Intravascular ultrasound evaluation of BYCROSS™ Atherectomy.

Abstract

Background: BYCROSS™ atherectomy allows minimally invasive plaque removal in patients with peripheral arterial disease (PAD). Previously published reports with this device provided promising results. However, data on atherectomy combined with intravascular ultrasound (IVUS) are limited. The aim of this study was to assess luminal gain in patients treated with the BYCROSS™ device in femoropopliteal lesions using IVUS. Patients and methods: Consecutive patients with symptomatic PAD due to symptomatic femoropopliteal lesions or occlusions underwent BYCROSS™ atherectomy-assisted endovascular revascularization. Safety in terms of perforation and embolization were evaluated, while area of stenosis (%) and minimal luminal area were measured by IVUS at baseline, after atherectomy and after adjunctive therapy. Results: 21 patients (68.2±8.8 years, 16 male and 11 with chronic limb-threatening ischemia) were included. Mean lesion length was 139.8±68.8 mm and 15 (71.4%) of the lesions were chronic total occlusions (CTO). Most lesions (52.4%) exhibited moderate-to-severe calcification. Median minimal lumen diameter (MLA) was 0.0 mm² (IQR=0.0-2.55 mm²) before treatment, increased to 8.0 mm² (IQR=6.6-11.2 mm²) after atherectomy (p<0.0001 vs. baseline) and further increased to 17.6 mm² (IQR=11.6-22.3 mmm²) after further treatment with angioplasty and if required stenting (p=0.0001 vs. after atherectomy). No perforations were noted, while peripheral embolization was noted in 3 (14.3%) cases, which all could be treated by catheter aspiration. Conclusion: The BYCROSS^TM atherectomy system can provide effective lumen gain in femoropopliteal lesions without barotrauma, which can be quantitatively assessed using IVUS. Further studies are now warranted to investigate the impact of luminal gain on long-term patency and limb-related outcomes.