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

PurposeTo 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 MethodsA 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. ResultsFrom 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. ConclusionsThe 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.