Rotarex Mechanical Debulking in Acute and Subacute Arterial Lesions.

Abstract

Data regarding the effectiveness and safety of percutaneous mechanical thrombectomy (PMT) in contemporary routine care are scarce. Consecutive patients undergoing PMT of native lower limb acutely/subacutely occluded arteries were included. In all, 525 consecutive patients were available for analysis with a mean age of 66.7 ± 10.7 years. Almost two-third (n = 324; 61.7%) were men with acutely (n = 211; 40.2%) or subacutely (n = 314; 59.8%) occluded lesions presenting mostly in Rutherford-Becker category (RBC): 3 (30.3%) and 4 (47.6%). Mean lesion length was 159 mm (range 22-279 mm), with moderate and severe calcification in 119 (23.3%) lesions. PMT was performed solely in 161(27.2%), PMT + balloon angioplasty in 232 (39.1%), provisional stenting in 169 (28.4%), and thrombolysis in 77 (13.9%) interventions. Procedural technical success rate was 97.7%, with improvement in RBC persisting in 74.1% of patients after 12 ± 2.4 months mean time follow-up. Overall 30 days major adverse events (MAEs) was 6.9% with a mortality rate of 1.1%. No death was directly related to the device. After 12 months, a promising overall target lesion revascularization (TLR; 10.1%), non-TLR (6.6%), and major amputation rates (2.3%) were found. One-year mortality was 8%. Treatment with PMT resulted in clinic and hemodynamic improvement in the majority of patients, thereby reducing the need for thrombolysis in a significant proportion of patients. Prospective studies in this issue are recommended.