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Comprehensive Endovascular and Open Surgical Management of Cerebral Arteriovenous Malformations
Published on: October 20, 2017
CIRSE vascular closure device registry
Jim A Reekers1, Stefan Müller-Hülsbeck, Martin Libicher
1Department of Radiology, Academic Medical Center, Meibergdreef 9, NH 1105 AZ, Amsterdam, The Netherlands. j.a.reekers@amc.uva.nl
Insights
Vascular closure devices are safe for interventional radiology procedures, showing a 97.2% deployment success rate. Serious access site complications were rare, with most bleeding managed by manual compression.
Area of Science:
- Interventional Radiology
- Vascular Surgery
- Medical Device Technology
Background:
- Vascular closure devices are commonly used after interventional radiology procedures.
- Major multicenter studies assessing their routine safety and effectiveness are lacking.
Purpose of the Study:
- To assess the safety and effectiveness of routine vascular closure device use in interventional radiology.
- To evaluate deployment success, complications, and outcomes in a large patient cohort.
Main Methods:
- A registry of 1,107 patients utilizing vascular closure devices with an anchor and plug was conducted.
- Data collected from January 2009 to August 2009.
Main Results:
- Deployment success rate was 97.2%.
- Deployment failure rates differed significantly between antegrade (8.8%) and retrograde (1.8%) access (P=0.001).
- Postdeployment bleeding occurred in 6.4% (51.5% managed with compression); other complications (false aneurysms, hematoma, occlusions) were reported in 1.3%.
Conclusions:
- Vascular closure devices with an anchor and plug are safe for interventional radiology.
- The incidence of serious access site complications is low.
- No significant difference in complications was observed between antegrade and retrograde access.
Purpose:
Vascular closure devices are routinely used after many vascular interventional radiology procedures. However, there have been no major multicenter studies to assess the safety and effectiveness of the routine use of closure devices in interventional radiology.
Methods:
The CIRSE registry of closure devices with an anchor and a plug started in January 2009 and ended in August 2009. A total of 1,107 patients were included in the registry.
Results:
Deployment success was 97.2%. Deployment failure specified to access type was 8.8% [95% confidence interval (95% CI) 5.0-14.5] for antegrade access and 1.8% (95% CI 1.1-2.9) for retrograde access (P = 0.001). There was no difference in deployment failure related to local PVD at the access site. Calcification was a reason for deployment failure in only <0.5% of patients. Postdeployment bleeding occurred in 6.4%, and most these (51.5%) could be managed with light manual compression. During follow-up, other device-related complications were reported in 1.3%: seven false aneurysms, three hematoma >5.9 cm, and two vessel occlusions.
Conclusion:
The conclusion of this registry of closure devices with an anchor and a plug is that the use of this device in interventional radiology procedures is safe, with a low incidence of serious access site complications. There seems to be no difference in complications between antegrade and retrograde access and other parameters.
