• Enhancing Stroke Prevention in...

Treffer: Enhancing Stroke Prevention in Transcatheter Aortic Valve Replacement: The Role of F2, a Novel Neuroprotection Device.

Title:
Enhancing Stroke Prevention in Transcatheter Aortic Valve Replacement: The Role of F2, a Novel Neuroprotection Device.
Authors:
Ghovvati M; Department of Radiological Sciences, David Geffen School of Medicine at UCLA, Los Angeles, California, USA., Imahori T; Department of Neurosurgery, Kitaharima Medical Center, Hyogo, Japan., Fukui N; Department of Radiological Sciences, David Geffen School of Medicine at UCLA, Los Angeles, California, USA., Sakuta K; Department of Neurology, Jikei University School of Medicine, Tokyo, Japan., Hanaoka Y; Department of Neurosurgery, Shinshu University School of Medicine, Matsumoto, Japan., Guo L; Department of Radiological Sciences, David Geffen School of Medicine at UCLA, Los Angeles, California, USA., Molaie AM; Department of Neurology, David Geffen School of Medicine at UCLA, Los Angeles, California, USA., Gajjar AM; Department of Radiological Sciences, David Geffen School of Medicine at UCLA, Los Angeles, California, USA., Tateshima S; Department of Radiological Sciences, David Geffen School of Medicine at UCLA, Los Angeles, California, USA., Duckwiler G; Department of Radiological Sciences, David Geffen School of Medicine at UCLA, Los Angeles, California, USA., Kaneko N; Department of Radiological Sciences, David Geffen School of Medicine at UCLA, Los Angeles, California, USA. nkaneko@ucla.edu.
Source:
Cardiovascular engineering and technology [Cardiovasc Eng Technol] 2025 Dec; Vol. 16 (6), pp. 703-713. Date of Electronic Publication: 2025 Oct 01.
Publication Type:
Journal Article
Language:
English
Journal Info:
Publisher: Springer Country of Publication: United States NLM ID: 101531846 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1869-4098 (Electronic) Linking ISSN: 1869408X NLM ISO Abbreviation: Cardiovasc Eng Technol Subsets: MEDLINE
Imprint Name(s):
Original Publication: New York, NY : Springer
MeSH Terms:
Transcatheter Aortic Valve Replacement*/adverse effects , Transcatheter Aortic Valve Replacement*/instrumentation , Embolic Protection Devices* , Intracranial Embolism*/prevention & control , Intracranial Embolism*/etiology , Intracranial Embolism*/physiopathology , Stroke*/prevention & control , Stroke*/etiology , Stroke*/physiopathology , Aortic Valve*/surgery , Aortic Valve*/physiopathology, Cerebrovascular Circulation ; Humans ; Prosthesis Design ; Models, Cardiovascular
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Contributed Indexing:
Keywords: Cerebral embolic protection (CEP); Embolic debris; F2 filter; Stroke prevention; Transcatheter aortic valve replacement (TAVR)
Entry Date(s):
Date Created: 20251001 Date Completed: 20251208 Latest Revision: 20251211
Update Code:
20251211
PubMed Central ID:
PMC12686061
DOI:
10.1007/s13239-025-00806-w
PMID:
41034468
Database:
MEDLINE

Weitere Informationen

Purpose: Transcatheter aortic valve replacement (TAVR) is an established treatment for severe aortic stenosis; however, it carries the risk of periprocedural strokes. Current cerebral embolic protection (CEP) devices, such as the Sentinel, provide partial protection but are limited by inadequate anatomical coverage and inability to capture smaller emboli effectively. This study aimed to evaluate the effectiveness of a novel CEP device, the F2 filter with a 28 μm pore size and full cervical vessel coverage, in preventing emboli from entering the cerebral circulation.
Methods: The Sentinel and F2 filter were evaluated for the ability to prevent embolic particles of various sizes (45-300 µm) from entering cerebral arteries using two in vitro flow models, incorporating standard and tortuous aortic anatomies. Additionally flow rates were also measured to confirm that normal perfusion was maintained while the devices were in place.
Results: The F2 filter maintained normal cerebral arterial flow and significantly reduced the number of particles across all sizes compared to the Sentinel and control groups. This reduction was observed in all four cerebral branches and across both standard and tortuous aorta models.
Conclusions: The F2 filter showed superior neuroprotective effectiveness to prevent embolic debris from entering the cerebral circulation in the in vitro models. By offering comprehensive coverage to all cervical arteries and with a smaller mesh size, this filter has the potential to improve cerebral protection during TAVR.
(© 2025. The Author(s).)

Declarations. Competing Interests: The authors, S.T., G.D. and N.K. have been consultants of EnCompass Technologies Inc. The other authors report no conflicts. Ethical Approval: Not applicable. Consent to Participate: Not applicable. Consent for Publication: All authors read and approved the final manuscript.