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 daysÕ 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.

Self-expandable stents of the Wallstent type were used in 26 iliac and 15 femoropopliteal artery lesions of 31 patients to treat stenoses or occlusions. The indications were confined to complex lesions, including residual stenoses and dissections after percutaneous procedures or previous surgery in the iliac artery lesions, and long-segment (mean, 13.5 cm) occlusions with inadequate response to percutaneous recanalization in the femoropopliteal artery lesions. In the iliac artery group, after stent placement, 96% of the lesions were patent at a mean follow-up of 16 months (range, 6-30 months). In the femoropopliteal artery group, of 11 patients available for follow-up, only six had patent stents at 7-26 months (mean, 20 months). Four of these six patients required one to three secondary interventions. Self-expanding endoprostheses are of great value in complex iliac artery lesions where simple balloon dilation is insufficient. Stent placement for long femoral artery lesions should be performed with utmost reserve, and the extent of stent placement should be as short as possible.

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