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Complications of arterial closure devices
Mary Beth Lewis-Carey1, Stephen T Kee
1University of New Mexico, Albuquerque, NM 87131-5336, USA.
Techniques in Vascular and Interventional Radiology
|August 7, 2003
Summary
Vascular closure devices offer a safe and effective alternative to manual compression for arterial access sites. Approved devices demonstrate high deployment success rates and comparable complication profiles, with minor issues being most common.
Area of Science:
- Cardiovascular interventions
- Medical device technology
Background:
- Vascular closure devices (VCDs) are used to seal punctures in arteries after catheter-based procedures.
- As of July 2000, four VCDs had received Food and Drug Administration (FDA) approval.
Purpose of the Study:
- To review the efficacy and safety of FDA-approved vascular closure devices.
- To compare complication rates of VCDs with manual compression.
Main Methods:
- Review of available data on four FDA-approved VCDs.
- Analysis of deployment success rates and complication profiles.
Main Results:
- Successful deployment rates for VCDs range from 89% to 98%.
- Complication rates associated with VCDs are comparable to manual compression.
- Minor complications include limited bleeding, small hematomas, and pain.
- Major complications encompass large hematomas, transfusion-requiring bleeding, pseudoaneurysm, arteriovenous fistula, retroperitoneal hemorrhage, plug embolization, infection, and death.
Conclusions:
- Vascular closure devices are a viable and safe option for achieving hemostasis after arterial access.
- The safety profile of VCDs supports their use as an alternative to manual compression.