OBJECTIVE: To prove the safety and effectiveness of high frequency rotational ablation of coronary artery stenoses and occlusion in humans. SUBJECTS: 106 patients with symptoms (91 men, 15 women) who had 67 significant stenoses, mainly types B and C, and 46-chronic occlusions. MAIN OUTCOME MEASURES: Mean change in diameter stenosis after rotational angioplasty alone and in combination with percutaneous transluminal coronary angioplasty immediately after treatment and 24 hours and six months later; restenosis rates at six months; complication of treatment. RESULTS: Rotational ablation could not be used in five stenoses and 16 chronic occlusions because of inability to reach or cross the lesion with the Rotablator guide wire. In four cases rotational ablation failed. Initial angiographic and clinical success by rotational ablation was achieved in 40 of the 67 stenoses (60%) and in 18 of the 46 chronic occlusions (39%). Additional balloon angioplasty was performed in 45 patients, increasing the success rates to 79% and 54%, respectively. In the 62 stenoses treated by rotational ablation the angiographic diameter stenoses were reduced from 76% (SD 14%) to 32% (14%) after Rotablator treatment alone and from 75% (11%) to 33% (17%) with additional balloon angioplasty. In the 30 chronic occlusions treated by rotational ablation the angiographic diameter stenoses were reduced to 38% (18%). At six months angiographic restenosis was evident in nine of the 25 (36%) stenoses treated with rotational ablation alone, in seven of the 22 (32%) stenoses treated with rotational and balloon angioplasty, and in 14 of the 24 (58%) chronic occlusions. There were no procedural deaths and two patients (2%) underwent emergency coronary artery bypass grafting. Although no transmural infarction occurred, there were five (6%) non-Q wave infarctions (two embolic side branch occlusions, two subacute occlusions, and one acute occlusion). Clinically insignificant slight increases in creatine kinase activity were seen in five patients (6%). Severe coronary artery spasm unresponsive to medical treatment was provoked in seven cases (8%). CONCLUSIONS: High frequency rotational ablation is a safe and effective method for treating type B and C coronary artery lesions with results comparable to percutaneous transluminal coronary balloon angioplasty. The combined use of rotational ablation and balloon angioplasty is feasible and is necessary in about half of all procedures, in most cases because the lumen created by the biggest burr is too small.
OBJECTIVE: To prove the safety and effectiveness of high frequency rotational ablation of coronary artery stenoses and occlusion in humans. SUBJECTS: 106 patients with symptoms (91 men, 15 women) who had 67 significant stenoses, mainly types B and C, and 46-chronic occlusions. MAIN OUTCOME MEASURES: Mean change in diameter stenosis after rotational angioplasty alone and in combination with percutaneous transluminal coronary angioplasty immediately after treatment and 24 hours and six months later; restenosis rates at six months; complication of treatment. RESULTS: Rotational ablation could not be used in five stenoses and 16 chronic occlusions because of inability to reach or cross the lesion with the Rotablator guide wire. In four cases rotational ablation failed. Initial angiographic and clinical success by rotational ablation was achieved in 40 of the 67 stenoses (60%) and in 18 of the 46 chronic occlusions (39%). Additional balloon angioplasty was performed in 45 patients, increasing the success rates to 79% and 54%, respectively. In the 62 stenoses treated by rotational ablation the angiographic diameter stenoses were reduced from 76% (SD 14%) to 32% (14%) after Rotablator treatment alone and from 75% (11%) to 33% (17%) with additional balloon angioplasty. In the 30 chronic occlusions treated by rotational ablation the angiographic diameter stenoses were reduced to 38% (18%). At six months angiographic restenosis was evident in nine of the 25 (36%) stenoses treated with rotational ablation alone, in seven of the 22 (32%) stenoses treated with rotational and balloon angioplasty, and in 14 of the 24 (58%) chronic occlusions. There were no procedural deaths and two patients (2%) underwent emergency coronary artery bypass grafting. Although no transmural infarction occurred, there were five (6%) non-Q wave infarctions (two embolic side branch occlusions, two subacute occlusions, and one acute occlusion). Clinically insignificant slight increases in creatine kinase activity were seen in five patients (6%). Severe coronary artery spasm unresponsive to medical treatment was provoked in seven cases (8%). CONCLUSIONS: High frequency rotational ablation is a safe and effective method for treating type B and C coronary artery lesions with results comparable to percutaneous transluminal coronary balloon angioplasty. The combined use of rotational ablation and balloon angioplasty is feasible and is necessary in about half of all procedures, in most cases because the lumen created by the biggest burr is too small.