Abstract
Purpose
To evaluate the safety, comfort, and efficacy of an extravascularly deployed bioabsorbable plug–based vascular closure device (VCD) for sealing 6-F antegrade access sites in patients requiring peripheral endovascular intervention.
Methods
A single-center, single-arm, prospective study to evaluate the 6-F ExoSeal VCD in terms of technical success, adverse events, and patient comfort enrolled 59 unselected symptomatic patients (42 men; mean age 72.1±9.3 years) suffering from peripheral artery disease in an 11-month period. Patients with high body mass index (BMI) or calcification at the access site were not excluded. Calcifications of the access vessel were scored as grades 1–4 from fluoroscopic images. The pain level during implantation was evaluated after the procedure using a visual rating scale.
Results
Technical success rate was 98.3%; 1 primary device failure was converted to manual compression. In addition, 1 (1.7%) pseudoaneurysm, 2 (3.4%) minor hematomas, and 1 (1.7%) minor secondary bleeding were observed. There was no intravascular application of the device detected. Neither BMI, calcification of the access vessel (present in 74.6%, mean score 1.4±1.1), age, nor blood clotting had any statistically significant influence on adverse events. In total, 55 (93.2%) patients felt no pain during the VCD implantation.
Conclusion
The tested VCD was safe, with an excellent technical success rate even in cases with severe access vessel calcification.
Keywords
Get full access to this article
View all access options for this article.