1. CRT 2011
Therapeutic Hypothermia After Out-of-Hospital Cardiac Arrest: PCI Centers should offer Therapeutic Hypothermia
Michael R. Mooney MD
Director of Interventional Cardiology
Director, Therapeutic Hypothermia Program
Minneapolis Heart Institute at Abbott Northwestern Hospital

2. Michael R. Mooney, MD
I have no real or apparent conflicts of interest to report.
I intend to reference off label or unapproved uses of drugs or devices in my presentation.
I intend to discuss therapeutic hypmia which is not FDA approved, it is ILCOR and ACC indicated, however.

3. Cardiac Arrest Out-of-hospital cardiac arrest (OOHCA)
295,000 people annually in the U.S.
7.9% median survival rate
Anoxic encephalopathy and neurologic deficits
Therapeutic hypothermia (TH) clinical trials
ILCOR, ACC/AHA and EMS recommendation for TH after resuscitation
Lloyd-Jones D, Adams R, Carnethon M et al. Heart disease and stroke statistics-2009 update. Circulation 2009;119:e21-e181.

4. Hypothermia Pivotal Studies
HACA,
2002
Bernard,
2002

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

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

7. Level 1 High Risk PatientsAN
(n=496)
Zone 1
(n=1,031)
Zone 2
(n=735)
p-value
Cardiogenic shock 57
(11.5%) 96
(9.3%) 60
(8.2%)
0.15
Cardiac arrest
29 (5.9%)
112 (10.9%)
55 (7.5%)
0.002
Out of hosp cardiac arrest
13 (2.6%)
73 (7.1%)
33 (4.5%)
<0.0001
TIMI Risk score
4.3 ± 2.5
4.0 ± 2.3
0.02

8. MHI Level 1 MI Program -2003 “Cool it” Therapeutic Hypothermia -2006
High volume cardiac center
STEMI –PCI /yr
3 critical care units
Rapid Response Team
Inhouse intensivists 24/7
Inhouse cardiologist 24/7
Inhouse anesthesiologist
Clinical PharmD 24/7
12% of STEMI had cardiac arrest

9. Goals of the Therapeutic Hypothermia Program:
Provide therapeutic hypothermia to the appropriate patient, at the appropriate setting.
Provide a multidiscipline approach to the care of these patients
Measure data immediately and continuously to improve both the care and the outcomes
Perform therapeutic hypothermia in a collaborative approach from EMS to emergency departments to cardiology
To address the neurocognitive recovery and support
To find cause of arrest and treat the condition including follow up clinically

10. Average time: 6 minutes

12. Education: 33 Community Hospitals in MN & WI
Inclusion/exclusion Is patient also a STEMI? Treatment What is needed to treat
Times

13. Standing Orders
Protocols we have several in the manual

15. Ice packs placed during resuscitation, at first outstate Emergency Dept or during transportation

16. Crit Care Med 2009;37 (Suppl):S211-S222.

17. Other Key Elements of Program
EMS initiate field ice packs and “Cool-It” protocol w/o Level 1 STEMI
Cath lab immediately for all STEMI and many others 70% of total. Excellent stabilization room for shock
Combined cooling methods effective
No lytics, heparin ½ life
Cardiology supervising inpt care
Mutidisciplinary “by in”

18. Demographics 140 patients (Feb ‘06 – August ‘09) Mean age: 62
Gender: 108 male, 32 female
Initial rhythms: 102 VT/VF, 32 PEA / asystole
Transferred: 75.7%
Level 1 STEMI: 54.3%
Cardiogenic shock: 43.57%
You go here 18

19. Outcomes Abbott Northwestern Hospital 72/140 51.4%
Alive at hospital discharge with favourable neurological recovery
Abbott Northwestern Hospital 72/140
51.4%
Survival by diagnosis
STEMI 49/ %
Other 29/ %
Survival by initial rhythm
VF/VT 68/ %
PEA/Asystole 7/ %
Survival by Age
≤75 years 65/ %
>75 years 13/ % 19

20. Transfer Outcomes Transfer = Blue line, ANW = Red line

21. Pre Cool It
Post Cool It
CPC mean
2.97
2.65
CPC median 3
1.5
Survivors only CPC mean
1.24
Survivors only CPC median 1
OVERALL SURVIVAL
57.90%
62.50%

22. Hypothermia Trials: Comparison
Alive at hospital discharge with favorable neurological recovery: HACA 72/136 (53%) Bernard 21/43 (49%) ANW 72/140 (51.4%)
ANW patient population includes: all initial rhythms transfers (75.7%) STEMI (54.3%) cardiogenic shock (43.6%)
ANW* 44/65
(67.7%)
*using HACA exclusion criteria:
cardiogenic shock, PEA, asystole

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

25. Resuscitation Center

26. Resuscitation Center of Excellence
“BAR “
neurocognitive
recovery plan
Support
neurology,
CT surgery
to provide supportive care
available within
30 min of notification
Head CT perfusion
and/or MRI on 24 hr
basis with
rapid radiology
interpretation
Electrophysiologist
“Shock” cardiologist
In house
intensivist/cardiologist
team
24/7 for comprehensive
In house management
Surgical
intervention:
Emergent cardiac
bypass/VAD/ECMO
within 1 hour of
determination
of need
Able to perform
high quality
human or mechanical
CPR for min
Ability to perform TH
within
1 hour of pt evaluation
Clinical PharmD
Cath lab 24/7
meets standards
and experience
for performing TH in lab
in combination
Pre-hospital EMS
transferring EMS
Educational support
Ongoing feedback
Data assistance
Community education
& awareness
Resuscitation
Center
of Excellence
MHI answer after 3 yrs experience much more expansive

27. Key Components Integrate into existing STEMI networks
Extensive training
Early cooling
Individualized transfer arrangements
Single phone call
Standardized protocol
Feedback/quality assurance
Data should expand to national standards and continue to work with Centers of Resuscitation to promote best practices

28. Impella/Tandem Heart
Tandem Heart

29. Intensivist/Cardiologist AHF Cardiologist or Assist
Heart Failure Program
Manager
Clinical Assistant
Bed Placement
Pharmacy
In house
Intensivist/Cardiologist
CCU charge nurse CV
Emergency
Mgr
Aurora Medical
Perfusionist
Cath Lab On Call Team
Interventional
Cardiologist
AHF Cardiologist or Assist
Device Surgeon
Cardiogenic
Shock Team
MHI answer after 3 yrs experience much more expansive
7/2010

30. PCI Centers Should Offer Therapeutic Hypothermia
1. Half of the patients have STEMI
2. Extensive training with protocolized care
3. Collaboration on presenting patient
4. Interhospital transfer systems
5. Exisiting transfer protocols and EMS relations
6. Data collection/evaluation/improvements
7. Care across continuum
8. Communication methods (FEEDBACK)
9. Research
10. Cardiac arrest is a Cardiovascular Emergency

31. Cardiovascular Emergency Centers
To maximize benefits, cooling should be initiated as soon as possible.
Survival benefits are dramatic.
But, we under-deliver this lifesaving treatment.
TH capable Acute MI PCI centers should offer this lifesaving treatment, it is a public health care imperative.
We can achieve equivalent access and outcomes in rural and metro patients by providing one Standard of Care for an entire Region for the most complex cardiac emergencies.

32. Discharge Coordination
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