Percutaneous treatment of carotid stenosis with protection system: Preliminary experience

PURPOSE: To assess the feasibility, safety, and efficacy of carotid artery stenting with filter device. MATERIALS AND METHODS: Between May 2001 and July 2002, a total of 96 consecutive patients (100 lesions) who presented with symptomatic >70% diameter stenosis, asymptomatic >90% diameter stenosis or post-endarterectomy as well as post-radiotherapy hemodynamically significant stenosis underwent carotid artery stenting with filter protection at our institute. The mean age of the patients was 72 (range 51-91). There were 22 female (23%), and 74 male (77%). Of the 96 patients, 62 patients (65%) did not filled the NASCET surgical criteria and 24 (26%) were classified as ASA 4. All the patients underwent pretreatment with antiplatelet agents. All procedures were performed with a standardized monitoring system by a multidisciplinary team. Filtration system for cerebral protection was consistently used. Outcome measures were procedural atheroembolic events, including all-stroke and death rates up to 30 days. RESULTS: A protection system type "TRAP" (Microvena, Italy) or a protection system type "EPIFILTER" (Boston Scientific, USA) were employed in 28% and 67% of cases, respectively. In the remaining 5% it was not possible to cross the stenosis with the filter. The stent placement was achieved in 95 of the procedures (95%). In 86% of cases a primary stenting technique was performed, with balloon pre-dilation of the lesion and subsequent stent advancement through the stenosis accounting for 9% of cases. At the time of protection system removal, 21 filter (21%) showed presence of macroscopic particles. We recorded 8 (8%) homolateral neurological events: two major strokes, one minor stroke and five TIAs (all the patients with TIA fully recovered within 2 hours). General complications (5%) included one lesion of the median nerve, two groin haematomas (one with disability for the patient, and one requiring surgery), one myocardial infarct and one lower limb ischaemia requiring surgical intervention. All major complications (4%) (two major strokes, one myocardial infarct and one lesion of the median nerve) occurred within the first 31 cases, the 69 following procedures not showing any neurological or non-neurological major events. At 30 days all patient were still alive. CONCLUSIONS: Filter protection during carotid artery stenting seems technically feasible as well as reasonably safe and effective. The EPIFILTER system turned out to be of easier employment due to its "monorail" system and because it does not usually need a catheter of dedicated recovery. Further studies in larger groups of patients are required to best characterize criteria guiding the choice for the right protection system.