Randomized Controlled Trial

. 2015 Jul 21;132(3):182-93.

doi: 10.1161/CIRCULATIONAHA.114.012805. Epub 2015 Jun 19.

Endovascular Versus External Targeted Temperature Management for Patients With Out-of-Hospital Cardiac Arrest: A Randomized, Controlled Study

Nicolas Deye¹, Alain Cariou², Patrick Girardie², Nicolas Pichon², Bruno Megarbane², Philippe Midez², Jean-Marie Tonnelier², Thierry Boulain², Hervé Outin², Arnaud Delahaye², Aurélie Cravoisy², Alain Mercat², Pascal Blanc², Charles Santré², Hervé Quintard², François Brivet², Julien Charpentier², Delphine Garrigue², Bruno Francois², Jean-Pierre Quenot², François Vincent², Pierre-Yves Gueugniaud², Jean-Paul Mira², Pierre Carli², Eric Vicaut², Frédéric J Baud²; Clinical and Economical Impact of Endovascular Cooling in the Management of Cardiac Arrest (ICEREA) Study Group

Collaborators, Affiliations

Collaborators

Clinical and Economical Impact of Endovascular Cooling in the Management of Cardiac Arrest (ICEREA) Study Group:
F J Baud, B Mégarbane, I Malissin, P Brun, D Résière, J M Eckérian, J Théodore, A Mohebbi, G Sideris, P Henry, A Cariou, J Charpentier, J P Mira, J D Chiche, S Marque, O Huet, M Thirion, V Lemiale, A Mathonnet, S Percheron, A Lanceleur, T Seguin, F Brivet, F Jacobs, N Pichon, F Bruno, P Vignon, M Clavel, J P Marsaud, J B Amiel, A P Dugard, F Mucke, P Midez, G Capellier, C Patry, E Laurent, D Perez, E Belle, T Boulain, I Runge, M Wolf, C Fleury, N Bercault, P Girardie, D Garrigue, C Séjourné, A Mercat, V Souday, A Kouatchet, E Lebas, C Sargentini, F Grelon, E Frenoy, F Meziani, J M Tonnelier, G Prat, E L'Her, M Lefevre, C Gut-Gobert, A Renault, S Jaffuel, A Delahaye, E Moreau, G Georget, P Blanc, E Boulet, J Richecoeur, V Gaday, J L Dubost, F Testart, H Outin, P Fangio, H Quintard, C Ichai, A Cravoisy, D Barraud, O Marcon, P E Bollaert, S Gibot, L Nace, F Hein, J P Quenot, B Blettery, J M Doise, S Prin, C Santré, M Sirodot, P A Charretier, D Dorez, M Vinclair, Y Cohen, F Gonzalez, P Karoubi, J P Fosse, J Didier, J P Perdrix, P Carli, B Vivien, A Mounir, N Tessier, B De Jonghe, E Dupré-Nalet, F Vincent, P Y Gueugniaud, L Gergele, E Vicaut, J J Portal

