Publications by authors named "Daniel Brodie"

222 Publications

Pulmonary Embolism Response Team utilization during the COVID-19 pandemic.

Vasc Med 2021 Apr 4:1358863X21995896. Epub 2021 Apr 4.

Department of Cardiology, Columbia Irving Medical Center, New York, NY, USA.

Coronavirus disease 2019 (COVID-19) may predispose patients to venous thromboembolism (VTE). Limited data are available on the utilization of the Pulmonary Embolism Response Team (PERT) in the setting of the COVID-19 global pandemic. We performed a single-center study to evaluate treatment, mortality, and bleeding outcomes in patients who received PERT consultations in March and April 2020, compared to historical controls from the same period in 2019. Clinical data were abstracted from the electronic medical record. The primary study endpoints were inpatient mortality and GUSTO moderate-to-severe bleeding. The frequency of PERT utilization was nearly threefold higher during March and April 2020 ( = 74) compared to the same period in 2019 ( = 26). During the COVID-19 pandemic, there was significantly less PERT-guided invasive treatment (5.5% vs 23.1%, = 0.02) with a numerical but not statistically significant trend toward an increase in the use of systemic fibrinolytic therapy (13.5% vs 3.9%, = 0.3). There were nonsignificant trends toward higher in-hospital mortality or moderate-to-severe bleeding in patients receiving PERT consultations during the COVID-19 period compared to historical controls (mortality 14.9% vs 3.9%, = 0.18 and moderate-to-severe bleeding 35.1% vs 19.2%, = 0.13). In conclusion, PERT utilization was nearly threefold higher during the COVID-19 pandemic than during the historical control period. Among patients evaluated by PERT, in-hospital mortality or moderate-to-severe bleeding were not significantly different, despite being numerically higher, while invasive therapy was utilized less frequently during the COVID-19 pandemic.
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http://dx.doi.org/10.1177/1358863X21995896DOI Listing
April 2021

Should we ration extracorporeal membrane oxygenation during the COVID-19 pandemic?

Lancet Respir Med 2021 04;9(4):326-328

Columbia University College of Physicians and Surgeons-New York-Presbyterian Hospital, New York, NY, USA; Center for Acute Respiratory Failure, Columbia University Medical Center, New York, NY, USA.

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http://dx.doi.org/10.1016/S2213-2600(21)00131-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8009624PMC
April 2021

Post-acute COVID-19 syndrome.

Nat Med 2021 Mar 22. Epub 2021 Mar 22.

Division of Cardiology, Department of Medicine, Vagelos College of Physicians and Surgeons, New York-Presbyterian/Columbia University Irving Medical Center, New York, New York, USA.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the pathogen responsible for the coronavirus disease 2019 (COVID-19) pandemic, which has resulted in global healthcare crises and strained health resources. As the population of patients recovering from COVID-19 grows, it is paramount to establish an understanding of the healthcare issues surrounding them. COVID-19 is now recognized as a multi-organ disease with a broad spectrum of manifestations. Similarly to post-acute viral syndromes described in survivors of other virulent coronavirus epidemics, there are increasing reports of persistent and prolonged effects after acute COVID-19. Patient advocacy groups, many members of which identify themselves as long haulers, have helped contribute to the recognition of post-acute COVID-19, a syndrome characterized by persistent symptoms and/or delayed or long-term complications beyond 4 weeks from the onset of symptoms. Here, we provide a comprehensive review of the current literature on post-acute COVID-19, its pathophysiology and its organ-specific sequelae. Finally, we discuss relevant considerations for the multidisciplinary care of COVID-19 survivors and propose a framework for the identification of those at high risk for post-acute COVID-19 and their coordinated management through dedicated COVID-19 clinics.
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http://dx.doi.org/10.1038/s41591-021-01283-zDOI Listing
March 2021

Media Portrayals of the Acute Respiratory Distress Syndrome.

Chest 2021 Mar 18. Epub 2021 Mar 18.

Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY, USA;; Center for Acute Respiratory Failure, New York-Presbyterian Hospital, New York, NY, USA.

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http://dx.doi.org/10.1016/j.chest.2021.03.017DOI Listing
March 2021

Venoarterial Extracorporeal Membrane Oxygenation for Postcardiotomy Shock-Analysis of the Extracorporeal Life Support Organization Registry.

Crit Care Med 2021 Feb 23. Epub 2021 Feb 23.

1 Department of Cardio-Thoracic Surgery, Heart and Vascular Centre, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands. 2 Clinical Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior and Administration, Centre of Postgraduate Medical Education, Warsaw, Poland. 3 Thoracic Research Centre, Collegium Medicum, Nicolaus Copernicus University, Innovative Medical Forum, Bydgoszcz, Poland. 4 Warsaw Medical University, Warsaw, Poland. 5 Center for Acute Respiratory Failure and Department of Medicine, Columbia University College of Physicians & Surgeons/New York-Presbyterian Hospital, New York, NY. 6 Cardiothoracic Intensive Care Unit, National University Hospital, Singapore;. 7 Cardiovascular Surgery Intensive Care Unit, Johns Hopkins Hospital, Baltimore, MD. 8 Cardiac Surgery Unit, ISMETT, Palermo, Italy. 9 Department of Cardiac Surgery, University of Dusseldorf, Dusseldorf, Germany. 10 Adult Intensive Care Services, The Prince Charles Hospital, Brisbane, VIC, Australia. 11 Cardiovascular Surgery and Pediatric Cardiovascular Surgery, National Taiwan University Hospital, Taipei, Taiwan. 12 Department of Cardiothoracic Surgery, Jefferson University, Philadelphia, PA. 13 Department of Cardio-Thoracic Surgery, Massachusetts Medical Centre, Boston, MA. 14 Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University, Beijing, P.R. of China. 15 Section of Cardiac Surgery, University of Michigan, Ann Arbor, MI. 16 2nd Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University, Prague, and General University Hospital, Prague, Czech Republic. 17 Department of Pathophysiology, Faculty of Pharmacy, Collegium Medicum, Nicolaus Copernicus University, Toruń, Poland. 18 Department of Cardiology, Boston Children's Hospital, Department of Pediatrics, Harvard Medical School, Boston, MA. 19 Department of Pediatrics, C.S. Mott Children's Hospital, University of Michigan Ann Arbor, MI. 20 Department of Cardio-Thoracic Surgery, Well Cornell Medicine, New York, NY. 21 Cardiac Surgery Unit, University Hospital, University of Chieti, Chieti, Italy. 22 Cardiovascular Research Institute Maastricht (CARIM), Maastricht, The Netherlands.

