How to Optimize Therapeutic Hypothermia and What to Expect CRT 2012 How to Optimize Therapeutic Hypothermia and What to Expect Dr. Michael Mooney Director Interventional Cardiology Minneapolis Heart Institute Associate Professor of Clinical Medicine University of Minnesota

I have no real or apparent conflicts of interest to report. Michael R. Mooney, MD I have no real or apparent conflicts of interest to report.

Cardiac Arrest Out-of-hospital cardiac arrest (OOHCA) affects 295,000 people annually in the US 7.9% median survival rate Anoxic encephalopathy and neurologic deficits are common and disabling - among survivors Modest gain with CPR advances, many failed clinical trials – BRCT - barbiturates Enormous public health issue - personal, family & societal burdens Growing awareness of needed cardio-cerebral protection Lloyd-Jones D, Adams R, Carnethon M et al. Heart disease and stroke statistics-2009 update. Circulation 2009;119:e21-e181.

Hypothermia Pivotal Studies HACA, 2002 Bernard, 2002

Therapeutic Hypothermia is: Hypothermia is the gold standard treatment for reperfusion injury Reperfusion injury is important in both cardiac arrest/anoxic encephalopathy and acute MI TH is pluripotent TH is standard of care for CA TH is an emerging treatment for Acute MII TH is markedly underutilized

Hypothermia: mechanisms ischemia reperfusion mitochondrial Dysfunction /Ca influx reactive oxygen species (ROS) inflammatory cascades hypothermia vascular dysfunction/hypotension apoptosis – organ dysfunction cerebral edema *Dr. Abella, University of Pennsylvania

Hypothermia Trials: Outcomes (%) P value Normothermia (%) RR (95% CI) Alive at hospital discharge with favourable neurological recovery HACA 0.006 72/136 (53%) 50/137 (36%) 1.51 (1.14-1.89) Bernard 21/43 (49%) 9/34 (26%) 2.65 (1.0-6.88) 0.046 Alive at 6 months with favourable neurological recovery HACA 71/136 (55%) 50/137 (39%) 1.44 (1.11-1.76) 0.009

Hypothermia guidelines New Guidelines – more aggressive, 30’ CPR Full recoil. 30:2 Less defib use Hypothermia Level I A recommendation Hypothermia guidelines

Theory meets Practice? – not yet Less than 7% of OOHCA pts get TH - <15,000 of 295,000 Fewer than 300 hospitals have programs or equipment of 6,000 eligible hospitals Awareness and funding limited – FDA approval and perceived complexity are barriers Cardiology is not yet in the lead Research continues – despite challenges b/o enormous persistent unmet need

. Helicopter Locations 2009 In Response to the STEMI Program at MHI Red– Zone II (90-120 mins) Blue– Zone I (< 90 mins) Helicopter Locations 2009 In Response to the STEMI Program at MHI Red– Zone II (90-120 mins) Blue– Zone I (< 9 mins) .

Arctic Sun Energy Transfer Pad ™ Placement

Why Use the Peritoneal Cavity? Efficient heat exchange > 50% of total blood flow Large surface area Unparalleled speed (10 - 15 minutes to 34°C) Eliminates femoral access interference Eliminates upper chest and neck area interference 15

Peritoneal Cooling - Velomedix™, Inc Automated Peritoneal Lavage System (APLS) Efficient heat exchange Tight control for cooling and warming Does not restrict access Fully automated system 16

Life Recovery Systems

Intravascular Coling Intravascular Cooling InnerCool - Phillips

The Main Concepts a Cardiac Emergency Program ACCESS TRANSPORTATION STREAMLINE CARE DATA COLLECTION FEEDBACK RESEARCH Prehospital Outstate Hospital EMS Transport Tertiary Center

Abbott Northwestern Hospital 72/140 51.4% Outcomes Abbott Northwestern Hospital 72/140 51.4% Survival by diagnosis STEMI: 49/76 64.5% Other: 29/64 45.3% Survival by initial rhythm VF/VT: 68/102 66.7% PEA/Asystole: 7/32 21.9% Alive at hospital discharge with favourable neurological recovery

Transfer and Nontransfer Outcomes Transfer = Blue line, nontransfer = Red line 75% of total patients in the Cool It Program are transfers

Early Cooling is Critical Source Chi Square DF P-value Time ROSC to First Cooling min 5.0785 1 0.0242 Estimate Lower CL Upper CL P-value 1.25 1.06 1.44 0.0081 If the time to first cooling increases by an hour the hazard of death increases 25%.

The best TH patient is: OOH with <15 min down time Witnessed VF Bystander CPR Has a STEMI Lives in Minnesota, Seattle , Arizona, (systems of care) Gets cooling in the first hour after rosc

Keys to Success Cardiology champion Form a team .. Educate Set and follow a protocol with standardized orders Intensivists , ICU nurses, ethics panel Get good early results Hold off on neuro consult for 5 days Prognosticate only after 4-5+ days Be patient – dark tunnel analogy

But, you have the equipment and will be asked to consider in hospital arrests Difficult intubation prolonged anoxia EMD/asystole - generally poor Drug overdose - hypoventilation EP incessant VT / tamponade Sepsis /respiratory failure uniformly poor Yes, consider but choose wisely Be careful, your success and failure will be remembered don’t go off the reservation early Always consider the reversibility of presenting profile

But, a more pressing issue How do we advance TH in the US as the standard of care for OOHCA Integrate into STEMI networks Eliminate the death penalty Foster a national comprehensive CV emergency system

Discharge Coordination CV Emergency Program Development Acute Coronary Syndromes Resuscitation Center Acute Aortic Emergency Level 1 STEMI Level 2 NSTEMI Urgent Cardiac Arrest Acute Aortic Dissection Critical Limb Ischemia Abdominal Aortic Aneurysm Stroke (Neurological Emergencies) Chest Pain Center Therapeutic Hypothermia Non-Traumatic Shock Treatment Heart Failure Center LVAD to Transplant ED HF MHI@ Abbott Northwestern Hospital System of CV Emergency Care Pre-Hospital Care Coordination Post-Hospital Discharge Coordination DATA COLLECTION/ ANALYSIS Clinical Support Services Research Education Publications Advanced Imaging Vascular Surgeons Hemodynamic Support 24/7 Intensivists Hospitalists Cardiac/Transplant Surgeons Rehabilitation Administrative Support Services CV Emergency Program Manager Nurse Educator Administrative Assistant Clinical Assistants Extensive Education for Patients, Community & Providers

To maximize benefits, cooling should be initiated as soon as possible. Survival benefits are dramatic. But, we under-deliver this lifesaving treatment Systems of Care Do Make a Difference TH capable Acute MI PCI centers should offer this lifesaving treatment, it is a public health care imperative.