Paul T Vaitkus1. 1. Cardiology Division, University of Illinois at Chicago, 60612, USA. pvaitkus@uic.edu
Abstract
BACKGROUND: While each of the available femoral arterial sealing devices claims equivalent safety to manual compression following invasive cardiac procedures, these claims are based on small, underpowered studies. Our aim was to increase the ability to detect a clinically meaningful difference by performing a meta-analysis. METHODS: We identified studies via Medline and manual searches and selected studies that were prospective, randomized clinical trials for inclusion. Pooling of data was performed by calculation of the Mantel-Haenszel odds ratio (OR) and the variance of the OR was estimated using the method of Robins, Greenland and Breslow. RESULTS: Sixteen studies enrolling 5,048 patients were included in the analysis. The pooled OR was 0.89 (95% confidence interval, 0.86-0.91), indicating a significant decrease in risk by devices. Excluding hematomas from the endpoint resulted in a concordant result. Angio-Seal was associated with a significant reduction in risk (OR, 0.51) and Perclose had a neutral result (OR, 1.0), whereas Vasoseal had an increased risk of complications (OR, 1.18). CONCLUSION: Overall, sealing devices may be associated with a reduction in risk of complications following invasive coronary procedures, but significant differences may exist among individual devices. These potential differences need to be explored in randomized, controlled clinical trials.
BACKGROUND: While each of the available femoral arterial sealing devices claims equivalent safety to manual compression following invasive cardiac procedures, these claims are based on small, underpowered studies. Our aim was to increase the ability to detect a clinically meaningful difference by performing a meta-analysis. METHODS: We identified studies via Medline and manual searches and selected studies that were prospective, randomized clinical trials for inclusion. Pooling of data was performed by calculation of the Mantel-Haenszel odds ratio (OR) and the variance of the OR was estimated using the method of Robins, Greenland and Breslow. RESULTS: Sixteen studies enrolling 5,048 patients were included in the analysis. The pooled OR was 0.89 (95% confidence interval, 0.86-0.91), indicating a significant decrease in risk by devices. Excluding hematomas from the endpoint resulted in a concordant result. Angio-Seal was associated with a significant reduction in risk (OR, 0.51) and Perclose had a neutral result (OR, 1.0), whereas Vasoseal had an increased risk of complications (OR, 1.18). CONCLUSION: Overall, sealing devices may be associated with a reduction in risk of complications following invasive coronary procedures, but significant differences may exist among individual devices. These potential differences need to be explored in randomized, controlled clinical trials.