Stroke remains a significant complication of transcatheter aortic valve implantation (TAVI). Whilst newer generations of valves have lower rates of peri-procedural stroke, there remains a risk of approximately 2.1% (1). Current European society of cardiology (ESC) guidelines suggest that cerebral embolic protection devices (CEPDs) can be considered in selected high-risk patients, with a class IIb recommendation (2). A CEPD functions as a filter in the brachiocephalic and left common carotid artery deployed during a TAVI procedure with the aim of preventing embolic debris released during valve deployment from reaching the cerebral circulation.

Previous studies have suggested that CEPDs reduce the number of new lesions seen on neuroimaging following TAVI (3). The PROTECTED-TAVR trial explored the use of the Sentinel device, the most commonly used CEPD, in TAVI, identifying no statistically significant difference in overall stroke rate, but a reduction in disabling strokes (4).

The BHF PROTECT-TAVI study is a randomised controlled trial that assigned 7635 participants undergoing TAVI for aortic stenosis in 33 UK centres to have a CEPD or no CEPD (5). The primary outcome was stroke within 72hrs after TAVI, with stroke defined as ‘new or worsened focal or global neurologic deficit of presumed vascular origin, that occurred after randomization and that persisted for more than 24 hours. The mean age was 81.2yrs, with 38.7% of participants female. The median AV gradient was 43mmHg, 76% of participants had good LV function, only 8% of patients had a bicuspid AV and 52% of patients did not have severe aortic valve calcification. A CEPD was successfully deployed in 81.2% of participants randomised to the CEPD group. A primary outcome event occurred in 81 of 3795 participants with a CEPD (2.1%) compared to 82 of 3799 participants (2.2%) in the control group (p=0.94). Disabling stroke occurred in 1.2% vs 1.4% in the CEPD group and control group respectively.

The BHF PROTECT-TAVI trial demonstrated no significant reduction in periprocedural stroke with routine use during TAVI, even among high-risk subgroups. Despite prior imaging studies suggesting a reduction in subclinical cerebral lesions, these findings have not translated into meaningful clinical benefit. As cerebral protection technologies continue to advance, further studies may help clarify whether selective use of CEPD offers benefit in specific high-risk patient groups.

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References

1. Winter MP, Bartko P, Hofer F, Zbiral M, Burger A, Ghanim B, et al. Evolution of outcome and complications in TAVR: a meta-analysis of observational and randomized studies. Sci Rep. 2020 Sept 23;10(1):15568.

2. Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J

[Internet]. 2022 Feb 12 [cited 2025 Aug 7];43(7):561–632. Available from: https://academic.oup.com/eurheartj/article/43/7/561/6358470

3. Haussig S, Mangner N, Dwyer MG, Lehmkuhl L, Lücke C, Woitek F, et al. Effect of a Cerebral Protection Device on Brain Lesions Following Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis: The CLEAN-TAVI Randomized Clinical Trial. JAMA. 2016 Aug 9;316(6):592–601.

4. Kapadia SR, Makkar R, Leon M, Abdel-Wahab M, Waggoner T, Massberg S, et al. Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement. N Engl J Med [Internet]. 2022 Oct 6 [cited 2025 Aug 7];387(14):1253–63. Available from: http://www.nejm.org/doi/10.1056/NEJMoa2204961

5. Kharbanda RK, Kennedy J, Jamal Z, Dodd M, Evans R, Bal KK, et al. Routine Cerebral Embolic Protection during Transcatheter Aortic-Valve Implantation. N Engl J Med [Internet]. 2025 June 26 [cited 2025 Aug 7];392(24):2403–12. Available from: http://www.nejm.org/doi/10.1056/NEJMoa2415120