Mechanical thrombectomy in in-stent restenosis: Preliminary experience at the iliac and femoropopliteal arteries with the Rotarex System

Aim. Iliac and femoropopliteal arterial stenting remainscontroversial due to frequent restenosis. This study aimsto evaluate the efficacy of a mechanical rotationalthrombectomy procedure with the Rotarex MechanicalThrombectomy System (Straub Medical, Wangs, CH) andpercutaneous transluminal angioplasty (PTA) in termsof technical success, patency rates and limb salvage.Methods. From May 2006 to March 2010, 32 selectedpatients with sub-acute or chronic in-stent restenosisat the iliac or femoropopliteal arteries were treated witha Rotarex and then PTA procedure.Results. Technical success was 100%. Intra-proceduralcomplications included a superficial femoral artery(SFA) dissection (1), SFA (1) and external iliac (1) perforationsand a groin hematoma (1). There was no incidenceof embolization in this series. One patient required reintervention(3.1%); an attempted surgical bypass andamputation. Secondary reinterventions were required in17 patients (53.1%). Limb salvage rate at 12 months was90.6%. Primary patency at 30 days was 96.8%. Primary,primary assisted and secondary patency rates at 6months were 75%, 75% and 89.6% and at 12 monthswere 58.1%, 58.1% and 75.5%, respectively. Late mortalitywas 18.75% at an average follow-up of 13.1 months(3-45).Conclusion. This treatment seems promising in terms oftechnical success and embolization risk. Reinterventionsare frequently required but mid-term limb salvage ratesare encouraging. Larger, randomised studies are neededto determine the cost/benefit advantage and longtermresults.