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Early changes in clinical characteristics after emergency department therapy for acute heart failure syndromes: identifying patients who do not respond to standard therapy

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Abstract

Clinical trials for acute heart failure syndromes (AHFS) have traditionally enrolled patients well after emergency department (ED) presentation. We hypothesized a large proportion of patients would undergo changes in clinical profiles during the first 24 h of hospitalization, and these changes would be associated with adverse events. We evaluated a prospective cohort of patients with clinical data available at ED presentation and 12–24 h after ED treatment for AHFS. Patients were categorized into distinct clinical profiles at these time points based on (1) systolic blood pressure: a—hypertensive (>160 mmHg); b—normotensive (100–159 mmHg); or c—hypotensive (<100 mmHg); (2) moderate-to-severe renal dysfunction (GFR ≤ 60 ml/min/1.73 m2); and (3) presence of troponin positivity. A composite outcome of 30-day cardiovascular events was determined by phone follow-up. In the 370 patients still hospitalized with data available at the 12–24 h time point, 196 (53.0%) had changed their clinical profiles, with 117 (59.7%) improving and 79 (40.3%) worsening. The composite 30-day event rate was 16.9%. Patients whose clinical profile started and stayed abnormal had a significantly greater proportion of events than those who started and stayed normal (26.1% vs. 11.3%; P = 0.03). Patients with abnormal clinical profiles at presentation that remain abnormal throughout the first 12–24 h of hospitalization are at increased risk of 30-day adverse events. Future clinical trials may need to consider targeting these patients, as they may be the most likely to benefit from experimental therapy.

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Acknowledgments

The authors would like to acknowledge Lyndi Goette, MBA, for her help in preparation of the manuscript. This work was supported in part by National Heart, Lung and Blood Institute grant K23HL085387 and an institutional Clinical and Translational Science Award NIH/NCRR Grant Number 1UL1RR026314-01.

Conflict of interest

Sean Collins: Consultant: Abbott Point of Care, Bayer, The Medicines Company, Trevena, Novartis;Grant Support: NIH/NHLBI, Abbott Point of Care, BG Medicine. Alan Storrow: Current Grant Support: Abbott Diagnostics, NIH/NHLBI (R01HL088459-02). NIH/NHLBI (K23HL085387-01A2), NIH/NHLBI (K12HL1090-01), Centers for Disease Control, Corthera, Roche Diagnostics, Abbott Diagnostics, Thermo Fisher. Current Consultant: Roche Diagnostics. Greg Fermann: Grant support: Dyax, Corthera, The Medicines Company. Advisory Board: Quest Diagnostics/Hemocue, Daiichi Sankyo. Frank Peacock: Research Grants (>$10,000) Abbott, Alere, BAS, Brahms, EKR, Nanosphere, The Medicine’s Company; Consultant (<$10,000) Abbott, Alere, Beckman Coulter, Electrocore, The Medicine’s Company; Speaker’s Bureau (<$10,000) Abbott, Alere; Ownership Interest (<$10,000) Comprehensive Research Associates LLC, Vital Sensors, Emergencies in Medicine LLC. Peter Pang: Dr. Pang has been a consultant for Bayer, J&J, Medtronic, Novartis, Otsuka, SigmaTau, and Trevena and a member of the DSMB for J&J and the Medicines Company. He has received research support from Abbott. Phil Levy: Consultant: The Medicines Company (Data Safety Monitoring Board), Corthera, Inc., Bayer Schering Pharma AG, EKR Therapeutics, Trevena, Inc Research support/grants: The Cleveland Clinic Foundation, Nile Therapeutics, Corthera, Inc., Bayer Schering Pharma AG Speakers Bureau: The Society of Chest Pain Centers Chris Lindsell: Grant support: Abbott Point of Care. Mihai Gheorghiade: Consultant (modest): Abbott Labs, Astellas, Astra Zeneca, Bayer Schering Pharma AG, CorThera, Inc., Cytokinetics, Inc., DebioPharm S.A., Errekappa Terapeutici (Milan, Italy), Glaxo Smith Kline, Johnson & Johnson, Medtronic, Merck, Novartis Pharma AG, Otsuka Pharmaceuticals, Pericor Therapeutics, Protein Design Laboratories, Sanofi Aventis, Sigma Tau, Solvay Pharmaceuticals. Dr. Gheorghiade receives $10,000 or more as a consultant from the following companies: Bayer Schering Pharma AG, DebioPharm S.A., Medtronic, Novartis Pharma AG, Otsuka Pharmaceuticals, Sigma Tau, Solvay Pharmaceuticals, DebioPharm S.A., Pericor Therapeutics. Drs. Doug Sawyer and Neal Weintraub have no conflicts of interest or financial ties to disclose.

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Collins, S.P., Lindsell, C.J., Storrow, A.B. et al. Early changes in clinical characteristics after emergency department therapy for acute heart failure syndromes: identifying patients who do not respond to standard therapy. Heart Fail Rev 17, 387–394 (2012). https://doi.org/10.1007/s10741-011-9294-7

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  • DOI: https://doi.org/10.1007/s10741-011-9294-7

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