The silent and apparent neurological injury in transcatheter aortic valve implantation study (SANITY) : concept, design and rationale

Fanning, Jonathon P, Wesley, Allan J, Platts, David G, Walters, Darren L, Eeles, Eamonn M, Seco, Michael, Tronstad, Oystein, Strugnell, Wendy, Barnett, Adrian G., Clarke, Andrew J, Bellapart, Judith, Vallely, Michael P, Tesar, Peter J, & Fraser, John F (2014) The silent and apparent neurological injury in transcatheter aortic valve implantation study (SANITY) : concept, design and rationale. BMC Cardiovascular Disorders, 14(1), pp. 45-55.

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Abstract

Background

The incidence of clinically apparent stroke in transcatheter aortic valve implantation (TAVI) exceeds that of any other procedure performed by interventional cardiologists and, in the index admission, occurs more than twice as frequently with TAVI than with surgical aortic valve replacement (SAVR). However, this represents only a small component of the vast burden of neurological injury that occurs during TAVI, with recent evidence suggesting that many strokes are clinically silent or only subtly apparent. Additionally, insult may manifest as slight neurocognitive dysfunction rather than overt neurological deficits. Characterisation of the incidence and underlying aetiology of these neurological events may lead to identification of currently unrecognised neuroprotective strategies.

Methods

The Silent and Apparent Neurological Injury in TAVI (SANITY) Study is a prospective, multicentre, observational study comparing the incidence of neurological injury after TAVI versus SAVR. It introduces an intensive, standardised, formal neurologic and neurocognitive disease assessment for all aortic valve recipients, regardless of intervention (SAVR, TAVI), valve-type (bioprosthetic, Edwards SAPIEN-XT) or access route (sternotomy, transfemoral, transapical or transaortic). Comprehensive monitoring of neurological insult will also be recorded to more fully define and compare the neurological burden of the procedures and identify targets for harm minimisation strategies.

Discussion

The SANITY study undertakes the most rigorous assessment of neurological injury reported in the literature to date. It attempts to accurately characterise the insult and sustained injury associated with both TAVI and SAVR in an attempt to advance understanding of this complication and associations thus allowing for improved patient selection and procedural modification.

Impact and interest:

6 citations in Scopus
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5 citations in Web of Science®

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ID Code: 79721
Item Type: Journal Article
Refereed: Yes
Additional URLs:
Keywords: aortic valve stenosis, heart valve prosthesis implantation, cerebrovascular disorders, stroke, embolism and thrombosis
DOI: 10.1186/1471-2261-14-45
ISSN: 1471-2261
Subjects: Australian and New Zealand Standard Research Classification > MEDICAL AND HEALTH SCIENCES (110000) > CLINICAL SCIENCES (110300)
Divisions: Current > QUT Faculties and Divisions > Faculty of Health
Current > Institutes > Institute of Health and Biomedical Innovation
Current > Schools > School of Public Health & Social Work
Copyright Owner: © 2014 Fanning et al.; licensee BioMed Central Ltd
Copyright Statement: This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Deposited On: 05 Jan 2015 23:53
Last Modified: 09 Jan 2015 06:03

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