Retrospective evaluation of safety and effectiveness of the EXOSEAL vascular closure device for single vascular closure and closure after repeat puncture in diagnostic and interventional radiology: single-center experience

Abstract

Purpose: To retrospectively evaluate the safety and effectiveness of the EXOSEAL vascular closure device (VCD) for first or repeated closure after retrograde percutaneous femoral arterial access.

Materials and methods: A retrospective analysis of 417 patients (271 men; mean age, 64.1 y±12.8; age range, 22-94 y) who had undergone arterial closure with the EXOSEAL VCD was performed. Procedures with retrograde femoral access and closure with the 5-F, 6-F, or 7-F EXOSEAL VCD according to the manufacturer's instructions were included. The clinical indications included the full procedural portfolio of a radiologic department with a focus on transarterial hepatic procedures. After EXOSEAL VCD closure, patients were restricted to bed rest for 4 hours.

Results: From August 2010 to March 2012, a total of 682 EXOSEAL VCDs (5-F, n = 276; 6-F, n = 394; 7-F, n = 12) were used in 659 procedures with a total of 404 repeated closures. The EXOSEAL VCD was used successfully in 676 of 682 procedures (99.1%). Hemostasis was achieved in 651 of 682 procedures (95.5%). No major complications were encountered. There were eight cases (1.17%) of minor complications despite a successful vascular closure procedure, none requiring further therapy. There were no complications in any of the 404 cases of repeated vascular closure.

Conclusions: The results of this study suggest that the EXOSEAL VCD is safe and effective in single and repeated closure of retrograde percutaneous femoral arterial access in interventional radiology cases.