• Effect of cerebral embolic pro...

Treffer: Effect of cerebral embolic protection device on new cerebral embolism during transcatheter aortic valve replacement: A prospective sentinel registry.

Title:
Effect of cerebral embolic protection device on new cerebral embolism during transcatheter aortic valve replacement: A prospective sentinel registry.
Authors:
Park HS; Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Suh CH; Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Ahn JM; Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Kang DY; Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Ahn SY; Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Wee SB; Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Lee SH; Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Seo KW; Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Kim MJ; Division of Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Park SJ; Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Park DW; Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. Electronic address: dwpark@amc.seoul.kr.
Source:
American heart journal [Am Heart J] 2026 Jan; Vol. 291, pp. 44-52. Date of Electronic Publication: 2025 Aug 14.
Publication Type:
Journal Article; Multicenter Study; Observational Study
Language:
English
Journal Info:
Publisher: Mosby Country of Publication: United States NLM ID: 0370465 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-6744 (Electronic) Linking ISSN: 00028703 NLM ISO Abbreviation: Am Heart J Subsets: MEDLINE
Imprint Name(s):
Original Publication: St. Louis, MO : Mosby
MeSH Terms:
Aortic Valve Stenosis*/surgery , Embolic Protection Devices* , Intracranial Embolism*/diagnostic imaging , Intracranial Embolism*/epidemiology , Intracranial Embolism*/etiology , Intracranial Embolism*/prevention & control , Postoperative Complications*/diagnostic imaging , Postoperative Complications*/epidemiology , Postoperative Complications*/prevention & control , Transcatheter Aortic Valve Replacement*/adverse effects, Aged ; Aged, 80 and over ; Female ; Humans ; Male ; Magnetic Resonance Imaging/methods ; Prospective Studies ; Registries/statistics & numerical data
Molecular Sequence:
ClinicalTrials.gov NCT05217888
Entry Date(s):
Date Created: 20250815 Date Completed: 20251009 Latest Revision: 20251122
Update Code:
20251123
DOI:
10.1016/j.ahj.2025.08.006
PMID:
40816554
Database:
MEDLINE

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Background: Cerebral embolization is a common complication following transcatheter aortic valve replacement (TAVR). Cerebral embolic protection (CEP) devices have the potential to reduce embolic burden to the cerebral circulation; however, their effectiveness in real-world patients at high risk of stroke remains insufficiently studied.
Methods: As part of imaging study of the prospective Sentinel registry (NCT05217888), we evaluated the effect of CEP on new cerebral embolism as determined by brain magnetic resonance imaging (MRI) in patients undergoing transfemoral TAVR who were considered at high risk for stroke. The primary endpoint was the number and volume of new cerebral lesions on brain MRI at postprocedure (2 to 7 days) compared to baseline in protected brain territories. The control group consists of enrolled patients in the ADAPT-TAVR trial (NCT03284827), in which TAVR was performed without the use of a CEP device.
Results: A total of 219 patients was included (49 in the SENTINEL registry and 170 patients in the ADAPT-TAVR trial). For the primary endpoint, the number and volume of new cerebral lesions was significantly lower in the CEP group than in the control group: the median no. of lesions; 1 (interquartile range [IQR], 1 to 2) vs 6 (IQR, 3 to 10), respectively; difference, -4 [IQR, -6 to -3]; P < .001, and the median volume of lesions; 113.5 mm <sup>3</sup> (IQR, 42.4-206.9) vs 283.5 mm <sup>3</sup> (IQR, 129.7-682.4), respectively; difference, -145.9 [IQR, -296.7 to -67.1]; P < .001). Strokes at 30 days occurred in 1 patient (2.0%) in the CEP group and 2 patients (1.2%) in the control group (P = .64).
Conclusions: Among patients who are at high risk for stroke undergoing TAVR, the use of CEP was associated with a significant reduction of new cerebral embolism in protected brain territories. Because the study was underpowered to detect clinically relevant events, the results cannot be considered clinically directive.
Clinical Trail Registration: http://ClinicalTrials.gov (Identifier: NCT05217888).
(Copyright © 2025 Elsevier Inc. All rights reserved.)

Disclosures S-J Park has received research grants or speaker’s fees from Abott Vascular, Medtronic, Daiichi-Sankyo, ChongKunDang Pharm, Daewoong Pharm, and Edwards. D-W Park has received research grants or speaker’s fees from Abott Vascular, Medtronic, Daiichi-Sankyo, 3 grants from ChongKunDang Pharm, grants from Daewoong Pharm. There were no potential competing interests among the other authors.