Abstract

OBJECTIVE--Preliminary assessment of the efficacy and safety of the low speed rotational angioplasty catheter system (ROTACS). DESIGN--Open prospective trial. SETTING--Department of cardiology in a teaching hospital. PATIENTS--Eleven patients (10 with chronic stable angina and one with acute coronary occlusion after conventional angioplasty) in whom a coronary angiogram showed occlusion or critical stenosis of the coronary artery (right in seven patients, circumflex in two, and left anterior descending in two). The nature or severity of the lesion ruled out conventional coronary angioplasty. INTERVENTIONS--An attempt was made to cross the lesion with a rotating guide wire with a blunt swelling at its tip. Where necessary progress was assessed by simultaneous injection of contrast into both main coronary arteries. MAIN OUTCOME MEASURES--Progress of the ROTACS through the lesion that allowed a guide wire to pass into the distal vessel was regarded as a device specific success. When a guide wire crossed the lesion aided only by the support of the ROTACS without the use of rotation this was counted as a success that was not device specific. Failure to cross the lesion and any associated complications were noted. RESULTS--The ROTACS crossed only two of the 10 chronic lesions (20% device specific success rate); however, the support it provided enabled a guide wire to cross a further two lesions and allowed subsequent successful angioplasty in four of the 10 patients. One of these four patients presented after five months with recurrent angina requiring bypass grafting. The other three were symptom free at follow up seven months after the procedure. In the one patient with acute coronary occlusion the ROTACS was advanced over the guide wire to allow passage of an angioplasty balloon where this had previously proved impossible. An excellent final result was obtained and this patient remains symptom free. Three of the six patients in whom the ROTACS was unsuccessful had coronary artery dissection without sequelae. Three patients required subsequent elective coronary bypass grafting for control of symptoms while the other three remain well on medical treatment. CONCLUSIONS--The ROTACS may extend the range of patients with coronary artery occlusion or critical stenosis who can be treated non-surgically. The low device specific success rate (20%) achieved in this study indicates that it should be compared with other simpler mechanical devices that may be just as effective.