Objectives: Refractory postcardiotomy cardiogenic shock complicating cardiac surgery yields nearly 100% mortality when untreated. Use of venoarterial extracorporeal membrane oxygenation for postcardiotomy cardiogenic shock has increased worldwide recently. The aim of the current analysis was to outline the trends in use, changing patient profiles, and in-hospital outcomes including complications in patients undergoing venoarterial extracorporeal membrane oxygenation for postcardiotomy cardiogenic shock.

Design: Analysis of extracorporeal life support organization registry from January 2010 to December 2018.

Setting: Multicenter worldwide registry.

Patients: Seven-thousand one-hundred eighty-five patients supported with venoarterial extracorporeal membrane oxygenation for postcardiotomy cardiogenic shock.

Interventions: Venoarterial extracorporeal membrane oxygenation.

Measurements And Main Results: Hospital death, weaning from extracorporeal membrane oxygenation, hospital complications. Mortality predictors were assessed by multivariable logistic regression. Propensity score matching was performed for comparison of peripheral and central cannulation for extracorporeal membrane oxygenation. A significant trend toward more extracorporeal membrane oxygenation use in recent years (coefficient, 0.009; p < 0.001) was found. Mean age was 56.3 ± 14.9 years and significantly increased over time (coefficient, 0.513; p < 0.001). Most commonly, venoarterial extracorporeal membrane oxygenation was instituted after coronary artery bypass surgery (26.8%) and valvular surgery (25.6%), followed by heart transplantation (20.7%). Overall, successful extracorporeal membrane oxygenation weaning was possible in 4,520 cases (56.4%), and survival to hospital discharge was achieved in 41.7% of cases. In-hospital mortality rates remained constant over time (coefficient, -8.775; p = 0.682), whereas complication rates were significantly reduced (coefficient, -0.009; p = 0.003). Higher mortality was observed after coronary artery bypass surgery (65.4%), combined coronary artery bypass surgery with valve (68.4%), and aortic (69.6%) procedures than other indications. Lower mortality rates were observed in heart transplantation recipients (46.0%). Age (p < 0.001), central cannulation (p < 0.001), and occurrence of complications while on extracorporeal membrane oxygenation were independently associated with poorer prognosis.

Conclusions: The analysis confirmed increased use of venoarterial extracorporeal membrane oxygenation for postcardiotomy cardiogenic shock. Mortality rates remained relatively constant over time despite a decrease in complications, in the setting of supporting older patients.
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http://dx.doi.org/10.1097/CCM.0000000000004922DOI Listing
February 2021

Ten things to consider when implementing rationing guidelines during a pandemic.

Intensive Care Med 2021 Mar 7. Epub 2021 Mar 7.

Cambia Palliative Care Center of Excellence at UW Medicine, Seattle, USA.

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http://dx.doi.org/10.1007/s00134-021-06374-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7937357PMC
March 2021

Outcome Prediction in Patients with Severe COVID-19 Requiring Extracorporeal Membrane Oxygenation-A Retrospective International Multicenter Study.

Membranes (Basel) 2021 Feb 27;11(3). Epub 2021 Feb 27.

Department of Medicine III (Interdisciplinary Medical Intensive Care), Medical Center, Faculty of Medicine, University of Freiburg, Hugstetter Strasse 55, 79106 Freiburg, Germany.

The role of veno-venous extracorporeal membrane oxygenation therapy (V-V ECMO) in severe COVID-19 acute respiratory distress syndrome (ARDS) is still under debate and conclusive data from large cohorts are scarce. Furthermore, criteria for the selection of patients that benefit most from this highly invasive and resource-demanding therapy are yet to be defined. In this study, we assess survival in an international multicenter cohort of COVID-19 patients treated with V-V ECMO and evaluate the performance of several clinical scores to predict 30-day survival.

Methods: This is an investigator-initiated retrospective non-interventional international multicenter registry study (NCT04405973, first registered 28 May 2020). In 127 patients treated with V-V ECMO at 15 centers in Germany, Switzerland, Italy, Belgium, and the United States, we calculated the Sequential Organ Failure Assessment (SOFA) Score, Simplified Acute Physiology Score II (SAPS II), Acute Physiology And Chronic Health Evaluation II (APACHE II) Score, Respiratory Extracorporeal Membrane Oxygenation Survival Prediction (RESP) Score, Predicting Death for Severe ARDS on V‑V ECMO (PRESERVE) Score, and 30-day survival.

Results: In our study cohort which enrolled 127 patients, overall 30-day survival was 54%. Median SOFA, SAPS II, APACHE II, RESP, and PRESERVE were 9, 36, 17, 1, and 4, respectively. The prognostic accuracy for all these scores (area under the receiver operating characteristic-AUROC) ranged between 0.548 and 0.605.

Conclusions: The use of scores for the prediction of mortality cannot be recommended for treatment decisions in severe COVID-19 ARDS undergoing V-V ECMO; nevertheless, scoring results below or above a specific cut-off value may be considered as an additional tool in the evaluation of prognosis. Survival rates in this cohort of COVID-19 patients treated with V‑V ECMO were slightly lower than those reported in non-COVID-19 ARDS patients treated with V-V ECMO.
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http://dx.doi.org/10.3390/membranes11030170DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7997249PMC
February 2021

ECMO for COVID-19: Updated 2021 Guidelines from the Extracorporeal Life Support Organization (ELSO).

ASAIO J 2021 Feb 26. Epub 2021 Feb 26.

