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Routine cerebral embolic protection during transcatheter aortic-valve implantation.

Kharbanda, Rajesh K
; 
Kennedy, James
; 
Jamal, Zahra
; 
Dodd, Matthew
; 
Evans, Richard
; 
Bal, Kiran K
; 
Perkins, Alexander D
; 
Blackman, Daniel J
; 
Hildick-Smith, David
; 
Banning, Adrian P
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Authors
Kharbanda, Rajesh K
 Kennedy, James
 Jamal, Zahra
 Dodd, Matthew
 Evans, Richard
 Bal, Kiran K
 Perkins, Alexander D
 Blackman, Daniel J
 Hildick-Smith, David
 Banning, Adrian P
 Baumbach, Andreas
 Ludman, Peter
 Palmer, Stephen
 Stables, Rodney H
 Henderson, Robert
 Appleby, Clare
 Cotton, James
 Curzen, Nick
 Ozkor, Muhiddin
 Byrne, Jonathan
 Aggarwal, Rajesh
 Das, Rajiv
 Doshi, Sagar
 Watkins, Stuart
 Muir, Douglas F
 Anderson, Richard
 Chowdhary, Saqib
 Varcoe, Richard
 Dorman, Stephen
 Firoozi, Sam
 Chelliah, Raj
 Owens, Colum
 Redwood, Simon
 Prendergast, Bernard
 Iqbal, Javaid
 Ratib, Karim
 Dospinescu, Ciprian
 Suresh, Venkatesan
 Cruden, Nicholas
 Rajathurai, Thirumaran
 Malik, Iqbal S
 Wiper, Andrew
 Costopoulos, Charis
 Khurana, Ayush
 Banning, Amerjeet
 Clayton, Tim
 BHF PROTECT-TAVI Investigators
Editors
Other contributors
Affiliation
University of Wolverhampton
Epub Date
Issue Date
2025-03-30
Submitted date
Subjects
BHF PROTECT-TAVI Investigators
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Accepted manuscript under copyright of the publisher, Massachusetts Medical Society. Shared under a CC BY-NC-ND licence.
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Abstract
Background Transcatheter aortic-valve implantation (TAVI) is associated with procedure-related stroke. Cerebral embolic protection (CEP) devices may reduce embolization to the cerebral circulation and hence the incidence of stroke. Methods We conducted a randomized, controlled trial across 33 centers in the United Kingdom. We randomly assigned 7635 participants with aortic stenosis in a 1:1 ratio to undergo TAVI with a CEP device (CEP group) or TAVI without a CEP device (control group). The primary outcome was stroke within 72 hours after TAVI or before discharge from the hospital (if discharge occurred sooner). Results A total of 3815 participants were assigned to the CEP group and 3820 to the control group. A primary-outcome event occurred in 81 of 3795 participants (2.1%) in the CEP group and in 82 of 3799 participants (2.2%) in the control group (difference, −0.02 percentage points; 95% confidence interval, –0.68 to 0.63; P=0.94). Disabling stroke occurred in 47 participants (1.2%) in the CEP group and in 53 (1.4%) in the control group. Death occurred in 29 participants (0.8%) in the CEP group and in 26 (0.7%) in the control group. Overall access-site complications appeared to be similar in the two groups (8.1% in the CEP group and 7.7% in the control group). A total of 24 serious adverse events occurred in 22 of 3798 participants (0.6%) in the CEP group, and 13 serious adverse events occurred in 13 of 3803 participants (0.3%) in the control group. Conclusions Among participants undergoing TAVI, routine use of CEP did not decrease the incidence of stroke within 72 hours. (Funded by the British Heart Foundation and Boston Scientific; BHF PROTECT-TAVI ISRCTN Registry number, ISRCTN16665769.)
Citation
Kharbanda, RK, Kennedy, J, Jamal, Z, Dodd, M et al. (2025) Routine cerebral embolic protection during transcatheter aortic-valve implementation, New England Journal of Medicine 392 (24), pp. 2403-2412.
Publisher
Massachusetts Medical Society
Journal
The New England journal of medicine
Research Unit
URI
https://wlv.openrepository.com/handle/2436/625930
DOI
10.1056/nejmoa2415120
PubMed ID
40162661 (pubmed)
PubMed Central ID
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Additional Links
https://www.nejm.org/doi/10.1056/NEJMoa2415120
Type
Journal article
Language
en
Description
This is an accepted manuscript of an article published by Massachusetts Medical Society in New England Journal of Medicine on 30/03/2025, available online: https://doi.org/10.1056/NEJMoa2415120 The accepted version of the publication may differ from the final published version.
Series/Report no.
ISSN
0028-4793
EISSN
1533-4406
ISBN
ISMN
Gov't Doc #
Sponsors
BHF PROTECT-TAVI is funded by the British Heart Foundation (BHF Clinical Study no. CS/20/1/34732). Funding for the CEP devices is provided by Boston Scientific, Inc. who were not involved in the coordination, conduct or reporting of the study.
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