Preliminary Experience in Carotid Artery Angioplasty and Stenting with a New Cerebral Protection Device.
Purpose: From the results of high-quality prospective randomized trials it has been apparent that symptomatic CA stenosis > 60–70% lead to a significant incidence of stroke if treated medically. Angioplasty and stenting is increasingly performed in the carotid artery and its most feared complication is distal emboli of dislodged plaque debris. We present, the partial results of CAFÉ protocol (Carotid Angioplasty-stenting Free of Emboli, a prospective multicentric study) of carotid angioplasty using a cerebral protection newly designed device in a single center. Clinical Material and Methods: The patient population was composed of 50 patients with 55 target lesions; 30 men and 20 women, with ages ranging from 51–84 (mean 60,6 years). All the patients presented at least 2 risk factors. 82.5 of the lesions were symptomatic. Before the procedure, cranial CT / MRI, cervical US and DSA of supraaortic vessels and cerebral parenchymography were performed. Stenosis were evaluated according to NASCET criteria. Mean stenosis: 79 %. Calcic plaque: 65%. Ulcerated plaque: 60 %. Associated lesions in supraaortic vessels: 45%. Mean lesion length: 21.1 mm. Results: The balloon-guidewire was able to successfully cross the lesion in all the cases. Mean balloon occlusion time was 10 min. The immediate angiographic result demonstrated residual stenosis of 0–20% in all the cases. Operative morbidity: bradychardia, 7 cases (12.7%); balloon intolerance, 2 cases (3.6%). 22 patients (44%) were followed clinically for more than 12 months. Postoperative morbidity: myocardial infarction, 1 case (2%); congestive heart failure, 1 case (2%). The mortality rate is 0%. Conclusions: Cerebral protection represents a major contrubution to carotid artery angioplasty and stenting technique reducing significantly the occurrence of procedural emboli.