Department of Emergency Medicine, University of Washington, USA Division of Pulmonary Critical Care and Sleep Medicine, University of Washington, USA General ICU, University Hospital of Parma, Italy Department of Biomedical, Metabolic and Neural Sciences, University of Modena & Reggio Emilia, Italy Extracorporeal Life Support Organization Texas Children's Hospital, Baylor College of Medicine Children's Medical Center of Dallas, University of Texas Southwestern Medical Center Extracorporeal Life Support Organization, President; Children's Healthcare of Atlanta, Emory University Department of Medicine, Columbia University College of Physicians and Surgeons, New York, USA Center for Acute Respiratory Failure, New York-Presbyterian Hospital, New York, USA University of Michigan Department of Critical Care, Guy's and St. Thomas' NHS Foundation Trust Centre for Human & Applied Physiological Sciences, Faculty of Life Sciences & Medicine, King's College London Sorbonne Université, INSERM, Institute of Cardiometabolism and Nutrition Service de médecine intensive-réanimation, Institut de Cardiologie, APHP Sorbonne Université Hôpital Pitié-Salpêtrière, F-75013 PARIS, France Department of Cardio-Thoracic Surgery - Maastricht University Medical Centre - Cardiovascular Research Institute Maastricht Maastricht, The Netherlands Department of Internal Medicine II, University Hospital Regensburg, Regensburg, Germany Nemours Children's Health System Congenital Heart Center, Departments of Surgery and Pediatrics, University of Florida, Gainesville, USA Intensive Care Unit, Alfred Health Melbourne, Victoria, Australia Critical Care ECMO service, King Saud Medical City - Ministry Of Health (MOH), Riyadh - Saudi Arabia. Fundación Cardiovascular de Colombia Service de Médecine Intensive-Réanimation, Institut de Cardiologie, AP-HP, Sorbonne Université Hôpital Pitié-Salpêtrière, Paris, France. Sorbonne Université, GRC n°30, GRC RESPIRE, INSERM, UMRS_1166-ICAN, Institute of Cardiometabolism and Nutrition, Paris, France. Adult Intensive Care Services, The Prince Charles Hospital, Brisbane, Queensland, Australia National University Hospital, Singapore Department of Medicine, Columbia University College of Physicians and Surgeons, New York, USA Center for Acute Respiratory Failure, New York-Presbyterian Hospital, New York, USA.

This is an updated guideline from the Extracorporeal Life Support Organization (ELSO) for the role of extracorporeal membrane oxygenation (ECMO) for patients with severe cardiopulmonary failure due to coronavirus disease 2019 (COVID-19). The great majority of COVID-19 patients (>90%) requiring ECMO have been supported using venovenous (V-V) ECMO for acute respiratory distress syndrome (ARDS). While COVID-19 ECMO run duration may be longer than in non-COVID-19 ECMO patients, published mortality appears to be similar between the two groups. However, data collection is ongoing, and there is a signal that overall mortality may be increasing. Conventional selection criteria for COVID-19-related ECMO should be used; however, when resources become more constrained during a pandemic, more stringent contraindications should be implemented. Formation of regional ECMO referral networks may facilitate communication, resource sharing, expedited patient referral, and mobile ECMO retrieval. There are no data to suggest deviation from conventional ECMO device or patient management when applying ECMO for COVID-19 patients. Rarely, children may require ECMO support for COVID-19-related ARDS, myocarditis or multisystem inflammatory syndrome in children (MIS-C); conventional selection criteria and management practices should be the standard. We strongly encourage participation in data submission to investigate the optimal use of ECMO for COVID-19.
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http://dx.doi.org/10.1097/MAT.0000000000001422DOI Listing
February 2021

Bridging the Gap Between Intensivists and Primary Care Clinicians in Extracorporeal Membrane Oxygenation for Respiratory Failure in Children: A Review.

JAMA Pediatr 2021 Mar 1. Epub 2021 Mar 1.

Cardiothoracic Intensive Care Unit, National University Health System, Singapore.

Importance: Extracorporeal membrane oxygenation (ECMO) is a form of advanced life support that may be used in children with refractory respiratory or cardiac failure. While it is required infrequently, in the US, ECMO is used to support childhood respiratory failure as often as children receive kidney or heart transplants. ECMO is complex, resource intensive, and potentially lifesaving, but it is also associated with risks of short-term complications and long-term adverse effects, most importantly with neurodevelopmental outcomes that are relevant to all pediatric clinicians, even those remote from the child's critical illness.

Observations: The 2009 influenza A(H1N1) pandemic, along with randomized clinical trials of adult respiratory ECMO support and conventional management, have catalyzed sustained growth in the use of ECMO. The adult trials built on earlier neonatal ECMO randomized clinical trials that demonstrated improved survival in severe perinatal lung disease. For children outside of the neonatal period, there appear to have been no respiratory ECMO clinical trials. Applying evidence from adult respiratory failure or perinatal lung disease to children outside the neonatal period has important potential pitfalls. For these children, the underlying diseases and risks of ECMO are different. Despite these differences, both neonates and older children are at risk of neurologic complications, such as intracranial hemorrhage, ischemic stroke, and seizures, and those complications may contribute to adverse neurodevelopmental outcomes. Without specific screening, subtle neurodevelopmental impairments may be missed, but when they are identified, children have the opportunity to receive therapy to optimize long-term development.

Conclusions And Relevance: All pediatric clinicians should be aware not only of the potential benefits and complications of ECMO but also that survivors need effective screening, support, and follow-up.
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http://dx.doi.org/10.1001/jamapediatrics.2020.5921DOI Listing
March 2021

Prone Positioning of Patients during Venovenous Extracorporeal Membrane Oxygenation.

Ann Am Thorac Soc 2021 03;18(3):421-423

Columbia University College of Physicians and Surgeons/NewYork-Presbyterian Hospital, New York, New York; and.

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http://dx.doi.org/10.1513/AnnalsATS.202011-1444EDDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7919146PMC
March 2021

Association between antecedent statin use and decreased mortality in hospitalized patients with COVID-19.

Nat Commun 2021 02 26;12(1):1325. Epub 2021 Feb 26.

NewYork-Presbyterian Hospital and the Columbia University Irving Medical Center, New York, NY, USA.

