Immediate sealing of arterial puncture sites after cardiac catheterization and coronary interventions: initial U.S. 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 percutaneous endovascular procedures. Immediately following a catheterization procedure, 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-brachial index measurement, and Doppler ultrasound of the treated femoral artery puncture site. Successful hemostasis was achieved with the Duett alone in 42/43 (97.7%) patients. There was one uncomplicated crossover to manual compression. 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 compression for treatment of a pseudoaneurysm. There were no other major complications. This novel vascular sealing device appears to achieve rapid and safe hemostasis successfully immediately following a wide range of percutaneous endovascular procedures.
Mooney
M R
MR
Department of Cardiology, Mpls. Heart Institute Foundation, Minneapolis, MN 55407, USA. mooney@allina.com
Ellis
S G
SG
Gershony
G
G
Yehyawi
K J
KJ
Kummer
B
B
Lowrie
M
M
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D015906:Angioplasty, Balloon, Coronary / Q000379:methods; D006328:Cardiac Catheterization / Q000379:methods; D002408:Catheters, Indwelling / Q000009:adverse effects*; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D005263:Femoral Artery / Q000293:injuries*; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011336:Probability; D011446:Prospective Studies; D011677:Punctures / Q000009:adverse effects; D012680:Sensitivity and Specificity; D014014:Tissue Adhesives
D014014:Tissue Adhesives