CytoSorb Therapy in COVID-19 (CTC) Patients Requiring Extracorporeal Membrane Oxygenation: A Multicenter, Retrospective Registry.

Tae Song,Mark Jaros,Andy Barksdale,Paul Mccarthy,Jeremiah Hayanga,Lucian Durham,Efthymios Deliargyris,Zsolt Molnar,Robert Bartlett,Peter Nelson,Nader Moazami,Lawrence Garrison,Deane Smith

doi:10.3389/fmed.2021.773461

Abstract

Introduction: CytoSorb extracorporeal blood purification therapy received FDA Emergency Use Authorization (EUA) to suppress hyperinflammation in critically ill COVID-19 patients. The multicenter CTC Registry was established to systematically collect patient-level data, outcomes, and utilization patterns of CytoSorb under the EUA.Methods: Patient-level data was entered retrospectively at participating centers. The primary outcome of the registry was ICU mortality. Patient disposition of death, continuing ICU care, or ICU discharge was analyzed up to Day 90 after start of CytoSorb therapy. Demographics, comorbidities, COVID-19 medications, inflammatory biomarkers, and details on CytoSorb use were compared between survivors and non-survivors in the veno-venous extracorporeal membrane oxygenation (ECMO) cohort.Results: Between April 2020 and April 2021, 52 patients received veno-venous ECMO plus CytoSorb therapy at 5 U.S. centers. ICU mortality was 17.3% (9/52) on day 30, 26.9% (14/52) on day 90, and 30.8% (16/52) at final follow-up of 153 days. Survivors had a trend toward lower baseline D-Dimer levels (2.3 ± 2.5 vs. 19.8 ± 32.2 μg/mL, p = 0.056) compared to non-survivors. A logistic regression analysis suggested a borderline association between baseline D-Dimer levels and mortality with a 32% increase in the risk of death per 1 μg/mL increase (p = 0.055). CytoSorb was well-tolerated without any device-related adverse events reported.Conclusions: CytoSorb therapy for critically ill COVID-19 patients on ECMO was associated with high survival rates suggesting potential therapeutic benefit. Elevated baseline D-Dimer levels may suggest increased risk of mortality. Prospective controlled studies are warranted to substantiate these results.Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT0439192, identifier: NCT04391920.

Highlights

CytoSorb extracorporeal blood purification therapy received Food and Drug Administration (FDA) Emergency Use Authorization (EUA) to suppress hyperinflammation in critically ill COVID-19 patients
CytoSorb therapy for critically ill COVID-19 patients on extracorporeal membrane oxygenation (ECMO) was associated with high survival rates suggesting potential therapeutic benefit
Between April 2020 and April 2021, 52 intensive care units (ICU) COVID-19 patients on ECMO were treated with CytoSorb therapy under EUA at 5 U.S centers

Summary

Introduction

CytoSorb extracorporeal blood purification therapy received FDA Emergency Use Authorization (EUA) to suppress hyperinflammation in critically ill COVID-19 patients. In the United States (U.S.) alone, mortality data from the Centers For Disease Control and Prevention (CDC) report that over 640,000 COVID-19 patients have died as of September 2021, mostly after admission to the ICU [2]. To help address this unmet need, the U.S Food and Drug Administration (FDA) has issued multiple Emergency Use Authorizations (EUA) since the start of the pandemic. Under the EUA, the intent of CytoSorb therapy for COVID-19 patients requiring ECMO is to reduce circulating inflammatory cytokines and other mediators that can cause ongoing injury to the lungs

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