Advice

The technology

The technology

The Arctic Sun 5000 temperature management system (Medivance/Bard) is a non-invasive system for controlling and monitoring body temperature within the range of 32°C to 38.5°C. It is intended for use in adults who are comatose after sudden cardiac arrest in or out of hospital, with the aim of inducing mild hypothermia to reduce brain injury and improve neurological outcomes. Mild hypothermia (32°C to 36°C, as recommended by European Resuscitation Council and European Society of Intensive Care Medicine guidelines) is induced as soon as possible after a cardiac arrest. The specific target temperature can be set by the lead clinician or according to hospital guidelines.

Arctic Sun 5000 has 3 modes: cooling, rewarming and maintaining temperature within the healthy range of 36°C to 37°C (normothermia).

Arctic Sun 5000 comprises 2 main components:

  • A closed loop system, which consists of a control module with a touch screen, water reservoir and water heater.

  • Four disposable, single-use, repositionable adhesive gel pads (2 for the upper body and 2 for the thighs). Temperature-controlled water is circulated through channels in the gel pads.

The gel pads are available in 4 sizes. The correct size is chosen for each patient to ensure that 40% of the body surface is covered, which is needed for efficient temperature control. The gel pads are MRI, CT and X-ray compatible. Their inner layer is made of a heat conductive hydrogel that sticks to the skin. The middle layer includes channels through which the water is circulated, and the outer layer is designed to insulate the circulating water and maintain its temperature.

Arctic Sun 5000 must be used with an indwelling Yellow Springs Instrument 400 series temperature probe. The probe is inserted into a core site, such as the bladder, rectum or oesophagus, and then connected to the control module so that core temperature can be monitored continually. A second temperature probe can be added at a core site in order to confirm the reading if needed. The gel pads are applied to the patient then connected to the control module, and water is circulated through the pads to prime the lines. Once primed, the water temperature can be set using the control module.

The operator sets the target body temperature, which can be saved into the system for future use. The control module automatically adjusts the temperature of the water in the gel pads every 2 minutes to maintain target core body temperature. Target temperature is maintained for 24 hours, after which the system can be used to rewarm the patient.

In addition to therapeutic cooling, patients should have standard critical care measures including intravenous sedation and muscle relaxants to prevent shivering. Controlled rewarming by any method is usually done over a number of hours at a rate of 0.25°C to 0.5°C per hour (as recommended by European Resuscitation Council and European Society of Intensive Care Medicine guidelines).

Arctic Sun 5000 is the current version of the device; the previous version, Arctic Sun 2000, was discontinued in 2016. The 2 versions are functionally identical and differ only in the user interface; Arctic Sun 5000 has a touchscreen which displays a patient trend indicator and status graph.

Innovations

The gel pads are designed to provide rapid cooling. The closed loop system of temperature monitoring and automatic adjustment is intended to reduce the amount of time needed for nurses to measure core temperature and manually adjust the temperature regulation system. Arctic Sun 5000 is also designed to be less invasive than endovascular systems.

Current NHS pathway or current care pathway

NICE interventional procedures guidance on therapeutic hypothermia following cardiac arrest states that the evidence on safety and efficacy is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, audit and consent. The guidance notes that after a cardiac arrest, comatose patients who have a return of spontaneous circulation can be cooled to a core temperature of between 32°C and 34°C with the aim of reducing brain injury and improving neurological outcome. This is in accordance with the European Resuscitation Council and European Society of Intensive Care Medicine guidelines, although these guidelines also state that milder therapeutic temperatures up to 36°C may be beneficial for some patients.

In current standard care, mild hypothermia is induced by using either surface techniques, such as heat-exchange cooling pads, or invasive techniques, including endovascular cooling devices.

NICE is aware of the following CE-marked devices that appear to fulfil a similar function to Arctic Sun 5000:

Population, setting and intended user

Artic Sun 5000 is most likely to be used for the induction, maintenance and re-warming phases of therapeutic hypothermia in a critical care setting by any critical care staff. It is designed for use in adults who are comatose after a sudden cardiac arrest in or out of hospital, and who have a return of spontaneous circulation. The system would replace current standard cooling methods with little expected change to the current care pathway.

