Favorable Single-Operator Experience with VasoSeal, a Vascular Closure Device with Extravascular Collagen in a Large High-Risk Cohort of Patients Undergoing Percutaneous Coronary Interventions

Abstract

BACKGROUND: Prolonged duration of manual or mechanical compression at the site of femoral artery access after sheath removal upon completion of coronary procedures followed by extended period of bed rest has significant logistical and practical problems for both patients and hospital staff. The availability of vascular closure devices (VCDs) has ushered in a new era in the routine clinical practice in the catheterization laboratory.

AIM: The aim of this prospective study was to assess the effectiveness and safety of the use of the VCD VasoSeal, a collagen plug, in patients undergoing cardiac catheterization and/or percutaneous coronary intervention (PCI).

PATIENTS AND METHODS: VasoSeal was employed over 2.5 years in 388 consecutive patients mostly presenting with acute coronary syndromes and subjected mainly to PCI procedures performed via transfemoral arterial access. All the patients who underwent PCI were given 7,000 IU of heparin intravenously during the procedure and had been receiving or were acutely loaded with dual antiplatelet therapy (aspirin and clopidogrel). The majority (90.7%) of patients also received a platelet glycoprotein IIb/IIIa inhibitor during and for 12-14 hours after the procedure. The sheaths were removed at the end of the procedure and hemostasis achieved with VasoSeal.

RESULTS: Deployment of the VCD was successful in 99.2%. Complete hemostasis without bleeding or hematoma was obtained in 95.4% of cases (370/388). In 3 patients VasoSeal could not be or was partially deployed. The mean time required for the placement of VasoSeal was 1 min. The mean time-to-hemostasis was 3 min. The mean time-to-mobilization was 3 hours. Only one patient developed a pseudoaneurysm of the right common femoral artery; the lesion was treated with ultrasonography -guided compression. In addition, 13 small local hematomas and 2 large inguinal hematomas (one requiring blood transfusion) were recorded. In 2 cases retroperitoneal bleeding occurred, requiring blood transfusion in one of them. Local infection (cellulitis) responding to antibiotic treatment was observed in 2 patients. No patient required local surgical intervention.

CONCLUSION: VasoSeal was a safe collagen closure device characterized by a high success rate of deployment and highly successful hemostasis with few manageable complications in a very high-risk patient cohort undergoing PCI under heavy anticoagulation and antiplatelet drug therapy. In these patients this vascular closure device reduced the time-to-hemostasis and time-to-mobilization and the incidence of complications.