Immediate sealing of arterial puncture sites after cardiac catheterizationand coronary interventions: Initial US feasibility trial using the Duett vascular closure device

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.