Effect of cerebral embolic protection devices on CNS infarction in surgical aortic valve replacement: A randomized clinical trial

JAMA - Journal of the American Medical Association

Volumn 318, Issue 6, 2017, Pages 536-547

  Mack, Michael J ^a   Acker, Michael A ^b   Gelijns, Annetine C ^c   Overbey, Jessica R ^c   Parides, Michael K ^c   Browndyke, Jeffrey N ^d   Groh, Mark A ^e   Moskowitz, Alan J ^c   Jeffries, Neal O ^f   Ailawadi, Gorav ^g   Thourani, Vinod H ^h   Moquete, Ellen G ^c   Iribarne, Alexander ⁱ   Voisine, Pierre ^j   Perrault, Louis P ^k   Bowdish, Michael E ^l   Bilello, Michel ^m   Davatzikos, Christos ^m   Mangusan, Ralph F ^e   Winkle, Rachelle A ^a   Smith, Peter K ^d   Michler, Robert E ⁿ   Miller, Marissa A ^f   O’Sullivan, Karen L ^c   Taddei Peters, Wendy C ^f   Rose, Eric A ^c   Weisel, Richard D ^o,p   Furie, Karen L ^q   Bagiella, Emilia ^c   Moy, Claudia Scala ^r   O'Gara, Patrick T ^s   Messé, Steven R ^b   more..

^a SCOTT AND WHITE MEMORIAL HOSPITAL   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^d DUKE UNIVERSITY MEDICAL CENTER   (United States)

^e Mission Health   (United States)

^f NATIONAL HEART LUNG AND BLOOD INSTITUTE   (United States)

^g UNIVERSITY OF VIRGINIA   (United States)

^h EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁱ DARTMOUTH HITCHCOCK MEDICAL CENTER   (United States)

^j LAVAL UNIVERSITY   (Canada)

^k MONTREAL HEART INSTITUTE   (Canada)

^l UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^m UNIVERSITY OF PENNSYLVANIA   (United States)

ⁿ ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^o UNIVERSITY HEALTH NETWORK   (Canada)

^p UNIVERSITY OF TORONTO   (Canada)

^q BROWN UNIVERSITY   (United States)

^r NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE   (United States)

^s BRIGHAM AND WOMEN S HOSPITAL   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ACUTE KIDNEY FAILURE; ADVERSE OUTCOME; AGED; AORTIC VALVE REPLACEMENT; ARTICLE; BRAIN ISCHEMIA; CANNULA; CEREBROVASCULAR ACCIDENT; CLINICAL EFFECTIVENESS; COGNITION ASSESSMENT; CONTROLLED STUDY; DELIRIUM; EMBOLIC PROTECTION DEVICE; FEMALE; FOLLOW UP; HEART ARRHYTHMIA; HIGH RISK POPULATION; HUMAN; LENGTH OF STAY; MAJOR CLINICAL STUDY; MALE; MORTALITY RATE; NATIONAL INSTITUTES OF HEALTH STROKE SCALE; POSTOPERATIVE PERIOD; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; ACUTE KIDNEY INJURY; ADVERSE EFFECTS; AORTIC VALVE; AORTIC VALVE STENOSIS; ARRHYTHMIAS, CARDIAC; BRAIN INFARCTION; CLINICAL TRIAL; HEART VALVE PROSTHESIS; HEART VALVE REPLACEMENT; INCIDENCE; MULTICENTER STUDY; POSTOPERATIVE COMPLICATIONS; RISK FACTOR; TREATMENT OUTCOME;

ACUTE KIDNEY INJURY; AGED; AORTIC VALVE; AORTIC VALVE STENOSIS; ARRHYTHMIAS, CARDIAC; BRAIN INFARCTION; DELIRIUM; EMBOLIC PROTECTION DEVICES; FEMALE; HEART VALVE PROSTHESIS; HEART VALVE PROSTHESIS IMPLANTATION; HUMANS; INCIDENCE; MALE; POSTOPERATIVE COMPLICATIONS; RISK FACTORS; TREATMENT OUTCOME;

EID: 85027525529     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2017.9479     Document Type: Article

References (33)

