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Page 2 of 14 Saadi et al. Vessel Plus 2020;4:41 I http://dx.doi.org/10.20517/2574-1209.2020.54

INTRODUCTION
Transcatheter aortic valve implantation (TAVI) is a well-established and widespread option to treat severe
aortic stenosis in intermediate and high-risk patients. However, its increased use brings some intrinsic
concerns, especially in low-risk and younger patients, a population in which even a low rate of adverse
[1-7]
events can be catastrophic . In this setting, to reduce or, ideally, to eliminate neurological complications
is especially relevant.

To mitigate neurological events risk, cerebral embolic protection devices (CEPD) were developed aiming to
capture embolized debris and/or to prevent them from reaching the cerebral circulation. Even with some
evidence supporting CEPD benefits and safety, the lack of a single randomized clinical trial demonstrating
reduction in hard outcomes, such as stroke and mortality, has limited the widespread acceptance of CEPD
and its routine use.

This article offers an updated state-of-the-art review on CEPD use and which patient profile is most likely
to benefit from this therapy.

Issue relevance
The incidence of clinically relevant neurological events after TAVI varies from 1 to 10%, but it can be as
[8]
high as 94% if silent events detected by brain imaging are also considered . The majority of post-TAVI
strokes have an embolic origin and occur in the early post-TAVI period (64% and 85% at 2 and 7 days,
respectively). These are referred to as procedure-related neurological events.

Calcium debris embolization can happen during catheter and wire manipulation, valve implantation, pre-
[2,5]
dilatation, and/or post-dilatation . Compared to native valves, valve-in-valve and bicuspid aortic valve
are associated with higher stroke rates due to the need for increased valve manipulation or the presence
of highly calcified anatomies. Debris embolization can also be secondary to small thrombus formation or
embolization from atherosclerotic plaques in the ascending aorta and aortic arch.

Regarding the clinical relevance, patients who suffer a stroke are at high risk for mortality and severe
[11]
morbidity including physical disability [9,10] . In a meta-analysis conducted by Eggebrecht et al. , patients
with cerebrovascular events presented a 3.5-fold higher 30-day mortality than those without events (25.5%
vs. 6.9%, respectively). In another study, short- and long-term mortality risks were incremental according
to cerebrovascular events severity, with a significantly higher mortality rates in the presence of major
stroke [30-day mortality: odds ratio (OR) = 7.43; 95% confidence interval (CI): 2.45-22.53; P = 0.001, late
mortality: hazard ratio (HR) = 1.75; 95%CI: 1.01-3.04; P = 0.043] . Similarly, a meta-analysis of 29,034
[12]
patients showed a 30-day mortality following stroke of 12.27%, with stroke-related mortality of 28.22%,
[13]
compared with 6.4% mortality in patients without a stroke (OR = 6.45; 95%CI: 3.9-10.66; P < 0.0001) .
Furthermore, it is valid to emphasize that 30-day permanent disability is found in around 50% of patients
who have suffered a stroke and that even silent cerebral emboli are associated with worse outcomes, three
[14]
times higher risk of clinical stroke, two times higher risk of dementia and declined cognitive function.

Notwithstanding, cerebrovascular events present a high impact on patient’s quality of life, a consequence
even more feared than death. Interesting research showed that, in terms of postoperative perspectives,
the majority of patients undergoing TAVI had as their primary objective the maintenance of their
independence and being able to practice daily hobbies, but only 7% had staying alive after the procedure
[15]
as their main goal . These results highlight the importance of patients’ quality of life as endpoint, which
should be considered during the TAVI decision-making process.