Success and reliability of extrafemoral Exoseal vascular closure device: "Off-label" usage

The aim of this study is to present the reliability and efficacy of Exoseal vascular closure device (EVCD) for closure of extrafemoral punctures.

All patients who were treated with EVCD following arterial endovascular treatment involving an extrafemoral puncture between April 2013 and January 2014 were examined retrospectively. This study included 11 patients (4 women and 7 men between the ages of 48 and 87 years; average age = 65 years). A total of 13 procedures were performed in 11 patients involving the following access routes: brachial artery (n = 5), popliteal artery (n = 4), and polytetrafluoroethylene graft (n = 4).

Twelve out of 13 EVCD procedures achieved technical success and procedural success. One minor and one major complications occurred. Both complications were revealed to be pseudoaneurysms, both in the brachial artery. Pseudoaneurysm of the minor complication was treated by Fibrin Sealant (Tisseel) injection guided by ultrasonography and the other pseudoaneurysm was treated by covered stent placement.

The femoral artery is an essential access route of arterial endovascular procedures; however, in some cases, the extrafemoral arterial route is necessary. In this study, EVCD was found to be useful for closing extrafemoral arterial routes. This study had a limited number of cases and more large-scale studies are needed.