Perioperative covert stroke in patients undergoing non-cardiac surgery (NeuroVISION): a prospective cohort study

Marko Mrkobrada; Matthew T.V. Chan; David Cowan; Douglas Campbell; Chew Yin Wang; David Torres; German Malaga; Robert D. Sanders; Manas Sharma; Carl Brown; Alben Sigamani; Wojciech Szczeklik; Mukul Sharma; Gordon Guyatt; Eric E. Smith; Ronit Agid; Adam A. Dmytriw; Jessica Spence; Nikesh R. Adunuri; Flavia K. Borges; Timothy G. Short; Michael D. Hill; Feryal Saad; Ingrid Copland; Shirley Pettit; Quazi Ibrahim; Shrikant I. Bangdiwala; Salim Yusuf; Scott Tsai; Demetrios J. Sahlas; Arun Mensinkai; Luciano A. Sposato; Sara Hussain; Steven Yang; Deborah Siegal; Alexander Khaw; Jennifer Mandzia; Sara Simpson; Manoj Raval; Ahmer Karimuddin; P. T. Phang; Vincent CT Mok; William KK Wu; Simon CH Yu; Tony Gin; Pui San Loh; Mun Thing Liew; Norlisah Ramli; Yee Lein Siow; Maite Fuentes; Victor Ortiz-Soriano; Ellen Waymouth; Jonathan Kumar; Divya Sadana; Lenimol Thomas; Bogusz Kaczmarek; Heidi Lindroth; Daniel Sessler; Sarah Apolcer; Amelia Trombetta; Stephanie Handsor; Monidipa Dasgupta; John M. Murkin; Shun Fu Lee; P. J. Devereaux

doi:10.1016/S0140-6736(19)31795-7

Perioperative covert stroke in patients undergoing non-cardiac surgery (NeuroVISION): a prospective cohort study

Marko Mrkobrada, Matthew T.V. Chan, David Cowan, Douglas Campbell, Chew Yin Wang, David Torres, German Malaga, Robert D. Sanders, Manas Sharma, Carl Brown, Alben Sigamani, Wojciech Szczeklik, Mukul Sharma, Gordon Guyatt, Eric E. Smith, Ronit Agid, Adam A. Dmytriw, Jessica Spence, Nikesh R. Adunuri, Flavia K. BorgesTimothy G. Short, Michael D. Hill, Feryal Saad, Ingrid Copland, Shirley Pettit, Quazi Ibrahim, Shrikant I. Bangdiwala, Salim Yusuf, Scott Tsai, Demetrios J. Sahlas, Arun Mensinkai, Luciano A. Sposato, Sara Hussain, Steven Yang, Deborah Siegal, Alexander Khaw, Jennifer Mandzia, Sara Simpson, Manoj Raval, Ahmer Karimuddin, P. T. Phang, Vincent CT Mok, William KK Wu, Simon CH Yu, Tony Gin, Pui San Loh, Mun Thing Liew, Norlisah Ramli, Yee Lein Siow, Maite Fuentes, Victor Ortiz-Soriano, Ellen Waymouth, Jonathan Kumar, Divya Sadana, Lenimol Thomas, Bogusz Kaczmarek, Heidi Lindroth, Daniel Sessler, Sarah Apolcer, Amelia Trombetta, Stephanie Handsor, Monidipa Dasgupta, John M. Murkin, Shun Fu Lee, P. J. Devereaux^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

