451. Systematic use of a collagen-based vascular closure device immediately after cardiac catheterization procedures in 1,317 consecutive patients.
- Author
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Eggebrecht H, Haude M, Woertgen U, Schmermund A, von Birgelen C, Naber C, Baumgart D, Kaiser C, Oldenburg O, Bartel T, Kroeger K, and Erbel R
- Subjects
- Aged, Equipment Design, Female, Humans, Male, Middle Aged, Prospective Studies, Time Factors, Angioplasty, Balloon, Coronary adverse effects, Angioplasty, Balloon, Coronary instrumentation, Cardiac Catheterization adverse effects, Cardiac Catheterization instrumentation, Collagen adverse effects, Collagen therapeutic use, Coronary Artery Disease surgery, Femoral Artery surgery, Hemostatic Techniques adverse effects, Hemostatic Techniques instrumentation, Postoperative Hemorrhage etiology, Postoperative Hemorrhage prevention & control
- Abstract
Despite recent advances in interventional cardiology, vascular access complications continue to be a significant problem. Conventional manual compression of the femoral access site is associated with prolonged immobilization and significant patient discomfort. We investigated the performance of a collagen-based closure device applied immediately after catheterization and its complication rate in 1,317 consecutive patients undergoing cardiac catheterization or coronary angioplasty. Patients undergoing coronary angioplasty (n = 644) received more heparin than patients with diagnostic cardiac catheterization (n = 673; 9,675 +/- 1,144 IU vs. 6,419 +/- 2,211 IU; P < 0.0001). Deployment success rates of the closure device were comparable for patients undergoing diagnostic vs. interventional procedures (95.8% vs. 96.7%; P = 0.46). Complete hemostasis immediately after deployment of the device was achieved in > 90% of all patients, but was lower in the interventional group (93.7% vs. 90.6%; P = 0.05). Major complications including any vascular surgery, major bleeding requiring transfusion, retroperitoneal hematoma, thrombosis or loss of distal pulses, groin infections, significant groin hematoma, and death were observed in 0.53% of all patients, with no differences between diagnostic or interventional patients (0.62% vs. 0.45%; P = 0.953). Subgroup analysis revealed female gender as a predictor of access site complications. Systematic sealing of femoral access sites after both diagnostic and interventional procedures allows for immediate sheath removal with reliable hemostasis. The use of a collagen-based closure device is associated with a low rate of clinically significant complications., (Copyright 2002 Wiley-Liss, Inc.)
- Published
- 2002
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