The coronavirus disease 2019 (COVID-19) can result in a hyperinflammatory state, leading to acute respiratory distress syndrome (ARDS), myocardial injury, and thrombotic complications, among other sequelae. Statins, which are known to have anti-inflammatory and antithrombotic properties, have been studied in the setting of other viral infections, but their benefit has not been assessed in COVID-19. This is a retrospective analysis of patients admitted with COVID-19 from February 1 through May 12, 2020 with study period ending on June 11, 2020. Antecedent statin use was assessed using medication information available in the electronic medical record. We constructed a multivariable logistic regression model to predict the propensity of receiving statins, adjusting for baseline sociodemographic and clinical characteristics, and outpatient medications. The primary endpoint includes in-hospital mortality within 30 days. A total of 2626 patients were admitted during the study period, of whom 951 (36.2%) were antecedent statin users. Among 1296 patients (648 statin users, 648 non-statin users) identified with 1:1 propensity-score matching, statin use is significantly associated with lower odds of the primary endpoint in the propensity-matched cohort (OR 0.47, 95% CI 0.36-0.62, p < 0.001). We conclude that antecedent statin use in patients hospitalized with COVID-19 is associated with lower inpatient mortality.
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http://dx.doi.org/10.1038/s41467-021-21553-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7910606PMC
February 2021

Classification and effectiveness of different oxygenation goals in mechanically ventilated critically ill patients: network meta-analysis of randomised controlled trials.

Eur Respir J 2021 Feb 25. Epub 2021 Feb 25.

Department of Anesthesiology, Yale University School of Medicine, New Haven, Connecticut, USA.

Background: The optimal oxygenation in mechanically ventilated critically ill patients remains unclear.

Methods: Randomised controlled trials investigating different oxygenation goal-directed mechanical ventilation in critically ill adult patients were eligible. The trinary classification classified oxygenation goals into conservative (PaO=55-90 mmHg), moderate (PaO=90-150 mmHg), and liberal (PaO>150 mmHg). The quadruple classification further divided the conservative goal from the trinary classification into far-conservative (PaO=55-70 mmHg) and conservative (PaO=70-90 mmHg) goals. The primary outcome was 30-day mortality. The secondary outcomes included intensive care unit, hospital, and 90-day mortalities. The effectiveness was estimated by the relative risk (RR) and 95% credible interval (CrI) using network meta-analysis and visualised using SUCRA scores and survival curves.

Results: We identified eight eligible studies involving 2532 patients. There were no differences between conservative and moderate goals (RR, 1.08; 95% CrI, 0.85 to 1.36; moderate quality), between moderate and liberal goals (RR, 0.83; 95% CrI, 0.61 to 1.10, low quality), and between conservative and liberal goals (RR, 0.89; 95% CrI, 0.61 to 1.30, low quality) based on the trinary classification. No differences in secondary outcomes among the different goals. The results were consistent between the trinary and quadruple classifications. The SUCRA scores and survival curves suggested that the moderate goal in the trinary and quadruple classifications and the conservative goal in the quadruple classification may be superior to the liberal and far-conservative goals.

Conclusions: Different oxygenation goals do not lead to different mortalities in mechanically ventilated critically ill patients. The potential superiority of maintaining PaO in the range of 70-150 mmHg remains to be validated.
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http://dx.doi.org/10.1183/13993003.02928-2020DOI Listing
February 2021

Elevated Venous to Arterial Carbon Dioxide Gap and Anion Gap Are Associated with Poor Outcome in Cardiogenic Shock Requiring Extracorporeal Membrane Oxygenation Support.

ASAIO J 2021 03;67(3):263-269

Critical Care Research Group, The Prince Charles Hospital and The University of Queensland, Queensland, Australia.

Optimal management of cardiogenic shock requiring extracorporeal membrane oxygenation (ECMO) is still an evolving area in which assessment and optimization of the microcirculation may be critically important. We hypothesized that the venous arterial carbon dioxide gap (P(v-a)CO2 gap); the ratio of this gap to arterio-venous oxygen content (P(v-a)CO2/C(a-v)O2 ratio) and the anion gap would be early indicators of microcirculatory status and useful parameters for outcome prediction during ECMO support. We retrospectively reviewed 31 cardiogenic shock patients requiring veno-arterial ECMO, calculating P(v-a)CO2 gap and P(v-a)CO2/C(a-v)O2 ratios in the first 36 hours and the final 24 hours of ECMO support. Sixteen patients (52%) survived and 15 (48%) died. After 24 hours of ECMO support, the P(v-a)CO2 gap (4.9 ± 1.5 vs. 6.8 ± 1.9 mm Hg; p = 0.004) and anion gap (5.2 ± 1.8 vs. 8.7 ± 2.7 mmol/L; p < 0.001) were significantly higher in non-survivors. In the final 24 hours of ECMO support, the P(v-a)CO2 gap (3.5 ± 1.6 vs. 10.5 ± 3.2 mm Hg; p < 0.001), P(v-a)CO2/C(a-v)O2 ratio (1.1 ± 0.5 vs. 2.7 ± 1.0; p < 0.001), anion gap (5.1 ± 3.0 vs. 9.3 ± 5.9 mmol/L; p = 0.02), and lactate (median 1.0 [interquartile range {IQR}: 0.7-1.5] vs. 2.8 [IQR: 1.7-7.7] mmol/L; p = <0.001) were all significantly lower in survivors. Increasing P(v-a)CO2 gap and increasing anion gap were significantly associated with increased risk of mortality. Optimum cut-points for prediction of mortality were 6 mm Hg for P(v-a)CO2 gap in combination with an anion gap above 6 mmol/L in the first 24 hours of ECMO in patients with cardiogenic shock requiring ECMO.
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http://dx.doi.org/10.1097/MAT.0000000000001215DOI Listing
March 2021

Extracorporeal Membrane Oxygenation for Coronavirus Disease 2019: Crisis Standards of Care.

ASAIO J 2021 03;67(3):245-249

From the Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University College of Physicians and Surgeons/NewYork-Presbyterian Hospital, New York, New York.

The coronavirus disease 2019 (COVID-19) pandemic has placed extraordinary strain on global healthcare systems. Use of extracorporeal membrane oxygenation (ECMO) for patients with severe respiratory or cardiac failure attributed to COVID-19 has been debated due to uncertain survival benefit and the resources required to safely deliver ECMO support. We retrospectively investigated adult patients supported with ECMO for COVID-19 at our institution during the first 80 days following New York City's declaration of a state of emergency. The primary objective was to evaluate survival outcomes in patients supported with ECMO for COVID-19 and describe the programmatic adaptations made in response to pandemic-related crisis conditions. Twenty-two patients with COVID-19 were placed on ECMO during the study period. Median age was 52 years and 18 (81.8%) were male. Twenty-one patients (95.4%) had severe ARDS and seven (31.8%) had cardiac failure. Fifteen patients (68.1%) were managed with venovenous ECMO while 7 (31.8%) required arterial support. Twelve patients (54.5%) were transported on ECMO from external institutions. Twelve patients were discharged alive from the hospital (54.5%). Extracorporeal membrane oxygenation was used successfully in patients with respiratory and cardiac failure due to COVID-19. The continued use of ECMO, including ECMO transport, during crisis conditions was possible even at the height of the COVID-19 pandemic.
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http://dx.doi.org/10.1097/MAT.0000000000001376DOI Listing
March 2021

Bleeding and Thrombotic Events During Extracorporeal Membrane Oxygenation for Postcardiotomy Shock.

