Executive Summary
The CEDIT (hospital based HTA agency) of AP-HP (Paris University Hospital) assessed the impact and value of extracorporeal membrane oxygenation (ECMO) used in a pre-hospital setting, for patients with refractory cardiac arrests. This assessment follows a request from an advanced life support unit from Necker Hospital to use the Cardiohelp® device (Maquet) for this purpose.
Technical aspects: setting up a veno-arterial ECMO system in an extra-hospital environment raises questions about the equipment, the conditions and the environment in which it is used. The technical description of ECMO devices has already been done in previous documents. Currently, the device best suited to an extra-hospital use is Cardiohelp®, due to its compact design and low weight. The introduction of the cannulas exposes the patient to risks of infection, bleeding and ischemia, if staff in charge of this intervention is not sufficiently trained and does not have experience of this kind of practice.
Clinical aspects: in patients with refractory cardiac arrest, the early implementation of hospital ECMO (less than 1 hour time or even 30 min.) increases the survival with favorable neurological status. The feasibility of using ECMO outside hospitals was studied in a trial on 7 patients by an emergency unit in Paris and has yet to be confirmed ; no other data is currently available. The comparative prospective study planned by the team of the Necker Hospital aims to demonstrate the clinical relevance of using ECMO outside hospitals and should provide the missing medical evidence.
Economic aspects: no economic study is currently available on the use of pre-hospital ECMO. As part of the proposed study by the team at the Necker Hospital, the collection of economic data could be performed to determine at the same time the medical and economic impacts of this new modality of support, compared to existing alternative.
It should be remarked that as part of the alternative treatment which is ECMO initiated at the hospital, classic ECMO devices that are cheaper than Cardiohelp® could be used.
Organizational and ethical aspects: the early use of ECMO for patients with refractory cardiac arrest requires a common policy framework and organization for the mobile and hospital teams, ensuring both safety and speed of use.
Under the principle of disconnection between the decision to stop therapy and the non-heart beating donations Maastricht III, ECMO is put in place only for the benefit of the patient with cardiac arrest. If unsuccessful, the decision to stop therapy is taken. It is from that moment that organ removal may be considered. In the light of this reflection, it may be useful to consider the difficulties of guaranteeing the principle of disconnection in real extra-hospital practice.
Recommendations of CEDIT:
- The small number of cases published argue for the feasibility of veno-arterial ECMO performed in a pre-hospital setting, but the level of evidence is low and the feasibility has to be confirmed. There is currently no conclusive evidence of efficacy and clinical safety.
- The few elements of presumption existing could warrant a clinical study comparing hospital and pre-hospital ECMO. The study is to demonstrate the clinical benefit of pre-hospital ECMO and provide arguments lacking in terms of medical evidence (eg understanding of the risk of infection and ischemic consequences for the canulated limb).
- Given the medical, economic and organizational uncertainties, CEDIT recommends that the use of veno-arterial pre-hospital ECMO at AP-HP should only be made in the context of a clinical trial involving a cooperation between the different teams.
- CEDIT wishes to re-evaluate the pre-hospital use of ECMO in the light of the results of this study.
- The importance of the subject could justify a national assessment.
