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Systematic use of a collagen-based vascular closure device immediately after cardiac catheterization procedures in
Holger Eggebrecht1, Michael Haude, Uta Woertgen
1Department of Cardiology, Center of Internal Medicine, University Hospital Essen, Essen, Germany. holger.eggebrecht@uni-essen.de
Insights
A collagen-based closure device effectively seals femoral access sites after cardiac procedures, achieving reliable hemostasis and significantly reducing complications compared to manual compression. This method allows immediate patient mobility.
Area of Science:
- Interventional Cardiology
- Vascular Access Management
Background:
- Vascular access complications remain a significant challenge in interventional cardiology.
- Conventional manual compression for femoral access site closure leads to prolonged patient immobilization and discomfort.
Purpose of the Study:
- To evaluate the performance and complication rates of a collagen-based closure device for femoral access sites.
- To compare device performance in patients undergoing diagnostic cardiac catheterization versus interventional coronary angioplasty.
Main Methods:
- A prospective study involving 1,317 consecutive patients undergoing cardiac catheterization or coronary angioplasty.
- Immediate application of a collagen-based closure device post-catheterization.
- Assessment of deployment success, immediate hemostasis, and major vascular access complications.
Main Results:
- High device deployment success rates (95.8% diagnostic, 96.7% interventional).
- Immediate hemostasis achieved in >90% of patients, slightly lower in the interventional group (90.6%).
- Low rate of major complications (0.53% overall), with no significant difference between diagnostic and interventional groups.
Conclusions:
- Systematic sealing of femoral access sites with a collagen-based device ensures reliable hemostasis and allows immediate sheath removal.
- The collagen-based closure device is associated with a low rate of clinically significant vascular access complications.
- Female gender was identified as a predictor of access site complications.
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.