Longitudinal Trends in Bleeding Complications on Extracorporeal Life Support (ECLS) Over the Past Two Decades – ELSO Registry Analysis (preprint)

Background: The use of extracorporeal life support (ECLS) has increased worldwide over the last decade including for new emerging indications like extracorporeal cardiopulmonary resuscitation, trauma, and COVID-19. Bleeding complications remain feared and frequent, with high morbidity and increased mortality. Yet, data about trends, and in-hospital outcomes, have been poorly investigated.Methods: The Extracorporeal Life Support Organization (ELSO) Registry database was explored for patients who received veno-venous (V-V) and veno-arterial (V-A) ECLS between the years 2000 and 2020. Trends in bleeding complications and mortality were analyzed. Bleeding complications were classified according to site (gastro-intestinal, cannulation site, surgical site, pulmonary, tamponade and central nervous system) and analyzed separately. Multivariable analysis was performed to identify risk factors for bleeding complications.Results: ELSO database analysis included 53.644 patients with single ECLS runs, mean age 51.4± 15.9 years, 33.859 (64.5%) male. Study cohort included 19.748 patients cannulated for V-V ECLS and 30.696 patients for V-A ECLS. Bleeding complications were reported in 14.786 patients (27.6%) and occurred more often in V-A-modalities compared to V-V modalities (30.0% versus 21.9%, p<0.001). Patients with a bleeding complication had a lower hospital survival in the V-V ECLS (49.6% versus 66.6%, p<0.001) and V-A ECLS subgroup (33.9 versus 44.9%, p<0.001). Bleeding complications in V-V ECLS and V-A ECLS have been decreasing over the past two decades with coefficient of -1.124; P<0.001 and -1.661; P<0.001, respectively. Cannulation site bleeding and surgical site bleeding rates showed the highest negative trend in both V-V and V-A ECLS patients. No change in mortality rates over time in V-V or V-A ECLS patients (coef.: -0.147; P=0.442 and coef.: -0.195; P=0.139) was observed. For V-V ECLS supported patients, multivariate regression revealed the following independent association with bleeding: advanced age, ECLS duration, surgical cannulation, pre-ECLS support with cardiopulmonary bypass, renal replacement therapy, prone positioning, vasodilatory and anti-hypotensive agents. For V-A ECLS supported patients, predictors for bleeding included: female gender, ECLS duration, pre-ECLS arrest or bridge to transplant, therapeutic hypothermia, surgical cannulation and pre-ECLS support with cardiopulmonary bypass, ventricular assist devices, cardiac pacemakers, vasodilatory and anti-hypotensive agents.Conclusions: The steady decrease in particular cannulation and surgical site related bleeding complications over the past 20 years suggests advances in equipment development (membrane and tubes surfaces) as well as better understanding of anticoagulation management. However, the high incidence of bleeding and association with hospital mortality reinforces the need for studies to understand bleeding complications more thoroughly during ECLS.Funding Information: No funding.Declaration of Interests: Prof. Dr. Lorusso is a consultant for Medtronic, Getinge and LivaNova and medical advisory board member for EUROSETS, all unrelated to this work; all honoraria to the university for research funding. Dr. Tonna is supported by a Career Development Award from the National Institutes of Health/National Heart, Lung, And Blood Institute (K23 HL141596). Dr. Tonna received speaker fees and travel compensation from LivaNova and Philips Healthcare, unrelated to this work. Prof. Ten Cate received research support from Bayer and Pfizer, is a consultant for Alveron and stockholder with Coagulation Profile; all unrelated to this work. Prof Zoe McQuilten is supported by an Australian National Health and Medical Council (NHMRC) Investigator Grant.Other authors have no conflict of interest to declare.Ethics Approval Statement: Each institution participating in ELSO Registry approves data reported to the registry through their local institutional review board. This study involved only analysis of pre-existing de-identified data from an international registry, and as such no ethics approval was required. Similarly, no patient consent was required.

