Endovascular versus External Targeted Temperature Management for Out-of Hospital Cardiac Arrest Patients: A Randomized Controlled Study THE ICEREA STUDY GROUP*

Background — Targeted temperature management is recommended after out-of-hospital cardiac arrest (OHCA). Whether advanced internal cooling is superior to basic external cooling remains presently unknown. The aim of this multicenter controlled trial was to evaluate the benefit of endovascular versus basic surface cooling. Methods and Results — Inclusion criteria were: age 18-79, OHCA related to a presumed cardiac cause, time to return of spontaneous circulation (ROSC) <60min, delay between ROSC and inclusion <240min, unconscious patient after ROSC and prior to start cooling. Exclusion criteria were: terminal disease, pregnancy, known coagulopathy, uncontrolled bleeding, temperature on admission <30°C, in-hospital CA, immediate need for extracorporeal life support or hemodialysis. Patients were randomized between two cooling strategies: endovascular femoral devices (Icy catheter, Coolgard™, Zoll, formerly Alsius, USA, n=203) or basic external cooling using fans, a home-made tent, and ice packs (n=197). The primary endpoint, i.e. favorable outcome evaluated by survival without major neurological damages (Cerebral Performance Categories 1-2) at day 28, was not significantly different between groups (odds ratio 1.41 [0.93-2.16], P=0.107). Improvement of favorable outcome at day 90 in favor of endovascular group did not reach significance (odds ratio 1.51 [0.96-2.35], P=0.07). Time to target temperature (33°C) was significantly shorter, and target hypothermia was more strictly maintained in the endovascular versus the surface group (P<0.001). Minor side effects directly related to the cooling method were more frequently observed in the endovascular group (P=0.009). Conclusions — Despite better hypothermia induction and maintenance, endovascular cooling was not significantly superior to basic external cooling regarding favorable outcome. Clinical Trial Registration Information ClinicalTrials.gov. Identifier: NCT00392639. tttimimiminininggg sssididide-e-e-eeeffffffeecectssts (((suuub-b-b-cacacatetetegogogoriesss

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