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Article first published online: 18 SEP 2006
Copyright © 2006 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 16, Issue 2, pages 125–131, February 2007
How to Cite
Tavris, D. R., Gallauresi, B. A., Dey, S., Brindis, R. and Mitchel, K. (2007), Risk of local adverse events by gender following cardiac catheterization. Pharmacoepidem. Drug Safe., 16: 125–131. doi: 10.1002/pds.1307
Ethics Statement: Because this study involved only a review of existing registry records, and approval for the registry had previously been granted by the American College of Cardiology, full review by the FDA's Human Subjects Committee was waived.
No conflict of interest was declared.
- Issue published online: 3 FEB 2007
- Article first published online: 18 SEP 2006
- Manuscript Accepted: 11 JUL 2006
- Manuscript Revised: 6 JUL 2006
- Manuscript Received: 29 NOV 2005
- Office of Women's Health of the Food and Drug Administration
- hemostasis device;
- cardiac catheterization;
- adverse event
To assess the reason for the relative high risk of local complications for women following cardiac catheterization by evaluating the associations between gender, sheath size, and local adverse outcomes following cardiac catheterization.
The data used in this study were obtained from a portion of the American College of Cardiology-National Cardiovascular Data Registry™ (ACC-NCDR™), which included 13 878 patients who underwent cardiac catheterization at one of 59 participating cardiac catheterization institutions throughout the United States during late 2003. Rates of serious local vascular adverse events were calculated by gender following cardiac catheterization, by type of vascular hemostasis used, stratified by arterial sheath size.
Serious local vascular events were reported in 3.54% of patients, most commonly hematoma (2.00%). The relative risk for women of any vascular complication was 1.40 [95%CI = 1.17, 1.67, p = 0.0002]. A statistically significant relative risk for woman was evident when collagen plug devices or manual compression alone were used as the first method for hemostasis. The rate of vascular complications increased progressively with increasing sheath size, more so in women than in men.
High relative risk for women of local vascular complications following cardiac catheterization was demonstrated with use of manual compression, as well as with collagen plug devices to control femoral artery bleeding. Large sheath size is associated with both a relatively high absolute risk and a high relative risk for women. Knowledge of this information should be considered by interventional cardiologists in making decisions on how to achieve hemostasis following cardiac catheterization. Copyright © 2006 John Wiley & Sons, Ltd.