Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: Results from the DEFLECT I study

EuroIntervention

Volumn 11, Issue 1, 2015, Pages 75-84

  Baumbach, Andreas ^a   Mullen, Michael ^b   Brickman, Adam M ^c   Aggarwal, Suneil K ^b   Pietras, Cody G ^d   Forrest, John K ^d   Hildick Smith, David ^e   Meller, Stephanie M ^d   Gambone, Louise ^d   Den Heijer, Peter ^f   Margolis, Pauliina ^g   Voros, Szilard ^h   Lansky, Alexandra J ^d  

^a UNIVERSITY HOSPITALS BRISTOL NHS FOUNDATION TRUST   (United Kingdom)

^b UNIVERSITY COLLEGE LONDON HOSPITALS   (United Kingdom)

^c Columbia University ^*  (United States)

^d YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e Worthing Hospital   (United Kingdom)

^f AMPHIA HOSPITAL   (Netherlands)

^g Keystone Heart Ltd   (Israel)

^h Natl Inst for Healthcare Research   (United States)

Author keywords

Cerebral ischaemia; Diffusion weighted imaging; Neuroprotection; Stroke prevention; Transcatheter aortic valve replacement

Indexed keywords

ACUTE KIDNEY FAILURE; AGED; AORTA DISSECTION; ARTICLE; BLEEDING; BRAIN EMBOLISM; BRAIN HEMATOMA; BRAIN HEMORRHAGE; BRAIN INFARCTION; BRAIN ISCHEMIA; CARDIOVASCULAR MORTALITY; CEREBROVASCULAR ACCIDENT; CLINICAL ARTICLE; DEVICE REMOVAL; DEVICE SAFETY; DIFFUSION WEIGHTED IMAGING; DOPPLER ECHOGRAPHY; EMBOLIC PROTECTION DEVICE; EPIDURAL HEMATOMA; FEMALE; HEART INFARCTION; HUMAN; MALE; MULTICENTER STUDY; NEUROIMAGING; OUTCOME ASSESSMENT; PERCUTANEOUS AORTIC VALVE; PROSPECTIVE STUDY; TRANSCATHETER AORTIC VALVE IMPLANTATION; TRANSIENT ISCHEMIC ATTACK; ADVERSE EFFECTS; AORTA VALVE; AORTIC VALVE STENOSIS; BRAZIL; CLINICAL TRIAL; COGNITION; COGNITION DISORDERS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEVICES; EUROPE; HEART CATHETERIZATION; HEART VALVE PROSTHESIS; HEART VALVE REPLACEMENT; INTRACRANIAL EMBOLISM; MORTALITY; PATHOPHYSIOLOGY; PREDICTIVE VALUE; PROCEDURES; PROSTHESIS DESIGN; RISK FACTOR; SEVERITY OF ILLNESS INDEX; STROKE; TIME FACTOR; TRANSCRANIAL DOPPLER ULTRASONOGRAPHY; TREATMENT OUTCOME; VERY ELDERLY;

ALLOY; NITINOL;

AGED; AGED, 80 AND OVER; ALLOYS; AORTIC VALVE; AORTIC VALVE STENOSIS; BRAIN ISCHEMIA; BRAZIL; CARDIAC CATHETERIZATION; COGNITION; COGNITION DISORDERS; DIFFUSION MAGNETIC RESONANCE IMAGING; EMBOLIC PROTECTION DEVICES; EUROPE; FEMALE; HEART VALVE PROSTHESIS; HEART VALVE PROSTHESIS IMPLANTATION; HUMANS; INTRACRANIAL EMBOLISM; MALE; PREDICTIVE VALUE OF TESTS; PROSPECTIVE STUDIES; PROSTHESIS DESIGN; RISK FACTORS; SEVERITY OF ILLNESS INDEX; STROKE; TIME FACTORS; TREATMENT OUTCOME; ULTRASONOGRAPHY, DOPPLER, TRANSCRANIAL;

EID: 85001728335     PISSN: 1774024X     EISSN: 19696213     Source Type: Journal    
DOI: 10.4244/EIJY15M04_01     Document Type: Article

References (28)

