Search

Importance: Uncontrolled studies suggest that pulmonary embolism (PE) can be safely ruled out using the YEARS rule, a diagnostic strategy that uses varying D-dimer thresholds.Objective: To prospectively validate the safety of a strategy that combines the YEARS rule with the pulmonary embolism rule-out criteria (PERC) rule and an age-adjusted D-dimer threshold.Design, Settings, and Participants: A cluster-randomized, crossover, noninferiority trial in 18 emergency departments (EDs) in France and Spain. Patients (N = 1414) who had a low clinical risk of PE not excluded by the PERC rule or a subjective clinical intermediate risk of PE were included from October 2019 to June 2020, and followed up until October 2020.Interventions: Each center was randomized for the sequence of intervention periods. In the intervention period (726 patients), PE was excluded without chest imaging in patients with no YEARS criteria and a D-dimer level less than 1000 ng/mL and in patients with 1 or more YEARS criteria and a D-dimer level less than the age-adjusted threshold (500 ng/mL if age <50 years or age in years × 10 in patients ≥50 years). In the control period (688 patients), PE was excluded without chest imaging if the D-dimer level was less than the age-adjusted threshold.Main Outcomes and Measures: The primary end point was venous thromboembolism (VTE) at 3 months. The noninferiority margin was set at 1.35%. There were 8 secondary end points, including chest imaging, ED length of stay, hospital admission, nonindicated anticoagulation treatment, all-cause death, and all-cause readmission at 3 months.Results: Of the 1414 included patients (mean age, 55 years; 58% female), 1217 (86%) were analyzed in the per-protocol analysis. PE was diagnosed in the ED in 100 patients (7.1%). At 3 months, VTE was diagnosed in 1 patient in the intervention group (0.15% [95% CI, 0.0% to 0.86%]) vs 5 patients in the control group (0.80% [95% CI, 0.26% to 1.86%]) (adjusted difference, -0.64% [1-sided 97.5% CI, -∞ to 0.21%], within the noninferiority margin). Of the 6 analyzed secondary end points, only 2 showed a statistically significant difference in the intervention group compared with the control group: chest imaging (30.4% vs 40.0%; adjusted difference, -8.7% [95% CI, -13.8% to -3.5%]) and ED median length of stay (6 hours [IQR, 4 to 8 hours] vs 6 hours [IQR, 5 to 9 hours]; adjusted difference, -1.6 hours [95% CI, -2.3 to -0.9]).Conclusions and Relevance: Among ED patients with suspected PE, the use of the YEARS rule combined with the age-adjusted D-dimer threshold in PERC-positive patients, compared with a conventional diagnostic strategy, did not result in an inferior rate of thromboembolic events.Trial Registration: ClinicalTrials.gov Identifier: NCT04032769. [ABSTRACT FROM AUTHOR]

Importance: Clinical guidelines for the early management of acute heart failure in the emergency department (ED) setting are based on only moderate levels of evidence, with subsequent low adherence to these guidelines.Objective: To test the effect of an early guideline-recommended care bundle on short-term prognosis in older patients with acute heart failure in the ED.Design, Setting, and Participants: Stepped-wedge cluster randomized trial in 15 EDs in France of 503 patients 75 years and older with a diagnosis of acute heart failure in the ED from December 2018 to September 2019 and followed up for 30 days until October 2019.Interventions: A care bundle that included early intravenous nitrate boluses; management of precipitating factors, such as acute coronary syndrome, infection, or atrial fibrillation; and moderate dose of intravenous diuretics (n = 200). In the control group, patient care was left to the discretion of the treating emergency physician (n = 303). Each center was randomized to the order in which they switched to the "intervention period." After the initial 4-week control period for all centers, 1 center entered in the intervention period every 2 weeks.Main Outcomes and Measures: The primary end point was the number of days alive and out of hospital at 30 days. Secondary outcomes included 30-day all-cause mortality, 30-day cardiovascular mortality, unscheduled readmission, length of hospital stay, and kidney impairment.Results: Among 503 patients who were randomized (median age, 87 years; 298 [59%] women), 502 were analyzed. In the intervention group, patients received a median (interquartile range) of 27.0 (9-54) mg of intravenous nitrates in the first 4 hours vs 4.0 (2.0-6.0) mg in the control group (adjusted difference, 23.8 [95% CI, 13.5-34.1]). There was a significantly higher percentage of patients in the intervention group treated for their precipitating factors than in the control group (58.8% vs 31.9%; adjusted difference, 31.1% [95% CI, 14.3%-47.9%]). There was no statistically significant difference in the primary end point of the number of days alive and out of hospital at 30 days (median [interquartile range], 19 [0- 24] d in both groups; adjusted difference, -1.9 [95% CI, -6.6 to 2.8]; adjusted ratio, 0.88 [95% CI, 0.64-1.21]). At 30 days, there was no significant difference between the intervention and control groups in mortality (8.0% vs 9.7%; adjusted difference, 4.1% [95% CI, -17.2% to 25.3%]), cardiovascular mortality (5.0% vs 7.4%; adjusted difference, 2.1% [95% CI, -15.5% to 19.8%]), unscheduled readmission (14.3% vs 15.7%; adjusted difference, -1.3% [95% CI, -26.3% to 23.7%]), median length of hospital stay (8 d in both groups; adjusted difference, 2.5 [95% CI, -0.9 to 5.8]), and kidney impairment (1% in both groups).Conclusions and Relevance: Among older patients with acute heart failure, use of a guideline-based comprehensive care bundle in the ED compared with usual care did not result in a statistically significant difference in the number of days alive and out of the hospital at 30 days. Further research is needed to identify effective treatments for acute heart failure in older patients.Trial Registration: ClinicalTrials.gov Identifier: NCT03683212. [ABSTRACT FROM AUTHOR]

