CIRSE vascular closure device registry.
OBJECTIVE
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.


CONCLUSIONS
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.
Reekers
Jim A
JA
Department of Radiology, Academic Medical Center, Meibergdreef 9, NH 1105 AZ, Amsterdam, The Netherlands. j.a.reekers@amc.uva.nl
Müller-Hülsbeck
Stefan
S
Libicher
Martin
M
Atar
Eli
E
Trentmann
Jens
J
Goffette
Pierre
P
Borggrefe
Jan
J
Zeleňák
Kamil
K
Hooijboer
Pieter
P
Belli
Anna-Maria
AM
D000368:Aged; D016009:Chi-Square Distribution; D004867:Equipment Design; D004869:Equipment Safety; D005060:Europe / Q000453:epidemiology; D005260:Female; D006489:Hemostatic Techniques / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology; D015641:Radiography, Interventional / Q000295:instrumentation*; D012042:Registries; D012955:Societies, Medical; D013525:Surgical Instruments; D016896:Treatment Outcome; D014656:Vascular Surgical Procedures / Q000295:instrumentation*