Abstract
To ascertain the safety and mid-term outcomes of RotarexS rotational atherectomy plus thrombectomy device (Straub Medical AG, Wangs, Switzerland) with or without adjunctive treatment (e.g., percutaneous transluminal angioplasty, PTA/Drug-coated balloon, DCB/stenting) in patients with in-stent restenosis (ISR) or occlusion in the iliac and/or infrainguinal arteries. French multicenter retrospective study of all patients treated by in-stent percutaneous mechanical debulking (PMD) of the lower limbs with RotarexS device between January 2013 and November 2018. The cohort consisted of 128 patients (88 men and 40 women), aged 39-94 years (median, 66.7 years). All patients presented with cardio-vascular risk factors. Overall, 51.5% of patients had critical limb ischemia. The study demonstrated a technical success of 96.9% in the population with PMD and adjunctive PTA (95/128, 74.2%) or adjunctive DCB (16/128, 12.5%) or both (13/128, 10.2%). At 12-months follow-up, the primary patency rate was 92.3% and the secondary patency rate was 91.4%. Rate of limb salvage was 93.7%. We accounted for 32 (25%) reinterventions with mean time from RotarexS treatment to reintervention of 7.1 ± 8.2 months. Target lesion revascularization (TLR) was 19.5% (25/128). Seven (5.5%) patients developed distal embolism that responded to endovascular treatment. At mean follow-up, major adverse events (MAE) observed were death (18/128, 14.1%), myocardial infarction (9/128, 7.0%), stroke (2/128, 1.6%) and renal failure (3/128, 2.3%). Recanalization with RotarexS rotational atherectomy plus thrombectomy device is a treatment of choice for arterial in-stent restenosis/occlusions of the iliac and/or infrainguinal arteries, regardless of the age of the thrombus, with satisfying TLR. Only adjunctive PTA is often necessary to further improve the recanalization.
Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
