Femoral vein hemostasis in children using a suture-mediated closure device

Area of Science:

• Pediatric Cardiology
• Vascular Surgery
• Medical Device Technology

Background:

• Percutaneous cardiac catheterization in children often requires large-bore femoral venous access.
• Achieving rapid and reliable hemostasis after large-sheath use is crucial for patient safety and procedural efficiency.
• Suture-mediated closure devices offer a potential alternative to manual compression for vascular hemostasis.

Purpose of the Study:

• To assess the safety and efficacy of a specific suture-mediated vascular closure device (Perclose) for hemostasis in pediatric patients.
• To compare the time to hemostasis and vessel integrity between the device and manual compression after cardiac catheterization.
• To evaluate vascular complications associated with the use of the device in children.

Main Methods:

• A randomized controlled trial involving 40 children undergoing cardiac catheterization with >=8-Fr sheath use.
• Patients were randomized to either suture-mediated device closure (n=20) or manual compression (n=20).
• Efficacy endpoints included time to hemostasis and vessel integrity assessed by Doppler ultrasound within 24 hours; complications were also monitored.

Main Results:

• Successful suture deployment was achieved in 14 out of 20 patients.
• Mean time to hemostasis was significantly shorter with the device (6.2 minutes) compared to manual compression (14.9 minutes) (P=0.003).
• No significant differences in vascular complications, such as intraluminal thrombus, were observed between the groups.

Conclusions:

• Suture-mediated vascular closure devices are safe and effective for achieving rapid hemostasis in pediatric patients after cardiac catheterization.
• The device demonstrates particular benefit in reducing the time to hemostasis, even when large sheath sizes are utilized.
• Further investigation may be warranted for optimal device use in younger children or those with lower body weight.