Immediate sealing of arterial puncture sites after cardiac catheterizationand coronary interventions: Initial US feasibility trial using the Duett vascular closure device
Mr. Mooney et al., Immediate sealing of arterial puncture sites after cardiac catheterizationand coronary interventions: Initial US feasibility trial using the Duett vascular closure device, CATHET C IN, 50(1), 2000, pp. 96-102
The aim of this first U.S. feasibility study was to investigate the safety
and efficacy of a novel vascular sealing device, Duett, following percutane
ous endovascular procedures. Immediately following a catheterization proced
ure, the sealing device was deployed at the femoral arterial access site in
43 patients (diagnostic 29, intervention 11, intervention + abciximab 3).
Patients were followed up at 1 month with clinical assessment, ankle-brachi
al index measurement, and Doppler ultrasound of the treated femoral artery
puncture site. Successful hemostasis was achieved with the Duett alone in 4
2/43 (97.7%) patients. There was one uncomplicated crossover to manual comp
ression. The time to hemostasis was 4.0 +/- 1.5, 6.9 +/- 4.2, and 5.8 +/- 1
.2 min for diagnostic, interventional, and abciximab patients, respectively
. At 1-month follow-up, one patient (2.3%) required ultrasound-guided compr
ession for treatment of a pseudoaneurysm, There were no other major complic
ations. This novel vascular sealing device appears to achieve rapid and saf
e hemostasis successfully immediately following a wide range of percutaneou
s endovascular procedures. (C) 2000 Wiley-Liss, Inc.