Effect of Emergency Department Care Bundle in Acute Heart Failure

Quick Takes

  • In a cluster randomized trial in 15 French emergency departments, early use of guideline-directed diuretics, nitrates, treatment of precipitating cause, and noninvasive ventilation in elderly patients admitted with acute HF did not change 30-day rehospitalization or survival.
  • Treatment differed significantly between intervention and control arms, suggesting results likely were not driven by Hawthorne effect.

Study Questions:

What is the clinical efficacy of an early, comprehensive, and guideline-recommended care bundle on older patients presenting with acute heart failure (HF) in the emergency department (ED)?

Methods:

This was an unblinded, stepped wedge, cluster randomized trial performed at 15 EDs in France between December 2018–September 2019. Patients presenting with acute HF who were aged ≥75 years were enrolled within 6 hours of presentation. Diagnosis of HF was at the discretion of the treating physician and echocardiogram was not mandatory. EDs were randomized to providing usual care or guideline-recommended care bundle including moderate-dose diuretics, high-dose intravenous nitrates, noninvasive ventilation if indicated, and management of precipitating cause. Patients ineligible to receive these therapies were excluded (e.g., if systolic blood pressure <100 mm Hg). All treatments were initiated within the first hour of medical management for ≥4 hours. All centers were randomized as clusters with a 4-week control period prior to the intervention period. The primary outcome was number of days alive and out of hospital in the 30 days following an ED visit.

Results:

Overall, 15 EDs recruited 503 patients for this trial. Primary analysis included 502 patients: 303 in the control group and 199 in the intervention group. The median age was 87 years (81-91 years), 59% were women, and 54% had known HF. Markers of pulmonary congestion were similar between both groups including oxygen saturation respiratory rate and systolic blood pressure. As intended, a greater proportion of patients in the intervention arm received guideline-directed early HF management. The median number of days alive out of hospital at 30 days was 19 (0-24) in the intervention arm and 19 (0-24) in control arm (adjusted risk ratio, 0.88; 95% confidence interval [CI], 0.64-1.21). There was no difference in all-cause mortality within 30 days (adjusted risk ratio, 1.17; 95% CI, 0.52-2.57). Similarly, there was no difference in mortality, cardiovascular mortality, number of days hospitalized, rates of rehospitalization, or acute kidney injury within the first 30 days.

Conclusions:

In this cluster randomized trial of early guideline-directed ED management of elderly patients with acute HF, early diuresis and vasodilatation (using nitrates) did not alter 30-day rehospitalization or survival post-discharge.

Perspective:

While several recent randomized trials have helped improve care for chronic HF patients by 'leaps and bounds,' little has changed in the acute management of HF. This study tackles the important question of whether early ED management of acute HF alters outcomes. Negative results of this study are less likely due to the Hawthorne effect (i.e., change in management of patients in the control group as an effect of trial participation), as treatment and medication doses differed significantly in the intervention and control arms. However, these results mimic results of other randomized trials that evaluated efficacy of vasodilators in acute HF. Limitations of this study include inclusion of all individuals aged >75 years as a homogenous group. However, studies have shown that HF patients respond differently to medical management based on preserved versus reduced ejection fraction. Additionally, elderly HF patients often have other competing comorbidities that impact survival more than HF. Notably, despite aggressive use of intravenous nitrates, the proportion of patients needing an intensive care unit stay did not differ statistically between the two groups. While an objective assessment of patient symptoms was not included as an endpoint, a strategy of rapid diuresis and vasodilatation may yield a faster improvement in symptoms. These results highlight the need for novel strategies addressing acute HF management.

Clinical Topics: Cardiovascular Care Team, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: Acute Kidney Injury, Blood Pressure, Diuresis, Diuretics, Emergency Service, Hospital, Geriatrics, Heart Failure, Hypotension, Nitrates, Noninvasive Ventilation, Patient Care Bundles, Patient Discharge, Respiratory Rate, Vasodilation, Vasodilator Agents


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