Initial Experience With the Absorb Bioresorbable Vascular Scaffold Below the Knee: Six-Month Clinical and Imaging Outcomes. (April 2015)

• Record Type: Journal Article
• Authors: Varcoe, Ramon L.; Schouten, Olaf; Thomas, Shannon D.; Lennox, Andrew F.
• Is Part Of: Journal of endovascular therapy. Volume 22:Number 2(2015:Apr.)
• Page Start: 226
• Page End: 232
• Publication Date: 2015-04
• Subjects: lower extremity -- ischemia -- angioplasty -- peripheral artery disease -- arterial occlusive diseases -- polymers -- absorbable implants -- drug-eluting device -- bioresorbable vascular scaffold -- everolimus; Blood-vessels -- Endoscopic surgery -- Periodicals; Angioscopy -- Periodicals; Intravenous catheterization -- Periodicals; Peripheral vascular diseases -- Treatment -- Periodicals; Vascular Surgical Procedures -- Periodicals; Angioscopy -- Periodicals; Catheterization, Peripheral -- Periodicals; Peripheral Vascular Diseases -- therapy -- Periodicals; Angioscopie; Maladies vasculaires périphériques; 617.413
• DOI: 10.1177/1526602815575256
• Languages: English
• ISSNs: 1526-6028

Abstract

Purpose: 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.Conclusion: 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.