title: Initial experience with the absorb bioresorbable vascular scaffold below the knee: six-month clinical and imaging outcomes.
abstract: OBJECTIVE
  To investigate a new bioresorbable vascular scaffold for the treatment of focal tibial and distal popliteal lesions.
  
  
  METHODS
  Tibial and distal popliteal angioplasty was performed in 15 limbs of 14 patients (9 men; median age 82 years) with critical limb ischemia (CLI, n=7) or severe claudication. The 18 lesions (mean length 22.2±14.0 mm) were implanted with 22 everolimus-eluting bioresorbable scaffolds (Absorb). Clinical and ultrasound follow-up was performed at 1, 3, 6, and 12 months to detect restenosis and evaluate safety, midterm restenosis rate, and clinical improvement.
  
  
  RESULTS
  Immediate technical success was 100%, although a single limb suffered 2 scaffold thromboses on the first day; it was salvaged with repeat endovascular intervention. All patients were available for surveillance examinations during a follow-up of 6.1±3.9 months; no patient died. Of the 15 limbs in the analysis, clinical improvement was present in 12 (4 of 7 CLI patients); there was no amputation, bypass surgery, or evidence of binary restenosis on follow-up sonographic examination.
  
  
  CONCLUSIONS
  Midterm follow-up for this small pilot sample demonstrates acceptable safety and patency results, together with freedom from all major adverse limb events, using the Absorb bioresorbable vascular scaffold below the knee.
authors: Prince of Wales Hospital, Sydney, New South Wales, Australia University of New South Wales, Sydney, New South Wales, Australia r.varcoe@unsw.edu.au.
authors: Ramon L
authors: RL
authors: Varcoe
authors: Prince of Wales Hospital, Sydney, New South Wales, Australia.
authors: Olaf
authors: O
authors: Schouten
authors: Prince of Wales Hospital, Sydney, New South Wales, Australia University of New South Wales, Sydney, New South Wales, Australia.
authors: Shannon D
authors: SD
authors: Thomas
authors: Prince of Wales Hospital, Sydney, New South Wales, Australia.
authors: Andrew F
authors: AF
authors: Lennox
mesh_terms: D020341:Absorbable Implants; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D003251:Constriction, Pathologic; D005260:Female; D006801:Humans; D007866:Leg / Q000098:blood supply*; D008297:Male; D009517:New South Wales; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D010865:Pilot Projects; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011474:Prosthesis Design; D011859:Radiography; D012008:Recurrence; D016909:Tibial Arteries / Q000000981:diagnostic imaging / Q000503:physiopathology; D013997:Time Factors; D016896:Treatment Outcome; D018615:Ultrasonography, Doppler, Color; D014654:Vascular Patency
keywords: absorbable implants; angioplasty; arterial occlusive diseases; bioresorbable vascular scaffold; drug-eluting device; everolimus; ischemia; lower extremity; peripheral artery disease; polymers