Affiliations

¹ From Réanimation Médicale Toxicologique, CHU Lariboisière, AP-HP, Paris, France (N.D., B.M., F.J.B.); Réanimation Médicale, CHU Cochin, AP-HP, Paris, France (A.C., J.C., J.-P.M.); Réanimation Polyvalente, CHU Salengro, Lille, France (P.G., D.G.); Réanimation Médico-Chirurgicale, CHU Dupuytren, Limoges, France (N.P., B.F.); Réanimation Médicale, CHU Minjoz, Besançon, France (P.M.); Réanimation Médicale, CHU La Cavale Blanche, Brest, France (J.-M.T.); Réanimation Polyvalente, CHR, Orléans, France (T.B.); Réanimation Médicale, CHI, Poissy, France (H.O.); Réanimation Polyvalente, CHR, Rodez, France (A.D.); Réanimation Médicale, CHU Central, Nancy, France (A.C.); Réanimation Médicale, CHU, Angers, France (A.M.); Réanimation Médicale, CHR Dubos, Pontoise, France (P.B.); Réanimation Polyvalente, CHR d'Annecy, Pringy, France (C.S.); Réanimation Médico-Chirurgicale, Hôpital Saint-Roch, Nice, France (H.Q.); Réanimation Médicale, CHU Béclère, AP-HP, Clamart, France (F.B.); Réanimation Médicale, Hôpital du Bocage, Dijon, France (J.-P.Q.); Réanimation Médico-Chirurgicale, Hôpital Avicenne, AP-HP, Bobigny, France (F.V.); Anesthésie-Réanimations-SAMU, CHU Lyon-Sud, Pierre-Bénite, France (P.-Y.G.); SAMU 75, CHU Necker, AP-HP, Paris, France (P.C.); and Unité Recherche Clinique, Hôpital Widal, AP-HP, Paris, France (E.V.). nicolas.deye@lrb.aphp.fr.
² From Réanimation Médicale Toxicologique, CHU Lariboisière, AP-HP, Paris, France (N.D., B.M., F.J.B.); Réanimation Médicale, CHU Cochin, AP-HP, Paris, France (A.C., J.C., J.-P.M.); Réanimation Polyvalente, CHU Salengro, Lille, France (P.G., D.G.); Réanimation Médico-Chirurgicale, CHU Dupuytren, Limoges, France (N.P., B.F.); Réanimation Médicale, CHU Minjoz, Besançon, France (P.M.); Réanimation Médicale, CHU La Cavale Blanche, Brest, France (J.-M.T.); Réanimation Polyvalente, CHR, Orléans, France (T.B.); Réanimation Médicale, CHI, Poissy, France (H.O.); Réanimation Polyvalente, CHR, Rodez, France (A.D.); Réanimation Médicale, CHU Central, Nancy, France (A.C.); Réanimation Médicale, CHU, Angers, France (A.M.); Réanimation Médicale, CHR Dubos, Pontoise, France (P.B.); Réanimation Polyvalente, CHR d'Annecy, Pringy, France (C.S.); Réanimation Médico-Chirurgicale, Hôpital Saint-Roch, Nice, France (H.Q.); Réanimation Médicale, CHU Béclère, AP-HP, Clamart, France (F.B.); Réanimation Médicale, Hôpital du Bocage, Dijon, France (J.-P.Q.); Réanimation Médico-Chirurgicale, Hôpital Avicenne, AP-HP, Bobigny, France (F.V.); Anesthésie-Réanimations-SAMU, CHU Lyon-Sud, Pierre-Bénite, France (P.-Y.G.); SAMU 75, CHU Necker, AP-HP, Paris, France (P.C.); and Unité Recherche Clinique, Hôpital Widal, AP-HP, Paris, France (E.V.).

PMID: 26092673
DOI: 10.1161/CIRCULATIONAHA.114.012805

Randomized Controlled Trial

Endovascular Versus External Targeted Temperature Management for Patients With Out-of-Hospital Cardiac Arrest: A Randomized, Controlled Study

Nicolas Deye et al. Circulation. 2015.

. 2015 Jul 21;132(3):182-93.

doi: 10.1161/CIRCULATIONAHA.114.012805. Epub 2015 Jun 19.

Authors

Collaborators

Clinical and Economical Impact of Endovascular Cooling in the Management of Cardiac Arrest (ICEREA) Study Group:
F J Baud, B Mégarbane, I Malissin, P Brun, D Résière, J M Eckérian, J Théodore, A Mohebbi, G Sideris, P Henry, A Cariou, J Charpentier, J P Mira, J D Chiche, S Marque, O Huet, M Thirion, V Lemiale, A Mathonnet, S Percheron, A Lanceleur, T Seguin, F Brivet, F Jacobs, N Pichon, F Bruno, P Vignon, M Clavel, J P Marsaud, J B Amiel, A P Dugard, F Mucke, P Midez, G Capellier, C Patry, E Laurent, D Perez, E Belle, T Boulain, I Runge, M Wolf, C Fleury, N Bercault, P Girardie, D Garrigue, C Séjourné, A Mercat, V Souday, A Kouatchet, E Lebas, C Sargentini, F Grelon, E Frenoy, F Meziani, J M Tonnelier, G Prat, E L'Her, M Lefevre, C Gut-Gobert, A Renault, S Jaffuel, A Delahaye, E Moreau, G Georget, P Blanc, E Boulet, J Richecoeur, V Gaday, J L Dubost, F Testart, H Outin, P Fangio, H Quintard, C Ichai, A Cravoisy, D Barraud, O Marcon, P E Bollaert, S Gibot, L Nace, F Hein, J P Quenot, B Blettery, J M Doise, S Prin, C Santré, M Sirodot, P A Charretier, D Dorez, M Vinclair, Y Cohen, F Gonzalez, P Karoubi, J P Fosse, J Didier, J P Perdrix, P Carli, B Vivien, A Mounir, N Tessier, B De Jonghe, E Dupré-Nalet, F Vincent, P Y Gueugniaud, L Gergele, E Vicaut, J J Portal

