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

BMC Cardiovascular Disorders

Volumn 14, Issue , 2014, Pages

  Fanning, Jonathon P ^a,b   Wesley, Allan J ^a,b   Platts, David G ^a,b   Walters, Darren L ^a,b   Eeles, Eamonn M ^a,b   Seco, Michael ^c,d   Tronstad, Oystein ^b   Strugnell, Wendy ^b   Barnett, Adrian G ^e   Clarke, Andrew J ^b   Bellapart, Judith ^a,b   Vallely, Michael P ^c,d,f,g   Tesar, Peter J ^b   Fraser, John F ^a,b  

^a UNIVERSITY OF QUEENSLAND   (Australia)

^b THE PRINCE CHARLES HOSPITAL   (Australia)

^c UNIVERSITY OF SYDNEY   (Australia)

^d The Baird Institute Australia   (Australia)

^e QUEENSLAND UNIVERSITY OF TECHNOLOGY   (Australia)

^f ROYAL PRINCE ALFRED HOSPITAL   (Australia)

^g MACQUARIE UNIVERSITY   (Australia)

Author keywords

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

Indexed keywords

ACCURACY; AORTA VALVE PROSTHESIS; AORTA VALVE REPLACEMENT; ARTICLE; BIOPROSTHESIS; CAROTID DUPLEX ULTRASOUND; CEREBROVASCULAR ACCIDENT; COMPUTER ASSISTED TOMOGRAPHY; ECHOCARDIOGRAPHY; ECHOGRAPHY; HUMAN; INCIDENCE; INTERMETHOD COMPARISON; NEUROMONITORING; NUCLEAR MAGNETIC RESONANCE IMAGING; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; OXIMETRY; PATIENT ASSESSMENT; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUALITY OF LIFE; RISK REDUCTION; SURGICAL APPROACH; TELEMETRY; TRANSCATHETER AORTIC VALVE IMPLANTATION;

AORTIC VALVE STENOSIS; CARDIAC CATHETERIZATION; CEREBRAL INFARCTION; CEREBROVASCULAR DISORDERS; CLINICAL PROTOCOLS; COGNITION; COGNITION DISORDERS; DIAGNOSTIC IMAGING; HEART VALVE PROSTHESIS IMPLANTATION; HUMANS; INCIDENCE; ISCHEMIC ATTACK, TRANSIENT; NEUROLOGIC EXAMINATION; NEUROPSYCHOLOGICAL TESTS; PREDICTIVE VALUE OF TESTS; PROSPECTIVE STUDIES; QUEENSLAND; RESEARCH DESIGN; RISK FACTORS; STROKE; TREATMENT OUTCOME;

EID: 84899634711     PISSN: None     EISSN: 14712261     Source Type: Journal    
DOI: 10.1186/1471-2261-14-45     Document Type: Article

References (44)

