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Post-Event Hypothermia

Post-Event Hypothermia

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Post-Event Hypothermia

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  1. DRAFT slides Post-Event Hypothermia Julie Swain M.D. Cardiovascular Surgeon Consultant to the FDA Circ System Devices Advisory Panel Sept 2004

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Brain Injury Outcome p = N.S. 57% 57% % of Patients Poor Outcome N = 193 N = 199 p = N.S. for all secondary endpoints Swain

  9. Brain Injury Study Results p = .01 p = .005 Swain

  10. 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

  11. Comparison of Cardiac Arrest Studies Swain ***91% of screened pts not eligible

  12. Comparison of Cardiac Arrest Studies Swain

  13. Comparison of Cardiac Arrest Studies Swain

  14. Comparison of Cardiac Arrest Studies Swain

  15. Comparison of Cardiac Arrest Studies {Europe} {Australia} *** p = .046 % success endpoint (***risk ratio 1.40, CI 1.08 – 1.81) Swain

  16. Comparison of Cardiac Arrest Studies {Australia} p = N.S. {Europe} *** % mortality (***risk ratio 0.74, CI .58 - .95) Swain

  17. 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

  18. 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

  19. 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