The association of cerebral embolic protection during transcatheter aortic valve replacement with periprocedural neurological outcomes

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Severe aortic stenosis requiring transfemoral transcatheter aortic valve replacement (TAVR) (n=1101). Intervention: Cerebral embolic protection (CEP) device (Sentinel or TriGuard 3) vs. Transfemoral TAVR without cerebral embolic protection. Primary outcome: Incidence of clinical ischemic stroke occurring within 3 days postoperatively (HR 0.32, 95% CI 0.14-0.74, p=0.007).

Q: What does this research mean for the field?

The use of cerebral embolic protection devices during transfemoral TAVR is associated with a significantly lower risk of early periprocedural ischemic stroke compared to unprotected procedures. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Funda Baysal; Kira Osipenko; Severin Laengle; Irene Steiner; Amila Kahrovic; Paul Werner; Philipp Emanuel Bartko; Daniel Zimpfer; Martin Andreas; Iuliana Coti

doi:10.3389/fcvm.2026.1881371

August 17, 2026Frontiers in Cardiovascular MedicineOpen Access

The association of cerebral embolic protection during transcatheter aortic valve replacement with periprocedural neurological outcomes

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Key result

Cerebral embolic protection during TAVR linked to ~68% lower risk of early ischemic stroke.

HR 0.32
95% CI 0.14-0.74
P=0.007
n=1,101

Figures

Graphical abstract published by Frontiers in Cardiovascular Medicine — Graphical abstract · Published by Frontiers in Cardiovascular Medicine · CC BY

Why the study?

The clinical significance of cerebral embolic protection devices during transfemoral TAVR remains under debate regarding their impact on periprocedural neurological outcomes.

Does routine use of cerebral embolic protection reduce early periprocedural ischemic stroke in patients undergoing transfemoral transcatheter aortic valve replacement?

Study Design

Type

Cohort (n=1,101)

Multicenter

No

Structured PICO

Does routine use of cerebral embolic protection reduce early periprocedural ischemic stroke in patients undergoing transfemoral transcatheter aortic valve replacement?

P

Population

1,101 intermediate-to-high surgical risk patients undergoing transfemoral transcatheter aortic valve replacement, observed retrospectively for periprocedural neurological outcomes.

E

Exposure

Cerebral embolic protection (CEP) used routinely during TF-TAVR. Devices used were the Sentinel device (inserted via right radial artery, 140-µm pore filters in brachiocephalic trunk and left common carotid artery; 92.6% of CEP cases) or the TriGuard 3 device (deflection device inserted via femoral artery, covering all three large branches; 7.4% of CEP cases).

C

Comparator

Transfemoral transcatheter aortic valve replacement (TF-TAVR) without cerebral embolic protection (non-CEP), dictated primarily by historical timeframe (pre-October 2019) or anatomical unsuitability (severe stenosis, tortuosity, soft plaques, or insufficient vascular access).

O

Outcome

Incidence of clinical ischemic stroke occurring within 3 days postoperatively (acute focal or multifocal neurological deficit consistent with a vascular territory in the brain, spinal cord, or retina; NeuroARC Type 1a or 1aH).hard clinical

Main Result

Hazard Ratio: 0.32 (95% CI 0.14–0.74)

Absolute Event Rate: 1.4% vs 4.1%

p-value: p=0.007

Limitations

Single-center retrospective analysis with potential for residual confounding regarding patient selection and treatment era
Positivity assumption required for propensity score methods was not met due to selection based on anatomical suitability
Limited number of outcome events restricted the analysis to univariable rather than multivariable Cox regression models
Diagnosis of postoperative delirium was based on medical records without systematic standardized screening
Missing data were handled using complete-case analysis without imputation
Retrospective, single-center design with potential time-dependent selection bias
Eligibility for CEP was determined by anatomical suitability, precluding propensity score matching
Limited number of events mandated univariable rather than multivariable Cox regression models
Lack of systematic postoperative neuroimaging means covert/silent CNS injuries were not included
Delirium was ascertained retrospectively without systematic CAM-ICU screening

Implication

Routine use of cerebral embolic protection during transfemoral TAVR in an intermediate-to-high risk population is associated with a significantly reduced incidence of early periprocedural clinical ischemic stroke.

Abstract

Objective Cerebral Embolic Protection Devices (CEPs) have been designed to minimize the risk of periprocedural stroke. The clinical significance of these devices, however, is still under debate. Aims We aimed to compare periprocedural neurological outcomes and mortality in patients undergoing transfemoral transcatheter aortic valve replacement (TF-TAVR) with versus without CEP. Methods A single-center retrospective analysis of 1101 patients undergoing transfemoral TAVR from August 2017 to May 2025 was performed. CEPs were used routinely at our institution whenever feasible beginning with October 2019. The primary outcome was defined as the incidence of ischemic stroke occurring within 3 days postoperatively. Secondary endpoints included overall neurological outcomes defined as a combined endpoint of stroke, transient ischemic attack (TIA) and delirium within 3 days and short-term all-cause mortality. Results Overall, 809 underwent TF-TAVR with CEP, while 292 were treated without. The primary endpoint of clinical ischemic stroke occurred less frequently in the CEP group (1.4% vs. 4.1%), and the group difference revealed a significant result in a univariable Cox regression analysis (p = 0.007). No clinically relevant differences were observed in the incidence of TIA (0.5% vs. 0.7%, p = 0.71) and postprocedural delirium (1.6% vs. 2.4%, p = 0.39). Although the 30-day mortality rate in the control group was higher, the difference did not reach statistical significance (3.9% vs. 1.9%, p = 0.06). Conclusions The use of neuroprotection during TAVR was associated with a reduced early periprocedural ischemic stroke.

Discussion

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Cite This Study

Baysal et al. (2026) conducted a cohort in Severe aortic stenosis requiring transfemoral transcatheter aortic valve replacement (TAVR) (n=1,101). Cerebral embolic protection (CEP) device (Sentinel or TriGuard 3) vs. Transfemoral TAVR without cerebral embolic protection was evaluated on Incidence of clinical ischemic stroke occurring within 3 days postoperatively (HR 0.32, 95% CI 0.14-0.74, p=0.007). The use of cerebral embolic protection during transfemoral TAVR was associated with a significantly reduced risk of early periprocedural ischemic stroke compared to no protection (1.4% vs. 4.1%, HR 0.32).

synapsesocial.com/papers/6ad1155900741cc3fba7d342 https://doi.org/10.3389/fcvm.2026.1881371

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The association of cerebral embolic protection during transcatheter aortic valve replacement with periprocedural neurological outcomes

Figures

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

The association of cerebral embolic protection during transcatheter aortic valve replacement with periprocedural neurological outcomes

Figures

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

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