Open Access Highly Accessed Study protocol

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

Jonathon P Fanning123*, Allan J Wesley14, David G Platts1239, Darren L Walters139, Eamonn M Eeles17, Michael Seco56, Oystein Tronstad238, Wendy Strugnell4, Adrian G Barnett10, Andrew J Clarke38, Judith Bellapart12, Michael P Vallely111256, Peter J Tesar38 and John F Fraser11323

Author Affiliations

1 School of Medicine, The University of Queensland, Brisbane, Queensland, Australia

2 Critical Care Research Group (CCRG), The Prince Charles Hospital, Rode Road, Chermside, Brisbane, Queensland 4032, Australia

3 The Heart and Lung Institute, The Prince Charles Hospital, Brisbane, Queensland, Australia

4 Department of Medical Imaging, The Prince Charles Hospital, Brisbane, Queensland, Australia

5 School of Medicine, The University of Sydney, Sydney, NSW, Australia

6 The Baird Institute, Sydney, NSW, Australia

7 Department of Internal Medicine, The Prince Charles Hospital, Brisbane, Queensland, Australia

8 Department of Cardiothoracic Surgery, The Prince Charles Hospital, Brisbane, Queensland, Australia

9 Department of Cardiology, The Prince Charles Hospital, Brisbane, Queensland, Australia

10 School of Public Health and Social Work, Queensland University of Technology, Brisbane, Queensland, Australia

11 The Royal Prince Alfred, Sydney, NSW, Australia

12 Macquarie University, Sydney, NSW, Australia

13 Adult Intensive Care Unit, The Prince Charles Hospital, Brisbane, Queensland, Australia

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BMC Cardiovascular Disorders 2014, 14:45  doi:10.1186/1471-2261-14-45

Published: 5 April 2014



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.


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.


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.

Aortic valve stenosis; Heart valve prosthesis implantation; Cerebrovascular disorders; Stroke; Embolism and thrombosis