RESUMO
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.
RESUMO
AIMS: Despite the results of recent randomised studies, the systematic use of aspiration techniques in ST-elevation myocardial infarction has not been included in the new guidelines. To date, there have been very few bench tests of the different systems and the aim of our study was to test two catheters on different models of arteries with thrombi at six and 12 hours. METHODS AND RESULTS: The test apparatus consisted of 3 mm diameter glass tubes of 150 mm in length. The thrombi were left for either six or 12 hours and ten models of tubes were used: straight, with a single bend and with two bends. Two types of catheters were tested: the Export® aspiration catheter (EAC) and the Proxis® embolic protection system (PES). The main assessment criterion was total thrombectomy. Total thrombectomy was achieved in only 55.3% of the tests and no difference appeared between the two systems. Total thrombectomy was achieved more frequently with 6-hour thrombi than with 12-hour thrombi for the two techniques, 62.5% vs. 42.5% (p = 0.018) and 67.5% vs. 48.7% (p = 0.025) for EAC and PES catheter, respectively. In contrast, total thrombectomy was more frequent in straight tubes and in tubes with a single bend than in tubes with double bends, respectively for EAC (64% vs. 44.8%, p = 0.028) and for PES (85.9% vs. 35.4%, p < 0.001). CONCLUSIONS: The use of thrombectomy in the invasive management of acute coronary syndromes is growing. Our work on a "laboratory bench" reveals important technical differences. In consequence, in clinical practice, we speculate that the catheter system must be chosen according to both the artery anatomy and the delay between chest pain and PCI.
