All ELSO site data managers receive detailed instructions and database definitions to guide data entry, and they all must pass the data entry exam in order to enter data into the ELSO Registry.
Accuracy is augmented by a point-of-entry data assessment with error and validity checks. There is also a full record validation triggered on submission of the record that ensures all mandatory fields are completed.
The data collected consist of the standard elements reported for all ECMO runs and additional elements entered into the newly created COVID addendum appendix pp 10— Follow-up data were updated until Aug 3, This subset of patients provided a more focused report on patients classified to have ARDS and receiving respiratory support alone via venovenous ECMO.
A time-to-event outcome was necessary because all patients might not have a final disposition at the time of database lock, and calculating in-hospital mortality without accounting for differential follow-up between patients would result in length-time bias. Records in which the last update indicated that the patient had not died, been discharged, or completed 90 days of follow-up after ECMO initiation were administratively censored at the time of their last update.
A patient being discharged alive to home or to an acute rehabilitation centre, discharged to a long-term acute care centre or unspecified location, or discharged to another hospital were treated as distinct competing events for the primary outcome of in-hospital mortality.
We also report proportion of in-hospital deaths in patients who reached a final disposition of death or discharge from the hospital. Secondary outcomes were the proportion of patients remaining in the intensive care unit ICU , discharged from the ICU but who remain hospitalised, discharged to home or an acute rehabilitation centre, discharged to a long-term acute care centre or unspecified location, and discharged to another hospital.
We report ECMO duration, hospital length of stay, tracheostomy use, discharge location, acute kidney injury related to the current illness, use of renal replacement therapy during ECMO regardless of indication , and the occurrence of complications while receiving ECMO. Descriptive statistics are provided as median IQR for continuous variables and as count and proportion for categorical variables. We calculated the Aalen—Johansen estimators of cumulative incidence of in-hospital mortality measured 90 days after ECMO initiation with discharged alive to home and discharged alive to another location treated as competing events.
The validity of this estimator requires the standard independent censoring assumption 15 —namely, that the mechanism in which patients are censored is statistically independent of the mechanisms in which patients die or are discharged appendix pp 11— To account for follow-up that is cut short by event incidence death or discharge , we estimated potential follow-up using reverse Kaplan-Meier methodology.
To estimate the relative risks between potential risk factors and mortality, we fit a Cox proportional hazards model for the primary outcome of death appendix pp 12—14, We censored patients who were still hospitalised at the time of the run's last registry update and those who were discharged alive at the time of their discharge date.
The Cox model estimated the hazard for death as a function of a linear combination of the following prespecified set of patient-level variables: age, race, sex, chronic cardiac disease, chronic respiratory disease excluding asthma , asthma, diabetes, cancer, immunocompromised state, duration of pre-ECMO intubation, the partial pressure of arterial oxygen to fraction of inspired oxygen ratio PaO 2 :FiO 2 , the partial pressure of arterial carbon dioxide, a diagnosis of acute kidney injury, cardiac arrest before ECMO, and initial ECMO mode venovenous vs venoarterial or venovenoarterial.
Venovenous ECMO support drains and returns blood to the systemic venous system to support the lungs, whereas venoarterial ECMO support drains systemic venous blood and returns blood to the systemic arterial system and can provide heart and lung support. Venovenoarterial ECMO returns blood to both the venous and the arterial systems, and provides both heart and lung support. We generated a second Cox model to estimate the hazard for death that was identical to the previous one with addition of the centre-level covariate, adult ECMO case volume.
If a centre entered reported cases before , but had no cases in an existing ELSO centre , that centre's cases were included and the ECMO centre volume was measured as zero. Multiple imputation was used to account for missing values in predictor variables.
Briefly, we used fully specified chained equations in the R package. All continuous variables apart from age were log 2 -transformed before model fitting. The parameter of interest from a Cox model is the hazard ratio HR , which describes the relative risk of in-hospital mortality associated with a change in a covariate. Robust sandwich-type estimates of the standard errors were used to account for centre-level clustering. All analyses were done with R version 3. There was no funding source for this study.
Staphylococcus aureus was the most commonly cultured organism for bacterial pneumonia and bloodstream infections. However, individual complications occurred relatively infrequently. No patients discharged alive to another facility were discharged to hospice. Discharged home or rehab refers to patients who were discharged to home or an acute rehabilitation centre. Discharge hospital refers to patients who were discharged to another hospital. Unknown status censored refers to patients who at the time of data analysis did not meet one of the following three criteria: 1 died, 2 discharged alive, or 3 survived at least 90 days after ECMO initiation.
Patients with acute kidney injury, chronic respiratory insufficiency, an immunocompromised state, or a pre-ECMO cardiac arrest had an associated higher risk of mortality.
Sex, body-mass index, race, and hours from endotracheal intubation to ECMO initiation were not independently associated with mortality. In this study, higher hospital ECMO case volume was not associated with lower mortality.
Our findings cannot be extrapolated to inexperienced centres. Patients surviving critical illness, 26 ARDS, 27 and ECMO support 23 often have disability that might require prolonged hospital stay or rehabilitation. In this study, few patients were discharged home; rather, the majority were transferred to either rehabilitation or long-term acute care facilities or another hospital to continue recovery. These data highlight the need for future studies to focus on the long-term outcomes of these patients.
Our study has important limitations. First, the ELSO Registry did not externally validate the submitted data or validate that all consecutive cases initiated between Jan 16 and May 1, , were submitted.
These centres were self-selected and needed to have the resources to submit patient data, particularly during a pandemic. Second, although the survival analyses for the primary outcome of mortality account for the incomplete follow-up, we might have underestimated the reported prevalence of complications during ECMO, given that not all patients had completed their ECMO course at the time of reporting.
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