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      Selective intra-carotid blood cooling in acute ischemic stroke: A safety and feasibility study in an ovine stroke model

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          Abstract

          Selective therapeutic hypothermia (TH) showed promising preclinical results as a neuroprotective strategy in acute ischemic stroke. We aimed to assess safety and feasibility of an intracarotid cooling catheter conceived for fast and selective brain cooling during endovascular thrombectomy in an ovine stroke model.

          Transient middle cerebral artery occlusion (MCAO, 3 h) was performed in 20 sheep. In the hypothermia group (n = 10), selective TH was initiated 20 minutes before recanalization, and was maintained for another 3 h. In the normothermia control group (n = 10), a standard 8 French catheter was used instead. Primary endpoints were intranasal cooling performance (feasibility) plus vessel patency assessed by digital subtraction angiography and carotid artery wall integrity (histopathology, both safety). Secondary endpoints were neurological outcome and infarct volumes.

          Computed tomography perfusion demonstrated MCA territory hypoperfusion during MCAO in both groups. Intranasal temperature decreased by 1.1 °C/3.1 °C after 10/60 minutes in the TH group and 0.3 °C/0.4 °C in the normothermia group (p < 0.001). Carotid artery and branching vessel patency as well as carotid wall integrity was indifferent between groups. Infarct volumes (p = 0.74) and neurological outcome (p = 0.82) were similar in both groups.

          Selective TH was feasible and safe. However, a larger number of subjects might be required to demonstrate efficacy.

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          Most cited references39

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          Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest.

          (2002)
          Cardiac arrest with widespread cerebral ischemia frequently leads to severe neurologic impairment. We studied whether mild systemic hypothermia increases the rate of neurologic recovery after resuscitation from cardiac arrest due to ventricular fibrillation. In this multicenter trial with blinded assessment of the outcome, patients who had been resuscitated after cardiac arrest due to ventricular fibrillation were randomly assigned to undergo therapeutic hypothermia (target temperature, 32 degrees C to 34 degrees C, measured in the bladder) over a period of 24 hours or to receive standard treatment with normothermia. The primary end point was a favorable neurologic outcome within six months after cardiac arrest; secondary end points were mortality within six months and the rate of complications within seven days. Seventy-five of the 136 patients in the hypothermia group for whom data were available (55 percent) had a favorable neurologic outcome (cerebral-performance category, 1 [good recovery] or 2 [moderate disability]), as compared with 54 of 137 (39 percent) in the normothermia group (risk ratio, 1.40; 95 percent confidence interval, 1.08 to 1.81). Mortality at six months was 41 percent in the hypothermia group (56 of 137 patients died), as compared with 55 percent in the normothermia group (76 of 138 patients; risk ratio, 0.74; 95 percent confidence interval, 0.58 to 0.95). The complication rate did not differ significantly between the two groups. In patients who have been successfully resuscitated after cardiac arrest due to ventricular fibrillation, therapeutic mild hypothermia increased the rate of a favorable neurologic outcome and reduced mortality.
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            Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia.

            Cardiac arrest outside the hospital is common and has a poor outcome. Studies in laboratory animals suggest that hypothermia induced shortly after the restoration of spontaneous circulation may improve neurologic outcome, but there have been no conclusive studies in humans. In a randomized, controlled trial, we compared the effects of moderate hypothermia and normothermia in patients who remained unconscious after resuscitation from out-of-hospital cardiac arrest. The study subjects were 77 patients who were randomly assigned to treatment with hypothermia (with the core body temperature reduced to 33 degrees C within 2 hours after the return of spontaneous circulation and maintained at that temperature for 12 hours) or normothermia. The primary outcome measure was survival to hospital discharge with sufficiently good neurologic function to be discharged to home or to a rehabilitation facility. The demographic characteristics of the patients were similar in the hypothermia and normothermia groups. Twenty-one of the 43 patients treated with hypothermia (49 percent) survived and had a good outcome--that is, they were discharged home or to a rehabilitation facility--as compared with 9 of the 34 treated with normothermia (26 percent, P=0.046). After adjustment for base-line differences in age and time from collapse to the return of spontaneous circulation, the odds ratio for a good outcome with hypothermia as compared with normothermia was 5.25 (95 percent confidence interval, 1.47 to 18.76; P=0.011). Hypothermia was associated with a lower cardiac index, higher systemic vascular resistance, and hyperglycemia. There was no difference in the frequency of adverse events. Our preliminary observations suggest that treatment with moderate hypothermia appears to improve outcomes in patients with coma after resuscitation from out-of-hospital cardiac arrest.
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              Stroke Treatment Academic Industry Roundtable X

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                Author and article information

                Contributors
                (View ORCID Profile)
                (View ORCID Profile)
                Journal
                Journal of Cerebral Blood Flow & Metabolism
                J Cereb Blood Flow Metab
                SAGE Publications
                0271-678X
                1559-7016
                November 2021
                June 23 2021
                November 2021
                : 41
                : 11
                : 3097-3110
                Affiliations
                [1 ]Institute for Biomedical Engineering, University of Stuttgart, Stuttgart, Germany
                [2 ]Faculty of Veterinary Medicine, Institute of Veterinary Anatomy, Histology and Embryology, Leipzig University, Leipzig, Germany
                [3 ]Department of Neuroradiology, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
                [4 ]Department of MR Physics, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
                [5 ]Department of Neuropathology, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
                [6 ]Department of Pathology, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
                [7 ]Department of Diagnostic and Interventional Radiology and Neuroradiology, Universitätsklinikum Augsburg, Augsburg, Germany
                [8 ]Acandis GmbH, Pforzheim, Germany
                [9 ]Department of Clinical Trials, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
                [10 ]Center for Experimental Models and Transgenic Service (CEMT), Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
                [11 ]Department of Neurology, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
                [12 ]Department of Neurosurgery, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany
                [13 ]School of Live Sciences, University of Warwick, Coventry, UK
                [14 ]Institute of Neuroradiology, Kepler University Hospital, Johannes Kepler University Linz, Austria
                Article
                10.1177/0271678X211024952
                34159825
                17dc8d81-53cd-4c43-b824-2ca1e145ebf8
                © 2021

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