A novel vascular sealing device for closure of percutaneous arterial access sites

The purpose of this study was to investigate the safety and efficacy of a n ovel vascular sealing device that incorporates a unique low-profile balloon -positioning catheter and a procoagulant delivered after diagnostic cardiac catheterization and percutaneous transluminal coronary angioplasty (PTCA) procedures. Current management of the vascular access site after percutaneo us interventions is associated with patient discomfort and complications. B ased on previously reported successful results in canine models, we proceed ed with this first human feasibility and safety study. Immediately after an invasive procedure, the sealing device was successfully deployed at the fe moral arterial access site in 24 of 24 procedures (diagnostic 19, PTCA 5). All patients were followed up at 1 month with clinical assessment, ankle-br anchial index measurement, and Doppler ultrasound. Successful hemostasis wa s achieved in all patients. The activated clotting time before sealing devi ce deployment was 125.5 +/- 22.2 and 267.8 +/- 60.0 seconds for diagnostic and PTCA patients, respectively. The time to hemostasis was 2.5 +/- 0.9 min utes for diagnostic and 6.0 +/- 2.2 minutes for PTCA patients, No major com plications were observed. Coagulation markers (fibrinogen, D-dimer, thrombi n-antithrombin-3 complex, and prothrombin fragment 1 and 2) measured before and after sealing device deployment did not reveal excessive intravascular thrombin generation or of her coagulopathy. This novel vascular sealing de vice successfully achieves safe and effective vascular access site hemostas is immediately after cardiac catheterization and PTCA. These promising firs t human results will need to be confirmed by a multicenter randomized trial . (C) 1999 by Excerpta Medica, Inc.