CHICAGO -- Routine use of devices to
prevent cerebral emboli during transcatheter aortic valve implantation
(TAVI) did not prevent strokes, a large randomized trial showed.
Incidence of stroke within 72 hours after TAVI or before discharge,
if sooner, came out a similar 2.1% with and 2.2% without cerebral
embolic protection (P=0.94), reported Rajesh K. Kharbanda, PhD, of Oxford University Hospitals NHS Foundation Trust in Oxford, England, at the American College of Cardiology (ACC) annual meeting.
Notably,
no significant difference emerged in disabling stroke either (1.2% with
the device and 1.4% without it during the 6-8 weeks after TAVI) in the
findings simultaneously published in the New England Journal of Medicine.
That contrasted with the PROTECTED TAVR trial,
which likewise found no impact of cerebral embolic protection during
TAVI on stroke within 72 hours but did find fewer disabling strokes with
its use.
That finding had warranted further evaluation, the researchers said,
prompting their British Heart Foundation PROTECT-TAVI trial.
Trial Implications
"I think all of us are disappointed that the two big trials now have
failed to show a benefit in clinical endpoint of stroke," an endpoint
that is perhaps even more important to patients than mortality, said ACC
press conference study discussant S. Chris Malaisrie, MD, of
Northwestern University in Chicago.
There's no support for routine use but could be room for personalized use, Kharbanda said.
"I
don't think the concept is dead," Kharbanda argued. "Stroke is still
very clinically relevant, and we need to identify strategies that are
going to help us. We need to understand whether there are specific
groups of patients that might benefit."
One example might be patients getting procedures to modify the
leaflets as part of TAVI, Kharbanda suggested. "In these special cases, I
think one can still make an argument to use it. Granted, there is no
evidence that it works in those cases."
"It's very hard to show reductions when you start off with a low
event rate," which was lower than anticipated in PROTECT-TAVI, Malaisrie
acknowledged.
A patient-level meta-analysis of the two trials is planned, which
might help define such a subgroup that could then be studied to prove
hard endpoint benefits, Kharbanda noted.
While Kharbanda suggested that U.K. regulators might move to limit
routine cerebral embolic protection device use based on the findings,
Raj Makkar, MD, of Cedars-Sinai Medical Center in Los Angeles, expressed
skepticism that it would come off the U.S. market. "We haven't seen any
data that actually suggest that there are safety issues," he noted.
Trial Details
Across 33 U.K. centers, the study randomized 7,635 patients with
aortic stenosis to undergo TAVI with or without a cerebral protection
device. Thirteen of the centers had already been using these devices in
clinical practice before the trial.
Sentinel is the only cerebral protection device approved for clinical use in the
U.S. and Europe, but use hasn't entered mainstream practice in the U.S.
due to controversy following multiple trial setbacks and what many
consider to be an unproven benefit of capturing debris dislodged during TAVI.
Both filters of the cerebral embolic protection device were fully and
correctly deployed for the full procedure in 81.2% assigned to its use,
while at least one of the filters was fully and correctly deployed for
the duration in 87.5%.
The trial's population largely represented TAVI patients in the U.K., with a mean age of 81 and about 39% women.
Death within 72 hours of TAVI occurred in 0.8% of the cerebral embolic protection group and 0.7% of the control group (P=NS).
Complications appeared to be similar in the two groups both for the
access site (8.1% vs 7.7%, respectively) and serious adverse events
occurred in 22 of 3798 participants (0.6%) in the cerebral embolic
protection group, and 13 serious adverse events occurred in 13 of 3,803
participants (0.3%) in the control group.
The researchers noted that their study (done during the COVID-19
pandemic) enrolled nearly 30% of all TAVIs done across the participating
sites, due to eligibility criteria that were broader than in the
PROTECTED TAVR trial.
Device deployment success for the first 100 cases at each site were
similar to those for subsequent cases, as was the incidence of stroke.
"There was no indication that any potential learning effect at centers
influenced the results," the researchers wrote.
However, they acknowledged the low diversity of the patient
population despite efforts to enroll more participants from minority
racial and ethnic groups. Another limitation was that the stroke rate
was lower than anticipated and required increasing the sample size
mid-trial.
Looking to the Future
The Sentinel device only protects the innominate artery in the left
carotid, without complete protection across the four vessels that go to
the brain.
A number of other cerebral embolic protection devices are being
studied in smaller trials that are ongoing, primarily guided by imaging
outcomes, Makkar noted.
Sentinel was also a first-generation device, noted Kharbanda.
"There's a lot of work that's going to go into this, and that evolution
is going to take time. But you know, ultimately I think we need the
large randomized trials before we put devices into our patients and
offer them treatments. And that's why it's important that we do develop
the mechanistic studies, but we need the large randomized trials."
Disclosures
PROTECT-TAVI was
funded by the British Heart Foundation, with support for the cerebral
protection devices through a grant from Boston Scientific.
Kharbanda
disclosed relationships with Boston Scientific grant funding to his
institution, and speakers or advisory board fees from Edwards
Lifesciences and Medtronic.
Malaisrie disclosed relationships with CryoLife, Medtronic, AtriCure, Edwards LifeSciences, and Terumo.
Primary Source
New England Journal of Medicine
Source Reference: Kharbanda
RK, et al "Routine cerebral embolic protection during transcatheter
aortic-valve implantation" N Engl J Med 2025; DOI:
10.1056/NEJMoa2415120.
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