Purpose: To evaluate a rotational thrombectomy device in the treatment of acute and subacute/chronic thrombotic infra-aortic occlusions of native vessels and bypass grafts.
Methods: From July 2000 to February 2002, 98 patients (65 men; mean age 66+/-9 years, range 47-90) with 100 thrombotic occlusions (mean age of occlusion 31+/-33 days, range 0-140) measuring an average of 21+/-11 cm long (range 2-40) were treated with rotational thrombectomy (Rotarex). There were 33 acute (</=14 days) thrombotic/embolic native artery occlusions (group I), 58 subacute/chronic (>14 days) native artery occlusions (group II), and 9 acute bypass graft occlusions (group III).
Results: The device activation time was 4.9+/-1.4 minutes, during which 4.0+/-1.4 passes of the device were performed. The amount of aspirated fluid was 240+/-119 mL. Slightly less than half the arteries (48%) were stented. Primary success (residual stenosis <30%) was achieved in 92% (94% for group I, 93% for group II, and 78% for group III; 100% for the ipsilateral approach, 56% for the crossover approach). Among the 18 complications, 3 were serious (2 amputations after unsuccessful intervention and 1 death); there were 8 vessel perforations and 7 cases of peripheral embolization. Thirty-day survival and limb salvage was 88% for group I, 100% for group II, and 66% for group III.
Conclusions: The device is an easy-to-handle, useful tool for ipsilateral treatment of acute and subacute thrombotic arterial and bypass graft occlusions. The use of this device is limited by the 8-F diameter of the catheter and the limited capacity for crossover interventions.