• In this retrospective analysis of patients with PE diagnosed in the ED from two cohorts in Spain and France, patients with COVID exhibited PEs of less severity. • However, COVID was associated with an increased risk of in-hospital mortality. • This study suggests that the usual tools for risk stratification, specifically the sPESI and RVD, are still valid in COVID patients, while the size of a PE is not valid in this particular population infected by SARS-CoV-2. To compare the severity of pulmonary embolism (PE) between patients with and without COVID, and to assess the association between severity and in-hospital-mortality. We performed an analysis of 549 COVID (71.3% PCR-confirmed) and 439 non-COVID patients with PE consecutively included by 62 Spanish and 16 French emergency departments. PE-severity was assessed by size, the presence of right ventricular dysfunction (RVD), and the sPESI. The association of PE-severity and in-hospital-mortality was assessed both in COVID and non-COVID patients, and the interaction of COVID status and PE severity/outcome associations was also evaluated. COVID patients had PEs of smaller size (43% vs 56% lobar or larger, 42% vs. 35% segmental and 13% vs. 9% subsegmental, respectively; p = 0.01 for trend), less RVD (22% vs. 16%, p = 0.02) and lower sPESI (p = 0.03 for trend). Risk of in-hospital death was higher in COVID patients (12.8% vs. 5.3%, p < 0.001). PE-severity assessed by RVD and sPESI was independently associated with in-hospital-mortality in COVID patients, while PE size and sPESI were significantly associated with in-hospital-mortality in non-COVID. COVID status showed a significant interaction in the association of PE size and outcome (p = 0.01), with OR for in-hospital mortality in COVID and non-COVID patients with lobar or larger PE of 0.92 (95%CI=0.19–4.47) and 4.47 (95%CI=1.60–12.5), respectively. Sensitivity analyses using only PCR-confirmed COVID cases confirmed these results. COVID patients present a differential clinical picture, with PE of less severity than in non-COVID patients. An increased sPESI was associated with the risk of mortality in both groups but, PE size did not seem to be associated with in-hospital mortality in COVID patients. [ABSTRACT FROM AUTHOR]

Purpose: The efficacy of the 1-h bundle for emergency department (ED) patients with suspected sepsis, which includes lactate measurement, blood culture, broad-spectrum antibiotics administration, administration of 30 mL/kg crystalloid fluid for hypotension or lactate ≥ 4 mmol/L, remains controversial., Methods: We carried out a pragmatic stepped-wedge cluster-randomized trial in 23 EDs in France and Spain. Adult patients with Sepsis-3 criteria or a quick sequential organ failure assessment (SOFA) score ≥ 2 or a lactate > 2 mmol/L were eligible. The intervention was the implementation of the 1-h sepsis bundle. The primary outcome was in-hospital mortality truncated at 28 days. Secondary outcomes included volume of fluid resuscitation at 24 h, acute heart failure at 24 h, SOFA score at 72 h, intensive care unit (ICU) length of stay, number of days on mechanical ventilation or renal replacement therapy, vasopressor free days, unnecessary antibiotic administration, and mortality at 28 days. 1148 patients were planned to be analysed; the study period ended after 873 patients were included., Results: 872 patients (mean age 66, 42% female) were analyzed: 387 (44.4%) in the intervention group and 485 (55.6%) in the control group. Median SOFA score was 3 [1-5]. Median time to antibiotic administration was 40 min in the intervention group vs 113 min in the control group (difference - 73 [95% confidence interval (CI) - 93 to - 53]). There was a significantly higher rate, volume, and shorter time to fluid resuscitation within 3 h in the intervention group. There were 47 (12.1%) in-hospital deaths in the intervention group compared to 61 (12.6%) in the control group (difference in percentage - 0.4 [95% CI - 5.1 to 4.2], adjusted relative risk (aRR) 0.81 [95% CI 0.48 to 1.39]). There were no differences between groups for other secondary endpoints., Conclusions: Among patients with suspected sepsis in the ED, the implementation of the 1-h sepsis bundle was not associated with significant difference in in-hospital mortality. However, this study may be underpowered to report a statistically significant difference between groups., (© 2024. Springer-Verlag GmbH Germany, part of Springer Nature.)

