A 2-year multicenter, observational, prospective, cohort study on extracorporeal CO2 removal in a large metropolis area

J L Augy, N Aissaoui, C Richard, E Maury, M Fartoukh, A Mekontso-Dessap, R Paulet, N Anguel, C Blayau, Y Cohen, J D Chiche, S Gaudry, S Voicu, A Demoule, A Combes, B Megarbane, E Charpentier, S Haghighat, M Panczer, J L Diehl, J L Augy, N Aissaoui, C Richard, E Maury, M Fartoukh, A Mekontso-Dessap, R Paulet, N Anguel, C Blayau, Y Cohen, J D Chiche, S Gaudry, S Voicu, A Demoule, A Combes, B Megarbane, E Charpentier, S Haghighat, M Panczer, J L Diehl

Abstract

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://ichgcp.net/clinical-trials-registry/NCT02965079.

Keywords: Acute respiratory distress syndrome; COPD exacerbation; Extracorporeal CO2 removal; Safety.

Conflict of interest statement

Competing interestsDr. Diehl reported receiving research support and personal fees from Alung and Novalung/Xenios.

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Source: PubMed

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