Initial experience with Angioseal™ : Safety and efficacy of the endovascular closure device

Abstract

Background:Vascular access site management is crucial to safe, efficient, and comfortable diagnostic or interventional percutaneous procedures. The Angioseal™ vascular closure device has been shown to be safe and effective in reducing the time to hemostasis following angiographic or interventional procedures. Relatively few studies have been conducted in the UK to assess the safety and efficacy of the device in a local setting.Materials and Methods:Data were retrospectively reviewed on 147 patients who underwent either diagnostic angiography or percutaneous interventional procedures from January 2008 to October 2009, and who had the femoral access site closed by 6F VIP Angioseal. A total of 147 patients (F: 49, M: 98), including 80 right femoral punctures, 57 left femoral punctures, and 10 bilateral punctures were reviewed using radiological reports and patients’ clinical data. Data on antiplatelet and anticoagulant therapy were recorded. All procedures were carried out by two interventional radiologists at a single institution, under similar operating conditions.Results:There were a total of six complications (4.47%), of which one was a major complication (0.75%), i.e., retroperitoneal bleed. There were five minor complications (3.73%), which included device deployment failure (2), device malfunction (2), and a superficial hematoma (>6 cm). Total complications were 6 out of 157 (3.8%) [95% CI = 0.8-6.8%)]. Successful hemostasis was achieved in less than 5 min in over 97% of patients. Successful device deployment was seen in over 98% of cases.Conclusion:We conclude that in our experience, the Angioseal vascular closure device is a safe and efficient means of achieving hemostasis post antegrade or retrograde puncture for diagnostic and percutaneous intervention procedures.