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01.12.2014 | Study protocol | Ausgabe 1/2014 Open Access

BMC Cardiovascular Disorders 1/2014

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

Zeitschrift:
BMC Cardiovascular Disorders > Ausgabe 1/2014
Autoren:
Jonathon P Fanning, Allan J Wesley, David G Platts, Darren L Walters, Eamonn M Eeles, Michael Seco, Oystein Tronstad, Wendy Strugnell, Adrian G Barnett, Andrew J Clarke, Judith Bellapart, Michael P Vallely, Peter J Tesar, John F Fraser
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1471-2261-14-45) contains supplementary material, which is available to authorized users.

Competing interests

DW is a consultant to Medtronic and Edwards, investigator for Edwards, Medtronic and Boston Scientific clinical studies and past proctor for Edwards. MV is a member of the Medtronic Asia-Pacific Surgical Advisory Board. No other author declares competing interests.

Authors’ contributions

JPF and JFF were involved in the conception and design of study and drafting of the manuscript. AW, MS, EE, OT, WS and AB were involved in the design of the study and drafting of the manuscript. AC, JB, MV, DP, DW and PT were involved in the design of the study. All authors read and approved the final manuscript.

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.
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