175 Scopus citations

Abstract

Background: In non-surgical settings, covert stroke is more common than overt stroke and is associated with cognitive decline. Although overt stroke occurs in less than 1% of adults after non-cardiac surgery and is associated with substantial morbidity, we know little about perioperative covert stroke. Therefore, our primary aim was to investigate the relationship between perioperative covert stroke (ie, an acute brain infarct detected on an MRI after non-cardiac surgery in a patient with no clinical stroke symptoms) and cognitive decline 1 year after surgery. Methods: NeuroVISION was a prospective cohort study done in 12 academic centres in nine countries, in which we assessed patients aged 65 years or older who underwent inpatient, elective, non-cardiac surgery and had brain MRI after surgery. Two independent neuroradiology experts, masked to clinical data, assessed each MRI for acute brain infarction. Using multivariable regression, we explored the association between covert stroke and the primary outcome of cognitive decline, defined as a decrease of 2 points or more on the Montreal Cognitive Assessment from preoperative baseline to 1-year follow-up. Patients, health-care providers, and outcome adjudicators were masked to MRI results. Findings: Between March 24, 2014, and July 21, 2017, of 1114 participants recruited to the study, 78 (7%; 95% CI 6–9) had a perioperative covert stroke. Among the patients who completed the 1-year follow-up, cognitive decline 1 year after surgery occurred in 29 (42%) of 69 participants who had a perioperative covert stroke and in 274 (29%) of 932 participants who did not have a perioperative covert stroke (adjusted odds ratio 1·98, 95% CI 1·22–3·20, absolute risk increase 13%; p=0·0055). Covert stroke was also associated with an increased risk of perioperative delirium (hazard ratio [HR] 2·24, 95% CI 1·06–4·73, absolute risk increase 6%; p=0·030) and overt stroke or transient ischaemic attack at 1-year follow-up (HR 4·13, 1·14–14·99, absolute risk increase 3%; p=0·019). Interpretation: Perioperative covert stroke is associated with an increased risk of cognitive decline 1 year after non-cardiac surgery, and perioperative covert stroke occurred in one in 14 patients aged 65 years and older undergoing non-cardiac surgery. Research is needed to establish prevention and management strategies for perioperative covert stroke. Funding: Canadian Institutes of Health Research; The Ontario Strategy for Patient Oriented Research support unit; The Ontario Ministry of Health and Long-Term Care; Health and Medical Research Fund, Government of the Hong Kong Special Administrative Region, China; and The Neurological Foundation of New Zealand.

Original language	English
Pages (from-to)	1022-1029
Number of pages	8
Journal	The Lancet
Volume	394
Issue number	10203
DOIs	https://doi.org/10.1016/S0140-6736(19)31795-7
State	Published - 21 Sep 2019

Bibliographical note

Funding Information:
EES reports personal fees from Portola Pharmaceuticals and Alnylam Pharmaceuticals, outside the submitted work. MDH reports personal fees from Merck, non-financial support from Hoffmann-La Roche Canada Ltd, and grants from Covidien (Medtronic), Boehringer Ingelheim, Stryker Inc, Medtronic LLC, and NoNO Inc, outside the submitted work. MDH has a patent on Systems and Methods for Assisting in Decision-Making and Triaging for Acute Stroke Patients issued to US Patent office number 62/086,077, owns stock in Calgary Scientific Incorporated, a company that focuses on medical imaging software, and is a director of the Canadian Federation of Neurological Sciences, a not-for-profit organisation. PJD reports grants from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, Roche Diagnostics, and Siemens, outside the submitted work. All other members of the writing committee declare no competing interests.

Funding Information:
This study was funded by a Foundation Grant from the Canadian Institutes of Health Research (CIHR); CIHR's Strategy for Patient Oriented Research (SPOR), through the Ontario SPOR Support Unit as well as the Ontario Ministry of Health and Long-Term Care; Health and Medical Research Fund ( 11120321 ), Food and Health Bureau, the Government of the Hong Kong Special Administrative Region, China; and the Auckland District Health Board Charitable Trust, Neurological Foundation of New Zealand. The Population Health Research Institute was the study-coordinating centre and was responsible for the maintenance of the database, data validation, analyses, and study coordination. The trial committees and their members, participating centres, and investigators are listed in the appendix .

Publisher Copyright:
© 2019 Elsevier Ltd

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10.1016/S0140-6736(19)31795-7

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Mrkobrada, M., Chan, M. T. V., Cowan, D., Campbell, D., Wang, C. Y., Torres, D., Malaga, G., Sanders, R. D., Sharma, M., Brown, C., Sigamani, A., Szczeklik, W., Sharma, M., Guyatt, G., Smith, E. E., Agid, R., Dmytriw, A. A., Spence, J., Adunuri, N. R., ... Devereaux, P. J. (2019). Perioperative covert stroke in patients undergoing non-cardiac surgery (NeuroVISION): a prospective cohort study. The Lancet, 394(10203), 1022-1029. https://doi.org/10.1016/S0140-6736(19)31795-7