Introduction: Worldwide, the COVID-19 epidemic has put health systems to the test. The excess mortality is partly due to the influx of patients requiring hospitalization and intensive care. We propose that the chronology of epidemic spread gives a window of time in which hospitals can act to prevent reaching capacity., Methods: The out-of-hospital SAMU Emergency Medical System in an entry point into the French health care system. We recorded the number of patients managed, of patients transferred to emergency departments (ED), and of mobile intensive care units (MICUs) dispatched. Each criterion was compared to the mean of the same criterion over the previous 5 years. The alert threshold which indicated a public health crisis was defined as a 20% increase compared to the 5-year mean., Results: The reference period, from January 2015 to December 2019, included 3 381 611 calls, and 1 137 856 patients. The study period, from 17 February to 28 March 2020, included 166 888 calls, and 56 708 patients. The daily numbers of patients managed crossed the threshold on February 25, and increased until the end of the study period. The daily number of patients transferred to ED crossed the threshold on March 16, and increased until the end of the period. The daily number of MICUs dispatched crossed the threshold on March 15, and increased until the end of the period., Conclusion: The COVID-19 epidemic reached our department in three consecutive waves which overwhelmed the health care system. The first wave preceded by 30 days the massive arrival of critical patients. Health care systems must take advantage of this delay to prepare for the third wave.

Background: Acute heart failure (AHF) is one of the most common diagnoses for elderly patients in the emergency department (ED), with an admission rate above 80% and 1-month mortality around 10%. The European guidelines for the management of AHF are based on moderate levels of evidence, due to the lack of randomized controlled trials and the scarce evidence of any clinical added value of a specific treatment to improve outcomes. Recent reports suggest that the very early administration of full recommended therapy may decrease mortality. However, several studies have highlighted that elderly patients often received suboptimal treatment. Our hypothesis is that an early care bundle that comprises early and comprehensive management of symptoms, along with prompt detection and treatment of precipitating factors should improve AHF outcome in elderly patients., Methods/design: ELISABETH is a stepped-wedge, cluster randomized controlled, clinical trial in 15 emergency departments in France recruiting all patients aged 75 years and older with a diagnosis of AHF. The tested intervention is a care bundle with a checklist that mandates detection and early treatment of AHF precipitating factors, early and intensive treatment of congestion with intravenously administered nitrate boluses, and application of other recommended treatment (low-dose diuretics, non-invasive ventilation when indicated, and preventive low-molecular-weight heparin). Each center is randomized to the order in which they will switch from a "control period" to an "intervention period." All centers begin the trials with the control period for 2 weeks, then after each 2-week step a new center will enter the intervention period. At the end of the trial, all clusters will receive the intervention regimen. The primary outcome is the number of days alive and out of the hospital at 30 days., Discussion: If our hypothesis is confirmed, this trial will strengthen the level of evidence of AHF guidelines and stress the importance of the associated early and comprehensive treatment of precipitating factors. This trial could be the first to report a reduction in short-term morbidity and mortality in elderly AHF patients., Trial Registration: ClinicalTrials.gov, ID: NCT03683212. Prospectively registered on 25 September 2018.

We aimed to evaluate the reliability of waiting times (WT) measures electronically retrieved. We prospectively collected true WT in four emergency departments during 20 predefined 2-h inclusion periods, and compared them with the electronically retrieved waiting time (ERWT). We assessed agreement with calculation of rate of outliers (difference exceeding 20 min), bias, and its 95% limits of agreements, and associated Bland and Altman plot. We analyzed 274 patients. The mean difference was -2 min (SD 13) between ERWT and true WT, with a 95% limits of agreements (-28 to 24 min). Bland and Altman plot showed a good agreement, and we report 7% of outliers. Using ERWT, 14 patients (5%) were misclassified as having their target WT exceeded or not. ERWT agree well with the true WT, although the significant rate of outlier and misclassification calls for caution in their interpretation.