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

The safety and efficacy of a suture-mediated vascular closure device (Perclose, Abbott, Redwood City, CA) for hemostasis after percutaneous vascular access using >or=8-Fr sheath in the femoral vein after cardiac catheterization in children was assessed. Efficacy was determined by time to hemostasis and vessel integrity, using Doppler vascular ultrasound within 24 hours of the procedure. Forty children were randomized to treatment with either the closure device (n = 20, 10 males, weight 34.8 +/- 21 kg) or manual compression (n = 20, 10 males, weight 33.7 +/- 16 kg, P = 0.57 between groups for weight). Sheath sizes used were >or=8 French (8 Fr, n = 8; 9 Fr, n = 7; 10 Fr, n = 1; 11 Fr, n = 1; 12 Fr, n = 2; and 14 Fr, n = 1). Successful suture deployment was achieved in 14 of the 20 children. Mean time to hemostasis was 6.2 +/- 0.9 versus 14.9 +/- 1.1 minutes in controls (P = 0.003). Five of six unsuccessful deployments were in children with weights <20 kg. There were no differences in the occurrence of vascular complications (i.e., intraluminal thrombus) between the two groups as determined by ultrasound. A suture-mediated device appears safe and effective in achieving rapid vascular hemostasis even after the use of large sheath sizes in children.