Extracorporeal Membrane Oxygenation in the Therapy of
Cardiogenic Shock: Results of the ECMO-CS Randomized Clinical
Trial

J 2023

Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock: Results of the ECMO-CS Randomized Clinical Trial

OSTADAL, Petr, Richard ROKYTA, Jiri KARASEK, Andreas KRUGER, Dagmar VONDRAKOVA et. al.

Basic information

Original name

Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock: Results of the ECMO-CS Randomized Clinical Trial

Authors

OSTADAL, Petr (203 Czech Republic, guarantor), Richard ROKYTA (203 Czech Republic), Jiri KARASEK (203 Czech Republic), Andreas KRUGER, Dagmar VONDRAKOVA (203 Czech Republic), Marek JANOTKA (203 Czech Republic), Jan NAAR (203 Czech Republic), Jana SMALCOVA (203 Czech Republic), Marketa HUBATOVA (203 Czech Republic), Milan HROMADKA (203 Czech Republic), Stefan VOLOVAR (203 Czech Republic), Miroslava SEYFRYDOVA (203 Czech Republic), Jiří JARKOVSKÝ (203 Czech Republic, belonging to the institution), Michal SVOBODA (203 Czech Republic, belonging to the institution), Ales LINHART (203 Czech Republic) and Jan BELOHLAVEK (203 Czech Republic)

Edition

Circulation, Philadelphia, Lippincott Williams Wilkins, 2023, 0009-7322

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30201 Cardiac and Cardiovascular systems

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 37.800 in 2022

RIV identification code

RIV/00216224:14110/23:00131021

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1161/CIRCULATIONAHA.122.062949

UT WoS

000931323600004

Keywords in English

clinical trial; shock; cardiogenic; therapy

Abstract

V originále

Background: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly being used for circulatory support in patients with cardiogenic shock, although the evidence supporting its use in this context remains insufficient. The ECMO-CS trial (Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock) aimed to compare immediate implementation of VA-ECMO versus an initially conservative therapy (allowing downstream use of VA-ECMO) in patients with rapidly deteriorating or severe cardiogenic shock.Methods: This multicenter, randomized, investigator-initiated, academic clinical trial included patients with either rapidly deteriorating or severe cardiogenic shock. Patients were randomly assigned to immediate VA-ECMO or no immediate VA-ECMO. Other diagnostic and therapeutic procedures were performed as per current standards of care. In the early conservative group, VA-ECMO could be used downstream in case of worsening hemodynamic status. The primary end point was the composite of death from any cause, resuscitated circulatory arrest, and implementation of another mechanical circulatory support device at 30 days.Results: A total of 122 patients were randomized; after excluding 5 patients because of the absence of informed consent, 117 subjects were included in the analysis, of whom 58 were randomized to immediate VA-ECMO and 59 to no immediate VA-ECMO. The composite primary end point occurred in 37 (63.8%) and 42 (71.2%) patients in the immediate VA-ECMO and the no early VA-ECMO groups, respectively (hazard ratio, 0.72 [95% CI, 0.46-1.12]; P=0.21). VA-ECMO was used in 23 (39%) of no early VA-ECMO patients. The 30-day incidence of resuscitated cardiac arrest (10.3.% versus 13.6%; risk difference, -3.2 [95% CI, -15.0 to 8.5]), all-cause mortality (50.0% versus 47.5%; risk difference, 2.5 [95% CI, -15.6 to 20.7]), serious adverse events (60.3% versus 61.0%; risk difference, -0.7 [95% CI, -18.4 to 17.0]), sepsis, pneumonia, stroke, leg ischemia, and bleeding was not statistically different between the immediate VA-ECMO and the no immediate VA-ECMO groups.Conclusions: Immediate implementation of VA-ECMO in patients with rapidly deteriorating or severe cardiogenic shock did not improve clinical outcomes compared with an early conservative strategy that permitted downstream use of VA-ECMO in case of worsening hemodynamic status.Registration:URL: ; Unique identifier: NCT02301819.

Citovat

OSTADAL, Petr, Richard ROKYTA, Jiri KARASEK, Andreas KRUGER, Dagmar VONDRAKOVA, Marek JANOTKA, Jan NAAR, Jana SMALCOVA, Marketa HUBATOVA, Milan HROMADKA, Stefan VOLOVAR, Miroslava SEYFRYDOVA, Jiří JARKOVSKÝ, Michal SVOBODA, Ales LINHART and Jan BELOHLAVEK. Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock: Results of the ECMO-CS Randomized Clinical Trial. Circulation. Philadelphia: Lippincott Williams Wilkins, 2023, vol. 147, No 6, p. 454-464. ISSN 0009-7322. Available from: https://dx.doi.org/10.1161/CIRCULATIONAHA.122.062949.

