Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials

European Heart Journal

Volumn 39, Issue 19, 2018, Pages 1687-1697

  Lansky, Alexandra J ^a,b   Messé, Steven R ^c   Brickman, Adam M ^d   Dwyer, Michael ^e   Bart Van Der Worp, H ^f   Lazar, Ronald M ^d   Pietras, Cody G ^a   Abrams, Kevin J ^g   McFadden, Eugene ^h   Petersen, Nils H ^a   Browndyke, Jeffrey ⁱ   Prendergast, Bernard ^j   Ng, Vivian G ^a   Cutlip, Donald E ^k   Kapadia, Samir ^l   Krucoff, Mitchell W ⁱ   Linke, Axel ^m   Scala Moy, Claudia ⁿ   Schofer, Joachim ^o   Van Es, Gerrit Anne ^p   Virmani, Renu ^q   Popma, Jeffrey ^r   Parides, Michael K ^r   Kodali, Susheel ^s   Bilello, Michel ^c   Zivadinov, Robert ^e   Akar, Joseph ^a   Furie, Karen L ^t   Gress, Daryl ^u   Voros, Szilard ^v   Moses, Jeffrey ^s   Greer, David ^a   Forrest, John K ^a   Holmes, David ^w   Kappetein, Arie P ^x   Mack, Michael ^y   Baumbach, Andreas ^b   more..

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^c HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA   (United States)

^d Department of Neurology and the Taub Institute for Research on Alzheimer's Disease and the Aging Brain   (United States)

^e UNIVERSITY AT BUFFALO   (United States)

^f UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^g BAPTIST CARDIAC AND VASCULAR INSTITUTE   (United States)

^h University College Cork   (Ireland)

ⁱ DUKE UNIVERSITY MEDICAL CENTER   (United States)

^j ST THOMAS HOSPITAL   (United Kingdom)

^k BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^l LERNER RESEARCH INSTITUTE   (United States)

^m UNIVERSITY OF LEIPZIG   (Germany)

ⁿ NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE   (United States)

^o Albertine Heart Center   (Germany)

^p CARDIALYSIS   (Netherlands)

^q CVPATH INSTITUTE   (United States)

^r MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^s New York Presbyterian Morgan Stanley Children's Hospital   (United States)

^t RHODE ISLAND HOSPITAL   (United States)

^u UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^v Global Institute for Research and Global Genomics Group LLC   (United States)

^w MAYO CLINIC   (United States)

^x ERASMUS MEDICAL CENTER   (Netherlands)

^y Heart Hospital Baylor Plano Research Center   (United States)

more..

Author keywords

cardiovascular; methodology; neurological definitions; outcomes; stroke; trials

Indexed keywords

ARTICLE; BRAIN HEMORRHAGE; BRAIN INFARCTION; CARDIOVASCULAR PROCEDURE; CEREBROVASCULAR ACCIDENT; CONSENSUS DEVELOPMENT; DIFFUSION WEIGHTED IMAGING; DISABILITY; DISEASE SEVERITY; HUMAN; HYPOXIC ISCHEMIC ENCEPHALOPATHY; INTERNATIONAL COOPERATION; NEUROLOGIC DISEASE; NEUROLOGIC EXAMINATION; NEUROPSYCHOLOGICAL TEST; NUCLEAR MAGNETIC RESONANCE IMAGING; PATIENT SAFETY; PRIORITY JOURNAL; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK FACTOR; STANDARDIZATION; TRANSIENT ISCHEMIC ATTACK; ADVERSE EVENT; BIOASSAY; CARDIOVASCULAR SURGERY; CATHETERIZATION; CLASSIFICATION; CLINICAL TRIAL (TOPIC); POSTOPERATIVE COMPLICATION;

CARDIOVASCULAR SURGICAL PROCEDURES; CATHETERIZATION; CLINICAL TRIALS AS TOPIC; ENDPOINT DETERMINATION; HUMANS; NERVOUS SYSTEM DISEASES; NEUROLOGIC EXAMINATION; POSTOPERATIVE COMPLICATIONS; RISK ASSESSMENT;

EID: 85047073803     PISSN: 0195668X     EISSN: 15229645     Source Type: Journal    
DOI: 10.1093/eurheartj/ehx037     Document Type: Article

References (68)

