A Meta-Analysis of Percutaneous Vascular Closure Devices
A Meta-Analysis of Percutaneous Vascular Closure Devices
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.
The management of arterial access sites for cardiac catheterization and percutaneous coronary interventions (PCI) continues to evolve. Recent years have witnessed the introduction of several hemostatic devices which continue to gain in popularity over the traditional approach of manual compression. Most studies evaluating these devices have been relatively small and have offered the conclusion that the devices present a safety profile comparable to manual compression and offer advantages in terms of early ambulation and patient comfort. Because of their small size, however, these studies are uniformly underpowered to detect as significant modest but clinically significant safety advantages or disadvantages. Accordingly, a meta-analysis of the clinical trials of these devices will have proportionately greater power to assess the issue of safety.
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.
The management of arterial access sites for cardiac catheterization and percutaneous coronary interventions (PCI) continues to evolve. Recent years have witnessed the introduction of several hemostatic devices which continue to gain in popularity over the traditional approach of manual compression. Most studies evaluating these devices have been relatively small and have offered the conclusion that the devices present a safety profile comparable to manual compression and offer advantages in terms of early ambulation and patient comfort. Because of their small size, however, these studies are uniformly underpowered to detect as significant modest but clinically significant safety advantages or disadvantages. Accordingly, a meta-analysis of the clinical trials of these devices will have proportionately greater power to assess the issue of safety.
