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Case Reports
. 2020 Mar;35(2):96-103.
doi: 10.1177/0267659119853950. Epub 2019 Jun 26.

Selective brain hypothermia: feasibility and safety study of a novel method in five patients

Seyed Mohammad Seyedsaadat  1 , Silvana F Marasco  2 , David J Daly  3 , Robin McEgan  4 , James Anderson  4 , Seth Rodgers  5 , Thomas Kreck  5 , Ramanathan Kadirvel  1 , David F Kallmes  1
Affiliations
Case Reports

Selective brain hypothermia: feasibility and safety study of a novel method in five patients

Seyed Mohammad Seyedsaadat et al. Perfusion. 2020 Mar.

Abstract

Background/objective: Reduction of brain temperature remains the most common method of neuroprotection against ischemic injury employed during cardiac surgery. However, cooling delivered via the cardiopulmonary bypass circuit is brief and cooling the body core along with the brain has been associated with a variety of unwanted effects. This study investigated the feasibility and safety of a novel selective brain cooling approach to induce rapid, brain-targeted hypothermia independent of the cardiopulmonary bypass circuit.

Methods: This first-in-human feasibility study enrolled five adults undergoing aortic valve replacement with cardiopulmonary bypass support. During surgery, the NeuroSave system circulated chilled saline within the pharynx and upper esophagus. Brain and body core temperature were continuously monitored. Adverse effects, cardiopulmonary function, and device function were noted.

Results: Patient 1 received cooling fluid for an insignificant period, and Patients 2-5 successfully underwent the cooling procedure using the NeuroSave system for 56-89 minutes. Cooling fluid was 12°C for Patients 1-3, 6°C for Patient 4, and 2°C for Patient 5. There were no NeuroSave-related adverse events and no alterations in cardiopulmonary function during NeuroSave use. Brain temperature decreased by 3°C within 15 minutes and remained at least 3.5°C colder than the body core. During a brief episode of hypotension in one patient, the brain cooled an additional 4°C in 2 minutes, briefly reaching 27.4°C.

Conclusion: The NeuroSave system can induce rapid brain-targeted hypothermia and simultaneously maintain a favorable body-brain temperature gradient, even during hypotension. Further studies are required to evaluate the function of the system during longer periods of use.

Keywords: cardiac surgical procedures; circulatory arrest; heart arrest; neuroprotection; stroke; therapeutic hypothermia.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: T.K. and S.R. founded and invested in NeuroSave, Inc. All other authors have no conflicts of interest to disclose.

Figures

Figure 1.
Figure 1.
Flow path of the cooling fluid. Cold fluid is delivered into both the nose and esophagus and exits via the mouth. Balloons in trachea and stomach prevent loss of cooling fluid into the stomach and lungs.
Figure 2.
Figure 2.
Reduction in brain temperature in the first 15 minutes in four patients. Patient 1 not displayed due to limited cooling system use.
Figure 3.
Figure 3.
Brain and body temperature for Patient 5. Brain temperature decreased 4°C in 2 minutes during a 3-minute episode of hypotension (mean arterial pressure [MAP] = 45 mm Hg). Circulation of cooling fluid (2°C) was discontinued when brain temperature decreased below 30°C.
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