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Risk of local adverse events by gender following cardiac catheterization
Dale R Tavris1, Beverly Albrecht Gallauresi, Syamal Dey
1Food and Drug Administration, Center for Devices and Radiological Health Epidemiology Branch Gallauresi Beverly, MA, USA. drt@cdrh.fda.gov
Insights
Women face a higher risk of local complications after cardiac catheterization, especially with manual compression or collagen plug devices. Larger sheath sizes also increase this risk for women.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Vascular Surgery
Background:
- Cardiac catheterization is a common procedure with potential local complications.
- Previous studies suggest a potential gender disparity in complication rates.
- Understanding factors influencing these complications is crucial for patient safety.
Purpose of the Study:
- To investigate the reasons for the higher risk of local complications in women undergoing cardiac catheterization.
- To evaluate the association between gender, arterial sheath size, and adverse outcomes.
- To identify specific hemostasis methods contributing to these complications.
Main Methods:
- Analysis of data from the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR).
- Inclusion of 13,878 patients from 59 US cardiac catheterization institutions.
- Calculation of local vascular adverse event rates stratified by gender, hemostasis type, and arterial sheath size.
Main Results:
- Overall serious local vascular events occurred in 3.54% of patients, with hematoma being most common (2.00%).
- Women had a 1.40-fold increased relative risk of vascular complications compared to men.
- This increased risk for women was significant with manual compression or collagen plug devices and worsened with larger sheath sizes.
Conclusions:
- Women experience a significantly higher relative risk of local vascular complications post-cardiac catheterization.
- Manual compression and collagen plug devices are associated with increased risk in women.
- Large arterial sheath size is a critical factor contributing to higher complication rates in women, necessitating careful consideration during hemostasis.
Purpose:
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.
Methods:
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.
Results:
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.
Conclusions:
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.
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