Background: To ascertain the safety and mid-term outcomes of Rotarex ® S 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.Methods: French multicenter retrospective study of all patients treated by in-stent percutaneous mechanical debulking (PMD) of the lower limbs with Rotarex ® S device between January 2013 and November 2018. Results:The cohort consisted of 128 patients (88 men and 40 women), aged 39-94 years (mean, 66.7±12 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 clinical success/patency rate was 92.3% and the secondary clinical success/patency rate was 91.4%. Rate of limb salvage was 93.7%. Overall 32 (25%) reinterventions were reported with mean time from Rotarex ® S 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 (MI) (9/128, 7.0%), stroke (2/128, 1.6%) and renal failure (3/128, 2.3%).Conclusions: Recanalization with Rotarex ® S rotational atherectomy plus thrombectomy device is a practical choice for arterial ISR/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.

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Surgical thromboembolectomy was the mainstay of treatment for acute limb ischemia (ALI), but in recent years, different endovascular thrombectomy devices have been introduced as alternative treatment options. The aim of this study is to evaluate, in a controlled setting, the preliminary results in terms of early safety and effectiveness of the Penumbra/Indigo Systems in patients with acute lower limb malperfusion due to peripheral acute occlusions (INDIAN Study). Methods: Patients with diagnosis of ALI were collected and treated with Penumbra/Indigo devices. The primary outcome was the technical success of thromboaspiration (evaluated with the thrombolysis in myocardial infarction [TIMI] score classifications before and after use of the device) and the clinical success at follow-up (defined as an improvement of Rutherford classification at 1-month follow-up). The secondary endpoints include the absence of any serious adverse events at discharge, primary patency at 1 month, and limb salvage at 1 month. Results: A total of 136 patients were recruited. The mean Ankle brachial index (ABI) before the procedure 0.46, Rutherford class for ALI IIB was present in 39% of the patients, the mean lesion length was 110 mm, and TIMI score 0 was recorded in 79%. After the thromboaspiration alone, TIMI score 2-3 was restored in 89.6% of patients and after additional procedure in the 95.4%. At 1-month follow-up, Rutherford class for ALI I was present in 90.2% of patients and serious adverse events were reported in nine patients (6.6%, of whom 1 amputation 0.8%). Conclusion: Preliminary results of the INDIAN Study showed that aspirationbased extraction technique with Indigo/Penumbra is safe and effective for revascularization of acute peripheral arterial occlusion as a primary therapy, and it can represent a viable tool as a secondary therapy after other surgical or endovascular techniques.

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