ABSTRACT
PURPOSE: To assess the efficacy and safety of a new rotational catheter for percutaneous removal of fresh and organized thrombi in the femoropopliteal artery. METHODS: Forty-one limbs in 38 patients (age 56--90 years, mean 75.6 years) with acute, subacute or chronic femoropopliteal occlusions of 1--180 days' duration (mean 31.6 days) were treated with the Rotarex device. The Fontaine stage was mainly IIB (Rutherford 2--3, 22 patients) or III (Rutherford 4, 14 patients). The length of occlusion varied from 2 to 35 cm (mean 13.1 cm). After recanalization percutaneous transluminal angioplasty (PTA) was performed if there was a residual stenosis of >25%. Patients were followed up with color Doppler ultrasound at 48 hr and clinically with Doppler pressures and oscillometry at 3, 6, and 12 months. RESULTS: After an average of two passages with the Rotarex catheter all but two limbs required PTA for residual stenosis >25%. Five patients needed additional stenting. Major complications were one groin hematoma requiring blood transfusion and one arteriovenous fistula spontaneously thrombosing after unsuccessful primary prolonged balloon dilation. Distal embolizations occurred in 10 patients; 6 clinically relevant emboli were aspirated. All occlusions were technically successfully recanalised there were 2 early reocclusions after 1 day and two at 2 weeks. Brachial-ankle indices improved from an average of 0.41 before to 0.93 after recanalization. Primary and secondary patency rates were 62% / 84% after 6 months and 39% / 68% after 1 year. The amputation-free survival at 12 months was 100%. CONCLUSION: The Rotarex mechanical thrombectomy device is an efficient, quick, easy to handle, and safe tool for the treatment of acute, subacute or even chronic peripheral arterial thromboembolic occlusions. It can be used for short or long occlusions with equal success, provided the obstruction is not heavily calcified and has been safely passed with a guidewire first.
