Cost-effectiveness in extracorporeal life support in critically ill adults in the Netherlands

Annemieke Oude Lansink-Hartgring, Dinis Dos Reis Miranda, Dirk W Donker, Jacinta J Maas, Thijs Delnoij, Marijn Kuijpers, Judith van den Brule, Erik Scholten, Hendrik Endeman, Alexander P J Vlaar, Walter M van den Bergh, Dutch ECLS study group, Annemieke Oude Lansink-Hartgring, Dinis Dos Reis Miranda, Dirk W Donker, Jacinta J Maas, Thijs Delnoij, Marijn Kuijpers, Judith van den Brule, Erik Scholten, Hendrik Endeman, Alexander P J Vlaar, Walter M van den Bergh, Dutch ECLS study group

Abstract

Background: Extracorporeal life support (ECLS) is used to support the cardiorespiratory function in case of severe cardiac and/or respiratory failure in critically ill patients. According to the ELSO guidelines ECLS should be considered when estimated mortality risk approximates 80%. ECLS seems an efficient therapy in terms of survival benefit, but no undisputed evidence is delivered yet. The aim of the study is to assess the health-related quality of life after ECLS treatment and its cost effectiveness.

Methods: We will perform a prospective observational cohort study. All adult patients who receive ECLS in the participating centers will be included. Exclusion criteria are patients in whom the ECLS is only used to bridge a procedure (like a high risk percutaneous coronary intervention or surgery) or the absence of informed consent. Data collection includes patient characteristics and data specific for ECLS treatment. Severity of illness and mortality risk is measured as precisely as possible using measurements for the appropriate age group and organ failure. For analyses on survival patients will act as their own control as we compare the actual survival with the estimated mortality on initiation of ECLS if conservative treatment would have been continued. Survivors are asked to complete validated questionnaires on health related quality of life (EQ5D-5 L) and on medical consumption and productivity losses (iMTA/iPCQ) at 6 and 12 months. Also the health related quality of life 1 month prior to ECLS initiation will be obtained by a questionnaire, if needed provided by relatives. With an estimated overall survival of 62% 210 patients need to be recruited to make a statement on cost effectiveness for all ECLS indications.

Discussion: If our hypothesis that ECLS treatment is cost-effective is confirmed by this prospective study this could lead to an even broader use of ECLS treatment.

Trial registration: The trial is registered at ( NCT02837419 ) registration date July 19, 2016 and with the Dutch trial register, http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6599.

Keywords: Cost-effectiveness; Critical care; Extracorporeal life support; Intensive care unit; Outcome; Quality of life.

Conflict of interest statement

Ethics approval and consent to participate

The need for ethical approval was waived by the Medical Ethical committee from the University Medical Center Groningen (METc 2017/196). Written informed consent will be obtained from all patients or legal representatives.

Participating centers have signed an intent to participate.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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