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Propensity score analysis of vascular complications after diagnostic cardiac catheterization and percutaneous
Robert J Applegate1, Matthew T Sacrinty, Michael A Kutcher
1Section of Cardiology, Wake Forest University School of Medicine, Winston-Salem, North Carolina 27157-1045, USA. bapplega@wfubmc.edu
Insights
Vascular closure devices (VCD) do not increase the risk of vascular complications after femoral artery access for cardiac procedures. This study found that VCD safety is not compromised in contemporary practice, supporting their continued use.
Area of Science:
- Cardiology
- Vascular Surgery
- Medical Devices
Background:
- Vascular closure devices (VCD) enable early patient ambulation after cardiac procedures.
- Uncertainty exists regarding the safety of VCDs in current medical practice.
- Femoral artery access is common for cardiac catheterization and interventions.
Purpose of the Study:
- To compare the adjusted risk of vascular complications between manual compression and VCDs.
- To evaluate the safety of VCDs for femoral artery access site management.
- To assess if VCD benefits are offset by increased complication rates.
Main Methods:
- Analysis of 21,841 cardiac catheterization and PCI procedures (1998-2003).
- Propensity score analysis to adjust for patient and procedural variables.
- Logistic regression models used to evaluate vascular complication incidence.
Main Results:
- Unadjusted complication rates were similar: 1.3% for VCD vs. 1.4% for manual compression.
- Propensity score-adjusted odds ratio for complications with VCD was 0.86 (95% CI: 0.67-1.11).
- Adjusted analysis showed no increased risk for diagnostic (0.80) or interventional (0.90) procedures.
Conclusions:
- VCD use is not associated with an increased risk of vascular complications in contemporary practice.
- The safety of VCDs is maintained, not offset by their benefits.
- Vascular closure devices remain a safe option for femoral artery access management.
Objectives:
To evaluate the adjusted risk of vascular complications after manual compression and vascular closure devices for femoral artery access site management in a large contemporary cohort, using propensity score analysis.
Background:
Vascular closure devices (VCD) allow early ambulation after cardiac procedures involving femoral artery access, but whether the benefit of use of vascular closure devices (VCD) is offset by reduced safety in contemporary practice remains uncertain.
Methods:
Twenty one thousand eight hundred and forty one consecutive diagnostic cardiac catheterization (n = 13,124) and percutaneous coronary intervention procedures (n = 8,717) performed via a femoral access at a single site (WFUBMC) between 1998 and 2003 were evaluated. VCD's were used based on operator preference. Propensity to receive a vascular closure device (VCD) was calculated. The relative incidence of vascular complications was evaluated by logistic regression models, using the propensity score as a covariate.
Results:
Overall, the unadjusted incidence of any vascular complication was 1.3% for VCD use and 1.4% for manual compression, p = NS. The propensity score-adjusted odds ratio for any vascular complication comparing VCD (n = 8,707) to manual compression (n = 13,034) was 0.86 (0.67-1.11) for all procedures, 0.80 (0.53-1.21) for diagnostic procedure, and 0.90 (0.65-1.26) for interventional procedures.
Conclusions:
In this large single-center, contemporary observational study, the risk-adjusted occurrence of vascular complications following VCD use for femoral artery access management is not increased by VCD use. Thus, in the current era, the benefit of VCD use is not offset by reduced safety.
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