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

BMC Cardiovascular Disorders

Study Protocol

Oystein Tronstad¹  Wendy Strugnell²  Judith Bellapart³  Jonathon P Fanning⁴  John F Fraser⁵  David G Platts⁶  Eamonn M Eeles⁷  Allan J Wesley⁸  Darren L Walters⁹  Michael Seco^1,10  Michael P Vallely^1,11  Adrian G Barnett^1,12  Andrew J Clarke^1,13  Peter J Tesar^1,13 

[1] Critical Care Research Group (CCRG), The Prince Charles Hospital, Rode Road, Chermside, 4032, Brisbane, Queensland, Australia;The Heart and Lung Institute, The Prince Charles Hospital, Brisbane, Queensland, Australia;Department of Cardiothoracic Surgery, The Prince Charles Hospital, Brisbane, Queensland, Australia;Department of Medical Imaging, The Prince Charles Hospital, Brisbane, Queensland, Australia;School of Medicine, The University of Queensland, Brisbane, Queensland, Australia;Critical Care Research Group (CCRG), The Prince Charles Hospital, Rode Road, Chermside, 4032, Brisbane, Queensland, Australia;School of Medicine, The University of Queensland, Brisbane, Queensland, Australia;Critical Care Research Group (CCRG), The Prince Charles Hospital, Rode Road, Chermside, 4032, Brisbane, Queensland, Australia;The Heart and Lung Institute, The Prince Charles Hospital, Brisbane, Queensland, Australia;School of Medicine, The University of Queensland, Brisbane, Queensland, Australia;Critical Care Research Group (CCRG), The Prince Charles Hospital, Rode Road, Chermside, 4032, Brisbane, Queensland, Australia;The Heart and Lung Institute, The Prince Charles Hospital, Brisbane, Queensland, Australia;Adult Intensive Care Unit, The Prince Charles Hospital, Brisbane, Queensland, Australia;School of Medicine, The University of Queensland, Brisbane, Queensland, Australia;Critical Care Research Group (CCRG), The Prince Charles Hospital, Rode Road, Chermside, 4032, Brisbane, Queensland, Australia;The Heart and Lung Institute, The Prince Charles Hospital, Brisbane, Queensland, Australia;Department of Cardiology, The Prince Charles Hospital, Brisbane, Queensland, Australia;School of Medicine, The University of Queensland, Brisbane, Queensland, Australia;Department of Internal Medicine, The Prince Charles Hospital, Brisbane, Queensland, Australia;School of Medicine, The University of Queensland, Brisbane, Queensland, Australia;Department of Medical Imaging, The Prince Charles Hospital, Brisbane, Queensland, Australia;School of Medicine, The University of Queensland, Brisbane, Queensland, Australia;The Heart and Lung Institute, The Prince Charles Hospital, Brisbane, Queensland, Australia;Department of Cardiology, The Prince Charles Hospital, Brisbane, Queensland, Australia;School of Medicine, The University of Sydney, Sydney, NSW, Australia;The Baird Institute, Sydney, NSW, Australia;School of Medicine, The University of Sydney, Sydney, NSW, Australia;The Baird Institute, Sydney, NSW, Australia;The Royal Prince Alfred, Sydney, NSW, Australia;Macquarie University, Sydney, NSW, Australia;School of Public Health and Social Work, Queensland University of Technology, Brisbane, Queensland, Australia;The Heart and Lung Institute, The Prince Charles Hospital, Brisbane, Queensland, Australia;Department of Cardiothoracic Surgery, The Prince Charles Hospital, Brisbane, Queensland, Australia;

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

DOI  :  10.1186/1471-2261-14-45

 received in 2014-01-27, accepted in 2014-03-04,  发布年份 2014

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsThe 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.DiscussionThe 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.

【 授权许可】

CC BY   
© Fanning et al.; licensee BioMed Central Ltd. 2014