ABSTRACT
PURPOSE: Crossing of lower-extremity arterial chronic total occlusion (CTO) can be challenging. Use of the Viance peripheral CTO crossing device (Covidien) in the superficial femoral (SFA), popliteal, and below-the knee (BTK) arterial locations has received limited study. METHODS: Fifty-eight patients from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) were treated between April 2010 and November 2013 with the Viance device. The procedural and 30-day clinical outcomes were collected. RESULTS: Mean age was 65.5 ± 8.7 years and 55.1% had diabetes mellitus. Most lesions (n = 58) were TASC classification type C (n = 16; 27.6%) and D (n = 16; 27.6%), with mean lesion length 140.0 ± 71.0 mm; 93.1% of lesions were de novo and 81.0% were severely calcified. Technical success (crossing without the use of a reentry device) was achieved in 87.9% of cases and procedural success was obtained in 86.2%; 51.7% of lesions received stents, with the remaining treated with balloon angioplasty and/or atherectomy. Average fluoroscopy time was 39.1 ± 21.2 min, with 187.8 ± 72.0 mL of contrast and 210.0 ± 212.0 Gy cm² radiation dose-area product. There was 1 periprocedural complication (access-site hematoma treated conservatively without blood transfusion). At 30 days post procedure, there was significant improvement in ankle-brachial index (0.72 ± 0.30 to 0.84 ± 0.16; P=.01) and Rutherford class (3.33 ± 0.81 to 1.54 ± 1.47; P<.001). Clinically-indicated target vessel revascularization, surgical intervention or amputation at 30 days was 5.2%. CONCLUSION: Use of Viance to cross infrainguinal arterial CTO was associated with high success, low complication rates, and significant symptom improvement.
