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.
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.
Authors: Joel L Ramirez; Devin S Zarkowsky; Thomas A Sorrentino; Caitlin W Hicks; Shant M Vartanian; Warren J Gasper; Michael S Conte; James C Iannuzzi Journal: J Vasc Surg Date: 2020-03-09 Impact factor: 4.268