Key Points:
- Study evaluates double cerebral embolic protection during CAS in high-risk patients
- Despite higher risk in group with double protection, outcomes similar
The use of double embolic protection devices—both proximal and distal—allows carotid artery stenting (CAS) to be performed in patients with high-risk clinical and lesion characteristics, according to research published online September 10, 2015, ahead of print in Catheterization and Cardiovascular Interventions.
Investigators led by Francesco Tomassini, MD, of Infermi Hospital (Rivoli, Italy), collected data on 294 consecutive patients (mean age 72 years; 24.5% women) with carotid artery stenosis who underwent CAS between November 2007 and August 2014. Double embolic protection was used in 11.9%. Proximal protection was performed using the Mo.Ma device (Medtronic) and distal protection was achieved using FilterWire EZ (Boston Scientific), Emboshield (Abbott Vascular), or SpiderFX (ev3 Endovascular).
Compared with patients treated with single protection, those treated with dual protection were at higher risk, as they were more likely to present with acute carotid syndrome (60.0% vs 45.2%; P < .001)—defined as recurrent TIAs within 48 hours, minor strokes within 14 days, or recent thrombolysis—and complex plaque (79.4% vs. 33.6%; P < 0.0001).
But despite the difference in risk, the primary success rate of CAS was similar in both groups (99.6% vs 100% for single and double protection, respectively), as were 30-day rates of major complications (table 1).
Table 1. CAS Outcomes at 30 Days
|
|
Single Protection (n = 259) |
Double Protection (n = 35) |
P Value |
|
Death |
0.8% |
0% |
.60 |
|
Major Stroke |
0.8% |
0% |
.42 |
|
Minor Stroke |
1.1% |
0% |
.66 |
|
MACCE |
2.7% |
0% |
.36 |
The use of dual protection has 2 theoretical advantages over either distal or proximal protection alone, the authors explain. “The first one is that, in case of poor tolerance of [the] proximal device, the embolic protection can be achieved with the distal filter already in place, minimizing the risk of complications,” they write. “The second one is to avoid the possible microembolization after deflation of the balloons.”
The study shows that “in very high-risk patients with high-risk lesions, the simultaneous use of double [embolic protection devices] (proximal and distal) is safe and effective in minimizing the risk of cerebral embolization,” the authors write, “but, to validate such a technique in [a] wide range of patients, further studies are warranted.”
The current study has limitations, they acknowledge. “Due to its retrospective design, a weakness of our study is a deficiency in accurately collecting some history and clinical information like the minimal lumen diameter of the stenosis and the cross lesion times,” they write. “Secondly, we did not evaluate the occurrence of cerebral embolization with image tools (ie, diffuse-weighted MRI analysis and/or transcranial Doppler), but just by assessing the clinical outcome. Finally, we analyzed only the MACCE at 30 days. Therefore, it is not possible to extend our results beyond this period.”
Source:
Varbella F, Gagnor A, Rolfo C, et al. Feasibility of carotid artery stenting with double cerebral embolic protection in high-risk patients. Catheter Cardiovasc Interv. 2015;Epub ahead of print.
Disclosure:
- Dr. Tomassini reports no relevant conflicts of interest.