1. Fanning JP, Platts DG, Walters DL, Fraser JF. Transcatheter aortic valve implantation (TAVI): Valve design and evolution. Int J Cardiol 2013, 168(3):1822-1831. 10.1016/j.ijcard.2013.07.117, 23972363.
2. Fanning JP, Walters DL, Platts DG, Eeles E, Bellapart J, Fraser JF. Characterization of Neurological Injury in Transcatheter Aortic Valve Implantation: How Clear Is the Picture?. Circulation 2014, 129(4):504-515. 10.1161/CIRCULATIONAHA.113.004103, 24470472.
3. Eggebrecht H, Schmermund A, Voigtlander T, Kahlert P, Erbel R, Mehta RH. Risk of stroke after transcatheter aortic valve implantation (TAVI): a meta-analysis of 10,037 published patients. Eurointervention 2012, 8(1):129-138. 10.4244/EIJV8I1A20, 22391581.
4. Vasques F, Messori A, Lucenteforte E, Biancari F. Immediate and late outcome of patients aged 80 years and older undergoing isolated aortic valve replacement: A systematic review and meta-analysis of 48 studies. Am Heart J 2012, 163(3):477-485. 10.1016/j.ahj.2011.12.005, 22424020.
5. O'Brien SM, Shahian DM, Filardo G, Ferraris VA, Haan CK, Rich JB, Normand SLT, DeLong ER, Shewan CM, Dokholyan RS, Peterson ED, Edwards FH, Anderson RP, Society of Thoracic Surgeons Quality Measurement Task Force The Society of Thoracic Surgeons 2008 Cardiac Surgery Risk Models: Part 2, Isolated Valve Surgery. Ann Thorac Surg 2009, 88(1, Supplement):S23-S42. 10.1016/j.athoracsur.2009.05.056, 19559823, Society of Thoracic Surgeons Quality Measurement Task Force.
6. Tay ELW, Gurvitch R, Wijesinghe N, Nielispach F, Wood D, Cheung A, Ye J, Lichtenstein SV, Carere R, Thompson C, Webb JG. A high-risk period for cerebrovascular events exists after transcatheter aortic valve implantation. J Am Coll Cardiol Intv 2011, 4(12):1290-1297.
7. Miller DC, Blackstone EH, Mack MJ, Svensson LG, Kodali SK, Kapadia S, Rajeswaran J, Anderson WN, Moses JW, Tuzcu EM, Webb JG, Leon MB, Smith CR, PARTNER Trial Investigators and Patients; PARTNER Stroke Substudy Writing Group and Executive Committee Transcatheter (TAVR) versus surgical (AVR) aortic valve replacement: occurrence, hazard, risk factors, and consequences of neurologic events in the PARTNER trial. J Thorac Cardiovasc Surg 2012, 143(4):832-843. 10.1016/j.jtcvs.2012.01.055, 22424519, PARTNER Trial Investigators and Patients; PARTNER Stroke Substudy Writing Group and Executive Committee.
8. Astarci P, Glineur D, Kefer J, D'Hoore W, Renkin J, Vanoverschelde J-L, El Khoury G, Grandin C. Magnetic resonance imaging evaluation of cerebral embolization during percutaneous aortic valve implantation: comparison of transfemoral and trans-apical approaches using Edwards Sapiens valve. Eur J Cardiothorac Surg 2011, 40(2):475-479.
9. Kahlert PMD, Al-Rashid FMD, Dottger PMS, Mori KMS, Plicht BMD, Wendt DMD, Bergmann LMD, Desa, Kottenberg EMD, Schlamann MMD, Mummel P, Holle D, Thielmann M, Jakob HG, Konorza T, Heusch G, Erbel R, Eggebrecht H. Cerebral embolization during transcatheter aortic valve implantation: a transcranial doppler study. Circulation 2012, 126(10):1245-1255. 10.1161/CIRCULATIONAHA.112.092544, 22899774.
10. Omran H, Schmidt H, Hackenbroch M, Illien S, Bernhardt P, von der Recke G, Fimmers R, Flacke S, Layer GN, Pohl C. Silent and apparent cerebral embolism after retrograde catheterisation of the aortic valve in valvular stenosis: a prospective, randomised study. Lancet 2003, 361(9365):1241-1246. 10.1016/S0140-6736(03)12978-9, 12699950.
11. Rudolph JL, Schreiber KA, Culley DJ, McGlinchey RE, Crosby G, Levitsky S, Marcantonio ER. Measurement of post-operative cognitive dysfunction after cardiac surgery: a systematic review. Acta Anaesthesiol Scand 2010, 54(6):663-677. 10.1111/j.1399-6576.2010.02236.x, 2919360, 20397979.
12. Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive Trajectories after Postoperative Delirium. N Engl J Med 2012, 367(1):30-39. 10.1056/NEJMoa1112923, 3433229, 22762316.
