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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.
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)

1Duncker 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
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.
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
Timeline STEMI

30 min → several h 15 min 15 min 15 min

Ambulance Arrival Angio- PCI Reperfusion


Cathlab graphy

Endovascular
catheter placement
Buspirone Temp
Meperidine iv
Cold saline 1-2 l
Feasibility
ECG
Patient Info Patient prep,
Randomization catheterization Angiography, PCI

14 ± 5 min 14 ± 6 min 15 ± 3 min Hypothermia


40 ± 6 min Control

3 min prolonged
procedure before
37 reperfusion
T e m p e ra tu re (C )

36 Hypothermia
Temp: 34.7 ± 0.3°C at
Control
35 reperfusion

34 All patients reached


target temp
33
0 10 20 30 40 50 60 70
Time (min)

Arrival at Initiation of Initiation of Time of End of PCI


cath lab cold saline endovascular reperfusion
infusion cooling
Clinical and Angiographic Data
Variable Hypothermia (n=9) Control (n=9)
Age 62 ± 10 58 ± 7 NS
Women 2 2 NS
Hypertension 3 2 NS
Diabetes 1 2 NS
Infarct related artery
LAD 6 7 NS
RCA 3 2 NS
Initial TIMI flow
0/1 7 8 NS
2/3 2 1 NS
Onset of symptoms 174 ± 51 174 ± 62 NS
to reperfusion (min)
Door-to-balloon time (min) 43 ± 7 40 ± 6 NS

Successful revascularization 9 9 NS
TIMI 3 flow post PCI 9 9 NS
Thrombectomy 8 7 NS
Abciximab 6 6 NS
Bivalirudin 3 3 NS

2/20 patients, One from each group was excluded for technical reasons
Safety

Variable Hypothermia Control


(n=9) (n=9) NT-proBNP day 1
30 day mortality0 0
Re-infarction 0 0
CABG 0 0 2000
30 day MACE 0 0

NT-proBNP (ng/l)
Heart failure 0 3 1500
VT/VF 0 2
Stroke 0 0 1000
Infection 3 0
Major bleeding 0 0 500
Bradycardia 0 0
0
Hypothermia Control
Efficacy
Reduction of infarct size Reduction in Troponin
Final Infarct Size/ Myocardium at Risk (Peak value)

Δ = 38% Δ = 43%
p = 0·04 p = 0·01
Infarct size / Myocardium at risk

80 8
70 7

Troponin T (ug/l)
60 6
50 5
40 4
30 3
20 2
10 1
0 0
Hypothermia Control Hypothermia Control
Speckled infarction in pig
Wavefront phenomenon Hypothermia Normothermia
(Jennings)

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
Speckled infarction in man
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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