Incidence of Sudden Arctic Sun Temperature Management

Cardiac Arrest in Europe System product codes

Article Number Description
400,000pa 9
50000101 Arctic Sun® Temperature Management System (EU)

>150,000 with ROSC14

50000102 Arctic Sun® Temperature Management System (UK)

3170302 Arctic Sun® Temperature Management System

<20% receive TTM14

ArcticGel™ pads – XSmall

3170502 Arctic Sun® Temperature Management System

ArcticGel™ pads – Small

3170702 Arctic Sun® Temperature Management System

ArcticGel™ pads – Medium

Non-VF Rhythms HYPERION study 3170902 Arctic Sun® Temperature Management System
ArcticGel™ pads – Large
Among patients with coma who had been resuscitated from cardiac arrest with
nonshockable rhythm, moderate therapeutic hypothermia at 33°C for 24 hours led 3170004 Arctic Sun® Temperature Management System
to a higher percentage of patients who survived with a favorable neurologic outcome ArcticGel™ pads – Universal
at day 90 than was observed with targeted normothermia.17
Indications for Use:
The Arctic Sun® Temperature Management System is a thermal regulating system, cumulative result of pressure, time and temperature. • Carefully remove ArcticGel™ Pads
indicated for monitoring and controlling patient temperature in adult and pediatric from the patient’s skin at the completion of use. Aggressive removal or removal of cold

In-Hospital Cardiac Arrest ERC Guidelines patients of all ages.

Warnings • When using the Arctic Sun® Temperature Management System, note that all
TTM is suggested for adults after IHCA with any initial rhythm who remain unresponsive after ROSC other thermal conductive systems, in use while warming or cooling with this device may
interfere with patient temperature control. • The Arctic Sun® Temperature Management
(weak recommendation, very low-quality evidence).3 Data from the GWTG-Resuscitation Registry System is not intended for use in the operating room environment.
found 26183 patients successfully resuscitated after IHCA, of whom 6% were treated with TTM.12 Cautions • Due to underlying medical or physiological conditions, some patients are
more susceptible to skin damage from pressure and heat or cold. Patients at risk include
those with poor tissue perfusion or poor skin integrity due to oedema, diabetes, peripheral
vascular disease, poor nutritional status, steroid use or high dose vasopressor therapy.
Examine the patient’s skin under the ArcticGel™ Pads. • Skin injury may occur as a
pads from the patient’s skin may result in skin tears. • The rate of temperature change
and potentially the final achievable patient temperature is affected by many factors.
Treatment application, monitoring and results are the responsibility of the attending
physician. If the patient does not reach target temperature in a reasonable time or the
patient is not able to be maintained at the target temperature, the skin may be exposed
to low or high water temperatures for an extended period of time which may increase
the risk for skin injury.
Please consult package insert for more detailed safety information and
instructions for use.

Selection of a technology for

TechTraditional

(blankets, etc.)

endo-vascular
computerised

computerised
(fan, ice, etc.)

Cold iv. fluids

High Quality TTM

Advanced

Advanced
Standard

surface
Techniques

Arctic Sun 5000

®
To deliver TTM therapy in the safest and most efficient way it Efficacy
is important to select the most appropriate technique Time to target Poor Moderate Moderate Excellent Excellent
Overshoot Poor Poor Moderate Excellent Excellent Temperature Management System
Post-cooling Poor Poor Moderate Excellent Excellent
Side effects
Infections Moderate Moderate Moderate Moderate Moderate
Haemodynamic Moderate Poor Moderate Excellent Excellent
Metabolic Moderate Moderate Moderate Moderate Moderate
Shivering
Catheter-related
Poor Moderate Moderate Good Good
Contact information
Good Good Excellent Excellent Poor
(thrombosis, infections)

