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.