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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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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 • ILCOR recommendations • Questions for panel Swain
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 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 P = n.s. for all complications, not powered to assess MACE • Data presented at TCT 2003 • (www.radiantmedical.com/download/TCT-ONeill.pdf Swain
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) • 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 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 p = .01 p = .005 Swain
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 Swain ***91% of screened pts not eligible
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 Studies {Australia} p = N.S. {Europe} *** % mortality (***risk ratio 0.74, CI .58 - .95) Swain
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 • Surface • Cool air • Water cooling • Head and neck cooling • GI lavage • Endovascular • Extracorporeal Circulation • Cardiopulmonary Bypass • Veno-venous • Arterial venous • IVC catheters Swain
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