Background: To evaluate the efficacy, safety and limitations of a new rotational thrombectomy device (Straub-Rotarex) in clinical practice.
Material and methods: The Straub-Rotarex catheter is a new, wire-guided rotational thrombectomy device for the treatment of acute and subacute occlusions of the femoro-popliteal arteries. Over a 6-month period, 28 patients (64% male, mean age 69 +/- 9.5, 51-91 years) with 31 legs, mean duration of occlusion 4.4 +/- 4 (0-20) weeks, mean occlusion length 22 +/- 11 (5-40) cm were treated with the device, 5 of them in a cross-over technique. Target lesions: Aortic-femoral bypass, common iliac artery, external iliac artery, common femoral artery: 1 each, superficial femoral artery: 23, popliteal artery: 17. Initial stage of claudication: IIa: 6%, IIb: 72%, III: 16%, IV: 6%.
Results: Primary success rate: 90% (ipsilateral: 100%, cross-over: 40%). Stage of claudication after intervention: I: 85%, IIa: 7%, III: 4%, IV 4%, one amputation. 3-months follow-up: stage I: 86% (n = 24), IIa: 14% (n = 4), one femoro-popliteal bypass. Restenosis rate 18%. 6-months follow-up: 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 puncture 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 restenosis as well in antegrade technique. Main complications are perforations. Cross-over interventions can only be done in special cases.