title: Systematic use of a collagen-based vascular closure device immediately after cardiac catheterization procedures in 1,317 consecutive patients.
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.
authors.affiliation: Department of Cardiology, Center of Internal Medicine, University Hospital Essen, Essen, Germany. holger.eggebrecht@uni-essen.de
authors.forename: Holger
authors.initials: H
authors.lastname: Eggebrecht
authors.forename: Michael
authors.initials: M
authors.lastname: Haude
authors.forename: Uta
authors.initials: U
authors.lastname: Woertgen
authors.forename: Axel
authors.initials: A
authors.lastname: Schmermund
authors.forename: Clemens
authors.initials: C
authors.lastname: von Birgelen
authors.forename: Christoph
authors.initials: C
authors.lastname: Naber
authors.forename: Dietrich
authors.initials: D
authors.lastname: Baumgart
authors.forename: Christoph
authors.initials: C
authors.lastname: Kaiser
authors.forename: Olaf
authors.initials: O
authors.lastname: Oldenburg
authors.forename: Thomas
authors.initials: T
authors.lastname: Bartel
authors.forename: Knut
authors.initials: K
authors.lastname: Kroeger
authors.forename: Raimund
authors.initials: R
authors.lastname: Erbel
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000295:instrumentation*; D006328:Cardiac Catheterization / Q000009:adverse effects* / Q000295:instrumentation*; D003094:Collagen / Q000009:adverse effects* / Q000627:therapeutic use*; D003324:Coronary Artery Disease / Q000601:surgery*; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000601:surgery*; D006489:Hemostatic Techniques / Q000009:adverse effects* / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000209:etiology* / Q000517:prevention & control*; D011446:Prospective Studies; D013997:Time Factors
chemical_list: D003094:Collagen