Safety and efficiency of femoral artery access closure with a novel biodegradable closure device: a prospective single-centre pilot study.

Abstract

Vascular closure devices can accelerate haemostasis after arteriotomy, but induce scarring. The aim of the study was to prospectively analyse the feasibility of a novel biodegradable arterial closure device (CD). Two hundred fifty-five patients (183 male; age 36-98 years) with an access vessel diameter >3 mm received the biodegradable CD after endovascular therapy. Technical success rate, time-to-haemostasis (TTH) and time-to-ambulation (TTA) were measured. Puncture site complications were categorized as minor (local hematoma, minor bleeding) or major (pseudoaneurysm, embolization, dissection, thrombotic occlusion, hematoma/major bleeding requiring surgery, access site infection). Technical success was achieved in 98.8 % (252 cases); device failure occurred in three cases (1.2 %). The average TTH and TTA were 11.3 ± 26.9 s and 73.0 ± 126.3 min. The major complication rate was 1.6 %, with three pseudoaneurysms and one retroperitoneal bleeding. The minor complication rate was 2.0 %, with five small hematomas. Neither cardiovascular risk factors nor access vessel characteristics had statistically significant influence on adverse events. Re-puncture was uncomplicated in 32 cases after 155.0 ± 128.8 days. Handling of the new biodegradable CD is safe. The complication rates are tolerably low and comparable to other CDs. Post-procedural sonography showed no significant palpable subcutaneous changes in the access site. • VCDs can increase time efficiency and patient comfort after intervention. • In this prospective single-centre-study, biodegradable CD was safe and easily applicable. • Its major and minor complication rates are comparable to other CDs. • Its mean time-to-haemostasis and time-to-ambulation were 11.3 ± 26.9 s and 73.0 ± 126.3 min. • Post-procedural sonography showed no significant palpable subcutaneous changes at the access site.