Costs

Table 1 Device costs

Component

Cost

Additional information

Arctic Sun 5000

£20,600.00

Multiple use

Temperature in cable

£116.36

Temperature out cable

£93.09

Fill tube

£37.23

Fluid delivery line

£1,394.41

Shunt line

£13.96

Single use (optional)

Drain bag

£26.71

Drain tube

£32.58

Multiple use

Foley catheter temperature sensor

£349.10

Multiple use: 14, 16 or 18 Fr

Arctic gel pad kit

£628.30

Single use for duration of treatment: extra small, medium or large

Arctic gel pad: universal kit (4 universal pads packaged individually, 1 used per patient)

£545.90

Single use for duration of treatment. Universal pads are intended to be used in addition to standard gel pad kits, to ensure 40% body coverage of larger people

Primary (Foley) temperature probe

£10.30

Single use

Secondary temperature probe

£1.59

Single use, optional

Oesophageal/rectal probe 9 Fr

£139.64

Maintenance

Option 1 (labour and parts)

£2,800.00

Per year

Option 2 (labour only)

£1,900.00

Assuming an 8‑year lifespan for the device, used at a rate of 100 patients per year (800 uses in total), the cost per treatment ranges from £697 to £833.

The cost per treatment for single-use components only is £556 to £738.

Costs of standard care

Tables 2 and 3 show example costs for surface and endovascular cooling systems.

Table 2 Cost of surface cooling (Blanketrol III)

Component

Cost

Additional information

Cooling control unit

£9,495.00

Multiple use

CSZ reusable connecting hose (2.7 m)

£79.00

CSZ patient temperature probe cable

£40.00

CSZ MaxiTherm Lite patient vest

£133.90

Instead of MaxiTherm Lite adult (below), single use

CSZ MaxiTherm Lite adult

£129.00

Instead of patient vest (above), single use

CSZ Kool Kit

£315.60

Single use

CSZ Kool Kit (large)

£347.12

Depending on which kit is used, the price per patient per treatment for single-use components only ranges from £129 to £347.

Table 3 Cost of endovascular cooling (Thermogard XP)

Component

Cost

Additional information

Heat exchanger unit

£21,500.00

Multiple use

Temperature probe interface cable

£89.00

Propylene glycol coolant (1 gallon)

£30.00

Coolant well lid

£150.00

Intravascular catheters

Cool Line: £318.27

Icy: £509.85

Quattro: £637.94

Single use, only 1 needed

Start‑up kit (model CG‑500D)

£235.87

Single use

Foley temperature probe

£10.00

Hospital monitor interface accessory

£1,759.00

Optional

Secondary temperature probe

£1.54

This would need to be supplied by the hospital

All costs are taken from the NICE medtech innovation briefing on Thermogard XP.

Depending on which catheter is used, the cost per patient treatment for single-use components only ranges from £574 to £894 (excluding VAT).

Resource consequences

Arctic Sun 5000 would add additional costs compared with other surface cooling methods, but these may be offset if it resulted in reduced staffing costs or if it reduced the cost of treating neurological damage by improving clinical endpoints. Compared with endovascular temperature management systems such as Thermogard XP, Arctic Sun 5000 could reduce costs depending on the consumables used and lifespan of the systems involved. The resource consequences of using Arctic Sun 5000 may also depend on whether it reduces the risk of complications compared with endovascular cooling, although this benefit may also apply to other non-invasive cooling methods.

The company provides training as part of the purchase cost. This includes 2 self-learning modules and a hands-on 3-hour workshop tailored to each hospital's needs. Clinical specialists are available to provide ongoing training and support. Advanced training is offered to selected members of the clinical team so that they can provide independent in-house training and support.

Arctic Sun systems are currently used in 30 NHS hospitals.