Ann Thorac Surg 2021 Feb 17. Epub 2021 Feb 17.

Department of Surgery, Division of Cardiothoracic and Vascular Surgery, Columbia University Medical Center, New York, NY. Electronic address:

Background: Anticoagulation management during veno-arterial extracorporeal membrane oxygenation (ECMO) is particularly difficult in postcardiotomy shock patients given a significant bleeding risk. We sought to determine the effect of anticoagulation on bleeding and thrombosis risk for postcardiotomy shock patients on ECMO.

Methods: We retrospectively reviewed patients who received ECMO for postcardiotomy shock from July 2007 through July 2019. Characteristics of patients who developed bleeding and thrombosis were investigated and risk factors were assessed via multi-level logistic regression.

Results: Of the 152 patients who received ECMO for postcardiotomy shock, 33 (23%) developed 40 thrombotic events and 64 (45%) developed 86 bleeding events. Predictors of bleeding were intraoperative packed red blood cell transfusion (OR 1.05, 95% CI [1.01-1.09]), platelet transfusion (OR 1.10, 95% CI [1.05-1.16]), international normalized ratio (OR 1.18, 95% CI [1.02-1.37]), and activated partial thromboplastin time (aPTT) greater than 60 seconds (OR 2.32, 95% CI [1.14-4.73]). Predictors of thrombosis were anticoagulation use (OR 0.39, 95% CI [0.19-0.79]), surgical venting (OR 3.07, 95% CI [1.29-7.31]), hemoglobin (OR 1.38, 95% CI [1.06-1.79]), and central cannulation (OR 2.06, 95% CI [1.03-4.11]). The daily predicted probability of thrombosis was between 0.075 and 0.038 in those who did not receive anticoagulation and decreased to between 0.030 and 0.013 in those who received anticoagulation at aPTTs between 25 and 80 seconds.

Conclusions: Anticoagulation can reduce thromboembolic events in postcardiotomy shock patients on ECMO, but bleeding risk may outweigh this benefit at aPTTs greater than 60 seconds.
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http://dx.doi.org/10.1016/j.athoracsur.2021.02.008DOI Listing
February 2021

Trends in COVID-19-related in-hospital mortality: lessons learned from nationwide samples.

Lancet Respir Med 2021 04 15;9(4):322-324. Epub 2021 Feb 15.

Division of Pulmonary, Allergy, and Critical Care, Columbia University Irving Medical Center and New York-Presbyterian Hospital, New York, NY 10032, USA. Electronic address:

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http://dx.doi.org/10.1016/S2213-2600(21)00080-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7906680PMC
April 2021

Ethical obligations for supporting healthcare workers during the COVID-19 pandemic.

Eur Respir J 2021 02 25;57(2). Epub 2021 Feb 25.

Columbia University College of Physicians and Surgeons/New York-Presbyterian Hospital, New York, NY, USA.

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http://dx.doi.org/10.1183/13993003.00124-2021DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7861049PMC
February 2021

Extracorporeal Membrane Oxygenation and Coronavirus Disease 2019.

JAMA Surg 2021 Jan 27. Epub 2021 Jan 27.

Department of Medicine, Columbia University College of Physicians and Surgeons, New York, New York.

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http://dx.doi.org/10.1001/jamasurg.2020.6631DOI Listing
January 2021

Sex differences in patients with cardiogenic shock requiring extracorporeal membrane oxygenation.

J Thorac Cardiovasc Surg 2020 Dec 23. Epub 2020 Dec 23.

Division of Cardiac Surgery, Department of Surgery, Columbia University College of Physicians and Surgeons/New York-Presbyterian Hospital, New York, NY. Electronic address:

Objective: Our study assesses differences between male and female patients placed on venoarterial extracorporeal membrane oxygenation for cardiogenic shock.

Method: We retrospectively analyzed 574 adult patients placed on venoarterial extracorporeal membrane oxygenation for cardiogenic shock at our institution between January 2007 and December 2018. Baseline characteristics and outcomes were assessed. Propensity score matching was used to compare outcomes. The primary end point was in-hospital mortality. Secondary outcomes include limb ischemia, limb ischemia interventions, distal perfusion cannula placement, stroke, bleeding, and continuous venovenous hemofiltration initiation.

Results: There were 394 male patients (69%) and 180 female patients (31%). After adjusting for baseline differences, propensity score matching compared 171 male patients with 171 female patients. No difference was seen between men and women in in-hospital mortality (60.2% vs 56.7%; P = .59), limb ischemia (47.4% vs 45.6%; P = .83), limb ischemia surgery (15.2% vs 12.9%; P = .64), bleeding (49.7% vs 49.1%; P = 1), continuous venovenous hemofiltration initiation (39.2% vs 32.7%; P = .26), and stroke (8.2% vs 9.4%; P = .85). Multivariable logistic regression showed that female patients who died were more likely to have had chronic kidney disease (odds ratio [OR], 2.67; 95% confidence interval [CI], 1.09-6.53; P = .032) than surviving women. Male patients who died were more likely to have had coronary artery disease (OR, 2.25; 95% CI, 1.34-3.78; P = .002) and higher lactate levels (OR, 1.14; 95% CI, 1.08-1.21; P < .001) than surviving men. Women with cardiac transplant primary graft dysfunction were more likely to survive (OR, 0.04; 95% CI, 0.01-0.27; P = .001), whereas men with cardiac transplant primary graft dysfunction were less likely to survive (OR, 0.28; 95% CI, 0.11-0.71; P = .007), than patients with other shock etiologies.

