Background Early administration of convalescent plasma obtained from blood donors who have recovered from coronavirus disease 2019 (Covid-19) may prevent disease progression in acutely ill, high-risk patients with Covid-19. Methods In this randomized, multicenter, single-blind trial, we assigned patients who were being treated in an emergency department for Covid-19 symptoms to receive either one unit of convalescent plasma with a high titer of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or placebo. All the patients were either 50 years of age or older or had one or more risk factors for disease progression. In addition, all the patients presented to the emergency department within 7 days after symptom onset and were in stable condition for outpatient management. The primary outcome was disease progression within 15 days after randomization, which was a composite of hospital admission for any reason, seeking emergency or urgent care, or death without hospitalization. Secondary outcomes included the worst severity of illness on an 8-category ordinal scale, hospital-free days within 30 days after randomization, and death from any cause. Results A total of 511 patients were enrolled in the trial (257 in the convalescent-plasma group and 254 in the placebo group). The median age of the patients was 54 years; the median symptom duration was 4 days. In the donor plasma samples, the median titer of SARS-CoV-2 neutralizing antibodies was 1:641. Disease progression occurred in 77 patients (30.0%) in the convalescent-plasma group and in 81 patients (31.9%) in the placebo group (risk difference, 1.9 percentage points; 95% credible interval, −6.0 to 9.8; posterior probability of superiority of convalescent plasma, 0.68). Five patients in the plasma group and 1 patient in the placebo group died. Outcomes regarding worst illness severity and hospital-free days were similar in the two groups. Conclusions The administration of Covid-19 convalescent plasma to high-risk outpatients within 1 week after the onset of symptoms of Covid-19 did not prevent disease progression. (SIREN-C3PO ClinicalTrials.gov number, NCT04355767 .)
This cohort study compares 30-day mortality and inpatient intensive care unit (ICU) admissions before and after the implementation of a novel emergency department–based ICU.
Background Disability-adjusted life years (DALY) are a common public health metric used to consistently estimate and compare health loss because of both fatal and nonfatal disease burden. The annual number of DALY because of adult out-of-hospital cardiac arrest (OHCA) in the United States is unknown. Our objective was to estimate the DALY after adult nontraumatic, emergency medical services–treated OHCA, and to compare OHCA DALY to other leading causes of death and disability in the US. Methods and Results The DALY were calculated as the sum of years of life lost and years lived with disability. The years of life lost were calculated using all adult nontraumatic emergency medical services–treated OHCA with complete data from the national Cardiac Arrest Registry to Enhance Survival database for 2016, and actuarial data for remaining life expectancy at the age of death. Cerebral performance category scores from the Cardiac Arrest Registry to Enhance Survival database and previously established disability weights were used to estimate years lived with disability. The cohort’s calculated DALY were extrapolated to a national level to estimate total US DALY. Data were reported as total, mean, and DALY per 100 000 individuals. A total of 59 752 OHCA met study inclusion criteria. The DALY for the study population were 1 194 993 (years of life lost, 1 194 069; years lived with disability, 924) in 2016. The estimated total DALY following adult nontraumatic emergency medical services–treated OHCA in the US were 4 354 192 (years of life lost, 4 350 825; years lived with disability, 3365) for the index year 2016. The rate of OHCA DALY were 1347 per 100 000 population, which ranked third in the US behind ischemic heart disease (2447) and low back and neck pain (1565). Sensitivity analyses yielded similar findings. Conclusions Adult nontraumatic OHCA is a leading cause of annual DALY in the US and should be a focus of public health policy and resources.
Aim Extracorporeal cardiopulmonary resuscitation (ECPR) is an emerging therapy for refractory cardiac arrest. The purpose of this study was to analyze and report characteristics and outcomes of adult patients treated with ECPR after out-of-hospital cardiac arrest (OHCA) in a large international registry. Methods The Extracorporeal Life Support Organization’s Extracorporeal Life Support Registry was queried for adult cardiac arrests with arrest location of “EMT Transport” or “Outside Hospital.” Results From 2010–2016, 217 cases of ECPR following OHCA were reported in Europe (47%), Asia-Pacific (29%), and North America (24%). The median age was 52 years (IQR 45–62, range 18–87); 73% were male. The median duration of ECPR was 47 h (IQR 17–94, range 0–711). Reported complications included hemorrhage (31.3%), limb complications (11.1%), circuit complications (8.8%), infection (7.4%), and seizures (5.5%). The rate of percutaneous coronary intervention (PCI) was higher in Europe (35.6%) and Asia-Pacific (25.8%) than North America (9.4%; p < 0.01). Survival to hospital discharge was 27.6% (95% CI 22.1–34.0%), and male gender was independently associated with mortality (adjusted odds ratio 2.1 [95% CI 1.1–4.2], p < 0.05). Survival did not differ by region, race, age, or year. Brain death was reported in 16.6% [95% CI 12.2–22.1%]; organ donation rate was not reported. Conclusion This international analysis of ECPR for refractory OHCA reveals a survival rate of 27.6%, demonstrates association of male gender with mortality, and highlights regional differences in PCI utilization. These results will help inform implementation and research of this potentially life-saving strategy for refractory OHCA.
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