Percutaneous Vascular Closure System Based on an Extravascular, Bioabsorbable Polyglycolic Plug (ExoSeal): Results from 1000 Patients

Abstract

PURPOSEThe objective of this prospective study was to evaluate the effectiveness and safety of a percutaneous closure system based on a polyglycolic acid plug for achieving hemostasis.MATERIAL AND METHODSIn this study from 2011 to 2014, a percutaneous vascular closure system (ExoSeal) was used in 1000 patients (mean age 70.6 ± 10.2 years), using antegrade and retrograde techniques within the context of an angiographic intervention. The system was used in conjunction with transfemoral approaches with a sheath size of 6F. Post the intervention (on the following day and after 6 weeks), follow-up was conducted clinically and using color-coded duplex ultrasound.RESULTSImmediate hemostasis was achieved in 939/1000 patients (93.9%). In the remaining 61 cases, a correct positioning of the polyglycolic acid plug was not possible because of malfunctioning of the device, massive vascular wall calcifications, postoperative scar tissue, or too steep a puncture angle. In these cases, manual compression was successful. There was one retroperitoneal bleeding requiring transfusion. Minor complications were observed (7.4% in total) with 10 pseudoaneurysm (1%), 63 inguinal hematomas (up to 3 cm; 6.3%), and 1 stenosis (0.1%).CONCLUSIONSafe and effective hemostasis is possible with the percutaneous ExoSeal closure system at puncture sizes of 6F.

Efficacy and Safety of Ultrasound-Guided Repeat Access and Repeat Closure With an ExoSeal Vascular Closure System in Patients With Peripheral Arterial Disease

“…Previous reports in ExoSeal series with 6 Fr access have found minor complication rates of 1-1.8% for pseudoaneurysm and 3.4-6.3% for inguinal hematoma. [11][12][13] Thus, sheath size may influence the access site complication rate. In addition, Ramirez et al 14 found that closure device use with CFA antegrade access had a higher risk than retrograde access (any access site hematoma, odds ratio = 1.46).…”

Successful bailout procedure for acute popliteal artery occlusion associated with EXOSEAL® vascular closure device: a case report

“…Kamusella et al reported a case of device related stenosis (0.1%) among 1000 patients in whom the EXOSEAL VCD was used. The stenosis was detected by the partially intravascular position of the plug, but hemodynamically significant stenosis was not evident [ 4 ]. As described above, complications of arterial occlusion induced by EXOSEAL VCD are thought to be very rare.…”