Purpose: To evaluate the efficacy and safety of a new atherectomy device for the treatment of infragenicular lesions in arteries with a reference diameter of at least 2.5 mm.
Methods: Twenty-seven below-the-knee lesions in 17 patients (12 men; mean age 69+/-12 years) with chronic peripheral arterial occlusive disease were treated with directional atherectomy. The target lesion was in the popliteal artery (segment 3) in 2 (7%) cases, the tibioperoneal trunk in 12 (44%), the peroneal artery in 8 (30%), the anterior tibial artery in 2 (7%), and the posterior tibial artery in 3 (11%). Six (22%) of the lesions were in-stent stenoses. The mean diameter stenosis was 87%+/-9%, and the mean lesion length was 34+/-24 mm.
Results: All but 2 (7%) of the lesions could be treated successfully (residual stenosis <30%) with the atherectomy catheter (93% technical success) using an average of 5+/-2 (range 1-10) passes of the device. Six lesions (22%) were treated after predilation and 21 (78%) with primary atherectomy. In 8 (30%) lesions, additional balloon angioplasty was performed. The 2 failures were in heavily calcified lesions through which the device could not pass despite predilation. The mean diameter stenosis after atherectomy was 14%+/-22% (range 0%-90%); after additional balloon angioplasty, the mean residual stenoses reduced to 12%+/-21% (range 0%-100%). One (6%) of the 2 patients who failed atherectomy sustained a thrombotic occlusion of the target vessel. This complication was treated successfully with local lysis, but the vessel reoccluded 3 days later; a stent was implanted. The mean ankle-brachial index increased from 0.50+/-0.27 to 0.86+/-0.40 before discharge.
Conclusions: Below-the-knee native vessel lesions and in-stent restenoses with a diameter of at least 2.5 mm can be treated successfully and safely with this new atherectomy catheter. Additional balloon angioplasty was necessary in only a few cases.