1. McKhann GM, Grega MA, Borowicz LM, Jr, Baumgartner WA, Selnes OA. Stroke and encephalopathy after cardiac surgery: an update. Stroke. 2006;37:562-71.
2. Nuis RJ, Piazza N, Van Mieghem NM, Otten AM, Tzikas A, Schultz CJ, van der Boon R, van Geuns RJ, van Domburg RT, Koudstaal PJ, Kappetein AP, Serruys PW, de Jaegere PP. In-hospital complications after transcatheter aortic valve implantation revisited according to the Valve Academic Research Consortium definitions. Catheter Cardiovasc Interv. 2011;78:457-67.
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;8:129-38.
4. Grube E, Buellesfeld L, Mueller R, Sauren B, Zickmann B, Nair D, Beucher H, Felderhoff T, Iversen S, Gerckens U. Progress and current status of percutaneous aortic valve replacement: results of three device generations of the CoreValve Revalving system. Circ Cardiovasc Interv. 2008;1:167-75.
5. Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014;370:1790-8.
6. Erdoes G, Basciani R, Huber C, Stortecky S, Wenaweser P, Windecker S, Carrel T, Eberle B. Transcranial Doppler-detected cerebral embolic load during transcatheter aortic valve implantation. Eur J Cardiothorac Surg. 2012;41:778-83; discussion 783-4.
7. Drews T, Pasic M, Buz S, Unbehaun A, Dreysse S, Kukucka M, Mladenow A, Hetzer R. Transcranial Doppler ultrasound detection of cerebral microembolism during transapical aortic valve implantation. Thorac Cardiovasc Surg. 2011;59:237-42.
8. Kahlert P, Knipp SC, Schlamann M, Mummel P, Holle D, Thielmann M, Jakob HG, Konorza T, Heusch G, Erbel R, Eggebrecht H. Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study. Circulation. 2010;121:870-8.
9. Arnold M, Schulz-Heise S, Achenbach S, Ott S, Dorfler A, Ropers D, Feyrer R, Einhaus F, Loders S, Mahmoud F, Roerick O, Daniel WG, Weyand M, Ensminger SM, Ludwig J. Embolic cerebral insults after transapical aortic valve implantation detected by magnetic resonance imaging. JACC Cardiovasc Interv. 2010;3:1126-32.
10. Fairbairn TA, Mather AN, Bijsterveld P, Worthy G, Currie S, Goddard AJ, Blackman DJ, Plein S, Greenwood JP. Diffusion-weighted MRI determined cerebral embolic infarction following transcatheter aortic valve implantation: assessment of predictive risk factors and the relationship to subsequent health status. Heart. 2012;98:18-23.
11. Vermeer SE, Longstreth WT Jr, Koudstaal PJ. Silent brain infarcts: a systematic review. Lancet Neurol. 2007;6:611-9.
12. Bernick C, Kuller L, Dulberg C, Longstreth WT Jr, Manolio T, Beauchamp N, Price T; Cardiovascular Health Study Collaborative Reseach Group. Silent MRI infarcts and the risk of future stroke: the cardiovascular health study. Neurology. 2001;57:1222-9.
13. Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53:695-9.
14. Leon MB, Piazza N, Nikolsky E, Blackstone EH, Cutlip DE, Kappetein AP, Krucoff MW, Mack M, Mehran R, Miller C, Morel MA, Petersen J, Popma JJ, Takkenberg JJ, Vahanian A, van Es GA, Vranckx P, Webb JG, Windecker S, Serruys PW. Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium. Eur Heart J. 2011;32:205-17.
15. Rodes-Cabau J, Dumont E, Boone RH, Larose E, Bagur R, Gurvitch R, Bedard F, Doyle D, De Larochelliere R, Jayasuria C, Villeneuve J, Marrero A, Cote M, Pibarot P, Webb JG. Cerebral embolism following transcatheter aortic valve implantation: comparison of transfemoral and transapical approaches. J Am Coll Cardiol. 2011;57:18-28.
16. Astarci P, Glineur D, Kefer J, D'Hoore W, Renkin J, Vanoverschelde JL, El Khoury G, Grandin C. Magnetic resonance imaging evaluation of cerebral embolization during percutaneous aortic valve implantation: comparison of transfemoral and transapical approaches using Edwards Sapiens valve. Eur J Cardiothorac Surg. 2011;40:475-9.
17. Ghanem A, Muller A, Nahle CP, Kocurek J, Werner N, Hammerstingl C, Schild HH, Schwab JO, Mellert F, Fimmers R, Nickenig G, Thomas D. Risk and fate of cerebral embolism after transfemoral aortic valve implantation: a prospective pilot study with diffusion-weighted magnetic resonance imaging. J Am Coll Cardiol. 2010;55:1427-32.
18. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597-607.
19. Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364:2187-98.
20. Stortecky S, Windecker S, Pilgrim T, Heg D, Buellesfeld L, Khattab AA, Huber C, Gloekler S, Nietlispach F, Mattle H, Juni P, Wenaweser P. Cerebrovascular accidents complicating transcatheter aortic valve implantation: frequency, timing and impact on outcomes. EuroIntervention. 2012;8:62-70.
21. Kahlert P, Al-Rashid F, Dottger P, Mori K, Plicht B, Wendt D, Bergmann L, Kottenberg E, Schlamann M, 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;126:1245-55.
22. Tay EL, Gurvitch R, Wijesinghe N, Nietlispach 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. JACC Cardiovasc Interv. 2011;4:1290-7.
23. Meller SM, Baumbach A, Brickman AM, Lansky AJ. Clinical implications for diffusion-weighted MRI brain lesions associated with transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2014;83:502-8.
24. Restrepo L, Wityk RJ, Grega MA, Borowicz L Jr, Barker PB, Jacobs MA, Beauchamp NJ, Hillis AE, McKhann GM. Diffusion- and perfusion-weighted magnetic resonance imaging of the brain before and after coronary artery bypass grafting surgery. Stroke. 2002;33:2909-15.
25. Barber PA, Hach S, Tippett LJ, Ross L, Merry AF, Milsom P. Cerebral ischemic lesions on diffusion-weighted imaging are associated with neurocognitive decline after cardiac surgery. Stroke. 2008;39:1427-33.
26. Choi SH, Na DL, Chung CS, Lee KH, Na DG, Adair JC. Diffusion-weighted MRI in vascular dementia. Neurology. 2000;54:83-9.
27. Fairbairn TA, Greenwood JP, Blackman DJ. Multiple cerebral emboli following dislocation and retraction of a partially deployed CoreValve prosthesis during transcatheter aortic valve implantation. Catheter Cardiovasc Interv. 2013;82:E911-4.
28. Knipp SC, Kahlert P, Jokisch D, Schlamann M, Wendt D, Weimar C, Jakob H, Thielmann M. Cognitive function after transapical aortic valve implantation: a single-centre study with 3-month follow-up. Interact Cardiovasc Thorac Surg. 2013;16:116-22.