One-Year Prognosis After Syncope and the Failure of the ROSE Decision Instrument to Predict One-Year Adverse Events
Study objective
We investigate the incidence of adverse events at 1 year in the cohort of emergency department (ED) syncope patients enrolled in the original Risk Stratification of Syncope in the Emergency Department (ROSE) study, the time to adverse event, and the test performance of the ROSE decision instrument to detect events at 1 year.
Methods
This report details the 1-year follow-up of adult syncope patients presenting to the ED who were enrolled into the ROSE study, a single-center, prospective, observational cohort study. The primary endpoint was the combination of serious outcome and all-cause death at 1 year. Serious outcome encompassed acute myocardial infarction, life-threatening arrhythmia, need for pacemaker/implantable defibrillator, pulmonary embolus, cerebrovascular accident, intracranial or subarachnoid hemorrhage, and interventional procedure or hemorrhage requiring blood transfusion. Secondary endpoints were all-cause death and cardiovascular serious outcome at 1 year.
Results
One thousand forty-three patients were available for analysis; 162 patients (15.5%) had a primary outcome. Twenty-eight (17%) of these were within 24 hours, 56 (35%) were within 1 week, and 78 (48%) were within 1 month. The remaining 84 (52%) outcomes occurred between months 2 and 12. At 1 year, 71 (6.8%) patients had died and 76 (7.3%) had a cardiovascular serious outcome. The sensitivity and specificity of the ROSE decision instrument for 1-year serious outcome and all-cause death were, respectively, 71.6% (95% confidence interval [CI] 63.9% to 78.3%) and 71.1% (95% CI 67.9% to 74.0%); for 1-year all-cause death, 76.1% (95% CI 64.2% to 85.1%) and 67.4% (95% CI 64.3% to 70.3%); and for 1-year cardiovascular serious outcome, 75.0% (95% CI 63.5% to 83.9%) and 67.5% (95% CI 64.5% to 70.5%).
Conclusion
The proportion of patients with serious outcome and all-cause death 1 year after syncope is similar to that reported in recent international syncope studies. We have defined the proportion of patients with cardiovascular serious outcome at 1 year and have shown that most events occurred in the first month, with decreased frequency of events observed after that time especially marked for cardiovascular serious outcome. More than 50% of the outcomes observed, however, occurred after the first month. The ROSE decision instrument does not perform well at predicting 1-year outcome of ED syncope patients.
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Supervising editor: Deborah B. Diercks, MD
Author contributions: All authors were involved in design of the study, analysis and interpretation of data and drafting the manuscript. MJR takes responsibility for the paper as a whole.
Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). This work was supported by funding from a Chief Scientist Office research fellowship (CSO/CAF/06/01) for Dr. Reed. The sponsor of the study had no role in study design, data collection, data management, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and has final responsibility for the decision to submit for publication. Dr. Reed has received a small travel grant from Alere, formerly Inverness Medical, which was formerly Biosite, to present previous work at the International Conference of Emergency Medicine in 2010.
Publication date: Available online February 2, 2011.
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PII: S0196-0644(10)01931-1
doi:10.1016/j.annemergmed.2010.12.021
© 2011 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.
