Simplified swift and safe vascular closure device deployment without a local arteriogram: Single center experience in 2074 consecutive patients.

OBJECTIVE

Vascular closure devices (VCDs), such as the Angio-Seal, a three-component hemostatic plug, have greatly facilitated the routine clinical practice in the catheterization laboratory. The manufacturer recommends a local angiogram before Angio-Seal deployment. However, from the outset, we employed a simplified routine of deploying this VCD, i.e. without use of local angiography.

METHODS

The Angio-Seal was employed without a preceding femoral arteriogram over 8 years in 2074 consecutive patients, 72% presenting with acute coronary syndromes and subjected to coronary angiography (n=1032) or PCI n=1042) via a transfemoral approach with use of heparin and dual antiplatelet therapy.

RESULTS

Deployment of the VCD was successful in 99.4%. Complete hemostasis was obtained in 98% of cases. In 14 patients, Angio-Seal deployment failed. Mean time for placement of Angio-Seal was <1min, to-hemostasis 1min, and to-mobilization 3h. Only 3 (0.15%) patients had a major complication with vessel occlusion that required emergent vascular surgery with a successful outcome. Two patients developed a local pseudoaneurysm treated with ultrasonography-guided compression. Six small and 4 large inguinal hematomas (one requiring blood transfusion) and 5 cases of retroperitoneal bleeding (one requiring blood transfusion) were recorded.

CONCLUSION

Deployment of Angio-Seal without use of local angiography was efficacious and safe, characterized by a high success rate of deployment and hemostasis with few correctable complications in a large patient cohort undergoing transfemoral catheterization for PCI and non-PCI procedures under anticoagulation and antiplatelet drug therapy. VCD reduced the time-to-hemostasis and time-to-mobilization and minimized the incidence of complications.