No significant increase in hematoma rates for small and large caliber arterial access closure, using the 8-F Angio-Seal Device

Many arterial endovascular interventions now require greater than 8-F access, but the options for approved endovascular closure are limited to suture-mediated devices. This retrospective study was performed to evaluate access complications when using the 8-F Angio-Seal device in closing ≤ 8-F arteriotomies compared to 9-F to 12-F arteriotomies.

137 consecutive patients were identified retrospectively, all who received the 8-F Angio-Seal Device. 76 patients had < 8-F accesses closed (mean sheath size 7.2-F), and 61 patients had 9-F to 12-F accesses closed (mean sheath size 9.7-F). Complication rate for all closures was 8%, with no statistically increased risk with closure of the larger accesses. Note is made, that of the 6 access complications seen with 9-F to 12-F access, none required intervention beyond manual compression (45 minutes ± 15), a Type 1 complication. Two of the five complications for 8-F or less group required intervention (Type 2 complication).

Comment: 

This study was well-designed and demonstrates the safety of use of the 8-F Angio-Seal device for 9-F to 12-F arteriotomies when compared to < 8-F arteriotomies. However, this study was limited by its somewhat small sample size and retrospective nature and this remains an off-label use of the device. While, there are other proven safe endovascular closure devices for accesses larger than 8-F, consideration should be given to the use of this device in access sites >8-F.


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Citation: Baumann, F. et al. Single-Center Experience Comparing the Application of Small-Caliber versus Large-Caliber Arterial Access Closure in a Consecutive Series of Patients. Journal of Vascular and Interventional Radiology (2015). doi:10.1016/j.jvir.2015.04.024


Post Author: Daniel Sheeran, MD. VIR Pathway Resident at University of Virginia