1. Eggebrecht H, Schmermund A, Voigtlander T, et al. Risk of stroke after transcatheter aortic valve implantation (TAVI): a meta-analysis of 10,037 published patients. EuroIntervention 2012;8:129-38.
2. Filsoufi F, Rahmanian PB, Castillo JG, et al. Incidence, imaging analysis, and early and late outcomes of stroke after cardiac valve operation. Am J Cardiol 2008;101:1472-8.
3. Puskas JD, Winston AD, Wright CE, et al. Stroke after coronary artery operation: incidence, correlates, outcome, and cost. Ann Thorac Surg 2000;69:1053-6.
4. Kapadia S, Agarwal S, Miller DC, et al. Insights into timing, risk factors, and outcomes of stroke and transient ischemic attack after transcatheter aortic valve replacement in the PARTNER Trial (Placement of Aortic Transcatheter Valves). Circ Cardiovasc Interv 2016;9:e002981.
5. Kleiman NS, Maini BJ, Reardon MJ, et al. Neurological events following transcatheter aortic valve replacement and their predictors: a report from the CoreValve Trials. Circ Cardiovasc Interv 2016;9:e003551.
6. McKhann GM, Grega MA, Borowicz LM Jr., et al. Stroke and encephalopathy after cardiac surgery: an update. Stroke 2006;37:562-71.
7. Stortecky S, Windecker S. Stroke: an infrequent but devastating complication in cardiovascular interventions. Circulation 2012;126:2921-4.
8. Auffret V, Regueiro A, Del Trigo M, et al. Predictors of early cerebrovascular events in patients with aortic stenosis undergoing transcatheter aortic valve replacement. J Am Coll Cardiol 2016;68:673-84.
9. Messé SR, Acker MA, Kasner SE, et al., for the Determining Neurologic Outcomes from Valve Operations (DeNOVO) Investigators. Stroke after aortic valve surgery: results from a prospective cohort. Circulation 2014;129:2253-61.
10. Lansky AJ, Schofer J, Tchetche D, et al. A prospective randomized evaluation of the TriGuard HDH embolic DEFLECTion device during transcatheter aortic valve implantation: results from the DEFLECT III trial. Eur Heart J 2015;36:2070-8.
11. Mack M. Can we make stroke during cardiac surgery a never event? J Thorac Cardiovasc Surg 2015;149:965-7.
12. Lansky AJ, Brown D, Pena C, et al. Neurologic complications of unprotected transcatheter aortic valve implantation (from the Neuro-TAVI Trial). Am J Cardiol 2016;118:1519-26.
13. Bonati LH, Jongen LM, Haller S, et al., for the ICSS-MRI Study Group. New ischaemic brain lesions on MRI after stenting or endarterectomy for symptomatic carotid stenosis: a substudy of the International Carotid Stenting Study (ICSS). Lancet Neurol 2010;9:353-62.
14. Bernick C, Kuller L, Dulberg C, et al., for the Cardiovascular Health Study Collaborative Group. Silent MRI infarcts and the risk of future stroke: the Cardiovascular Health Study. Neurology 2001;57:1222-9.
15. Vermeer SE, Longstreth WT Jr., Koudstaal PJ. Silent brain infarcts: a systematic review. Lancet Neurol 2007;6:611-9.
16. Gress DR. The problem with asymptomatic cerebral embolic complications in vascular procedures: what if they are not asymptomatic? J Am Coll Cardiol 2012;60:1614-6.
17. Krucoff MW, Mehran R, van Es GA, et al. The Academic Research Consortium governance charter. J Am Coll Cardiol Intv 2011;4:595-6.
18. Kappetein AP, Head SJ, Généreux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg 2013;145:6-23.
19. Stone GW, Adams DH, Abraham WT, et al., for the Mitral Valve Academic Research Consortium (MVARC). Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 2: endpoint definitions: a consensus document from the Mitral Valve Academic Research Consortium. J Am Coll Cardiol 2015;66:308-21.
20. Sacco RL, Kasner SE, Broderick JP, et al., for the American Heart Association Stroke Council; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 2013;44:2064-89.
21. Saver JL, Warach S, Janis S, et al., for the National Institute of Neurological Disorders and Stroke (NINDS) Stroke Common Data Element Working Group. Standardizing the structure of stroke clinical and epidemiologic research data: the National Institute of Neurological Disorders and Stroke (NINDS) Stroke Common Data Element (CDE) project. Stroke 2012;43:967-73.