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title = "Perioperative covert stroke in patients undergoing non-cardiac surgery (NeuroVISION): a prospective cohort study",

abstract = "Background: In non-surgical settings, covert stroke is more common than overt stroke and is associated with cognitive decline. Although overt stroke occurs in less than 1% of adults after non-cardiac surgery and is associated with substantial morbidity, we know little about perioperative covert stroke. Therefore, our primary aim was to investigate the relationship between perioperative covert stroke (ie, an acute brain infarct detected on an MRI after non-cardiac surgery in a patient with no clinical stroke symptoms) and cognitive decline 1 year after surgery. Methods: NeuroVISION was a prospective cohort study done in 12 academic centres in nine countries, in which we assessed patients aged 65 years or older who underwent inpatient, elective, non-cardiac surgery and had brain MRI after surgery. Two independent neuroradiology experts, masked to clinical data, assessed each MRI for acute brain infarction. Using multivariable regression, we explored the association between covert stroke and the primary outcome of cognitive decline, defined as a decrease of 2 points or more on the Montreal Cognitive Assessment from preoperative baseline to 1-year follow-up. Patients, health-care providers, and outcome adjudicators were masked to MRI results. Findings: Between March 24, 2014, and July 21, 2017, of 1114 participants recruited to the study, 78 (7%; 95% CI 6–9) had a perioperative covert stroke. Among the patients who completed the 1-year follow-up, cognitive decline 1 year after surgery occurred in 29 (42%) of 69 participants who had a perioperative covert stroke and in 274 (29%) of 932 participants who did not have a perioperative covert stroke (adjusted odds ratio 1·98, 95% CI 1·22–3·20, absolute risk increase 13%; p=0·0055). Covert stroke was also associated with an increased risk of perioperative delirium (hazard ratio [HR] 2·24, 95% CI 1·06–4·73, absolute risk increase 6%; p=0·030) and overt stroke or transient ischaemic attack at 1-year follow-up (HR 4·13, 1·14–14·99, absolute risk increase 3%; p=0·019). Interpretation: Perioperative covert stroke is associated with an increased risk of cognitive decline 1 year after non-cardiac surgery, and perioperative covert stroke occurred in one in 14 patients aged 65 years and older undergoing non-cardiac surgery. Research is needed to establish prevention and management strategies for perioperative covert stroke. Funding: Canadian Institutes of Health Research; The Ontario Strategy for Patient Oriented Research support unit; The Ontario Ministry of Health and Long-Term Care; Health and Medical Research Fund, Government of the Hong Kong Special Administrative Region, China; and The Neurological Foundation of New Zealand.",

author = "Marko Mrkobrada and Chan, {Matthew T.V.} and David Cowan and Douglas Campbell and Wang, {Chew Yin} and David Torres and German Malaga and Sanders, {Robert D.} and Manas Sharma and Carl Brown and Alben Sigamani and Wojciech Szczeklik and Mukul Sharma and Gordon Guyatt and Smith, {Eric E.} and Ronit Agid and Dmytriw, {Adam A.} and Jessica Spence and Adunuri, {Nikesh R.} and Borges, {Flavia K.} and Short, {Timothy G.} and Hill, {Michael D.} and Feryal Saad and Ingrid Copland and Shirley Pettit and Quazi Ibrahim and Bangdiwala, {Shrikant I.} and Salim Yusuf and Scott Tsai and Sahlas, {Demetrios J.} and Arun Mensinkai and Sposato, {Luciano A.} and Sara Hussain and Steven Yang and Deborah Siegal and Alexander Khaw and Jennifer Mandzia and Sara Simpson and Manoj Raval and Ahmer Karimuddin and Phang, {P. T.} and Mok, {Vincent CT} and Wu, {William KK} and Yu, {Simon CH} and Tony Gin and Loh, {Pui San} and Liew, {Mun Thing} and Norlisah Ramli and Siow, {Yee Lein} and Maite Fuentes and Victor Ortiz-Soriano and Ellen Waymouth and Jonathan Kumar and Divya Sadana and Lenimol Thomas and Bogusz Kaczmarek and Heidi Lindroth and Daniel Sessler and Sarah Apolcer and Amelia Trombetta and Stephanie Handsor and Monidipa Dasgupta and Murkin, {John M.} and Lee, {Shun Fu} and Devereaux, {P. J.}",