Conclusions: After adjusting for baseline difference, there was no difference in outcomes between male and female patients despite differing risk profiles for in-hospital mortality. (supplementary video).
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http://dx.doi.org/10.1016/j.jtcvs.2020.12.044DOI Listing
December 2020

Allocating scarce intensive care resources during the COVID-19 pandemic: practical challenges to theoretical frameworks.

Lancet Respir Med 2021 04 12;9(4):430-434. Epub 2021 Jan 12.

Columbia University College of Physicians & Surgeons, New York-Presbyterian Hospital, New York, NY, USA; Center for Acute Respiratory Failure, Columbia University Medical Center, New York, NY, USA.

The COVID-19 pandemic strained health-care systems throughout the world. For some, available medical resources could not meet the increased demand and rationing was ultimately required. Hospitals and governments often sought to establish triage committees to assist with allocation decisions. However, for institutions operating under crisis standards of care (during times when standards of care must be substantially lowered in the setting of crisis), relying on these committees for rationing decisions was impractical-circumstances were changing too rapidly, occurring in too many diverse locations within hospitals, and the available information for decision making was notably scarce. Furthermore, a utilitarian approach to decision making based on an analysis of outcomes is problematic due to uncertainty regarding outcomes of different therapeutic options. We propose that triage committees could be involved in providing policies and guidance for clinicians to help ensure equity in the application of rationing under crisis standards of care. An approach guided by egalitarian principles, integrated with utilitarian principles, can support physicians at the bedside when they must ration scarce resources.
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http://dx.doi.org/10.1016/S2213-2600(20)30580-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7837018PMC
April 2021

ECMO support for COVID-19: a balancing act - Authors' reply.

Lancet 2021 01;397(10269):95

Division of Pulmonary, Allergy and Critical Care Medicine and Center for Acute Respiratory Failure, Columbia University College of Physicians and Surgeons, New York-Presbyterian Hospital, New York, NY, USA.

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http://dx.doi.org/10.1016/S0140-6736(20)32517-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7832424PMC
January 2021

Hemolysis at low blood flow rates: in-vitro and in-silico evaluation of a centrifugal blood pump.

J Transl Med 2021 01 5;19(1). Epub 2021 Jan 5.

Department of Pneumology and Critical Care Medicine, Cologne-Merheim Hospital, ARDS and ECMO Centre, Kliniken der Stadt Köln GmbH, Witten/Herdecke University Hospital, Ostmerheimer Strasse 200, 51109, Cologne, Germany.

Background: Treating severe forms of the acute respiratory distress syndrome and cardiac failure, extracorporeal membrane oxygenation (ECMO) has become an established therapeutic option. Neonatal or pediatric patients receiving ECMO, and patients undergoing extracorporeal CO removal (ECCOR) represent low-flow applications of the technology, requiring lower blood flow than conventional ECMO. Centrifugal blood pumps as a core element of modern ECMO therapy present favorable operating characteristics in the high blood flow range (4 L/min-8 L/min). However, during low-flow applications in the range of 0.5 L/min-2 L/min, adverse events such as increased hemolysis, platelet activation and bleeding complications are reported frequently.

Methods: In this study, the hemolysis of the centrifugal pump DP3 is evaluated both in vitro and in silico, comparing the low-flow operation at 1 L/min to the high-flow operation at 4 L/min.

Results: Increased hemolysis occurs at low-flow, both in vitro and in silico. The in-vitro experiments present a sixfold higher relative increased hemolysis at low-flow. Compared to high-flow operation, a more than 3.5-fold increase in blood recirculation within the pump head can be observed in the low-flow range in silico.

Conclusions: This study highlights the underappreciated hemolysis in centrifugal pumps within the low-flow range, i.e. during pediatric ECMO or ECCOR treatment. The in-vitro results of hemolysis and the in-silico computational fluid dynamic simulations of flow paths within the pumps raise awareness about blood damage that occurs when using centrifugal pumps at low-flow operating points. These findings underline the urgent need for a specific pump optimized for low-flow treatment. Due to the inherent problems of available centrifugal pumps in the low-flow range, clinicians should use the current centrifugal pumps with caution, alternatively other pumping principles such as positive displacement pumps may be discussed in the future.
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http://dx.doi.org/10.1186/s12967-020-02599-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7784380PMC
January 2021

Media Portrayals of Outcomes After Extracorporeal Membrane Oxygenation.

JAMA Intern Med 2021 Mar;181(3):391-394

Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Columbia University College of Physicians and Surgeons, New York, New York.

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http://dx.doi.org/10.1001/jamainternmed.2020.6094DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7783587PMC
March 2021

Protocol-driven daily optimisation of venovenous extracorporeal membrane oxygenation blood flows: an alternate paradigm?

J Thorac Dis 2020 Nov;12(11):6854-6860

Columbia University College of Physicians and Surgeons/New York-Presbyterian Hospital, New York, NY, USA.

Venovenous extracorporeal membrane oxygenation (VV ECMO) is now an established modality of support for patients with the who are failing evidence-based conventional therapies. Minimising ventilator-induced lung injury is the guiding principle behind patient management with VV ECMO. Patients with acute respiratory distress syndrome (ARDS) supported with VV ECMO are liberated from ECMO at a stage when native lungs have recovered sufficiently to support physiologic demands and the risks of iatrogenic lung injuries after discontinuation of ECMO are perceived to be small. However, native lung recovery is a dynamic process and patients rely on varying degrees of contributions from both native lungs and ECMO for gas exchange support. Patients often demonstrate near total ECMO dependence for oxygenation and decarboxylation early in the course of the illness and this may necessitate higher ECMO blood flow rates (EBFRs). Although, reliance on high EBFR for oxygenation support may remain variable over the course of ECMO, blood flow requirements typically diminish over time as native lungs start to recover. Currently, protocol-driven modulation of the EBFR based on changing physiologic needs is not common practice and consequently patients may remain on higher than physiologically necessary EBFR. This exposes the patient to potential risks because maintaining higher blood flows often requires a less restrictive fluid balance and deeper sedation. Both may be harmful in the setting of recovery from ARDS. In this article, we propose a strategy that involves daily assessments of native lung function and a protocol-driven daily optimisation of EBFR. This is followed by optimisation of sweep gas flow rate (SGFR) and the fraction of delivered oxygen in the sweep gas (FdO). This staged approach to weaning VV ECMO allows us to fully utilise the "decoupling" of oxygenation and decarboxylation that is possible only during extracorporeal support. This approach may benefit patients by allowing for greater fluid restriction, more aggressive fluid removal, expedited weaning of sedation and neuromuscular blocking agents (NMBAs), and early physical rehabilitation. Ultimately, prospective studies are needed to evaluate optimal VV ECMO weaning practices.
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http://dx.doi.org/10.21037/jtd-20-1515DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7711363PMC
November 2020

How I approach membrane lung dysfunction in patients receiving ECMO.

