Advice

Summary

Summary

The Thermogard XP temperature management system controls a patient's body temperature through central venous heat exchange. It can be used to induce and maintain therapeutic hypothermia in critically ill patients after cardiac arrest. One retrospective cohort study based on registry data found that Thermogard XP cooled the body more rapidly than surface‑cooling devices with automatic temperature feedback systems. However, in this study, there was no statistically significant difference in neurological outcomes or in‑hospital mortality. The per‑patient consumable cost of Thermogard XP is between £500 and £900 depending on the type of catheter needed.

Product summary and likely place in therapy

  • Thermogard XP controls a patient's body temperature through central venous heat exchange. It can be used for both cooling and warming clinical applications. This briefing focuses on its use for initiating and maintaining therapeutic hypothermia in critically ill adult patients after cardiac arrest.

  • Thermogard XP would be used in a hospital setting in place of standard interventions for the induction and maintenance of therapeutic cooling.

  • There is some uncertainty about the place in therapy of therapeutic hypothermia after cardiac arrest, compared with normothermia, and about the target temperature.

Effectiveness and safety

  • Ten studies were identified that reported cooling efficiency outcomes in patients after cardiac arrest. One of these used the Thermogard XP device and 2 others used its immediate predecessor, the CoolGard 3000. The other 7 studies also used the CoolGard system but did not specify the version.

  • A retrospective cohort study based on registry data (n=803) reported no statistically significant difference in neurological outcomes or in‑hospital mortality between the surface cooling and Thermogard XP groups.

  • One prospective case series using CoolGard 3000 (n=49) reported a time to target temperature of 33°C of 410 minutes. Faster cooling was associated with better neurological outcomes in this study.

  • One retrospective cohort study (n=1038) compared CoolGard 3000 against standard post‑resuscitation therapy. The proportion of survivors with good neurological recovery was 53% in the CoolGard 3000 group and 34% in the standard care group.

Technical and patient factors

  • The system circulates temperature‑controlled saline within a closed‑loop, multi‑balloon intravascular catheter. The patient's blood is cooled or warmed as it passes over the saline‑filled balloons. No fluid is infused into or removed from the patient.

  • The immediate predecessor to the Thermogard XP is the CoolGard 3000 system. The manufacturer states that the only notable difference between these 2 versions is that the Thermogard XP has increased cooling power output over the CoolGard 3000 (190 watts compared to 115 watts).

  • Using Thermogard requires the placement of a triple‑lumen central venous catheter which provides saline inflow/outflow and standard central line ports for infusion, measuring central venous pressure and sampling. A temperature probe placed in the bladder is also needed.

Cost and resource use

  • The list price of the Thermogard XP heat exchange control unit is £21,500. Single use intravascular catheters for use with the system range in price from £318.27 to £637.94. The single‑use start‑up kit is £235.87. A number of consumables, accessories and options are also available.

  • The UK supplier, Delta Surgical, may provide Thermogard XP control units free of charge to the NHS, based on commitment to purchase disposable components.

  • No published evidence on the resource consequences of Thermogard XP was identified.