note = "Funding Information: EES reports personal fees from Portola Pharmaceuticals and Alnylam Pharmaceuticals, outside the submitted work. MDH reports personal fees from Merck, non-financial support from Hoffmann-La Roche Canada Ltd, and grants from Covidien (Medtronic), Boehringer Ingelheim, Stryker Inc, Medtronic LLC, and NoNO Inc, outside the submitted work. MDH has a patent on Systems and Methods for Assisting in Decision-Making and Triaging for Acute Stroke Patients issued to US Patent office number 62/086,077, owns stock in Calgary Scientific Incorporated, a company that focuses on medical imaging software, and is a director of the Canadian Federation of Neurological Sciences, a not-for-profit organisation. PJD reports grants from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, Roche Diagnostics, and Siemens, outside the submitted work. All other members of the writing committee declare no competing interests. Funding Information: This study was funded by a Foundation Grant from the Canadian Institutes of Health Research (CIHR); CIHR's Strategy for Patient Oriented Research (SPOR), through the Ontario SPOR Support Unit as well as the Ontario Ministry of Health and Long-Term Care; Health and Medical Research Fund ( 11120321 ), Food and Health Bureau, the Government of the Hong Kong Special Administrative Region, China; and the Auckland District Health Board Charitable Trust, Neurological Foundation of New Zealand. The Population Health Research Institute was the study-coordinating centre and was responsible for the maintenance of the database, data validation, analyses, and study coordination. The trial committees and their members, participating centres, and investigators are listed in the appendix . Publisher Copyright: {\textcopyright} 2019 Elsevier Ltd",

year = "2019",

month = sep,

day = "21",

doi = "10.1016/S0140-6736(19)31795-7",

language = "English",

volume = "394",

pages = "1022--1029",

journal = "The Lancet",

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publisher = "Elsevier Ltd.",

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Mrkobrada, M, Chan, MTV, Cowan, D, Campbell, D, Wang, CY, Torres, D, Malaga, G, Sanders, RD, Sharma, M, Brown, C, Sigamani, A, Szczeklik, W, Sharma, M, Guyatt, G, Smith, EE, Agid, R, Dmytriw, AA, Spence, J, Adunuri, NR, Borges, FK, Short, TG, Hill, MD, Saad, F, Copland, I, Pettit, S, Ibrahim, Q, Bangdiwala, SI, Yusuf, S, Tsai, S, Sahlas, DJ, Mensinkai, A, Sposato, LA, Hussain, S, Yang, S, Siegal, D, Khaw, A, Mandzia, J, Simpson, S, Raval, M, Karimuddin, A, Phang, PT, Mok, VCT, Wu, WKK, Yu, SCH, Gin, T, Loh, PS, Liew, MT, Ramli, N, Siow, YL, Fuentes, M, Ortiz-Soriano, V, Waymouth, E, Kumar, J, Sadana, D, Thomas, L, Kaczmarek, B, Lindroth, H, Sessler, D, Apolcer, S, Trombetta, A, Handsor, S, Dasgupta, M, Murkin, JM, Lee, SF & Devereaux, PJ 2019, 'Perioperative covert stroke in patients undergoing non-cardiac surgery (NeuroVISION): a prospective cohort study', The Lancet, vol. 394, no. 10203, pp. 1022-1029. https://doi.org/10.1016/S0140-6736(19)31795-7

TY - JOUR

T1 - Perioperative covert stroke in patients undergoing non-cardiac surgery (NeuroVISION)

T2 - a prospective cohort study

AU - Mrkobrada, Marko

AU - Chan, Matthew T.V.

AU - Cowan, David

AU - Campbell, Douglas

AU - Wang, Chew Yin

AU - Torres, David

AU - Malaga, German

AU - Sanders, Robert D.

AU - Sharma, Manas

AU - Brown, Carl

AU - Sigamani, Alben

AU - Szczeklik, Wojciech

AU - Sharma, Mukul

AU - Guyatt, Gordon

AU - Smith, Eric E.

AU - Agid, Ronit

AU - Dmytriw, Adam A.

AU - Spence, Jessica

AU - Adunuri, Nikesh R.

AU - Borges, Flavia K.

AU - Short, Timothy G.

AU - Hill, Michael D.

