title: Safety and efficiency of femoral artery access closure with a novel biodegradable closure device: a prospective single-centre pilot study.
abstract: OBJECTIVE
  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).
  
  
  METHODS
  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).
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  • 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.
authors.affiliation: Institute for Clinical Radiology, Hospitals of the Ludwig-Maximilian-University of Munich, Nussbaumstr. 20, D-80336, Munich, Germany. karlamaria.treitl@med.uni-muenchen.de.
authors.forename: Karla M
authors.initials: KM
authors.lastname: Treitl
authors.affiliation: Institute for Clinical Radiology, Hospitals of the Ludwig-Maximilian-University of Munich, Nussbaumstr. 20, D-80336, Munich, Germany.
authors.forename: Alma
authors.initials: A
authors.lastname: Ali
authors.affiliation: Institute for Clinical Radiology, Hospitals of the Ludwig-Maximilian-University of Munich, Nussbaumstr. 20, D-80336, Munich, Germany.
authors.forename: Marcus
authors.initials: M
authors.lastname: Treitl
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D005263:Femoral Artery / Q000601:surgery*; D006489:Hemostatic Techniques / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D012307:Risk Factors; D016896:Treatment Outcome; D065506:Vascular Closure Devices
keywords: Biodegradable implants; Endovascular techniques; Time-to-ambulation; Time-to-haemostasis; Vascular closure device