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S. Salwi et al.
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69
Embolic Protection Devices
forCarotid Artery Stenting:
Where Is theEvidence?
MohanadSulaiman
andMandyJ.Binning
Introduction
Stroke is one of the most common causes of death and disability
among all ages. Carotid artery disease (CAD) remains a common
clinical entity that can lead to stroke. Present treatment options for
CAD include open surgical carotid endarterectomy (CEA) or
endovascular carotid artery stenting (CAS) via either a transfemoral (TFCAS) or transcarotid approach (TCAR). CEA and CAS are
equivalent in long-term prevention of stroke ipsilateral to the
treated carotid artery [1]. However, despite two decades of evolution, CAS has failed to be adopted as a superior alternative to
CEA due to increased periprocedural stroke rates. Patients at high
risk for CEA may be candidates for CAS.The decision to treat
high-risk carotid stenosis by CEA or CAS is controversial.
However, the most widely accepted indications for CAS are
patients with clinically signicant cardiac risk or those with highrisk neck anatomic features, including very high carotid bifurcation, restenosis following a prior CEA, or prior neck radiation.
5
M. Sulaiman · M. J. Binning (*)
Global Neurosciences Institute (GNI), Drexel University,
Pennington, NJ, USA
e-mail: msulaiman@gnineuro.org; mbinning@gnineuro.org
© The Author(s), under exclusive license to Springer Nature
Switzerland AG 2025
E. Veznedaroglu (ed.), Advanced Technologies in Vascular
Neurosurgery, https://doi.org/10.1007/978-3-031-67492-1_5
71
72
M. Sulaiman and M. J. Binning
CAS is also recommended for acute carotid occlusion especially
in the presence of symptomatic acute occlusion with a large ischemic penumbra. CEA remains the standard of care in the treatment of CAD due to its ability to achieve ow arrest that prevents
distal embolization of plaque particles from plaque disruption. If
periprocedural stroke events occur, they are typically ipsilateral to
the treated artery. The median time of stroke onset is zero days
after the procedure, which suggests that these events are directly
related to plaque characteristics and disruption as well as the
manipulation of endovascular catheters and wires through the
unprotected aortic arch or stenotic carotid artery [1]. In order to
mitigate this risk, embolic protection devices (EPDs) were developed. The evolution of endovascular technology has included the
development of a wide array of proximal and distal EPDs. More
recently, transcarotid artery revascularization (TCAR) has been
an option for CAS. Embolic protection devices (EPDs) can theoretically reduce periprocedural strokes. Although data regarding
their effectiveness are controversial, and there is a lack of randomized controlled trials (RCTs) supporting the superiority of
protected to unprotected CAS, EPDs have become the standard of
care in CAS.
Embolic Protection Devices
Angioplasty for carotid bifurcation was rst reported by Mathias
and his colleagues in 1980. However, the risk of an embolic complication was extremely high (8–10%). Rapid improvement in
endovascular technology resulted in the development of EPDs
with different mechanisms for stroke prevention. Distal lter
EPDs (F-EPDs) are small baskets deployed in the ICA distal to
the lesion to catch any debris that may be produced by manipulation during angioplasty and stent placement. Proximal EPDs
(P-EPDs) use balloons or ow-reversal mechanisms to arrest or
reverse ow to the ICA so that angioplasty and stenting can be
performed with reduced risk of antegrade embolization. Aspiration
is performed either continuously or before balloon deation to
capture any debris released by the procedure. The indications for
5 Embolic Protection Devices for Carotid Artery Stenting: Where…
73
proximal versus distal protection use have yet to be clearly
dened. In theory, intraluminal thrombus, vulnerable plaque, and
poor distal landing zone anatomy would require proximal protection. Furthermore, the revolution that has ensued in the endovascular arena has yet to widely adopt newer protection techniques,
such as transcarotid artery revascularization (TCAR). This is a
relatively new procedure that combines the minimally invasive
advantages of CAS while also using complete carotid artery blood
ow reversal as neuroprotection. To briey describe the procedure, embolic protection is accomplished by proximal carotid
artery clamp placement followed by reversal of carotid artery
blood ow through an extracorporeal circuit from the carotid
artery to the femoral vein. This facilitates proximal protection,
avoids traversing the aortic arch, allows retrograde removal of
atherosclerotic debris, and establishes protection before manipulation of the carotid bifurcation lesion. This procedure will be
described in greater detail at the end of this chapter.
