Clinical and Economical Interest of Endovascular Cooling in the Management of Cardiac Arrest - ICEREA

Aug 20, 2015
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
French Health Ministry
Date Published:
06/19/2015
Original Posted Date:
08/20/2015
References

Description:

The goal of the trial was to evaluate if endovascular cooling would be superior to external targeted temperature management in regards to favorable outcome after out-of-hospital cardiac arrest.

Contribution to the Literature: The ICEREA trial failed to show that endovascular cooling improved favorable outcomes after out-of-hospital cardiac arrest.

Study Design

  • Randomized
  • Parallel

Patients who remained unconscious after return of spontaneous circulation (ROSC) from an out-of-hospital cardiac arrest were randomized to endovascular cooling (n = 203) versus basic external cooling (n = 197).

  • Total number of enrollees: 400
  • Duration of follow-up: 90 days
  • Mean patient age: 60 years
  • Percentage female: 24%
  • Percentage diabetics: 16%
  • First documented cardiac rhythm: ventricular fibrillation in 31% and asystole in 38%

Inclusion criteria:

  • Patients 18-79 years of age who had a presumed cardiac cause for an out-of-hospital cardiac arrest
  • ROSC <60 minutes
  • Unconscious patient after ROSC

Exclusion criteria:

  • Do-not-resuscitate order or terminal disease
  • Pregnancy
  • Known coagulopathy or uncontrolled bleeding
  • Spontaneous hypothermia
  • Extracardiac cause of out-of-hospital cardiac arrest
  • In-hospital cardiac arrest
  • Contraindication to intravascular device
  • Immediate need for extracorporeal life support or renal replacement therapy

Principal Findings:

Time to target temperature 33ᵒC was 7.1 hours in the endovascular cooling group vs. 10.0 hours in the basic external cooling group (p < 0.0001). 

The primary outcome, survival without major neurological damage at 28 days, occurred in 36.0% of the endovascular cooling group vs. 28.4% of the basic external cooling group (p = 0.11). This beneficial trend favoring endovascular therapy failed to reach significance at 90 days (p = 0.07).

Secondary outcomes: Minor bleeding, hematoma, or arteriovenous (AV) fistula, were 25 vs. 10, respectively, for endovascular vs. external cooling.

Interpretation:

Among patients who remained unconscious after ROSC from an out-of-hospital cardiac arrest, endovascular cooling resulted in a shorter time to target temperature (33ᵒC) compared with basic external cooling. Despite this advantage, endovascular cooling failed to improve survival without major neurological damage at 28 or 90 days, and was associated with a numerical excess in minor bleeding events.

References:

Deye N, Cariou A, Girardie P, et al., on behalf of the ICEREA Study Group. Endovascular versus External Targeted Temperature Management for Out-of-Hospital Cardiac Arrest Patients: A Randomized Controlled Study. Circulation 2015;Jun 19:[Epub ahead of print].

Keywords: Arrhythmias, Cardiac, Endovascular Procedures, Heart Arrest, Hemorrhage, Hematoma, Hypothermia, Out-of-Hospital Cardiac Arrest, Primary Prevention, Temperature, Ventricular Fibrillation


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