Crit Care 2020 11 30;24(1):671. Epub 2020 Nov 30.

Columbia University College of Physicians and Surgeons, New York-Presbyterian Hospital, New York, USA.

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http://dx.doi.org/10.1186/s13054-020-03388-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7704102PMC
November 2020

Will Not Breathing on Extracorporeal Membrane Oxygenation Help One Survive Acute Respiratory Distress Syndrome?

Crit Care Med 2020 Dec;48(12):1901-1904

Critical Care Research Group, Adult Intensive Care Services, The Prince Charles Hospital; Queensland University of Technology; and University of Queensland, Brisbane, QLD, Australia, Brisbane and Bond University, Gold Coast, QLD, Australia Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast; and Regional Intensive Care Unit, Royal Victoria Hospital, Belfast, United Kingdom Department of Medicine, Columbia University College of Physicians and Surgeons; and, Centre for Acute Respiratory Failure, New York-Presbyterian Hospital, New York, NY.

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http://dx.doi.org/10.1097/CCM.0000000000004647DOI Listing
December 2020

Clinical trials in critical care: can a Bayesian approach enhance clinical and scientific decision making?

Lancet Respir Med 2021 02 20;9(2):207-216. Epub 2020 Nov 20.

Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada; Department of Medicine, University of Toronto, Toronto, ON, Canada; Department of Medicine, Division of Respirology, University Health Network and Sinai Health System, Toronto, ON, Canada; Toronto General Hospital Research Institute, Toronto, ON, Canada.

Recent Bayesian reanalyses of prominent trials in critical illness have generated controversy by contradicting the initial conclusions based on conventional frequentist analyses. Many clinicians might be sceptical that Bayesian analysis, a philosophical and statistical approach that combines prior beliefs with data to generate probabilities, provides more useful information about clinical trials than the frequentist approach. In this Personal View, we introduce clinicians to the rationale, process, and interpretation of Bayesian analysis through a systematic review and reanalysis of interventional trials in critical illness. In the majority of cases, Bayesian and frequentist analyses agreed. In the remainder, Bayesian analysis identified interventions where benefit was probable despite the absence of statistical significance, where interpretation depended substantially on choice of prior distribution, and where benefit was improbable despite statistical significance. Bayesian analysis in critical care medicine can help to distinguish harm from uncertainty and establish the probability of clinically important benefit for clinicians, policy makers, and patients.
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http://dx.doi.org/10.1016/S2213-2600(20)30471-9DOI Listing
February 2021

The Pandemic That Always Strains Critical Care: Smoking.

Ann Am Thorac Soc 2021 04;18(4):582-583

Department of Medicine, Columbia University College of Physicians and Surgeons, New York, New York; and.

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http://dx.doi.org/10.1513/AnnalsATS.202009-1137VPDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8009005PMC
April 2021

What's new in ECMO for COVID-19?

Intensive Care Med 2021 01 12;47(1):107-109. Epub 2020 Nov 12.

Columbia University College of Physicians and Surgeons/New York-Presbyterian Hospital, New York, USA.

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http://dx.doi.org/10.1007/s00134-020-06284-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7658301PMC
January 2021

Effect of Hydroxychloroquine on Clinical Status at 14 Days in Hospitalized Patients With COVID-19: A Randomized Clinical Trial.

