The Journal of Thoracic and Cardiovascular Surgery
Adult: Aortic ValveThe impact of perioperative stroke and delirium on outcomes after surgical aortic valve replacement
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Section snippets
Study Population
The study population included 383 patients enrolled in a randomized trial evaluating embolic protection devices in SAVR, conducted by CTSN.8 Patients were randomly assigned (1:1:1 ratio) to receive an intra-aortic filtration embolic protection device (EMBOL-X, Edwards Lifesciences), a suction-based extraction embolic protection device (CardioGard; CardioGard, Inc), or a standard aortic cannula. The primary aim of the trial was to establish the efficacy of 2 mechanistically different embolic
Patient Characteristics
Table 1 depicts baseline and operative characteristics of patients stratified by whether or not they experienced stroke or delirium (see Table E1 in Appendix E1 for characteristics of all trial patients). By postoperative day 7, 6.6% (25/379) of patients experienced clinically apparent stroke and 28.5% (103/362) showed evidence of delirium. The median NIHSS at diagnosis of stroke was 5 (IQR, 2-14). Of those who presented evidence of a clinically apparent stroke, 11 were mild (NIHSS 0-4), 9
Discussion
The CTSN neuroprotection trial, which found that both stroke and delirium were common in patients who underwent SAVR, is one of the largest randomized trials of embolic protection devices that included repeated neurologic examinations and a postoperative MRI.8 By day 7 after surgery, 7% of patients experienced clinically apparent stroke when assessed with active surveillance. Patients who experienced these events had longer hospitalizations, were almost 6 times more likely to be disabled, 5
Conclusions
There is a high risk of stroke and delirium after SAVR when ascertained by active surveillance, and such events have profound clinical consequences. Patients who experience these complications have increased disability, depression, and cognitive decline, along with reduced quality of life. These findings support the use of serial examinations and MRI in neuroprotection studies of surgical patients, as advocated in a recent Neurologic Academic Research Consortium consensus statement on
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The neuroprotection trial was supported by a cooperative agreement (U01 HL088942) funded by the National Heart Lung and Blood Institute and the National Institute of Neurological Disorders and Stroke of the National Institutes of Health, Bethesda, Md, and the Canadian Institutes for Health Research, Ottawa, Ontario, Canada. The embolic protection device companies provided no financial support but did provide training in device use.
ClinicalTrials.gov Identifier: NCT02389894.
The views expressed in this article are those of the authors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute; National Institute of Neurological Disorders and Stroke; National Institutes of Health; or the United States Department of Health and Human Services.
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Cardiothoracic Surgical Trials Network (CTSN) Investigators (see Appendix E1).