Author + information
- Jason Ricci1,
- Abhishek Sinha2,
- Fabio Komlos3,
- Bahman Nouri3,
- Ajanta De3,
- Kush Agrawal2 and
- James Joye3
To determine whether routine aspiration, from the distal filter embolic protection device (EPD) back through the stent, during carotid artery stenting (CAS) would result in fewer clinical neurologic events and/or lesions on diffusion-weighted magnetic resonance imaging (DW-MRI) compared to CAS with a distal EPD alone.
Despite reducing neurologic events, clinically successful CAS with distal EPD’s may still result in increased lesions on DW-MRI. A small study revealed that routine aspiration during CAS w/ distal EPDs consistently recovered atherothrombotic debris (Tex Heart Inst J 2009; 36(5):404-8).
31 patients with symptomatic, severe carotid stenosis at two different medical centers were randomized to either CAS w/ distal EPD with aspiration vs CAS with distal EPD alone. A Xact Rapid Exchange Carotid Stent System along with an Emboshield NAV6 Embolic Protection System (Abbott Vascular) was used, and aspiration was performed with an Export catheter (Medtronic). A NIHSS neurologic assessment was done pre-procedure, post-procedure prior to discharge, and at 30 day follow up. Pre-procedure and post-procedure DW-MRIs were performed and interpreted by an experienced, blinded observer.
17 pts were randomized to the CAS w/ distal EPD and routine aspiration while 14 patients were randomized to CAS w/ distal EPD alone (control group). There was no significant difference between demographics, risk factors, lesion/anatomic (48% Type II/III arches) or procedural characteristics between the two groups. Post procedure, aside from 1 TIA in the aspiration group (P = NS), there were no strokes, MIs, or deaths. The aspiration group had more positive post-procedure MRIs (88 vs 66%, P=0.10) and increased average number of lesions per patient (6.65 vs 3.69, P = 0.15). The avg max area per lesion (0.249 cm2 aspiration vs 0.296, P = 0.50) and total lesion area per pt (1.19 vs 1.012 cm2, P = 0.21) were similar. No events were at 30 day follow up.
While all the post-procedure lesions on DW-MRI were small, routine aspiration of the distal filter EPD did not result in fewer clinical events or fewer lesions on post-procedure DW-MRI. In fact, there was an increase in the percentage of positive post-procedure DW-MRIs and average number of lesions per patient in the aspiration group, though this was not statistically significant. Until demonstrated otherwise by larger scale studies, routine aspiration prior to filter removal cannot be supported and should be reserved for select cases where post-stent flow is impaired.