The safety and efficacy of a novel coronary atherectomy device were evaluated in the first 50 patients who underwent 53 such procedures at the Mayo Clinic. This treatment was used for atheromatous lesions in 27 patients and for restenosis after percutaneous transluminal coronary angioplasty in 23; in 3 patients, it was repeated for recurrent stenosis (2) or a persistent intimal flap (1). Successful results, defined as a reduction of the stenosis by 40% or more in association with removal of tissue, absence of Q-wave infarction, and no need for a bypass surgical procedure during in-hospital follow-up, were achieved in 47 of the 53 procedures (89%). Atherectomy reduced the stenoses from a mean of 87% to 15%. Failures occurred in 6 of the 53 procedures (11%). Three of these patients subsequently underwent successful conventional balloon angioplasty, and three required surgical treatment. Six patients had minor complications—embolization of atheromatous material in two, intimal dissection in two, and side-branch occlusion and transient thrombosis in one each. Coronary atherectomy with use of this device promises to be a relatively safe and efficient treatment of coronary artery stenosis.
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