Extracorporeal Membrane Oxygenation in COVID-19-Related Acute Respiratory Distress Syndrome – A EuroELSO International Survey (preprint)

Extracorporeal membrane oxygenation (ECMO) is a means to support patients with acute respiratory failure. Initially, recommendations to treat severe cases of pandemic Coronavirus Disease 2019 (COVID-19) with ECMO have been restrained. In the meantime, ECMO has been shown to produce similar outcomes in patients with severe COVID-19 compared to existing data on ARDS mortality.Objective: We performed an international email survey to assess how ECMO providers worldwide have previously used ECMO during the treatment of critically ill patients with COVID-19.MethodsA questionnaire with 45 questions (covering e.g. indication, technical aspects, benefit and reasons for treatment discontinuation), mostly multiple-choice, was distributed by email to ECMO centers. The survey was approved by the European branch of the Extracorporeal Life Support Organization (ELSO).Results: 276 centers worldwide responded that they employed ECMO for very severe COVID-19 cases, mostly in veno-venous configuration (87%). The most common reason to establish ECMO was isolated hypoxemic respiratory failure (50%), followed by a combination of hypoxemia and hypercapnia (39%). Only a small fraction of patients required veno-arterial cannulation due to heart failure (3%). Time on ECMO varied between less than two and more than four weeks. The main reason to discontinue ECMO treatment prior to patient’s recovery was lack of clinical improvement (53%), followed by major bleeding, mostly intracranially (13%). Only 4% of respondents reported that triage situations, lack of staff or lack of oxygenators were responsible for discontinuation of ECMO support. Most ECMO physicians (66% ± 26%) agreed that patients with COVID-19 induced ARDS (CARDS) benefitted from ECMO. Overall mortality of COVID-19 patients on ECMO was estimated to be about 55%, scoring higher than what has previously been reported for Influenza patients on ECMO (29 – 36%).Conclusion: ECMO has been utilized successfully during the COVID-19 pandemic to stabilize CARDS patients in hypoxemic or hypercapnic lung failure. Age and multimorbidity limited the use of ECMO. Triage situations were rarely a concern. ECMO providers stated that patients with severe COVID-19 benefitted from ECMO. An increasing use in patients with respiratory failure in a future stage of the pandemic may be expected.Funding Statement: COVID-19 research was funded by the Federal state of Saarland, Saarland University and Dr. Rolf M. Schwiete Foundation.Declaration of Interests: Robert Bals declares funding from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Grifols, Novartis, CLS Behring, the German Federal Ministry of Education and Research (BMBF) Competence Network Asthma and COPD (ASCONET), Sander-Stiftung, Schwiete-Stiftung, Krebshilfe and Mukoviszidose eV. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. All other authors: No potential conflicts of interest.Ethics Approval Statement: The ethical committee (Ärztekammer des Saarlandes) waived the need for a formal approval since the questionnaire did not retrieve actual patient data.

Managing Patients on Extracorporeal Membrane Oxygenation Support During The COVID-19 Pandemic – A Proposal for A Nursing Standard Operating Procedure (preprint)

Background: Extracorporeal membrane oxygenation (ECMO) therapy is proven to be efficient in a selected critically ill patient population and is showing promising results in refractory hypoxemia in the novel coronavirus disease (COVID-19). However, it necessitates specialized clinicians and advanced technological resources. While COVID-19 is an ongoing global emergency, there is no evidence-based practice in preparedness. This article proposes an innovative and optimized nursing care protocol, the Standard Operating Procedure (SOP), that increase safety, and prevents overuse of personal protective equipment (PPE) without interfering with therapy during ECMO in COVID-19 patients. Methods: A high-fidelity simulation scenario was developed. It included practicing safe and proper PPE donning and doffing during work organization, ECMO cannulation and ECMO-related procedures, and routine daily nursing care and management of patients on ECMO over nine hours. Results: Results were collected in three parts – proposal of nursing standardized operating procedures. They provide including work organization, work load references, competences and infrastructural conditions. Additionally, the cannulation equipment checklist proposal and daily routine nursing algorithm with other procedures during extracorporeal support were created.Conclusions: High-fidelity medical simulation can play an important role in staff training, improvement in previously gained proficiency, and development of optimal SOP for nursing care and management during ECMO in patients with COVID-19. Optimal SOPs may further guide multidisciplinary teams including intensive care units and interventional departments.