TTM in Sudden Cardiac Arrest

AUSTRIA Bard Medica S.A., Rinnböckstraße 3, 1030 Wien, Austria Tel: +43 149 49 130 Fax: +43 1 49 49 130 30
BENELUX Bard Benelux n.v., Hagelberg 2, 2250 Olen, Belgium Tel: +32 14 286950 Fax: +32 14 286966
1. Scientific evidence underlying the recommendations of critical care clinical practice guidelines: a lack of high level evidence; A Zhang et al; Intensive Care CZECH REPUBLIC Bard Czech Republic s.r.o., Na hrebenech II 1718/8, 140 00 Praha 4, Czech Republic Tel: +420 242 408630 Fax: +420 242 410185
Medicine 2018 July 1432-1238. FRANCE Bard France SAS, Av. Joseph Kessel 164-166, Parkile P14, 78960 Voisins-le-Bretonneux, France Tel: +33 1 39305858 Fax: +33 1 3935859
2. HACA Study M. Holzer et al (N Engl J Med 2002; 346:549-56. GERMANY C.R. Bard GmbH, Wachhausstraße 6, 76227 Karlsruhe, Germany Tel: +49 721 94450 Fax: +49 721 9445 100
3. European Resuscitation Council and European Society of IntensiveCare Medicine Guidelines for Post-resuscitation Care 2015Section 5 of the European GREECE Bard Hellas SA, 1, Filellinon Str. & Megalou Alexandrou, 16452, Argyroupoli, Greece Tel: +30 210 9690770 Fax: +30 210 9628810
Resuscitation Council Guidelines for Resuscitation 2015; Nolan J. et al: Resuscitation 95 (2015) 202–222. ITALY Bard Srl, Via Cina 444, 00144 Roma, Italy Tel: +39 06 524931 Fax: +39 06 5295852
4. Therapeutic Hypothermia After Out-of-Hospital Cardiac Arrest: Evaluation of a regional system to increase access to cooling; Circulation. 2011;124:206-214;
Mooney et al.
5. Efficacy of different cooling technologies for therapeutic temperature management: a prospective intervention study; Resuscitation 124 (2018) 14-20;
NORDIC
POLAND
SPAIN
Bard Norden AB, Rönnowsgatan 10, 252 25 Helsingborg, Sweden Tel: +46 42 386000 Fax: +46 42 386010
Bard Poland sp.z.o.o., ul. Osmańska 14, 02-823 Warsaw, Poland Tel: +48 22 3210930 Fax: +48 22 3210938
Bard de Espana S.L.U., Plaza Europe 41-43, 5A Planta (Torre Realia), 08908 L’Hospitalet de Llobregat, Spain Tel: +34 93 2537800 Fax: +34 93 2058200
Neuroprotection in the anoxic injured brain
Polderman et al. SWITZERLAND Bard Medica .S.A, Seestrasse 64, 8942 Oberrieden/Zürich, Switzerland Tel: +41 44 7225360 Fax: +41 44 7225370
6. Therapeutic Hypothermia after Cardiac Arrest; Circulation; 2013; 127:244-250; Scririca. UK Bard Limited, Forest House, Tilgate Forest Business Park, Brighton Road, Crawley, West Sussex RH11 9BP, UK Tel: +44 1293 527888 Fax: +44 1293 552428
7. Early achievement of mild therapeutic hypothermia and the neurologic outcome after cardiac arrest; Int J Cardiol. 2009 Apr 3;133(2):223-8; Wolff et al.
8. Targeted temperature management in the ICU: guidelines from a French expert panel;. Ann. Intensive Care; (2017) 7:70; Cariou et al.
9. Cardiac Rhythm news - https://cardiacrhythmnews.com/european-sudden-cardiac-arrest-network-will-look-at-gender-based-prevention-and-treatment/
Not for distribution outside of the European Union or Russia
10. Changing target temperature from 33˚C to 36˚C in the ICUmanagement of out-of-hospital cardiac arrest:A before and after study; Resuscitation. 2017
Apr;113:39-43; Bernard et al.
11. Bedside Shivering Assessment Scale (BSAS); Neurocritical Care 2007;6:228; N Badjatia et al.
12. Confusion Around Therapeutic Temperature Management Hypothermia After In-Hospital Cardiac Arrest?; Circulation. 2018;137:219–221; Polderman & Veron.
13. Tailored Temperature Management in Neurocritical Care; European Neurological Review, 2016;11 (Suppl. 1):3-6: Amey.
14. Data on file
15. Bernd Böttiger presentation on file from TTM course 2019; From Proof to Practice
16. Door-to-Targeted Temperature Management Initiation After Out-of-Hospital Cardiac Arrest: A New Quality Metric in Postresuscitation Care?
bd.com
Aldo L. Schenone, Venu Menon. J Am Heart Assoc. 2019 May 7; 8(9): e012666. Published online 2019 May 6. doi: 10.1161/JAHA.119.012666
© 2019 BD. BD, the BD Logo and Arctic Sun Temperature Management System are trademarks of Becton, Dickinson and Company. 0519
17. Targeted Temperature Management for Cardiac Arrest with Nonshockable Rhythm; JB Lascarrou et al; N Engl J Med. 2019 Dec 12;381(24):2327-2337
TTM is one of only 9% of all Procedures
in the ICU to have a Strong Guideline 1
“TTM is the only therapy that we have to
