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Femoral access management: comparison between two different vascular closure devices after percutaneous coronary
Victor Legrand1, Pierre Doneux, Christophe Martinez
1Centre Hospitalier Universitaire de Liège, Department of Cardiology, Sart-Tilman, Liège, Belgium. vlegrand@chu.ulg.ac.be
Insights
Angio-Seal (AS) and Bio-Disc (BD) devices offer improved outcomes for femoral artery access management compared to manual compression (MC). AS demonstrated fewer complications and reduced nursing time, justifying its cost in selected patients undergoing PCI.
Area of Science:
- Cardiology
- Vascular Surgery
- Medical Devices
Background:
- Femoral artery access management following catheterization often utilizes manual compression (MC).
- Vascular closure devices (VCDs) have been developed as alternatives to MC, aiming for earlier patient ambulation.
- The cost-effectiveness and complication rates of VCDs compared to MC require further investigation.
Purpose of the Study:
- To compare the efficacy and safety of Angio-Seal (AS) and Bio-Disc (BD) VCDs against manual compression (MC) for femoral access management (FAME).
- To evaluate vascular complications, nursing time, and patient satisfaction associated with each method.
Main Methods:
- A study involving 463 consecutive patients undergoing percutaneous coronary intervention (PCI).
- Patients were randomized to receive hemostasis via MC, AS, or BD.
- Outcomes assessed included vascular/systemic complications, nursing time for puncture site management, and patient satisfaction.
Main Results:
- Angio-Seal (AS) showed a higher deployment success rate (98%) compared to Bio-Disc (BD) (90%).
- Vascular complication rates were 10.8% for MC, 4.0% for AS, and 5.8% for BD (not statistically significant).
- AS significantly reduced nursing time (9.9 min) compared to BD (28.1 min) and MC (48.9 min), with higher patient satisfaction scores.
Conclusions:
- Angio-Seal (AS) use is linked to reduced vascular complications and enhanced patient well-being.
- AS significantly decreases nursing time required for femoral access site management.
- The cost of AS is considered justified in selected patients undergoing PCI due to improved outcomes and efficiency.
Objectives:
Several devices have been proposed as an alternative to manual compression (MC) for femoral access management (FAME) following catheterization. Although these devices allow earlier ambulation, they have not always been shown to reduce vascular complications. As a consequence, their cost efficacy is not obvious.
Methods:
During MC a special catheter deployed temporarily within the artery to achieve haemostasis (Bio-DISC) (BD) was compared with an anchor-collagen based system Angio-Seal (AS) among 463 consecutive patients undergoing PCI. We examined vascular or systemic complications, nursing time spent to puncture site management and patient's satisfaction.
Results:
Relative contra-indications to the use of vascular closure devices were encountered in 158 patients. There were no significant differences in baseline characteristics between the patients assigned to each of the 3 treatment groups. The deployment success rate was 98% for AS and 90% for BD (p = 0.037). Vascular complications occurred in 10.8%, 4.0% and 5.8% (p: NS) of MC, AS and BD patients, respectively. The longer sheath dwell time contributed to most of the complications in MC and BD. Nursing time spent for access management was 48.9 min in MC; 28.1 min in BD and 9.9 min in AS (p < 0.0001 ). Satisfaction score above 70 was noted in 46%, 86% and 92% of patients managed by MC, BD and AS, respectively.
Conclusion:
AS use is associated with fewer complications, improved patient well being and saves 39 minutes of nursing time. The additional cost of AS is justified when used in selected patients undergoing PCI.