AU - Saad, Feryal

AU - Copland, Ingrid

AU - Pettit, Shirley

AU - Ibrahim, Quazi

AU - Bangdiwala, Shrikant I.

AU - Yusuf, Salim

AU - Tsai, Scott

AU - Sahlas, Demetrios J.

AU - Mensinkai, Arun

AU - Sposato, Luciano A.

AU - Hussain, Sara

AU - Yang, Steven

AU - Siegal, Deborah

AU - Khaw, Alexander

AU - Mandzia, Jennifer

AU - Simpson, Sara

AU - Raval, Manoj

AU - Karimuddin, Ahmer

AU - Phang, P. T.

AU - Mok, Vincent CT

AU - Wu, William KK

AU - Yu, Simon CH

AU - Gin, Tony

AU - Loh, Pui San

AU - Liew, Mun Thing

AU - Ramli, Norlisah

AU - Siow, Yee Lein

AU - Fuentes, Maite

AU - Ortiz-Soriano, Victor

AU - Waymouth, Ellen

AU - Kumar, Jonathan

AU - Sadana, Divya

AU - Thomas, Lenimol

AU - Kaczmarek, Bogusz

AU - Lindroth, Heidi

AU - Sessler, Daniel

AU - Apolcer, Sarah

AU - Trombetta, Amelia

AU - Handsor, Stephanie

AU - Dasgupta, Monidipa

AU - Murkin, John M.

AU - Lee, Shun Fu

AU - Devereaux, P. J.

N1 - Funding Information: EES reports personal fees from Portola Pharmaceuticals and Alnylam Pharmaceuticals, outside the submitted work. MDH reports personal fees from Merck, non-financial support from Hoffmann-La Roche Canada Ltd, and grants from Covidien (Medtronic), Boehringer Ingelheim, Stryker Inc, Medtronic LLC, and NoNO Inc, outside the submitted work. MDH has a patent on Systems and Methods for Assisting in Decision-Making and Triaging for Acute Stroke Patients issued to US Patent office number 62/086,077, owns stock in Calgary Scientific Incorporated, a company that focuses on medical imaging software, and is a director of the Canadian Federation of Neurological Sciences, a not-for-profit organisation. PJD reports grants from Abbott Diagnostics, Boehringer Ingelheim, Philips Healthcare, Roche Diagnostics, and Siemens, outside the submitted work. All other members of the writing committee declare no competing interests. Funding Information: This study was funded by a Foundation Grant from the Canadian Institutes of Health Research (CIHR); CIHR's Strategy for Patient Oriented Research (SPOR), through the Ontario SPOR Support Unit as well as the Ontario Ministry of Health and Long-Term Care; Health and Medical Research Fund ( 11120321 ), Food and Health Bureau, the Government of the Hong Kong Special Administrative Region, China; and the Auckland District Health Board Charitable Trust, Neurological Foundation of New Zealand. The Population Health Research Institute was the study-coordinating centre and was responsible for the maintenance of the database, data validation, analyses, and study coordination. The trial committees and their members, participating centres, and investigators are listed in the appendix . Publisher Copyright: © 2019 Elsevier Ltd

