The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

Neuroprotection by selective endovascular brain cooling - the TwinFlo™ Catheter

DOI: 10.4244/EIJ-D-19-00316

1. ThermopeutiX, Inc. San Diego, CA, USA, UNITED STATES
2. Department of Endovascular and Cerebrovascular Neurosurgery, University of Rochester Medical Center, Rochester, NY, USA
3. Departments of Clinical Neurological Sciences, Medical Imaging and Otolaryngology, Western University / London Health Sciences Centre, University Hospital, London, ON, Canada
4. Department of Cardiology, Shaare Zedek Medical Center, Jerusalem, Israel


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Aims: The TwinFlo™ Catheter was designed to provide selective brain cooling with faster cooling rates, and temperatures much lower than what can be achieved by other hypothermia techniques. This report describes the in vivo studies and initial clinical experience.

Methods and results: Using standard transfemoral technique in large swine TwinFlo™ was positioned to isolate the right or left common carotid artery. Blood was withdrawn from the aorta via one lumen, cooled extracorporeally, and reperfused through a central lumen into the carotid artery. Temperatures were measured in bilateral frontal lobes, nasopharynx, ear, esophagus, rectum, jugular vein and descending aorta. In a porcine stroke model, 25 pigs were randomly assigned to 3 hours of selective cerebral cooling to 26°C or normothermia following 3 hours of ischemia. Brain MRI and histology were evaluated by experts who were blinded to the intervention.Cerebral cooling to as low as 15°C and rates up to 1.8°C/min were achieved with no significant systemic cooling. No adverse events were observed. In the stroke reperfusion model, a significant reduction in stroke volume was achieved by selective cerebral cooling to 26°C. In initial human experience, selective cerebral cooling to 26°C resulted in excellent outcomes with no neurological deficits in the settings of neurosurgery and out of hospital cardiac arrest.

Conclusions: This new catheter-based system and technique, shows promise in providing rapid, selective, deep cerebral hypothermia, and may offer an improved method for neuroprotection during neurosurgery, cardiac arrest, acute stroke and other ischemic insult.

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