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

PURPOSE: The 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 METHODS: In 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. RESULTS: Immediate 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%). CONCLUSION: Safe and effective hemostasis is possible with the percutaneous ExoSeal closure system at puncture sizes of 6F.