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DRAFT slides. Post-Event Hypothermia. Julie Swain M.D. Cardiovascular Surgeon Consultant to the FDA. Circ System Devices Advisory Panel Sept 2004. Outline of Presentation. Post-event hypothermia in MI Post-event hypothermia in head trauma Post-event hypothermia in resuscitation

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post event hypothermia

DRAFT slides

Post-Event Hypothermia

Julie Swain M.D.

Cardiovascular Surgeon

Consultant to the FDA

Circ System Devices Advisory Panel

Sept 2004

outline of presentation
Outline of Presentation
  • Post-event hypothermia in MI
  • Post-event hypothermia in head trauma
  • Post-event hypothermia in resuscitation
  • ILCOR recommendations
  • Questions for panel

Swain

post event hypothermia in myocardial infarction cool mi study
Post-Event Hypothermia in Myocardial Infarction (Cool-MI Study)
  • Data presented at TCT 2003

(www.radiantmedical.com/download/TCT-ONeill.pdf)

  • Prospective, randomized (cooling with IVC catheter vs normothermia during PCI)
  • MI < 6 hrs, cool to 33°C for 3 hrs
  • Quantitative Endpoint – infarct size at 30 days

Swain

cool mi study results
COOL-MI Study Results

p = N.S.

% LV

Infarct

Size

N = 180

N = 177

  • Data presented at TCT 2003
    • (www.radiantmedical.com/download/TCT-ONeill.pdf

Swain

cool mi results
COOL-MI Results

P = n.s. for all complications, not powered to assess MACE

  • Data presented at TCT 2003
    • (www.radiantmedical.com/download/TCT-ONeill.pdf

Swain

slide6

Post-Event Hypothermia in Brain Injury(Clifton GL, et al. Lack of Effect of Induction of Hypothermia after Acute Brain Injury.  N Engl J Med 2001; 344: 556-63)

  • Prospective, randomized, surface and GI cooling vs normothermia
  • Injury < 6 hrs, cool to 33°C for 48 hrs
  • Endpoint – Glasgow Outcome Score at 6 months (functional independence with mild or moderate disability)
  • Secondary endpoints of psychometric tests

Swain

secondary endpoints in brain injury trial at 6 mos
Secondary Endpoints in Brain Injury Trial (at 6 mos)
  • Neurobehavioral Rating Scale – Revised
  • Disability Rating Scale
  • Galveston Orientation and Amnesia test
  • Selective Reminding Test
  • Rey-Osterrieth Complex Figure Test
  • Symbol Digit Modalities Test
  • Trail Making Test B
  • Controlled Oral Word Association Test
  • Grooved Pegboard Test

Swain

brain injury outcome
Brain Injury Outcome

p = N.S.

57%

57%

% of

Patients

Poor

Outcome

N = 193

N = 199

p = N.S. for all secondary endpoints

Swain

brain injury study results
Brain Injury Study Results

p = .01

p = .005

Swain

post event hypothermia cardiac arrest
Post-Event HypothermiaCardiac Arrest
  • Bernard SA, et al.  Treatment of Comatose Survivors of Out-of-Hospital Cardiac Arrest with Induced Hypothermia.  N Engl J Med 2002; 346:557-63 [Australia]
  • The Hypothermia After Cardiac Arrest Study Group.  Mild Therapeutic Hypothermia to Improve the Neurologic Outcome after Cardiac Arrest.  N Engl J Med 2002; 346:549-56 [Europe]

Swain

comparison of cardiac arrest studies
Comparison of Cardiac Arrest Studies

Swain

***91% of screened pts not eligible

comparison of cardiac arrest studies15
Comparison of Cardiac Arrest Studies

{Europe}

{Australia}

***

p = .046

% success

endpoint

(***risk ratio 1.40, CI 1.08 – 1.81)

Swain

comparison of cardiac arrest studies16
Comparison of Cardiac Arrest Studies

{Australia}

p = N.S.

{Europe}

***

% mortality

(***risk ratio 0.74, CI .58 - .95)

Swain

slide17
ILCOR Recommendations(ILCOR Advisory Statement.  Therapeutic Hypothermia after Cardiac Arrest.  Circulation 2003;108:18-21)
  • Unconscious adult patients with spontaneous circulation after out-of-hospital cardiac arrest should be cooled to 32°C to 34°C for 12 to 24 hours when the initial rhythm was ventricular fibrillation (VF).
  • Such cooling may also be beneficial for other rhythms or in-hospital cardiac arrest.

Swain

safety profile of cooling methods
Safety Profile of Cooling Methods
  • Surface
    • Cool air
    • Water cooling
    • Head and neck cooling
  • GI lavage
  • Endovascular
    • Extracorporeal Circulation
      • Cardiopulmonary Bypass
      • Veno-venous
      • Arterial venous
    • IVC catheters

Swain

summary
Summary
  • Is post-event hypothermia the standard for treating out-of-hospital arrest patients in the U.S.?
  • Is surface-induced hypothermia comparable to endovascular hypothermia in safety and efficacy?

Swain