Large-scale experience with an anchorless vascular closure device in a real-life clinical setting.

AIMS

This study was designed to evaluate safety and effectiveness of the vascular closure device Exoseal (Cordis) for hemostatic control following cardiac catheterization in a real-life clinical setting.

METHODS AND RESULTS

This prospective, single-center study enrolled n = 2,031 consecutive patients who underwent coronary angiography via the femoral artery ± PCI (n = 801). Patients were excluded if they had radial access, percutaneous repair of structural heart disease, or if they had severe peripheral artery disease. If clinical abnormalities were discovered at the access site, color Doppler ultrasound was performed. The composite primary endpoint was defined as bleeding/vascular complications and device failure, and it was experienced by 5.4 % (n = 110) of patients. The most frequent complications were pseudoaneurysm (2.9 %, n = 58) and access-site hematoma >6 cm (1.8 %, n = 37). The overall device failure rate was 0.7 % (n = 14). Multiple logistic regression analysis demonstrated that the strongest independent predictors of bleeding/vascular complications and/or device failure were procedure duration (OR 2.1, CI 1.4-3.2), PCI (OR 2.7, CI 1.7-4.2), GP IIb/IIIa inhibitors (OR 2.9, CI 1.5-5.7), and age (OR 2.2, CI 1.4-3.5).

CONCLUSIONS

These results indicate that Exoseal was safe in a broad collective of patients. However, lengthy procedures, PCIs, the use of GP IIb/IIIa inhibitors, and elderly patients require special attention.