Percutaneous Mechanical Atherothrombectomy Using the Rotarex Device in Acute Ischemic Disease of Lower Limbs: A China Retrospective Multicenter Study on 186 Patients

Abstract

To evaluate the efficacy and safety of the Rotarex mechanical thrombectomy device in treating acute lower extremity arterial ischemia and to explore the appropriate indication of the Rotarex device. A retrospective analysis was performed in 186 patients with acute lower extremity arterial ischemia treated with the Rotarex mechanical thrombectomy device from April 2015 to March 2020 in three vascular surgery centers of Tianjin. As per the comprehensive judgment of the etiology, onset time, imaging of ultrasonography (US) and angiography, and findings during treatment, the patients were divided into the embolization group (69 cases), thrombosis group (primary artery stenosis with thrombosis; 86 cases), and restenosis group (stent restenosis with thrombosis; 31 cases). The primary study outcomes included the success rate of Rotarex mechanical thrombectomy device alone, percutaneous transluminal angioplasty (PTA), stent, catheter-directed thrombolysis (CDT) auxiliary rate, target vessel patency rate, and freedom from clinically driven target lesion revascularization rate (f-CD-TLR). The secondary study outcomes included intraoperative distal arterial embolization, postoperative 30-day bleeding, and deterioration of renal function, amputation, and mortality. The success rate of Rotarex mechanical thrombectomy device alone in the embolization group (44.93%) was significantly higher than that in the thrombosis group (13.95%) and restenosis group (0%) (P<0.01). The PTA auxiliary rate in the embolization group (26.09%) was significantly lower than that in the thrombosis group (72.09%) and restenosis group (100%) (P<0.01). The stent implantation rates in the embolization group and restenosis group(11.60% and 33.30%, respectively) were significantly lower than that in the thrombosis group (72.09%) (P<0.01). There were no significant differences in the CDT auxiliary rate, distal arterial embolization, hemorrhage, renal function deterioration, amputation rate, and mortality among the three groups (P>0.05). The primary patency at 3months, 6months, and 12months postoperatively was 98.6%, 98.6%, and 84.3% in the embolization group, 96.4%, 89.5%, and 74.9% in the thrombosis group, and 93.2%, 84.7%, and 67.5% in the restenosis group, respectively (P<0.01). The f-CD-TLR at 12months postoperatively was 88.9% in the embolization group, which was higher than 77.8% in the thrombosis group and 67.5% in the restenosis group (P<0.01). The Rotarex mechanical thrombectomy device is a minimally invasive, safe, and effective treatment option for acute lower extremity arterial ischemia, particularly acute arterial embolization. For acute thrombosis secondary to primary artery stenosis and in-stent restenosis, Rotarex device can effectively reduce the thrombus burden and create favorable conditions for other concurrent interventions.