Purpose: To compare the closure of ≤ 8-F versus 9-F to 12-F femoral access using the 8-F Angio-Seal VIP device (St. Jude Medical, Inc, St. Paul, Minnesota).
Materials and methods: In this investigator-initiated, retrospective analysis, a consecutive series of 137 patients (n = 92 male patients [67.2%]; overall mean age, 71.0 y ± 9.8) was evaluated. Common femoral artery access was performed in all patients, and either unfractionated heparin or bivalirudin was used for anticoagulation. Access site complications were defined as follows: type 0, no bleeding; type 1, no actionable bleeding; type 2, actionable bleeding.
Results: The 8-F Angio-Seal VIP device was used for closure of ≤ 8-F femoral access in 76 patients (55.5%) and for 9-F to 12-F femoral access in 61 patients (44.5%). Access site complications were observed after 8-F Angio-Seal deployment in 11 patients (8.0%) (≤ 8 F, n = 5 [6.6%]; 9-12 F, n = 6 [9.8%]; P = .54). Comparing ≤ 8-F with 9-F to 12-F femoral access, type 1 complications were observed in 3 and 6 patients (P = .19) and type 2 complications were observed in 2 and 0 patients (P = .50), respectively. All type 1 complications were managed by applying external compression. Type 2 complications (n = 2 pseudoaneurysms) were treated with thrombin injection in 1 patient and secondary percutaneous intervention in 1 patient.
Conclusions: Use of the 8-F Angio-Seal for the closure of > 8-F femoral access is safe and effective. Complication rates when using the 8-F Angio-Seal for closure of ≤ 8-F and 9-F to 12-F femoral access are comparable.
Copyright © 2015 SIR. Published by Elsevier Inc. All rights reserved.