Safety and efficacy of the Perclose suture-mediated closure device after diagnostic and interventional catheterizations in a large consecutive population.

Arterial puncture sites after cardiac catheterization are a troublesome cause of complications. Closure devices have been developed to improve on patient comfort and safety. We evaluated a suture-mediated closure device, the Prostar-Plus device, in a consecutive population of over 10,001 diagnostic and interventional catheterizations. A significantly higher complication rate was noted for both major and minor complications in the diagnostic catheterization patients treated with the Prostar-Plus device compared to diagnostic catheterization patients treated with manual compression (2.6% major and 4.6% minor complication rate for the Prostar-Plus treatment group vs. 0.2% major and 1.8% minor complication rate for the manual compression treatment group). For the interventional patients, there were no statistical differences noted for both major and minor complications between patients treated with the Prostar-Plus device vs. manual compression. Subgroup analysis showed that older, thinner women were more likely to have complications related to the Prostar-Plus device. Copyright 2002 Wiley-Liss, Inc.