Authors:
Wesley H Self Matthew W Semler Lindsay M Leither Jonathan D Casey Derek C Angus Roy G Brower Steven Y Chang Sean P Collins John C Eppensteiner Michael R Filbin D Clark Files Kevin W Gibbs Adit A Ginde Michelle N Gong Frank E Harrell Douglas L Hayden Catherine L Hough Nicholas J Johnson Akram Khan Christopher J Lindsell Michael A Matthay Marc Moss Pauline K Park Todd W Rice Bryce R H Robinson David A Schoenfeld Nathan I Shapiro Jay S Steingrub Christine A Ulysse Alexandra Weissman Donald M Yealy B Taylor Thompson Samuel M Brown Jay Steingrub Howard Smithline Bogdan Tiru Mark Tidswell Lori Kozikowski Sherell Thornton-Thompson Leslie De Souza Peter Hou Rebecca Baron Anthony Massaro Imoigele Aisiku Lauren Fredenburgh Raghu Seethala Lily Johnsky Richard Riker David Seder Teresa May Michael Baumann Ashley Eldridge Christine Lord Nathan Shapiro Daniel Talmor Thomas O’Mara Charlotte Kirk Kelly Harrison Lisa Kurt Margaret Schermerhorn Valerie Banner-Goodspeed Katherine Boyle Nicole Dubosh Michael Filbin Kathryn Hibbert Blair Parry Kendall Lavin-Parsons Natalie Pulido Brendan Lilley Carl Lodenstein Justin Margolin Kelsey Brait Alan Jones James Galbraith Rebekah Peacock Utsav Nandi Taylor Wachs Michael Matthay Kathleen Liu Kirsten Kangelaris Ralph Wang Carolyn Calfee Kimberly Yee Gregory Hendey Steven Chang George Lim Nida Qadir Andrea Tam Rebecca Beutler Joseph Levitt Jenny Wilson Angela Rogers Rosemary Vojnik Jonasel Roque Timothy Albertson James Chenoweth Jason Adams Skyler Pearson Maya Juarez Eyad Almasri Mohamed Fayed Alyssa Hughes Shelly Hillard Ryan Huebinger Henry Wang Elizabeth Vidales Bela Patel Adit Ginde Marc Moss Amiran Baduashvili Jeffrey McKeehan Lani Finck Carrie Higgins Michelle Howell Ivor Douglas Jason Haukoos Terra Hiller Carolynn Lyle Alicia Cupelo Emily Caruso Claudia Camacho Stephanie Gravitz James Finigan Christine Griesmer Pauline Park Robert Hyzy Kristine Nelson Kelli McDonough Norman Olbrich Mark Williams Raj Kapoor Jean Nash Meghan Willig Henry Ford Jayna Gardner-Gray Mayur Ramesh Montefiore Moses Michelle Ng Gong Michael Aboodi Ayesha Asghar Omowunmi Amosu Madeline Torres Savneet Kaur Jen-Ting Chen Aluko Hope Brenda Lopez Kathleen Rosales Jee Young You Jarrod Mosier Cameron Hypes Bhupinder Natt Bryan Borg Elizabeth Salvagio Campbell R Duncan Hite Kristin Hudock Autumn Cresie Faysal Alhasan Jose Gomez-Arroyo Abhijit Duggal Omar Mehkri Andrei Hastings Debasis Sahoo Francois Abi Fadel Susan Gole Valerie Shaner Allison Wimer Yvonne Meli Alexander King Thomas Terndrup Matthew Exline Sonal Pannu Emily Robart Sarah Karow Catherine Hough Bryce Robinson Nicholas Johnson Daniel Henning Monica Campo Stephanie Gundel Sakshi Seghal Sarah Katsandres Sarah Dean Akram Khan Olivia Krol Milad Jouzestani Peter Huynh Alexandra Weissman Donald Yealy Denise Scholl Peter Adams Bryan McVerry David Huang Derek Angus Jordan Schooler Steven Moore Clark Files Chadwick Miller Kevin Gibbs Mary LaRose Lori Flores Lauren Koehler Caryn Morse John Sanders Caitlyn Langford Kristen Nanney Masiku MdalaGausi Phyllis Yeboah Peter Morris Jamie Sturgill Sherif Seif Evan Cassity Sanjay Dhar Marjolein de Wit Jessica Mason Andrew Goodwin Greg Hall Abbey Grady Amy Chamberlain Samuel Brown Joseph Bledsoe Lindsay Leither Ithan Peltan Nathan Starr Melissa Fergus Valerie Aston Quinn Montgomery Rilee Smith Mardee Merrill Katie Brown Brent Armbruster Estelle Harris Elizabeth Middleton Robert Paine Stacy Johnson Macy Barrios John Eppensteiner Alexander Limkakeng Lauren McGowan Tedra Porter Andrew Bouffler J. Clancy Leahy Bennet deBoisblanc Matthew Lammi Kyle Happel Paula Lauto Wesley Self Jonathan Casey Matthew Semler Sean Collins Frank Harrell Christopher Lindsell Todd Rice William Stubblefield Christopher Gray Jakea Johnson Megan Roth Margaret Hays Donna Torr Arwa Zakaria David Schoenfeld Taylor Thompson Douglas Hayden Nancy Ringwood Cathryn Oldmixon Christine Ulysse Richard Morse Ariela Muzikansky Laura Fitzgerald Samuel Whitaker Adrian Lagakos Roy Brower Lora Reineck Neil Aggarwal Karen Bienstock Michelle Freemer Myron Maclawiw Gail Weinmann Laurie Morrison Mark Gillespie Richard Kryscio Daniel Brodie Wojciech Zareba Anne Rompalo Michael Boeckh Polly Parsons Jason Christie Jesse Hall Nicholas Horton Laurie Zoloth Neal Dickert Deborah Diercks

JAMA 2020 12;324(21):2165-2176

Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray, Utah.

Importance: Data on the efficacy of hydroxychloroquine for the treatment of coronavirus disease 2019 (COVID-19) are needed.

Objective: To determine whether hydroxychloroquine is an efficacious treatment for adults hospitalized with COVID-19.

Design, Setting, And Participants: This was a multicenter, blinded, placebo-controlled randomized trial conducted at 34 hospitals in the US. Adults hospitalized with respiratory symptoms from severe acute respiratory syndrome coronavirus 2 infection were enrolled between April 2 and June 19, 2020, with the last outcome assessment on July 17, 2020. The planned sample size was 510 patients, with interim analyses planned after every 102 patients were enrolled. The trial was stopped at the fourth interim analysis for futility with a sample size of 479 patients.

Interventions: Patients were randomly assigned to hydroxychloroquine (400 mg twice daily for 2 doses, then 200 mg twice daily for 8 doses) (n = 242) or placebo (n = 237).

Main Outcomes And Measures: The primary outcome was clinical status 14 days after randomization as assessed with a 7-category ordinal scale ranging from 1 (death) to 7 (discharged from the hospital and able to perform normal activities). The primary outcome was analyzed with a multivariable proportional odds model, with an adjusted odds ratio (aOR) greater than 1.0 indicating more favorable outcomes with hydroxychloroquine than placebo. The trial included 12 secondary outcomes, including 28-day mortality.

Results: Among 479 patients who were randomized (median age, 57 years; 44.3% female; 37.2% Hispanic/Latinx; 23.4% Black; 20.1% in the intensive care unit; 46.8% receiving supplemental oxygen without positive pressure; 11.5% receiving noninvasive ventilation or nasal high-flow oxygen; and 6.7% receiving invasive mechanical ventilation or extracorporeal membrane oxygenation), 433 (90.4%) completed the primary outcome assessment at 14 days and the remainder had clinical status imputed. The median duration of symptoms prior to randomization was 5 days (interquartile range [IQR], 3 to 7 days). Clinical status on the ordinal outcome scale at 14 days did not significantly differ between the hydroxychloroquine and placebo groups (median [IQR] score, 6 [4-7] vs 6 [4-7]; aOR, 1.02 [95% CI, 0.73 to 1.42]). None of the 12 secondary outcomes were significantly different between groups. At 28 days after randomization, 25 of 241 patients (10.4%) in the hydroxychloroquine group and 25 of 236 (10.6%) in the placebo group had died (absolute difference, -0.2% [95% CI, -5.7% to 5.3%]; aOR, 1.07 [95% CI, 0.54 to 2.09]).

Conclusions And Relevance: Among adults hospitalized with respiratory illness from COVID-19, treatment with hydroxychloroquine, compared with placebo, did not significantly improve clinical status at day 14. These findings do not support the use of hydroxychloroquine for treatment of COVID-19 among hospitalized adults.

Trial Registration: ClinicalTrials.gov: NCT04332991.
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http://dx.doi.org/10.1001/jama.2020.22240DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7653542PMC
December 2020