13. Meller S, Baumbach A, Voros S, Mullen M, Lansky A. Challenges in cardiac device innovation: is neuroimaging an appropriate endpoint? Consensus from the 2013 Yale-UCL Cardiac Device Innovation Summit. BMC Medicine 2013, 11(1):257. 10.1186/1741-7015-11-257, 24330754.
14. Van Mieghem NM, Schipper MEI, Ladich E, Faqiri E, van der Boon R, Randjgari A, Schultz C, Moelker A, Van Geuns R-J, Otsuka F, Serruys PW, Virmani R, De Jaegere PP. Histopathology of embolic debris captured during transcatheter aortic valve replacement. Circulation 2013, 127(22):2194-2201. 10.1161/CIRCULATIONAHA.112.001091, 23652860.
15. Caplan Lr HM. Impaired clearance of emboli (washout) is an important link between hypoperfusion, embolism, and ischemic stroke. Arch Neurol 1998, 55(11):1475-1482. 10.1001/archneur.55.11.1475, 9823834.
16. Bila RH, Augustine T, Hartley M, Humphries C, Roberts S, Moore R, Sogliani F. Cerebral oximetry monitoring during transcatheter aortic valve implantation (TAVI) [Conference Abstract]. Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery 2012, 7(2):134.
17. Kappetein AP, Head SJ, Genereux P, Piazza N, Van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, Van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodés-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. Eur Heart J 2012, 33(19):2403-2418. 10.1093/eurheartj/ehs255, 23026477.
18. Godefroy O, Fickl A, Roussel M, Auribault C, Bugnicourt JM, Lamy C, Canaple S, Petitnicolas G. Is the montreal cognitive assessment superior to the mini-mental state examination to detect poststroke cognitive impairment?: a study with neuropsychological evaluation. Stroke 2011, 42(6):1712-1716. 10.1161/STROKEAHA.110.606277, 21474808.
19. Inouye SK, Van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. Ann Intern Med 1990, 113(12):941. 10.7326/0003-4819-113-12-941, 2240918.
20. Seco M, Edelman JJB, Wilson MK, Bannon PG, Vallely MP. Serum biomarkers of neurologic injury in cardiac operations. Ann Thorac Surg 2012, 94(3):1026-1033. 10.1016/j.athoracsur.2012.04.142, 22857981.
21. Colli A, D'Amico R, Kempfert J, Borger MA, Mohr FW, Walther T. Transesophageal echocardiographic scoring for transcatheter aortic valve implantation: impact of aortic cusp calcification on postoperative aortic regurgitation. J Thorac Cardiovasc Surg 2011, 142(5):1229-1235. 10.1016/j.jtcvs.2011.04.026, 22014345.
22. Lenders GD, Paelinck BP, Wouters K, Claeys MJ, Rodrigus IE, Van Herck PL, Vrints CJ, Bosmans JM. Transesophageal echocardiography for cardiac thromboembolic risk assessment in patients with severe, symptomatic aortic valve stenosis referred for potential transcatheter aortic valve implantation. Am J Cardiol 2013, 111(10):1470-1474. 10.1016/j.amjcard.2013.01.302, 23433762.
23. American Heart Association Heart disease and stroke statistics: 2005 update 2004, Dallas, Texas: American Heart Association, American Heart Association.
24. Aono Y, Ohkubo T, Kikuya M, Hara A, Kondo T, Obara T, Metoki H, Inoue R, Asayama K, Shintani Y, Hashimoto J, Totsune K, Hoshi H, Satoh H, Izumi S, Imai Y. Plasma fibrinogen, ambulatory blood pressure, and silent cerebrovascular lesions: the Ohasama study. Arterioscler Thromb Vasc Biol 2007, 27:963-968. 10.1161/01.ATV.0000258947.17570.38, 17272746.
25. Allison MA, Criqui M, Wright CM. Patterns and risk factors for systemic calcified atherosclerosis. Ateriosclerosis Thrombosis and Vascular Biology 2004, 24:331-336.
26. Agaston AS, Janowitz WR, Hildner FJ, Zusmer NR, Viamonte M, Detrano R. Quantification of coronary artery calcium using ultrafast computed tomography. J Am Coll Cardiol 1990, 14(4):827-832.
27. Allen LM, Hasso AN, Handwerker J, Farid H. Sequence-specific MR Imaging Findings that are useful in Dating Ischemic Stroke. RadioGraphics 2012, 32:1285-1297. 10.1148/rg.325115760, 22977018.
28. Schlaug G, Siewert B, Benfield A, Edelman RR, Warach S. Time course of the apparent diffusion coefficient (ADC) abnormality in human stroke. Neurology 1997, 49(1):113-119. 10.1212/WNL.49.1.113, 9222178.