To date, there have not been any RCTs comparing CAS with
and without EPDs or any RCTs comparing the use of lters versus
proximal balloon occlusion so far. Most evidence comes from
studies using historical controls in the unprotected arm. In 2003,
Kastrup etal. performed one of the earliest literature reviews to
evaluate the efcacy of cerebral protection devices in preventing
thromboembolic complications during CAS [2]. They evaluated
the results of 40 CAS studies without cerebral protection and 14
CAS studies with protection. The stroke and death rate within
30 days was 1.8% in patients treated with cerebral protection
devices versus 5.5% in patients treated without cerebral protection devices. The death rates between the two groups showed no
signicant difference (0.8%, P= 0.6). However, these were primarily retrospective analyses of small studies and case series
from single-center groups with no consistency in protection type
(balloon versus lter), stent type, or operator experience. These
possible confounding variables must be considered when the
results of CAS procedures with cerebral protection devices are
interpreted. Nevertheless, the authors concluded that in early
analysis, the use of cerebral protection devices appeared to reduce
thromboembolic complications during CAS.Ouriel etal. looked
74
M. Sulaiman and M. J. Binning
at a series of 261 patients who underwent CAS [3]. EPDs were
used in 90 patients during this study. Debris in the retrieved lters
was reported to be found in 54% of patients. There were fewer
major ipsilateral strokes in the EPD group (0.0%) versus the
group without EPDs (2.3%, p=0.05). The authors concluded that
EPDs may decrease the risk of postprocedural major ipsilateral
strokes. Similarly, Cossotini et al. reported on their series of 52
patients who underwent CAS, 30 with EPD and 22 without EPD
[4]. Magnetic resonance (MR) diffusion-weighted imaging (DWI)
was performed in both groups of patients following stenting.
Ischemic lesions were detected in 26% of patients in the protected
group and 36% of patients in the unprotected group, with an overall incidence of 30% across both groups. In addition, the protected
group was found to have fewer DWI lesions on MRI.There was
no difference in the number of contralateral lesions between the
two groups. These ndings led to a recommendation that distal
protection for carotid stenting may decrease the risk of ipsilateral
stroke from CAS. As a result of some of the early evidence
depicted by these studies, carotid stenting trials began to use
EPDs in an effort to show equipoise to CEA.The Stenting and
Angioplasty with Protection in Patients at High Risk for
Endarterectomy (SAPPHIRE) trial mandated the use of EPDs in
the stenting group in patients who were high risk for CEA [5]. The
stroke or death rate within 30days was 4.8% in patients treated
with CAS versus 5.6% in CEA group. However, only a minority
of the patients were randomized between stenting and carotid
endarterectomy, and the enrollment in the CEA arm was very low
in the nonrandomized group. In total, 334 patients were randomized, but 413 were not. Of this nonrandomized group, 406 had
stenting with protection and only 7 had carotid endarterectomy.
Therefore, instead of comparing outcomes to active controls, outcomes were compared to surgical and medical data in similar
patient populations. Furthermore, the lower incidence of myocardial infarction (MI) in patients who underwent stenting may be
attributed to the use of clopidogrel, which was not utilized in the
CEA group. Interestingly, the lead author of SAPPHIRE invented
the EPD used in the trial, and the majority of the remaining
authors (11 of the 15) either worked for Cordis at the time or had
5 Embolic Protection Devices for Carotid Artery Stenting: Where…
75
nancial relationships with the company [6]. Similarly, the
ACCULINK for Revascularization of Carotids in High-Risk
Patients (ARCHeR) trial reported that the 30-day death/stroke/
myocardial infarction plus ipsilateral stroke at 1year was 9.6%
which is below the 14.4% reported in literature for CEA. The
authors indicated that extracranial carotid artery stenting with
embolic lter protection is noninferior to CEA [7]. As the
SAPPHIRE and ARCHeR trials showed that CAS stenting with
EPDs is noninferior to CEA, the trend of using EPDs in all future
trials began. The Food and Drug Administration (FDA) consequently approved the ACCULINK stent and ACCUNET EPD
based on data reported in the ARCHeR trial [8]. However, it
should be noted that the FDA does not require use of EPDs with
carotid stents. Nevertheless, EPDs are mandated for reimbursement by Medicare and used in more than 95% of all CAS cases in
the United States. However, to date, no RCTs exist that compare
protected and unprotected CAS with results depicting better outcomes with the use of EPDs.
