Treatment of the femoropopliteal arteries with a novel rotational atherectomy system: early single-center experience with the Pathway PV trademark Atherectomy System

Purpose: The main problem when treating the superficial femoral and popliteal artery with PTA or stent implantation is the relatively high restenosis rate. Several ablative systems are available as an alternative. The purpose of this prospective study was to evaluate the safety and performance of a novel rotational and aspirating atherectomy system. Materials and Methods: From June to December 2006, we treated 23 patients, median age 70.3 years (58 - 91), with the rotational atherectomy system. All patients had de-novo lesions of the SFA or PA with a minimum stenosis of 70%. According to the Rutherford classification, 39% of the patients were in category 2 and 61% in category 3. The median lesion length was 26.3 mm (5 - 100 mm). 26% of the patients had occlusions. Results: The technical success rate was 100%. In 14 cases (61%) additional balloon dilatation was applied, in two cases stent implantation were performed. The median treatment duration with the device was 187.7 ± 106.1 s (59 - 391 s). The aspirated volume was 116.5 ± 72.0 ml. The ankle brachial index improved from preinterventional 0.60 ± 0.16 to postinterventional 0.85 ± 0.13 and after 6 month 0.80 ± 0.13. During follow-up, two (8%) restenosis occurred. There were two complications, one dissection and one distal embolization. Follow-up could not be performed for two patients (8%). Conclusion: Atherectomy of femoropopliteal lesions with the Pathway PV trademark Atherectomy System is very safe and effective. The low restenosis rate of 8% is promising, but there is still a lack of long-term results