prevent neurological damage after SCA” 15
-Prof Bernd Böttiger, University of Cologne, Germany
ERC 2015 Guidelines3
All patients all rhythms
Emergency Room
ABC-T
Temperature is a vital sign with
airway breathing and circulation
Immediate treatment with TTM
Cath lab
ICU
Continuous treatment with
TTM for >72hrs
Time to
initiation
“Initiation of TTM within 122
minutes of hospital admission was
associated with improved survival.” 16
Guideline
TTM is recommended to use
immediately alongside Airways
& Breathing and Circulation3
Evidence
A 20% increase in the risk
of death was observed
for every hour of delay to
initiation of cooling4
Point of Control
(Start of TTM)
Cardiac Arrest
Arctic Sun provides a nurse-
driven two-button start therapy
and is initiated within minutes.
ERC Guidelines for Device Choice
In the maintenance phase, a cooling method with effective temperature
monitoring that avoids temperature fluctuations is preferred. This is
best achieved with external or internal cooling devices that include
continuous temperature feedback to achieve a set target temperature.
The temperature is typically monitored from a thermistor placed in the
bladder and/or oesophagus.3
Induction
“Perhaps a time dependant
threshold exists.”
Guideline
Temperature control should
happen immediately on
hospital admission3
Evidence
Early achievement of TTM
appears to reduce hypoxic brain
injury and to favour a good
neurologic outcome after CA7
Excellent heat transfer
through Arctic Gel Pads
to provide rapid
induction of
therapy.
Maintenance
“Adhesive Gel Pads provide
more effective temperature
maintenance.” 5
Guideline
Maintain a constant, target
temperature between 32˚C
and 36˚C for those patients in
whom temperature control is
used (strong recommendation,
moderate-quality evidence).
If targeted temperature
management is used, it is
suggested that the duration is
at least 24 h (as undertaken in
the two largest previous RCTs
31,187) (weak recommendation,
very low-quality evidence).3
Evidence
After the change from a TTM
target of 33˚C–36˚C, we report
low compliance with target
temperature, higher rates of
fever, and a trend towards clinical
worsening in patient outcomes10
36°
33°
The Arctic Sun provides stable
temperature management
through precise adoption of
the water temperature.
24 hours
Rewarming
“We suggest considering
the control of rewarming in
patients treated with TTM.” 8
Guideline
rewarming should be achieved
slowly: the optimal rate is not
known, but the consensus is
currently about 0.25–0.5˚C
of rewarming per hour3
Evidence
Once rewarming commences
until a core temperature
of 37˚C is reached using a
devices designed to counteract
accelerated rewarming and
rebound hyperthermia4
37°
The Arctic
Sun provides
controlled rewarming
from 0.01 - 0.5°C/hour.
36
hours
Normothermia
“Once normothermia is achieved the
goal of the therapy is to maintain
37˚C avoiding hyperthermia.
Post-CA fevers are particularly
harmful and associated with
worse neurological outcomes.” 6
Guideline
The TTM trial provided strict
normothermia (<37.5°C) after
hypothermia until 72 h after ROSC3
Evidence
At 36 hours, mandatory sedation
was discontinued or tapered.
After the intervention period, the
intention was to maintain the body
temperature for unconscious
patients below 37.5°C until 72
hours after the cardiac arrest, with
the use of fever-control measures
at the discretion of the sites.13
The Arctic Sun provides
therapy without limitation
regarding the length of use.
Arctic Sun 5000
Temperature Management System
Induction
Heat transfer
mimics water immersion.
The Arctic Sun 5000
temperature management
system’s heat transfer rate is
equal to water immersion.
English MJ, et al, European Journal of
Anaesthesiology 2008; 25:531-537.
Maintenance
During a typical therapy, Arctic Sun
5000 temperature management
system monitors patient
temperature by measuring it
over 259,200 times and adjusting
it 2,900 times compared to a
typical water blanket which only
measures temperature 1,440
times and adjusts it 144 times 14
Rewarming
An advanced algorithm checks
patient temperature every
second and micro-adjusts
water temperature every
two minutes.
Normothermia
No limits to length of
use* ArcticGel Pads
ArcticGel pads are required
*
to be changed every 5 days