22. Knipp SC, Matatko N, Wilhelm H, et al. Cognitive outcomes three years after coronary artery bypass surgery: relation to diffusionweighted magnetic resonance imaging. Ann Thorac Surg 2008;85:872-9.
23. Tatemichi TK, Paik M, Bagiella E, et al. Dementia after stroke is a predictor of long-term survival. Stroke 1994;25:1915-9.
24. Easton JD, Saver JL, Albers GW, et al. Definition and evaluation of transient ischemic attack: a scientific statement for healthcare professionals from the American Heart Association/American Stroke Association Stroke Council; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; and the Interdisciplinary Council on Peripheral Vascular Disease. Stroke 2009;40: 2276-93.
25. Muttikkal TJ, Wintermark M. MRI patterns of global hypoxic-ischemic injury in adults. J Neuroradiol 2013;40:164-71.
26. Schneider A, Böttiger BW, Popp E. Cerebral resuscitation after cardiocirculatory arrest. Anesth Analg 2009;108:971-9.
27. Rosamond WD, Folsom AR, Chambless LE, et al. Stroke incidence and survival among middleaged adults: 9-year follow-up of the Atherosclerosis Risk in Communities (ARIC) cohort. Stroke 1999;30:736-43.
28. Witlox J, Eurelings LS, de Jonghe JF, et al. Delirium in elderly patients and the risk of postdischarge mortality, institutionalization, and dementia: a meta-analysis. JAMA 2010;304:443-51.
29. Saczynski JS, Marcantonio ER, Quach L, et al. Cognitive trajectories after postoperative delirium. N Engl J Med 2012;367:30-9.
30. Quinn TJ, Dawson J, Walters MR, et al. Functional outcome measures in contemporary stroke trials. Int J Stroke 2009;4:200-5.
31. Wu CM, McLaughlin K, Lorenzetti DL, et al. Early risk of stroke after transient ischemic attack: a systematic review and meta-analysis. Arch Intern Med 2007;167:2417-22.
32. Shi Q, Presutti R, Selchen D, et al. Delirium in acute stroke: a systematic review and meta-analysis. Stroke 2012;43:645-9.
33. Jones WJ, Williams LS, Meschia JF. Validating the Questionnaire for Verifying Stroke-Free Status (QVSFS) by neurological history and examination. Stroke 2001;32:2232-6.
34. Karanjia PN, Nelson JJ, Lefkowitz DS, et al. Validation of the ACAS TIA/stroke algorithm. Neurology 1997;48:346-51.
35. van Swieten JC, Koudstaal PJ, Visser MC, et al. Interobserver agreement for the assessment of handicap in stroke patients. Stroke 1988;19:604-7.
36. Brazzelli M, Sandercock PA, Chappell FM et al. Magnetic resonance imaging versus computed tomography for detection of acute vascular lesions in patients presenting with stroke symptoms. Cochrane Database Syst Rev 2009:CD007424.
37. Augustin M, Bammer R, Simbrunner J, et al. Diffusion-weighted imaging of patients with subacute cerebral ischemia: comparison with conventional and contrast-enhanced MR imaging. AJNR Am J Neuroradiol 2000;21:1596-602.
38. Gass A, Ay H, Szabo K, et al. Diffusion-weighted MRI for the small stuff: the details of acute cerebral ischaemia. Lancet Neurol 2004;3:39-45.
39. Li F, Liu KF, Silva MD, et al. Transient and permanent resolution of ischemic lesions on diffusion-weighted imaging after brief periods of focal ischemia in rats: correlation with histopathology. Stroke 2000;31:946-54.
40. Campbell BC, Purushotham A, Christensen S, et al., for the EPITHET-DEFUSE Investigators. The infarct core is well represented by the acute diffusion lesion: sustained reversal is infrequent. J Cereb Blood Flow Metab 2012;32:50-6.
41. Albach FN, Brunecker P, Usnich T, et al. Complete early reversal of diffusionweighted imaging hyperintensities after ischemic stroke is mainly limited to small embolic lesions. Stroke 2013;44:1043-8.
42. Oppenheim C, Stanescu R, Dormont D, et al. False-negative diffusion-weighted MR findings in acute ischemic stroke. AJNR Am J Neuroradiol 2000;21:1434-40.
