Cerebral protection devices were started to be
used with the assumption that they would prevent
cerebral embolism during carotid stent placement.
Case reviews compared old unprotected data with
newly protected data.[
11,
12] However, this mostly
reflects advances in technique and patient selection.
New studies reveal that cerebral protection devices
have no effect on death, stroke, and myocardial
infarction in the first 30 days, contrary to today's
general use.[
13,
14] In another study, it was found
that the use of a protective device led to new
ischemic lesions revealed by diffusion MRI after the procedure.[
14] Contrary to these studies, in the
first 80 patients of the EVA-3 (Endarterectomy
Versus Angioplasty in Patients With Symptomatic
Severe Carotid Stenosis) study, stroke was detected
four times more frequently in unprotected CAS,
and the study was interrupted.[
15] However, this
difference is unlikely to be explained by the use of
a protection device since only two of the patients
who did not use a filter had a stroke on the day of
the procedure. In our study, although it was not
statistically significant, stroke or transient ischemic
attack developed in six patients in whom protection
was used, while it occurred in only one case in which
protection was not used.
The 2017 European Society of Cardiology
guideline raised the use of protective devices to
class 2A.[16] However, the studies used justified to
this change are old and not multicenter, randomized
studies. Two small randomized studies have shown
that microemboli protection devices increase
microemboli.[6-11,17] In our study, microemboli
were more common in the unprotected group in
postprocedure MRI (p=0.020). However, our study
was not a randomized study, and the unprotected
group consisted of more difficult cases where the use
of filters was not possible. More ischemic foci were
detected in the MRI images before the procedure
in the unprotected group. However, the number of
clinically significant events after the procedure was
higher in the protected group. In addition, bradycardia
and atropine requirement during the procedure were
higher in the group using the protective device.
The reason for this was thought to be the increased
stimulation of the carotid bulb due to manipulation of
the protection device. This is an important problem
of the CAS process and adversely affects the results.
The main limitation of the study is that it was
not a randomized controlled trial. Another limitation
is the lack of statistical significance in the primary
endpoints due to the relatively small number of
patients.
In conclusion, the present study showed that
cerebral protection devices used in carotid stenting
did not reduce the risk of clinically reflected cerebral
embolism but significantly reduced the risk of silent
microemboli.
Ethics Committee Approval: The study protocol was
approved by the Acibadem University Medical Research
Evaluation Board (date: 31.03.2016, no: 2016-5/8). The study was conducted in accordance with the principles of the
Declaration of Helsinki.
Patient Consent for Publication: A written informed
consent was obtained from each patient.
Data Sharing Statement: The data that support the
findings of this study are available from the corresponding
author upon reasonable request.
Author Contributions: Conception and design of the
study, data collection and drafting of manuscript: Y.D., A.D.;
Analysis and interpretation of data: O.Ş.; Acquisition of data
and critical revision: A.E.
Conflict of Interest: The authors declared no conflicts
of interest with respect to the authorship and/or publication
of this article.
Funding: The authors received no financial support for
the research and/or authorship of this article.
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