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The subgroups of patients randomized to hypothermia and who reached

Cold saline and endovascular cooling induces rapid hypothermia before reperfusion in STEMI patients treated with primary PCI, is safe and reduces infarct size with a scattered myocardial salvage Presented by Prof David Erlinge, MD, PhD, On behalf of the RAPID MI-ICE Investigators

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The subgroups of patients randomized to hypothermia and who reached

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  1. Cold saline and endovascular cooling induces rapid hypothermia before reperfusion in STEMI patients treated with primary PCI, is safe and reduces infarct size with a scattered myocardial salvage Presented by Prof David Erlinge, MD, PhD, On behalf of the RAPID MI-ICE Investigators Matthias Götberg, MD, Göran Olivecrona, MD,PhD, Sasha Koul, MD, Marcus Carlsson, MD, PhD, Henrik Engblom, MD, PhD, Martin Ugander, MD, PhD, Jesper van der Pals, MD, Lars Algotsson, MD, PhD Håkan Arheden, MD, PhD, David Erlinge, MD, PhD Lund University, Skane University Hospital Lund, Sweden Disclosure statement: The study was partly sponsored by an unrestricted research grant from Innercool Therapies, a fully owned subsidiary of Philips Healthcare.

  2. Hypothermia in Acute MI • A large number of animal studies have shown that hypothermia reduces myocardial infarct size1-2. • In a pig model, we have shown that myocardial infarct size is significantly reduced only if the temperature < 35°C before reperfusion3. • Two large randomized trials using hypothermia as adjunct treatment to primary PCI in patients with acute MI (ICE-IT4 and COOL MI5), failed to reach primary endpoint. However, only 1/3 of the patients randomized to hypothermia reached a core body temperature < 35°C at the time of reperfusion. • The subgroups of patients randomized to hypothermia and who reached • < 35°C at the time of reperfusion seemed to benefit (RRR 49% and 43% respectively) 1 Duncker et al. 1996 (Am J Physiol 270, H1189),2 Dae MW, et al. 2002 (Am J Physiol Heart Circ Physiol 282:H1584-91).,3 Götberg M et al . BMC Cardiovasc Disord. 2008, 8:7, 4 Grines CL et al. TCT 2004, 5 O'Neill WW et al. TCT 2004

  3. Hypothermia in Acute MI We hypotesized that a combination of cold saline and endovascular cooling would cool all patients to target temp < 35°C before primary PCI reperfusion.

  4. RAPID MI-ICE • The Rapid Intravascular Cooling in Myocardial Infarction as Adjunctive to Percutaneous Coronary Intervention study • (Safety & Feasibility study in man) • 20 Patients • Anterior or large Inferior STEMI • <6 hrs from onset of symtoms • Rapid infusion 1-2 liters 4°C Saline solution. • Endovascular cooling with Philips InnerCool endovascular system with Accutrol catheter starting before angiogram and continuing 3 h after PCI • Cardiac MRI day 4±2, infarct size/ myocardium at risk (T2 stir) • Primary outcome: Safety and Feasibility • Secondary outcome: Reduction in infarct size

  5. Timeline STEMI 15 min 15 min 30 min → several h 15 min Reperfusion PCI Ambulance Arrival Cathlab Angio-graphy Endovascular catheter placement Buspirone Meperidine iv Cold saline 1-2 l Temp

  6. ECG Patient Info Randomization Patient prep, catheterization Angiography, PCI Hypothermia 14 ± 5 min 14 ± 6 min 15 ± 3 min Control 40 ± 6 min Arrival at cath lab Initiation of cold saline infusion Time of reperfusion Initiation of endovascular cooling End of PCI Feasibility 3 min prolonged procedure before reperfusion Temp: 34.7 ± 0.3°C at reperfusion All patients reached target temp

  7. Clinical and Angiographic Data VariableHypothermia (n=9)Control (n=9) Age62 ± 1058 ± 7 NS Women2 2 NS Hypertension 3 2 NS Diabetes 1 2 NS Infarct related artery   LAD 6 7 NS RCA 3 2 NS Initial TIMI flow 0/17 8 NS 2/32 1 NS Onset of symptoms 174 ± 51 174 ± 62 NS to reperfusion (min) Door-to-balloon time (min) 43 ± 7 40 ± 6 NS Successful revascularization9 9 NS TIMI 3 flow post PCI99 NS Thrombectomy8 7 NS Abciximab6 6 NS Bivalirudin3 3 NS 2/20 patients, One from each group was excluded for technical reasons

  8. Safety VariableHypothermia Control (n=9) (n=9) 30 day mortality0 0 Re-infarction0 0 CABG0 0 30 day MACE0 0 Heart failure0 3 VT/VF0 2 Stroke0 0 Infection3 0 Major bleeding0 0 Bradycardia0 0 NT-proBNP day 1 2000 1500 1000 NT-proBNP (ng/l) 500 0 Hypothermia Control

  9. Efficacy Reduction of infarct size Final Infarct Size/ Myocardium at Risk Reduction in Troponin (Peak value) Δ = 38% Δ = 43% p = 0·04 p = 0·01 80 8 70 7 60 6 50 5 Troponin T (ug/l) 40 Infarct size / Myocardium at risk 4 30 3 20 2 1 10 0 0 Hypothermia Control Hypothermia Control

  10. Speckled infarction in pig Wavefront phenomenon (Jennings) Normothermia Hypothermia Hypothermia causes disruption of the wavefront phenomenon. Götberg M et al . BMC Cardiovasc Disord. 2008, 8:7 Also seen in hypothermia treatment by Dae et al., Am J Physiol, 2002, with SPECT

  11. Speckled infarction in man

  12. Conclusions • Rapid induction of hypothermia with 1-2 l cold saline and endovascular catheter is safe and feasible in awake patients with acute MI. • All patients reached target temperature, <35°C, at the time of reperfusion. • Myocardial infarct size was significantly reduced. • Troponin T release was significantly reduced. • Hypothermia disrupts the wavefront phenomenon into a speckled infarction. • A Randomized multicenter trial with hypothermia to reduce infarct size is planned (CHILL-MI). The study is accepted for publication in Circulation: Cardiovascular Interventions

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