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

Iliac and femoropopliteal arterial stenting remains controversial due to frequent restenosis. This study aims to evaluate the efficacy of a mechanical rotational thrombectomy procedure with the Rotarex Mechanical Thrombectomy System (Straub Medical, Wangs, CH) and percutaneous transluminal angioplasty (PTA) in terms of technical success, patency rates and limb salvage.From May 2006 to March 2010, 32 selected patients with sub-acute or chronic in-stent restenosis at the iliac or femoropopliteal arteries were treated with a Rotarex and then PTA procedure.Technical success was 100%. Intra-procedural complications included a superficial femoral artery (SFA) dissection (1), SFA (1) and external iliac (1) perforations and a groin hematoma (1). There was no incidence of embolization in this series. One patient required reintervention (3.1%); an attempted surgical bypass and amputation. Secondary reinterventions were required in 17 patients (53.1%). Limb salvage rate at 12 months was 90.6%. Primary patency at 30 days was 96.8%. Primary, primary assisted and secondary patency rates at 6 months were 75%, 75% and 89.6% and at 12 months were 58.1%, 58.1% and 75.5%, respectively. Late mortality was 18.75% at an average follow-up of 13.1 months (3-45) due to the severe disease state of these patients..This treatment seems promising in terms of technical success and embolization risk. Reinterventions are frequently required but mid-term limb salvage rates are encouraging. Larger, randomised studies are needed to determine the cost/benefit advantage and long-term results.