Exoseal for puncture site closure after antegrade procedures in peripheral arterial disease patients

PURPOSE

Exoseal is a vascular clo sure device consisting of a plug applier and a bio-absorbent polyglycolic acid plug available in sizes 5 F, 6 F, and 7 F. In this study, we aimed to evaluate the effectiveness and safety of the Exoseal vascular closure device (Cordis Corporation, Bridgewater, New Jersey, USA) for puncture site closure after antegrade endovascular procedures in peripheral arterial occlusive disease (PAOD) patients.

MATERIALS AND METHODS

In this retrospective study, a total of 168 consecutive patients who underwent an interventional procedure due to PAOD, were included. In each case, an antegrade peripheral endovascular procedure was performed via the common femoral artery using the Seldinger technique, and Exoseal 5 F, 6 F, or 7 F was used for access site closure. The primary endpoint was a technically successful application of Exoseal. All complications at the access site within 24 hours were registered as a secondary endpoint.

RESULTS

In a group of 168 patients (64.9% men, average age 71.9±11.9 years), the technical application of Exoseal was successful in 166 patients (98.8%). Within the first 24 hours after the procedure, 12 complications (7.2%) were recorded including, three pseudoaneurysms (1.8%) and nine hematomas (5.4%). None of the complications required surgical intervention.

CONCLUSION

Exoseal is a safe and effective device with high technical success and acceptable complication rates for access site closure after antegrade peripheral endovascular procedures.Femoral access sites are important sources of complications in endovascular procedures. In addition to conventional manual compression, arterial closure devices have been successfully used for the purpose of hemostasis at the femoral arterial access site in interventional radiology, cardiology, and angiology for several years. The effectiveness and safety of these devices have already been proven in numerous studies (1). Vascular closure devices were developed to address the increasing time constraints in everyday clinical routine, as well as to increase patient comfort after interventional procedures. Most of these devices have been evaluated for retrograde access.Exoseal (Cordis Corporation, Bridgewater, New Jersey, USA) is a vascular closure device consisting of a plug applier and a bio-absorbent polyglycolic acid plug available in sizes 5 F, 6 F, and 7 F. Exoseal is inserted into the branch canal directly outside the arterial vessel wall and underneath the fascia of the neurovascular bundle. The polyglycolic acid plug increases platelet aggregation, as well as promoting erythrocyte accumulation within the network of the plug. This results in closure of both vessel wall and branch canal. Exoseal gets hydrolyzed into carbon dioxide and water via the Kreb’s cycle and it is completely reabsorbed within 60–90 days (2).The available data studying the role of Exoseal in peripheral vascular interventions is limited, and to this date, there are only two studies published that address the use of this device in antegrade femoral access (3, 4).The aim of this study was to evaluate the effectiveness and safety of Exoseal use for access site closure following antegrade vascular procedures on peripheral arterial occlusive disease (PAOD) patients. According to our literature research, this is the largest patient cohort that has been investigated in that respect so far.