Affiliations

¹ From Réanimation Médicale Toxicologique, CHU Lariboisière, AP-HP, Paris, France (N.D., B.M., F.J.B.); Réanimation Médicale, CHU Cochin, AP-HP, Paris, France (A.C., J.C., J.-P.M.); Réanimation Polyvalente, CHU Salengro, Lille, France (P.G., D.G.); Réanimation Médico-Chirurgicale, CHU Dupuytren, Limoges, France (N.P., B.F.); Réanimation Médicale, CHU Minjoz, Besançon, France (P.M.); Réanimation Médicale, CHU La Cavale Blanche, Brest, France (J.-M.T.); Réanimation Polyvalente, CHR, Orléans, France (T.B.); Réanimation Médicale, CHI, Poissy, France (H.O.); Réanimation Polyvalente, CHR, Rodez, France (A.D.); Réanimation Médicale, CHU Central, Nancy, France (A.C.); Réanimation Médicale, CHU, Angers, France (A.M.); Réanimation Médicale, CHR Dubos, Pontoise, France (P.B.); Réanimation Polyvalente, CHR d'Annecy, Pringy, France (C.S.); Réanimation Médico-Chirurgicale, Hôpital Saint-Roch, Nice, France (H.Q.); Réanimation Médicale, CHU Béclère, AP-HP, Clamart, France (F.B.); Réanimation Médicale, Hôpital du Bocage, Dijon, France (J.-P.Q.); Réanimation Médico-Chirurgicale, Hôpital Avicenne, AP-HP, Bobigny, France (F.V.); Anesthésie-Réanimations-SAMU, CHU Lyon-Sud, Pierre-Bénite, France (P.-Y.G.); SAMU 75, CHU Necker, AP-HP, Paris, France (P.C.); and Unité Recherche Clinique, Hôpital Widal, AP-HP, Paris, France (E.V.). nicolas.deye@lrb.aphp.fr.
² From Réanimation Médicale Toxicologique, CHU Lariboisière, AP-HP, Paris, France (N.D., B.M., F.J.B.); Réanimation Médicale, CHU Cochin, AP-HP, Paris, France (A.C., J.C., J.-P.M.); Réanimation Polyvalente, CHU Salengro, Lille, France (P.G., D.G.); Réanimation Médico-Chirurgicale, CHU Dupuytren, Limoges, France (N.P., B.F.); Réanimation Médicale, CHU Minjoz, Besançon, France (P.M.); Réanimation Médicale, CHU La Cavale Blanche, Brest, France (J.-M.T.); Réanimation Polyvalente, CHR, Orléans, France (T.B.); Réanimation Médicale, CHI, Poissy, France (H.O.); Réanimation Polyvalente, CHR, Rodez, France (A.D.); Réanimation Médicale, CHU Central, Nancy, France (A.C.); Réanimation Médicale, CHU, Angers, France (A.M.); Réanimation Médicale, CHR Dubos, Pontoise, France (P.B.); Réanimation Polyvalente, CHR d'Annecy, Pringy, France (C.S.); Réanimation Médico-Chirurgicale, Hôpital Saint-Roch, Nice, France (H.Q.); Réanimation Médicale, CHU Béclère, AP-HP, Clamart, France (F.B.); Réanimation Médicale, Hôpital du Bocage, Dijon, France (J.-P.Q.); Réanimation Médico-Chirurgicale, Hôpital Avicenne, AP-HP, Bobigny, France (F.V.); Anesthésie-Réanimations-SAMU, CHU Lyon-Sud, Pierre-Bénite, France (P.-Y.G.); SAMU 75, CHU Necker, AP-HP, Paris, France (P.C.); and Unité Recherche Clinique, Hôpital Widal, AP-HP, Paris, France (E.V.).