PY - 2019/9/21

Y1 - 2019/9/21

N2 - Background: In non-surgical settings, covert stroke is more common than overt stroke and is associated with cognitive decline. Although overt stroke occurs in less than 1% of adults after non-cardiac surgery and is associated with substantial morbidity, we know little about perioperative covert stroke. Therefore, our primary aim was to investigate the relationship between perioperative covert stroke (ie, an acute brain infarct detected on an MRI after non-cardiac surgery in a patient with no clinical stroke symptoms) and cognitive decline 1 year after surgery. Methods: NeuroVISION was a prospective cohort study done in 12 academic centres in nine countries, in which we assessed patients aged 65 years or older who underwent inpatient, elective, non-cardiac surgery and had brain MRI after surgery. Two independent neuroradiology experts, masked to clinical data, assessed each MRI for acute brain infarction. Using multivariable regression, we explored the association between covert stroke and the primary outcome of cognitive decline, defined as a decrease of 2 points or more on the Montreal Cognitive Assessment from preoperative baseline to 1-year follow-up. Patients, health-care providers, and outcome adjudicators were masked to MRI results. Findings: Between March 24, 2014, and July 21, 2017, of 1114 participants recruited to the study, 78 (7%; 95% CI 6–9) had a perioperative covert stroke. Among the patients who completed the 1-year follow-up, cognitive decline 1 year after surgery occurred in 29 (42%) of 69 participants who had a perioperative covert stroke and in 274 (29%) of 932 participants who did not have a perioperative covert stroke (adjusted odds ratio 1·98, 95% CI 1·22–3·20, absolute risk increase 13%; p=0·0055). Covert stroke was also associated with an increased risk of perioperative delirium (hazard ratio [HR] 2·24, 95% CI 1·06–4·73, absolute risk increase 6%; p=0·030) and overt stroke or transient ischaemic attack at 1-year follow-up (HR 4·13, 1·14–14·99, absolute risk increase 3%; p=0·019). Interpretation: Perioperative covert stroke is associated with an increased risk of cognitive decline 1 year after non-cardiac surgery, and perioperative covert stroke occurred in one in 14 patients aged 65 years and older undergoing non-cardiac surgery. Research is needed to establish prevention and management strategies for perioperative covert stroke. Funding: Canadian Institutes of Health Research; The Ontario Strategy for Patient Oriented Research support unit; The Ontario Ministry of Health and Long-Term Care; Health and Medical Research Fund, Government of the Hong Kong Special Administrative Region, China; and The Neurological Foundation of New Zealand.

AB - Background: In non-surgical settings, covert stroke is more common than overt stroke and is associated with cognitive decline. Although overt stroke occurs in less than 1% of adults after non-cardiac surgery and is associated with substantial morbidity, we know little about perioperative covert stroke. Therefore, our primary aim was to investigate the relationship between perioperative covert stroke (ie, an acute brain infarct detected on an MRI after non-cardiac surgery in a patient with no clinical stroke symptoms) and cognitive decline 1 year after surgery. Methods: NeuroVISION was a prospective cohort study done in 12 academic centres in nine countries, in which we assessed patients aged 65 years or older who underwent inpatient, elective, non-cardiac surgery and had brain MRI after surgery. Two independent neuroradiology experts, masked to clinical data, assessed each MRI for acute brain infarction. Using multivariable regression, we explored the association between covert stroke and the primary outcome of cognitive decline, defined as a decrease of 2 points or more on the Montreal Cognitive Assessment from preoperative baseline to 1-year follow-up. Patients, health-care providers, and outcome adjudicators were masked to MRI results. Findings: Between March 24, 2014, and July 21, 2017, of 1114 participants recruited to the study, 78 (7%; 95% CI 6–9) had a perioperative covert stroke. Among the patients who completed the 1-year follow-up, cognitive decline 1 year after surgery occurred in 29 (42%) of 69 participants who had a perioperative covert stroke and in 274 (29%) of 932 participants who did not have a perioperative covert stroke (adjusted odds ratio 1·98, 95% CI 1·22–3·20, absolute risk increase 13%; p=0·0055). Covert stroke was also associated with an increased risk of perioperative delirium (hazard ratio [HR] 2·24, 95% CI 1·06–4·73, absolute risk increase 6%; p=0·030) and overt stroke or transient ischaemic attack at 1-year follow-up (HR 4·13, 1·14–14·99, absolute risk increase 3%; p=0·019). Interpretation: Perioperative covert stroke is associated with an increased risk of cognitive decline 1 year after non-cardiac surgery, and perioperative covert stroke occurred in one in 14 patients aged 65 years and older undergoing non-cardiac surgery. Research is needed to establish prevention and management strategies for perioperative covert stroke. Funding: Canadian Institutes of Health Research; The Ontario Strategy for Patient Oriented Research support unit; The Ontario Ministry of Health and Long-Term Care; Health and Medical Research Fund, Government of the Hong Kong Special Administrative Region, China; and The Neurological Foundation of New Zealand.

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U2 - 10.1016/S0140-6736(19)31795-7

DO - 10.1016/S0140-6736(19)31795-7

M3 - Article

C2 - 31422895

AN - SCOPUS:85072255847

SN - 0140-6736

VL - 394

SP - 1022

EP - 1029

JO - The Lancet

JF - The Lancet

IS - 10203

ER -

Perioperative covert stroke in patients undergoing non-cardiac surgery (NeuroVISION): a prospective cohort study

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