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. and 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 . doi:10.1186/1471-2261-14-45


Author 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.
Title The silent and apparent neurological injury in transcatheter aortic valve implantation study (SANITY): concept, design and rationale
Journal name BMC Cardiovascular Disorders   Check publisher's open access policy
ISSN 1471-2261
Publication date 2014-04
Year available 2014
Sub-type Article (original research)
DOI 10.1186/1471-2261-14-45
Open Access Status DOI
Volume 14
Total pages 10
Place of publication London, United Kingdom
Publisher BioMed Central
Collection year 2015
Language eng
Formatted 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.
Keyword Aortic valve stenosis
Heart valve prosthesis implantation
Cerebrovascular disorders
Stroke
Embolism and thrombosis
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Article no. 14:45

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2015 Collection
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