; 95% confidence interval (CI), 0.5-13.0; p = NS]. However, patients treated by ASE showed a significantly higher risk for minor vascular complications (OR, 2.2; 95% CI, 1.1-4.3; p = 0.029). In comparison to successful deployment, early ASE failure was associated with a very high risk for both major (OR, 15.7; 95% CI, 1.56-158.7; p = 0.002) and minor (OR, 6.1; 95% CI, 1.2-31.8; p = 0.015) vascular complications. CONCLUSION: In a large, single-center experience, early ASE failure was rare and the rate of major vascular complications following ASE deployment was similar to controls. However, an excess of minor vascular complications (generally large groin hematomas) was observed in patients treated by ASE. Our study confirms that early ASE failure is an important risk factor for severe vascular complications.