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Complications with Angio-Seal™ vascular closure devices compared with manual compression after diagnostic cardiac
Deborah Gregory1, William Midodzi, Neil Pearce
1Memorial University, St. John's Newfoundland, Canada.
Insights
Vascular closure devices (VCDs) significantly reduced vascular complications in cardiac catheterization (CATH) and percutaneous coronary intervention (PCI) compared to manual compression. Angio-Seal VCD use lowered complication risks by 57% in CATH and 49% in PCI.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Device Technology
Background:
- Vascular access complications are a concern in cardiac procedures like cardiac catheterization (CATH) and percutaneous coronary intervention (PCI).
- Comparing vascular closure devices (VCDs) with manual compression (MC) is crucial for patient safety and procedural outcomes.
Purpose of the Study:
- To assess and compare the incidence of vascular complications associated with Angio-Seal™ VCDs versus MC in CATH and PCI.
- To evaluate the safety and efficacy of VCDs in reducing access site bleeding and other vascular issues.
Main Methods:
- Secondary analysis of a multiyear, population-based cohort database (May 2006 - December 2010).
- Comparison of femoral access-related vascular outcomes between VCD and MC groups.
- Propensity score adjusted analysis to control for confounding variables and reduce bias.
Main Results:
- A total of 11,897 procedures were analyzed; 59.4% utilized a VCD.
- Vascular complications occurred in 2.0% of CATHs and 2.7% of PCIs.
- VCD use was associated with a 57% lower odds of vascular complication in CATH (OR=0.43) and a 49% lower risk in PCI (OR=0.51).
Conclusions:
- The Angio-Seal™ VCD demonstrated a low incidence of vascular complications compared to manual compression for both CATH and PCI.
- VCDs represent a safe and effective alternative to manual compression for managing vascular access sites in cardiac procedures.
Objectives:
This study assessed and compared vascular complications in CATHs and PCIs using an Angio-Seal™ vascular closure device (VCD) versus manual compression (MC).
Methods:
Secondary data analysis of a population-based multiyear cohort database was conducted to compare femoral access-related vascular outcomes in cardiac procedures using VCD and MC between May 1, 2006 and December 31, 2010. The primary outcome was any vascular complication. Propensity score adjusted analysis was conducted to reduce bias associated with covariate imbalance between the groups compared.
Results:
Of the 11,897 procedures, 7,063 (59.4%) used a VCD. Vascular complications occurred in 174/8,796 (2.0%) of CATHs and 82/3,004 (2.7%) of PCIs. In the CATH sample, the odds of vascular complication were 57% lower if a VCD was used (OR = 0.43, 95% CI 0.31-0.60). For the PCI sample, the risk was 49% lower if a VCD was used (OR = 0.51, 95% CI 0.31-0.81).
Conclusions:
A low incidence of vascular complications was observed with the use of an Angio-Seal VCD relative to MC for both procedures.
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