1. Duke Clinical Research Institute. Adult cardiac surgery database: executive summary 10 years. http://www.sts.org/sites/default/files/documents/2016Harvest2_ExecutiveSummary_new.pdf. Accessed July 10, 2017.
2. Grover FL, Vemulapalli S, Carroll JD, et al. 2016 Annual report of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Ann Thorac Surg. 2017;103(3):1021-1035.
3. Floyd TF, Shah PN, Price CC, et al. Clinically silent cerebral ischemic events after cardiac surgery. Ann Thorac Surg. 2006;81(6):2160-2166.
4. Alassar A, Soppa G, Edsell M, et al. Incidence and mechanisms of cerebral ischemia after transcatheter aortic valve implantation compared with surgical aortic valve replacement. Ann Thorac Surg. 2015;99(3):802-808.
5. Messé SR, Acker MA, Kasner SE, et al. Stroke after aortic valve surgery. Circulation. 2014;129(22): 2253-2261.
6. Puskas JD, Winston AD, Wright CE, et al. Stroke after coronary artery operation. Ann Thorac Surg. 2000;69(4):1053-1056.
7. Salazar JD, Wityk RJ, Grega MA, et al. Stroke after cardiac surgery: short- and long-term outcomes. Ann Thorac Surg. 2001;72(4):1195-1201.
8. Banbury MK, Kouchoukos NT, Allen KB, et al. Emboli capture using the Embol-X intraaortic filter in cardiac surgery. Ann Thorac Surg. 2003;76(2): 508-515.
9. Bolotin G, Huber CH, Shani L, et al. Novel emboli protection system during cardiac surgery. Ann Thorac Surg. 2014;98(5):1627-1633.
10. Sacco RL, Kasner SE, Broderick JP, et al. An updated definition of stroke for the 21st century. Stroke. 2013;44(7):2064-2089.
11. DeMets DL, Lan KKG. Interim analysis: the alpha spending function approach. Stat Med. 1994;13(13-14):1341-1352.
12. O’Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979;35(3): 549-556.
13. Glas KE, Swaminathan M, Reeves ST, et al. Guidelines for the performance of a comprehensive intraoperative epiaortic ultrasonographic examination. J Am Soc Echocardiogr. 2007;20(11): 1227-1235.
14. Stolz E, Gerriets T, Kluge A, et al. Diffusion-weighted magnetic resonance imaging and neurobiochemical markers after aortic valve replacement. Stroke. 2004;35(4):888-892.
15. Cook DJ, Huston J III, Trenerry MR, et al. Postcardiac surgical cognitive impairment in the aged using diffusion-weighted magnetic resonance imaging. Ann Thorac Surg. 2007;83(4):1389-1395.
16. Barber PA, Hach S, Tippett LJ, et al. Cerebral ischemic lesions on diffusion-weighted imaging are associated with neurocognitive decline after cardiac surgery. Stroke. 2008;39(5):1427-1433.
17. Patel N, Horsfield MA, Banahan C, et al. Impact of perioperative infarcts after cardiac surgery. Stroke. 2015;46(3):680-686.
18. Knipp SC, Matatko N, Schlamann M, et al. Small ischemic brain lesions after cardiac valve replacement detected by diffusion-weighted magnetic resonance imaging. Eur J Cardiothorac Surg. 2005;28(1):88-96.
19. Uddin A, Fairbairn TA, Djoukhader IK, et al. Consequence of cerebral embolism after transcatheter aortic valve implantation compared with contemporary surgical aortic valve replacement. Circ Cardiovasc Interv. 2015;8(3): e001913.
20. Vermeer SE, Hollander M, van Dijk EJ, et al. Silent brain infarcts and white matter lesions increase stroke risk in the general population. Stroke. 2003;34(5):1126-1129.
21. Patel N, Minhas JS, Chung EM. Risk factors associated with cognitive decline after cardiac surgery: a systematic review. Cardiovasc Psychiatry Neurol. 2015;2015:370612.
22. Patel N, Minhas JS, Chung EM. The presence of new MRI lesions and cognitive decline after cardiac surgery. J Card Surg. 2015;30(11):808-812.
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(3):502-508.
24. König IR, Ziegler A, Bluhmki E, et al. Predicting long-term outcome after acute ischemic stroke. Stroke. 2008;39(6):1821-1826.
25. Shahian DM, O’Brien SM, Filardo G, et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models. Ann Thorac Surg. 2009;88(1) (suppl):S43-S62.
26. O’Brien SM, Shahian DM, Filardo G, et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models. Ann Thorac Surg. 2009;88(1) (suppl):S23-S42.
27. Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014;383 (9920):911-922.
28. Franco K, Litaker D, Locala J, Bronson D. The cost of delirium in the surgical patient. Psychosomatics. 2001;42(1):68-73.
29. Saczynski JS, Marcantonio ER, Quach L, et al. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012;367(1):30-39.
30. Gottesman RF, Grega MA, Bailey MM, et al. Delirium after coronary artery bypass graft surgery and late mortality. Ann Neurol. 2010;67(3):338-344.
31. Doganci S, Gunaydin S, Kocak OM, et al. Impact of the intensity of microemboli on neurocognitive outcome following cardiopulmonary bypass. Perfusion. 2013;28(3):256-262.
32. Kapadia SR, Kodali S, Makkar R, et al. Protection against cerebral embolism during transcatheter aortic valve replacement. J Am Coll Cardiol. 2017;69 (4):367-377.
33. Lansky AJ, Messé SR, Brickman AM, et al. Proposed standardized neurological endpoints for cardiovascular clinical trials. J Am Coll Cardiol. 2017; 69(6):679-691.