PMID: 26092673
DOI: 10.1161/CIRCULATIONAHA.114.012805

Erratum in

Correction.
[No authors listed] [No authors listed] Circulation. 2016 Feb 23;133(8):e418. doi: 10.1161/CIR.0000000000000387. Circulation. 2016. PMID: 26903029 No abstract available.

Abstract

Background: Targeted temperature management is recommended after out-of-hospital cardiac arrest. Whether advanced internal cooling is superior to basic external cooling remains 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 the following: age of 18 to 79 years, out-of-hospital cardiac arrest related to a presumed cardiac cause, time to return of spontaneous circulation <60 minutes, delay between return of spontaneous circulation and inclusion <240 minutes, and unconscious patient after return of spontaneous circulation and before the start of cooling. Exclusion criteria were terminal disease, pregnancy, known coagulopathy, uncontrolled bleeding, temperature on admission <30°C, in-hospital cardiac arrest, immediate need for extracorporeal life support or hemodialysis. Patients were randomized between 2 cooling strategies: endovascular femoral devices (Icy catheter, Coolgard, Zoll, formerly Alsius; n=203) or basic external cooling using fans, a homemade tent, and ice packs (n=197). The primary end point, that is, favorable outcome evaluated by survival without major neurological damage (Cerebral Performance Categories 1-2) at day 28, was not significantly different between groups (odds ratio, 1.41; 95% confidence interval, 0.93-2.16; P=0.107). Improvement in favorable outcome at day 90 in favor of the endovascular group did not reach significance (odds ratio, 1.51; 95% confidence interval, 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 than in the surface group (P<0.001). Minor side effects directly related to the cooling method were observed more frequently in the endovascular group (P=0.009).

Conclusion: Despite better hypothermia induction and maintenance, endovascular cooling was not significantly superior to basic external cooling in terms of favorable outcome.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00392639.

Keywords: endovascular procedures; heart arrest; hypothermia; prognosis; therapy.

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Comment in

How to Stay Cool in the Intensive Care Unit? Endovascular Versus Surface Cooling.
Polderman KH. Polderman KH. Circulation. 2015 Jul 21;132(3):152-7. doi: 10.1161/CIRCULATIONAHA.115.017350. Epub 2015 Jun 19. Circulation. 2015. PMID: 26092672 No abstract available.
Letter by Guo et al Regarding Article, "Endovascular Versus External Targeted Temperature Management for Patients With Out-of-Hospital Cardiac Arrest: A Randomized, Controlled Study".
Guo J, Wu MJ, Kang Y. Guo J, et al. Circulation. 2016 Feb 23;133(8):e412. doi: 10.1161/CIRCULATIONAHA.115.019384. Circulation. 2016. PMID: 26903024 No abstract available.
Response to Letter Regarding Article, "Endovascular Versus External Targeted Temperature Management for Patients With Out-of-Hospital Cardiac Arrest: A Randomized, Controlled Study".
Deye N, Cariou A, Girardie P, Pichon N, Megarbane B, Midez P, Tonnelier JM, Boulain T, Outin H, Delahaye A, Cravoisy A, Mercat A, Blanc P, Santré C, Quintard H, Brivet F, Charpentier J, Garrigue D, Francois B, Quenot JP, Vincent F, Gueugniaud PY, Mira JP, Carli P, Vicaut E, Baud FJ; ICEREA Study Group. Deye N, et al. Circulation. 2016 Feb 23;133(8):e413-4. doi: 10.1161/CIRCULATIONAHA.115.019996. Circulation. 2016. PMID: 26903025 No abstract available.

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Endovascular Versus External Targeted Temperature Management for Patients With Out-of-Hospital Cardiac Arrest: A Randomized, Controlled Study

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Endovascular Versus External Targeted Temperature Management for Patients With Out-of-Hospital Cardiac Arrest: A Randomized, Controlled Study

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