Abstract 12208: Mode of Death in Heart Failure With Preserved Ejection Fraction: A Systematic Review
Introduction: Despite its tremendous clinical and economic impact, remarkably little is known about the specific modes of death (MOD) in patients with heart failure with preserved ejection fraction (HFpEF).
Methods: We conducted a systematic review of published HFpEF clinical trials and epidemiological studies from January 1st, 1985 to December 31st, 2015 using the PubMed and EMBASE databases. Two independent investigators manually screened 1,608 articles in duplicate, selected studies, and extracted relevant data. The systematic search yielded 8 major randomized controlled trials and 24 epidemiological studies that reported MOD data.
Results: Definitions of cardiovascular (CV), sudden, heart failure (HF), and non-CV deaths in HFpEF trials were similar to those used in contemporary trials of HF with reduced ejection fraction (HFrEF). CV causes accounted for ~60-70% of total deaths in HFpEF clinical trials (Figure), while this proportion was more variable (14-83%) in epidemiological studies. Only 4 (50%) trials and 5 (20.8%) epidemiological studies reported data on sudden death (SD). SD accounted for ~40% of the CV deaths in clinical trials, but only 20-28% in epidemiological studies. Proportions of HF deaths were consistent across clinical trials (20-30% of CV deaths) but varied in epidemiological studies (17-60%). Cancer was the most frequently reported non-CV MOD (~30-40% of non-CV deaths), followed by infection/sepsis, which accounted for a quarter of non-CV deaths.
Conclusions: Cause-specific mortality is infrequently reported, informed by <1,000 events (in trials) and <500 events (in epidemiological studies), and when it is, event definitions are directly applied from HFrEF studies. The definition of SD is non-specific and suboptimal in the majority of studies; therefore, it is unclear whether these truly represent arrhythmic deaths. Reporting and definitions of MOD must be standardized and tailored to the HFpEF population.
Author Disclosures: R.B. Patel: None. M. Vaduganathan: None. A. Michel: Employment; Significant; Bayer Pharma AG. S.J. Shah: Research Grant; Significant; National Institutes of Health (R01 HL107577, R01 HL127028), the American Heart Association (16SFRN28780016, 15CVGPSD27260148). Other Research Support; Modest; Actelion, Novartis. Consultant/Advisory Board; Modest; AstraZeneca, Bayer, Merck, Novartis. M. Senni: Consultant/Advisory Board; Modest; Abbott Vascular, Novartis, and Bayer. M. Gheorghiade: Consultant/Advisory Board; Modest; Abbott Laboratories, Astellas, Astra Zeneca, CorThera Inc., Cytokinetics Inc., Errekappa Terapeutici, GlaxoSmithKline, Johnson & Johnson, Merck, Protein Design Laboratories, Sanofi-Aventis. Consultant/Advisory Board; Significant; Bayer Schering Pharma AG, DebioPharm SA, Medtronic, Novartis Pharma AG, Otsuka Pharmaceuticals, PeriCor Therapeutics, Sigma Tau, Solvay Pharmaceuticals. J. Butler: Other Research Support; Significant; National Institutes of Health, European Union, Health Resource Services Administration, and Food and Drug Administration, Amgen. Consultant/Advisory Board; Modest; Takeda, Medtronic, Z Pharma, Zensun, Celladon, Gambro, GE Healthcare, Janssen, Ono. Consultant/Advisory Board; Significant; Bayer, CardioCell, Merck, Novartis, Relypsa, Trevena,.
- © 2016 by American Heart Association, Inc.