The Straub-Rotarex (TM) thrombectomy device: first experience

Background: To evaluate the efficacy, safety and limitations of a new rotat ional thrombectomy device (Straub-Rotarex (TM)) in clinical practice. Mater ial and Methods: The Straub-Rotarex (TM) catheter is a new, wire-guided rot ational thrombectomy device for the treatment of acute and subacute occlusi ons of the femoro-popliteal arteries. Over a 6-month period, 28 patients (6 4% male, mean age 69 +/-9.5, 51-91 years) with 31 legs, mean duration of oc clusion 4.4 +/-4 (0-20) weeks, mean occlusion length 22 +/- 11 (5-40) cm we re treated with the device, 5 of them in a cross-over technique. Target les ions: Aortic-femoral bypass, common iliac artery, external iliac artery, co mmon femoral artery: I each, superficial femoral artery: 23, popliteal arte ry: 17. Initial stage of claudication: IIa: 6%, IIb: 72%, III: 16%, IV: 6%. Results: Primary success rate: 90% (ipsilateral: 100%, cross-over: 40%). S tage of claudication after intervention: I: 85%, IIa: 7%, III: 4%, IV 4%, o ne amputation. 3-months follow-up: stage I: 86% (n = 24), IIa: 14% (n = 4), one femoro-popliteal bypass. Restenosis rate 18%. 6-months followup: stage I: 56% (n = 9), IIa: 31% (n = 5), IIb: 13% (n = 2). Restenosis rate 56 %. Complications: 32 % (5 perforations, three cases of embolism after PTA, one wire-induced dissection, one retroperitoneal bleeding coming from the punc ture site). Conclusions: The new device is a useful tool for the treatment of (sub)acute long-distance occlusions of the SFA and popliteal artery and in-stent restenoses as well in antegrade technique. Main complications are perforations. Cross-over interventions can only be done in special cases.