43. Beaulieu C, de Crespigny A, Tong DC, et al. Longitudinal magnetic resonance imaging study of perfusion and diffusion in stroke: evolution of lesion volume and correlation with clinical outcome. Ann Neurol 1999;46:568-78.
44. Ringer TM, Neumann-Haefelin T, Sobel RA, et al. Reversal of early diffusionweighted magnetic resonance imaging abnormalities does not necessarily reflect tissue salvage in experimental cerebral ischemia. Stroke 2001;32:2362-9.
45. Smith EE, Schneider JA, Wardlaw JM, et al. Cerebral microinfarcts: the invisible lesions. Lancet Neurol 2012;11:272-82.
46. Nandigam RN, Viswanathan A, Delgado P, et al. MR imaging detection of cerebral microbleeds: effect of susceptibility-weighted imaging, section thickness, and field strength. AJNR Am J Neuroradiol 2009;30:338-43.
47. Berger M, Nadler JW, Browndyke J, et al. Postoperative cognitive dysfunction: minding the gaps in our knowledge of a common postoperative complication in the elderly. Anesthesiol Clin 2015;33:517-50.
48. Krupp W, Klein C, Koschny R, et al. Assessment of neuropsychological parameters and quality of life to evaluate outcome in patients with surgically treated supratentorial meningiomas. Neurosurgery 2009;64:40-7; discussion 47.
49. Ravdin LD, Mattis PJ, Lachs MS. Assessment of cognition in primary care: neuropsychological evaluation of the geriatric patient. Geriatrics 2004;59:37-40.
50. Salmon DP, Bondi MW. Neuropsychological assessment of dementia. Annu Rev Psychol 2009;60:257-82.
51. Garrett KD, Browndyke JN, Whelihan W, et al. The neuropsychological profile of vascular cognitive impairment-no dementia: comparisons to patients at risk for cerebrovascular disease and vascular dementia. Arch Clin Neuropsychol 2004;19:745-57.
52. Vasquez BP, Zakzanis KK. The neuropsychological profile of vascular cognitive impairment not demented: a meta-analysis. J Neuropsychol 2015;9:109-36.
53. Nasreddine ZS, Phillips NA, Bédirian V, et al. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc 2005;53:695-9.
54. Morley J, Tumosa N. Saint Louis University mental status examination (SLUMS). Aging Successfully 2002;12:4.
55. Wilkinson G, Robertson G. Wide Range Achievement Test Fourth Edition (WRAT-4) professional manual. Lutz, FL: Psychological Assessment Resources, Inc, 2004.
56. Wechsler D. Wechsler Test of Adult Reading: WTAR. San Antonio, TX: Psychological Corporation, 2001.
57. Wechsler D. Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson, 2008.
58. Army Individual Test Battery. Manual of directions and scoring. Washington, DC: War Department, Adjutant General's Office, 1944.
59. Conners CK, MHS Staff. Conners' Continuous Performance Test II (CPT II V. 5). North Tonawanda, NY: Multi-Health Systems Inc., 2000:1-16.
60. Randolph C, Tierney MC, Mohr E, et al. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity. J Clin Exp Neuropsychol 1998;20:310-9.
61. Benedict RHB, Schretlen D, Groninger L, et al. Hopkins Verbal Learning Test-Revised: normative data and analysis of inter-form and testretest reliability. Clin Neuropsychol 1998;12:43-55.
62. Delis DC, Kramer JH, Kaplan E et al. California Verbal Learning Test, 2nd Edition (CVLT-II). San Antonio, TX: Psychological Corporation, 2000.
63. Benedict RHB. Brief Visual Memory Test-Revised: Professional Manual. Odessa, FL: Psychological Assessment Resources, 1997.
64. Benton AL, Hamsher KD, Sivan AB. Multilingual Aphasia Examination: Manual of Instructions, 3rd edition. Iowa City, IA: AJA Associates, 1994.
65. Ruff RM. Ruff Figural Fluency Test: Professional Manual. Lutz, FL: Psychological Assessment Resources, 1996.
66. Golden CJ. Stroop Color and Word Test: A Manual for Clinical and Experimental Uses. Chicago, IL: Stoelting Co., 1978.
67. Meyers J, Meyers KR. Rey Complex Figure Test and Recognition Trial. Lutz, FL: Psychological Assessment Resources, 1995.
68. Hooper HE. Hooper Visual Organization Test (VOT): Manual. Los Angeles, CA: Western Psychological Services, 1983.