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


CONCLUSIONS
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.
School of Medicine, The University of Queensland, Brisbane, Queensland, Australia. Jonathon_fanning@me.com.
Jonathon P
JP
Fanning
Allan J
AJ
Wesley
David G
DG
Platts
Darren L
DL
Walters
Eamonn M
EM
Eeles
Michael
M
Seco
Oystein
O
Tronstad
Wendy
W
Strugnell
Adrian G
AG
Barnett
Andrew J
AJ
Clarke
Judith
J
Bellapart
Michael P
MP
Vallely
Peter J
PJ
Tesar
John F
JF
Fraser
D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000601:surgery / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects*; D002544:Cerebral Infarction / Q000175:diagnosis / Q000453:epidemiology; D002561:Cerebrovascular Disorders / Q000175:diagnosis / Q000453:epidemiology* / Q000523:psychology; D002985:Clinical Protocols; D003071:Cognition; D003072:Cognition Disorders / Q000175:diagnosis / Q000453:epidemiology* / Q000523:psychology; D003952:Diagnostic Imaging / Q000379:methods; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects* / Q000379:methods; D006801:Humans; D015994:Incidence; D002546:Ischemic Attack, Transient / Q000175:diagnosis / Q000453:epidemiology; D009460:Neurologic Examination; D009483:Neuropsychological Tests; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011793:Queensland; D012107:Research Design; D012307:Risk Factors; D020521:Stroke / Q000175:diagnosis / Q000453:epidemiology; D016896:Treatment Outcome