29. Paarmann H, Heringlake M, Heinze H, Hanke T, Sier H, Karsten J, Schon J. Non-invasive cerebral oxygenation reflects mixed venous oxygen saturation during the varying haemodynamic conditions in patients undergoing transapical transcatheter aortic valve implantation. Interact Cardiovasc Thorac Surg 2012, 14(3):268-272. 10.1093/icvts/ivr102, 3290361, 22159266.
30. Sa K, Pb S, Klein KUA. Transcranial doppler and near infrared spectroscopy in the perioperative period. Curr Opin Anaesthesiol 2013, 26(5):543-548.
31. Bila RH, Augustine T, Hartley M, Humphries C, Roberts S, Moore R, Sogliani F. Cerebral oximetry monitoring during transcatheter aortic valve implantation (TAVI). Conference Abstract from: Innovations: Technology and Techniques in Cardiothoracic and Vascular Surgery 2012, Conference: 15th Annual Meeting of the International Society for Minimally Invasive Cardiothoracic Surgery, ISMICS 2012 2012, Los Angeles, CA United States: Conference Publication: (var.pagings), 7(2):134.
32. Brodt J, Maratea E. Cerebral Oxygenation During Transcatheter Aortic Valve Implantation. Poster session presented at: Anesthesiology 2012 2012, Washington, D.C., United States: American Society of Anesthesiologists Annual Meeting.
33. Kapadia S. Three-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) in "inoperable" Patients with severe Aortic Stenosis: The PARTNER Trial 2012, Miami, FL, USA: Presentation at: Transcatheter Cardiovascular Therapies (TCT) 2012.
34. Chou CC, Lien LM, Chen WH, Wu MS, Lin SM, Chiu HC, Chiou HY, Bai CH. Adults with late stage 3 chronic kidney disease are at high risk for prevalent silent brain infarction: a population-based study. Stroke 2011, 42(8):2120-2125. 10.1161/STROKEAHA.110.597930, 21700935.
35. Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol 2000, 35(5):1245-1255. 10.1016/S0735-1097(00)00531-3, 10758967.
36. Group TE. EuroQol - a new facility for the measurement of health-related quality of life. Health Policy 1990, 16(3):199-208.
37. Eguchi K, Kario K, Hoshide S, Hoshide Y, Ishikawa J, Morinari M, Hashimoto T, Shimada K. Smoking is associated with silent cerebrovascular disease in a high-risk Japanese community-dwelling population. Hypertens Res 2004, 27(10):747-754. 10.1291/hypres.27.747, 15785010.
38. Eguchi K, Kario K, Shimada K. Greater impact of coexistence of hypertension and diabetes on silent cerebral infarcts. Stroke 2003, 34(10):2471-2474. 10.1161/01.STR.0000089684.41902.CD, 14500939.
39. Feiwell RJ, Besmertis L, Sarkar R, Saloner DA, Rapp JH. Detection of clinically silent infarcts after carotid endarterectomy by use of diffusion-weighted imaging. AJNR Am J Neuroradiol 2001, 22(4):646-649.
40. Fujishima M, Yao H, Terashi A, Tagawa K, Matsumoto M, Hara H, Akiguchi I, Suzuki K, Nishimaru K, Udaka F, Gyoten T, Takeuchi J, Hamada R, Yoshida Y, Ibayashi S. Deep white matter lesions on MRI, and not silent brain infarcts are related to headache and dizziness of non-specific cause in non-stroke Japanese subjects. Intern Med 2000, 39(9):727-731. 10.2169/internalmedicine.39.727, 10969904.
41. Gerriets T, Swarz N, Bachmann G, Kaps M, Kloevekorn WP, Sammer G, Tschernatsch M, Nottbohm R, Blaes F, Schönburg M. Evaluation of methods to predict early long-term neurobehavioral outcome after coronary artery bypass grafting. Am J Cardiol 2010, 105(8):1095-1101. 10.1016/j.amjcard.2009.12.009, 20381659.
42. McMillan GJ, Hubbard RE. Frailty in older inpatients: what physicians need to know. QJM 2012, 105(11):1059-1065. 10.1093/qjmed/hcs125, 22753676.
43. Eeles EMP, White SV, O'Mahony SM, Bayer AJ, Hubbard RE. The impact of frailty and delirium on mortality in older inpatients. Age Ageing 2012, 41(3):412-416. 10.1093/ageing/afs021, 22391613.
44. Rockwood K, Mitnitski A. Frailty in Relation to the Accumulation of Deficits. J Gerontol A: Biol Med Sci 2007, 62(7):722-727.