The Evidence Against Distal Embolic Protection
The technical innovations in CAS are still ongoing and are aimed
at increasing safety and decreasing complication rates.
Theoretically, EPDs provide an effective mechanism to reduce
periprocedural strokes during CAS.However, despite the results
of several retrospective studies that support the use of EPDs, specically distal protection devices (lters), some interventionalists
are still concerned about the routine use of EPDs. The debate
against the efcacy of EPDs during CAS rises from the fact that
the risk of stroke associated with CAS is clearly related to embolic
phenomena that occur during the intravascular instrumentation of
the aortic arch, supra-aortic trunks, and carotid plaque itself. All
these unprotected steps during the procedure are taken place
before EPDs are installed. In addition, distal lters are bulky
devices, and their use can be associated with internal carotid
artery dissection, spasm, and embolic complications especially
when tortuous anatomy and tight stenosis are present. The design
76
M. Sulaiman and M. J. Binning
also has important limitations as distal lters do not have ideal
wall apposition, allowing material to embolize around the lter or
particles smaller than their pore sizes to pass through. Furthermore,
the lter can become overloaded with debris, thereby increasing
the risk of dislodgement from the lter during recapturing.
Additionally, recapturing and retrieving the lter can occasionally
be difcult or fail, and lter contents can spill during this step as
well. In this discussion, we aim to shed light on the results from
the most recent prospective multicenter trials supporting the presumption that EPDs do not reduce but may actually increase CAS
complication rates. Pro-CAS is a prospective registry of CAS procedures implemented by the German Society of Angiology/
Vascular Medicine and the German Society of Radiology [9].
During the study’s time frame, 4709 patients were included, 3543
of which were treated with EPDs and 1166 were treated without
EPDs. Data analysis of the registry revealed no differences in
periprocedural stroke or death rates between the two groups of
patients (3.2% with EPDs vs. 3.4% without EPDs, p=0.6517).
These results are consistent with the Stent-Supported Percutaneous
Angioplasty of the Carotid Artery versus Endarterectomy
(SPACE) clinical trial that also assessed the use of EPDs in CAS
procedures while also factoring in stent design (open vs. closed
cell). Overall, 563 patients were treated with a stent, of which 145
patients were treated with EPDs and 418 without EPDs. Data
analysis of patients that underwent CAS with and without EPDs
showed that there was no difference in stroke or death rates
between the two groups (8.3% vs. 6.2%, p=0.40). When factoring in the stent design, there were signicantly fewer adverse
events in patients who underwent CAS with a closed-cell stent
(5.5%), as opposed to those that were treated with an open stent
(11%). Furthermore, there was no signicant difference in adverse
event rates with the use of EPDs in each stent design group: 6.7%
in the closed-cell group versus 10% in the open-cell group
(p=0.554). When EPDs were not utilized, there was an adverse
outcome rate of 5.3% in the closed-cell group vs. 12.3% in the
open-cell group with no signicant difference (p=0.068) [10].
This secondary analysis of data does not support the need for
EPDs in CAS.The Endarterectomy Versus Angioplasty in Patients
5 Embolic Protection Devices for Carotid Artery Stenting: Where…
77
with Symptomatic Carotid Stenosis (EVA-3S) trial assessed the
utility of employing EPDs to modify the risk of periprocedural
complications. After 80 patients were enrolled, the unprotected
CAS arm was stopped early by the safety committee as the 30-day
rate of stroke was 3.9 times higher than that of CAS with cerebral
protection (4/15 vs. 5/58) [11]. However, the lower limits of the
condence interval indicated an absence of difference in adverse
events between protected and unprotected CAS.In addition, most
of the patients who underwent unprotected CAS and had an
adverse event did so in the 30days following the procedure and
not during the procedure itself, thereby casting doubt on whether
cerebral protection was truly a factor in inciting the adverse event.
