法国巴黎大学Alexandre Mebazaa联合索邦大学Yonathan Freund团队研究了急诊室综合护理对老年急性心力衰竭患者30天出院生存的影响。2020年11月17日，该研究发表在《美国医学会杂志》上。
503例患者的中位年龄为87岁，其中女性占59%，共有502例接受了分析。干预组患者在最初4小时内静脉注射硝酸盐的中位数为27.0 mg，显著高于对照组（4.0 mg）。干预组因诱发因素而接受治疗的患者占58.8%，显著高于对照组（31.9%）。两组在30天时的平均存活出院天数均为19天，没有统计学差异。在30天时，干预组和对照组的死亡率、心血管死亡率、计划外再入院率、住院时间中位数和肾脏损害率亦均无显著差异。
Title: Effect of an Emergency Department Care Bundle on 30-Day Hospital Discharge and Survival Among Elderly Patients With Acute Heart Failure: The ELISABETH Randomized Clinical Trial
Author: Yonathan Freund, Marine Cachanado, Quentin Delannoy, Said Laribi, Youri Yordanov, Judith Gorlicki, Tahar Chouihed, Anne-Laure Féral-Pierssens, Jennifer Truchot, Thibaut Desmettre, Celine Occelli, Xavier Bobbia, Mehdi Khellaf, Olivier Ganansia, Jérme Bokobza, Frédéric Balen, Sebastien Beaune, Ben Bloom, Tabassome Simon, Alexandre Mebazaa
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.