@article{2292979,
   author = {Ostadal, Petr and Rokyta, Richard and Karasek, Jiri and Kruger, Andreas and Vondrakova, Dagmar and Janotka, Marek and Naar, Jan and Smalcova, Jana and Hubatova, Marketa and Hromadka, Milan and Volovar, Stefan and Seyfrydova, Miroslava and Jarkovský, Jiří and Svoboda, Michal and Linhart, Ales and Belohlavek, Jan},
   article_location = {Philadelphia},
   article_number = {6},
   doi = {http://dx.doi.org/10.1161/CIRCULATIONAHA.122.062949},
   keywords = {clinical trial; shock; cardiogenic; therapy},
   language = {eng},
   issn = {0009-7322},
   journal = {Circulation},
   title = {Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock: Results of the ECMO-CS Randomized Clinical Trial},
   url = {https://www.ahajournals.org/doi/suppl/10.1161/CIRCULATIONAHA.122.062949},
   volume = {147},
   year = {2023}
}

TY  - JOUR
ID  - 2292979
AU  - Ostadal, Petr - Rokyta, Richard - Karasek, Jiri - Kruger, Andreas - Vondrakova, Dagmar - Janotka, Marek - Naar, Jan - Smalcova, Jana - Hubatova, Marketa - Hromadka, Milan - Volovar, Stefan - Seyfrydova, Miroslava - Jarkovský, Jiří - Svoboda, Michal - Linhart, Ales - Belohlavek, Jan
PY  - 2023
TI  - Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock: Results of the ECMO-CS Randomized Clinical Trial
JF  - Circulation
VL  - 147
IS  - 6
SP  - 454-464
EP  - 454-464
PB  - Lippincott Williams Wilkins
SN  - 00097322
KW  - clinical trial
KW  - shock
KW  - cardiogenic
KW  - therapy
UR  - https://www.ahajournals.org/doi/suppl/10.1161/CIRCULATIONAHA.122.062949
N2  - Background: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly being used for circulatory support in patients with cardiogenic shock, although the evidence supporting its use in this context remains insufficient. The ECMO-CS trial (Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock) aimed to compare immediate implementation of VA-ECMO versus an initially conservative therapy (allowing downstream use of VA-ECMO) in patients with rapidly deteriorating or severe cardiogenic shock.Methods: This multicenter, randomized, investigator-initiated, academic clinical trial included patients with either rapidly deteriorating or severe cardiogenic shock. Patients were randomly assigned to immediate VA-ECMO or no immediate VA-ECMO. Other diagnostic and therapeutic procedures were performed as per current standards of care. In the early conservative group, VA-ECMO could be used downstream in case of worsening hemodynamic status. The primary end point was the composite of death from any cause, resuscitated circulatory arrest, and implementation of another mechanical circulatory support device at 30 days.Results: A total of 122 patients were randomized; after excluding 5 patients because of the absence of informed consent, 117 subjects were included in the analysis, of whom 58 were randomized to immediate VA-ECMO and 59 to no immediate VA-ECMO. The composite primary end point occurred in 37 (63.8%) and 42 (71.2%) patients in the immediate VA-ECMO and the no early VA-ECMO groups, respectively (hazard ratio, 0.72 [95% CI, 0.46-1.12]; P=0.21). VA-ECMO was used in 23 (39%) of no early VA-ECMO patients. The 30-day incidence of resuscitated cardiac arrest (10.3.% versus 13.6%; risk difference, -3.2 [95% CI, -15.0 to 8.5]), all-cause mortality (50.0% versus 47.5%; risk difference, 2.5 [95% CI, -15.6 to 20.7]), serious adverse events (60.3% versus 61.0%; risk difference, -0.7 [95% CI, -18.4 to 17.0]), sepsis, pneumonia, stroke, leg ischemia, and bleeding was not statistically different between the immediate VA-ECMO and the no immediate VA-ECMO groups.Conclusions: Immediate implementation of VA-ECMO in patients with rapidly deteriorating or severe cardiogenic shock did not improve clinical outcomes compared with an early conservative strategy that permitted downstream use of VA-ECMO in case of worsening hemodynamic status.Registration:URL: ; Unique identifier: NCT02301819.
ER  -

OSTADAL, Petr, Richard ROKYTA, Jiri KARASEK, Andreas KRUGER, Dagmar VONDRAKOVA, Marek JANOTKA, Jan NAAR, Jana SMALCOVA, Marketa HUBATOVA, Milan HROMADKA, Stefan VOLOVAR, Miroslava SEYFRYDOVA, Jiří JARKOVSKÝ, Michal SVOBODA, Ales LINHART and Jan BELOHLAVEK. Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock: Results of the ECMO-CS Randomized Clinical Trial. \textit{Circulation}. Philadelphia: Lippincott Williams Wilkins, 2023, vol.~147, No~6, p.~454-464. ISSN~0009-7322. Available from: https://dx.doi.org/10.1161/CIRCULATIONAHA.122.062949.

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