Another issue is the lack of randomization within the CAS group
as to which patient undergoes the procedure with and without
EPDs. The International Carotid Stenting Study (ICSS) looked at
a subgroup of patients who underwent MRI before and after CAS
and CEA.The CAS group was further subdivided into patients
who underwent stenting with and without EPDs. Interestingly,
more patients had new ischemic lesions on MRI diffusionweighted imaging (DWI) after stenting with cerebral protection
devices (37 of 51 (73%)) than without (25 of 73 (34%)) [12]. In
addition, the rate of stroke was higher in the EPD group (5.1%)
than the unprotected group (2.4%). The authors conclude that
EPDs did not seem to be effective in preventing cerebral ischemia
during stenting. Tietke and Jansen evaluated CAS with and without EPD by pooling data from multiple studies including SPACE,
EVA-3S, and ICSS [13]. The authors concluded that the most
recent data from multiple perspective multicenter trials support
the impression that EPDs may actually increase the perioperative
complication rates instead of reducing them. A couple of small,
randomized trials also shed light on the postoperative events in
CAS with and without EPDs. In one such study, Macdonald etal.
showed that patients undergoing lter-protected CAS had signicantly higher rates of total as well as particulate emboli on transcranial Doppler studies (426.5 and 251.3) than during unprotected
CAS (165.2 and 92) (p=0.01 and 0.03, respectively). On procedural MRI 1–3hours and 24 hours after stenting, there was an
increase in new lesions on DWI in 7/24 (29%) patients in the pro-
78
M. Sulaiman and M. J. Binning
tected group and 4/22 (18%) patients in the unprotected group. At
30days, lesions were detected in 9/33 (26%) patients in the protected group and in 4/33 (12%) patients in the unprotected group
[14]. A small, randomized study by Barbato etal. showed similar
results with new lesions noted on MRI in 72% of patients in the
cerebral protection group and 44% of patients in the unprotected
group (p=0.09) [15]. In 2011, Tallarita etal. conducted a retrospective review of a prospective nonrandomized database at their
institution of patients that underwent CAS with and without
embolic protection [16]. They reviewed 357 CAS patients, 105 of
whom underwent unprotected CAS and 252 of whom underwent
lter-protected CAS.No signicant difference in the primary end
points of perioperative stroke rate (0.8% in the EP group vs. 3.8%
in the non-EP group; P=0.6), death (1in each group), or MI (3in
the EP group and 1in the non-EP group, P=nonsignicant) was
discovered between the two groups. Similarly, Pandey etal. retrospectively reviewed a series of 105 patients that underwent CAS
without the use of EPDs and reported a perioperative stroke and
death rate of 2.85% [17]. The authors revealed that CAS can be
performed safely, with similar risks and lower costs when compared to series in which EPDs were used. Interestingly, most
patients in this study did not undergo post-stenting angioplasty.
Pandey etal. showed that by avoiding this step, there were lower
complication rates with unprotected CAS. However, the author
did not discuss the signicance of this nuance. Binning etal. retrospectively reviewed a data from our institute and reported a 0%
perioperative stroke and death rate and 2% perioperative non-ST
elevation myocardial infarction (NSTEMI) rate [18] in patients
who underwent CAS without EPD and without post-stent plasty.
In the CREST trial, the rate of minor stroke was 4.1%, rate of
major stroke was 0.9%, and overall rate of stroke, death, and MI
was 5.2% [1]. In our institution, the MI rate is 2%, which is comparable to the rate observed in the carotid endarterectomy (CEA)
group from the CREST trial (2.3%) [1]. In addition, the rate of
perioperative stroke and death rate in the SAPPHIRE trial was
3.6% [5]. The low rate observed in our group is most likely attributable to the fact that the majority of our cases are performed