TY - JOUR
T1 - A 2-year multicenter, observational, prospective, cohort study on extracorporeal CO2 removal in a large metropolis area
AU - Augy, J. L.
AU - Aissaoui, N.
AU - Richard, C.
AU - Maury, E.
AU - Fartoukh, M.
AU - Mekontso-Dessap, A.
AU - Paulet, R.
AU - Anguel, N.
AU - Blayau, C.
AU - Cohen, Y.
AU - Chiche, J. D.
AU - Gaudry, S.
AU - Voicu, S.
AU - Demoule, A.
AU - Combes, A.
AU - Megarbane, B.
AU - Charpentier, E.
AU - Haghighat, S.
AU - Panczer, M.
AU - Diehl, J. L.
N1 - Funding Information:
Accordingly, within the great Paris area, the use of the ECCO2R as part of the current care was rigorously organized. As a result of a referral, a report (supported by a clinician’s interviews and by a systematic analysis of the literature) was released in June 2014 by an institutional Agency for Health Technology Assessment attached to the Assistance Publique–Hôpitaux de Paris (AP-HP) [17]. The main recommendations were to establish a working group led by clinicians able to give a scientific opinion on the appropriateness of the ECCO2R activity, to authorize the use of ECCO2R in selected voluntary centers, to organize a systematic recording of the activity on an individual basis, and to reassess periodically the ECCO2R activity (on the basis of the available literature and of results of records). The project was supported by the Office of Technology Transfer and Partnerships Industrialists of the AP-HP and by the Institutional Pharmacy Agency (AGEPS). Test markets were concluded by the AGEPS with industrial firms, with a strict follow-up of the orders. We here report our initial experience based on the first 70 patients included in the corresponding registry.
Publisher Copyright:
© 2019 The Author(s).
PY - 2019/8/20
Y1 - 2019/8/20
N2 - Background: Extracorporeal carbon dioxide removal (ECCO2R) is a promising technique for the management of acute respiratory failure, but with a limited level of evidence to support its use outside clinical trials and/or data collection initiatives. We report a collaborative initiative in a large metropolis. Methods: To assess on a structural basis the rate of utilization as well as efficacy and safety parameters of 2 ECCO2R devices in 10 intensive care units (ICU) during a 2-year period. Results: Seventy patients were recruited in 10 voluntary and specifically trained centers. The median utilization rate was 0.19 patient/month/center (min 0.04; max 1.20). ECCO2R was started under invasive mechanical ventilation (IMV) in 59 patients and non-invasive ventilation in 11 patients. The Hemolung Respiratory Assist System (Alung) was used in 53 patients and the iLA Activve iLA kit (Xenios Novalung) in 17 patients. Main indications were ultraprotective ventilation for ARDS patients (n = 24), shortening the duration of IMV in COPD patients (n = 21), preventing intubation in COPD patients (n = 9), and controlling hypercapnia and dynamic hyperinflation in mechanically ventilated patients with severe acute asthma (n = 6). A reduction in median V T was observed in ARDS patients from 5.9 to 4.1 ml/kg (p <0.001). A reduction in PaCO2 values was observed in AE-COPD patients from 67.5 to 51 mmHg (p< 0.001). Median duration of ECCO2R was 5 days (IQR 3-8). Reasons for ECCO2R discontinuation were improvement (n = 33), ECCO2R-related complications (n = 18), limitation of life-sustaining therapies or measures decision (n = 10), and death (n = 9). Main adverse events were hemolysis (n = 21), bleeding (n = 17), and lung membrane clotting (n = 11), with different profiles between the devices. Thirty-five deaths occurred during the ICU stay, 3 of which being ECCO2R-related. Conclusions: Based on a registry, we report a low rate of ECCO2R device utilization, mainly in severe COPD and ARDS patients. Physiological efficacy was confirmed in these two populations. We confirmed safety concerns such as hemolysis, bleeding, and thrombosis, with different profiles between the devices. Such results could help to design future studies aiming to enhance safety, to demonstrate a still-lacking strong clinical benefit of ECCO2R, and to guide the choice between different devices. Trial registration: ClinicalTrials.gov: Identifier: NCT02965079 retrospectively registered https://clinicaltrials.gov/ct2/show/NCT02965079
AB - Background: Extracorporeal carbon dioxide removal (ECCO2R) is a promising technique for the management of acute respiratory failure, but with a limited level of evidence to support its use outside clinical trials and/or data collection initiatives. We report a collaborative initiative in a large metropolis. Methods: To assess on a structural basis the rate of utilization as well as efficacy and safety parameters of 2 ECCO2R devices in 10 intensive care units (ICU) during a 2-year period. Results: Seventy patients were recruited in 10 voluntary and specifically trained centers. The median utilization rate was 0.19 patient/month/center (min 0.04; max 1.20). ECCO2R was started under invasive mechanical ventilation (IMV) in 59 patients and non-invasive ventilation in 11 patients. The Hemolung Respiratory Assist System (Alung) was used in 53 patients and the iLA Activve iLA kit (Xenios Novalung) in 17 patients. Main indications were ultraprotective ventilation for ARDS patients (n = 24), shortening the duration of IMV in COPD patients (n = 21), preventing intubation in COPD patients (n = 9), and controlling hypercapnia and dynamic hyperinflation in mechanically ventilated patients with severe acute asthma (n = 6). A reduction in median V T was observed in ARDS patients from 5.9 to 4.1 ml/kg (p <0.001). A reduction in PaCO2 values was observed in AE-COPD patients from 67.5 to 51 mmHg (p< 0.001). Median duration of ECCO2R was 5 days (IQR 3-8). Reasons for ECCO2R discontinuation were improvement (n = 33), ECCO2R-related complications (n = 18), limitation of life-sustaining therapies or measures decision (n = 10), and death (n = 9). Main adverse events were hemolysis (n = 21), bleeding (n = 17), and lung membrane clotting (n = 11), with different profiles between the devices. Thirty-five deaths occurred during the ICU stay, 3 of which being ECCO2R-related. Conclusions: Based on a registry, we report a low rate of ECCO2R device utilization, mainly in severe COPD and ARDS patients. Physiological efficacy was confirmed in these two populations. We confirmed safety concerns such as hemolysis, bleeding, and thrombosis, with different profiles between the devices. Such results could help to design future studies aiming to enhance safety, to demonstrate a still-lacking strong clinical benefit of ECCO2R, and to guide the choice between different devices. Trial registration: ClinicalTrials.gov: Identifier: NCT02965079 retrospectively registered https://clinicaltrials.gov/ct2/show/NCT02965079
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U2 - 10.1186/s40560-019-0399-8
DO - 10.1186/s40560-019-0399-8
M3 - Article
C2 - 31452899
AN - SCOPUS:85070946119
SN - 2052-0492
VL - 7
JO - Journal of Intensive Care
JF - Journal of Intensive Care
IS - 1
M1 - 45
ER -