OBJECTIVES: To quantify the risk of outcomes experienced by patients receiving standard of care treatment in trials for non-pharmaceutical heart failure interventions.

METHODS: A systematic literature review (Prospero registration CRD42023410084) of literature on heart failure in the US was conducted. Searches in EMBASE and PubMed identified literature published between 2008 and 2023. The inclusion criteria were that the randomized controlled trial had to be completed in the US with patients who were over the age of 18 and who had been diagnosed with heart failure in the last 12 months. Heart failure monitoring was the intervention, and the comparator was watchful waiting. Outcomes extracted were hospital readmission, emergency room visits, survival, and length of hospital stay. A meta-analysis of proportion was performed using R software (Meta and Metafor packages).

RESULTS: Across the two databases 2,936 abstracts were identified. Once duplicates were removed, 2,248 remained for screening. After full-text review, 31 were included for data extraction, and analysis. The pooled rates of all -cause and heart failure-specific hospital readmission for 3 months were: 32.55% (95% confidence interval 24.03%; 41.63%) and 33.19% (24.16%;42.83%) respectively. The emergency room visit pooled rates of all-cause and heart failure-specific visits for 3 months were: 21.91% (7.56%; 40.65%) and 27.19% (7.06%; 53.52%). The 3-month all-cause mortality pooled rate was 3.46% (2.12%; 5.06%). Heart failure-specific data were only sufficient for 6-months, the rate was 5.92% (2.82%;9.92%). The data on length of hospital stay was heterogenous, the pooled value being 11.8 days (range 1.41 – 18).

CONCLUSIONS: Events that can increase the cost of care are relatively common in patients recently diagnosed with heart failure. Hospitalization and emergency room visit rates are similar between all-cause and heart failure-specific populations at 3-months. Interventions that could optimize care and prevent such events would likely be beneficial to both patients and payers.