Hypothermia during Carotid Endarterectomy: A Safety Study

PLoS One. 2016 Apr 8;11(4):e0152658. doi: 10.1371/journal.pone.0152658. eCollection 2016.

Abstract

Background: CEA is associated with peri-operative risk of brain ischemia, due both to emboli production caused by manipulation of the plaque and to potentially noxious reduction of cerebral blood flow by carotid clamping. Mild hypothermia (34-35°C) is probably the most effective approach to protect brain from ischemic insult. It is therefore a substantial hypothesis that hypothermia lowers the risk of ischemic brain damage potentially associated with CEA. Purpose of the study is to test whether systemic endovascular cooling to a target of 34.5-35°C, initiated before and maintained during CEA, is feasible and safe.

Methods: The study was carried out in 7 consecutive patients referred to the Vascular Surgery Unit and judged eligible for CEA. Cooling was initiated 60-90 min before CEA, by endovascular approach (Zoll system). The target temperature was maintained during CEA, followed by passive, controlled rewarming (0.4°C/h). The whole procedure was carried out under anesthesia.

Results: All the patients enrolled had no adverse events. Two patients exhibited a transient bradycardia (heart rate 30 beats/min). There were no significant differences in the clinical status, laboratory and physiological data measured before and after CEA.

Conclusions: Systemic cooling to 34.5-35.0°C, initiated before and maintained during carotid clamping, is feasible and safe.

Trial registration: ClinicalTrials.gov NCT02629653.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Brain Ischemia / etiology
  • Brain Ischemia / prevention & control*
  • Endarterectomy, Carotid / adverse effects*
  • Feasibility Studies
  • Female
  • Heart Rate
  • Humans
  • Hypothermia*
  • Male
  • Safety

Associated data

  • ClinicalTrials.gov/NCT02629653

Grants and funding

The Movi Spa (www.movigroup.com) was the source of support for the study, providing the equipment and paying for the patient’s health insurance. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.