Remote patient management of heart failure across the ejection fraction spectrum

Aims: The benefit of non-invasive remote patient management (RPM) for patients with heart failure (HF) has been demonstrated. We evaluated the effect of left ventricular ejection fraction (EF) on treatment outcomes in the TIM-HF2 (Telemedical Interventional Management in Heart Failure II; NCT01878630) randomized trial.

Methods and results: TIM-HF2 was a prospective, randomized, multi-center trial investigating the effect of a structured RPM intervention vs usual care in patients, who had been hospitalized for HF within 12 months before randomization. The primary endpoint was the percentage of days lost due to all-cause death or unplanned cardiovascular hospitalization. Key secondary endpoints were all-cause and cardiovascular mortality. The authors assessed outcomes by left ventricular EF in guideline-defined subgroups of ≤40% (HFrEF), 41%-49% (HFmrEF), and ≥50% (HFpEF). Out of 1538 participants, 818 (53%) had HFrEF, 224 (15%) had HFmrEF, and 496 (32%) had HFpEF. Within each EF subgroup, the primary endpoint was lower in the treatment group, i.e. the incidence rate ratio, IRR, remained below 1.0. Comparing intervention and control group, the percentage of days lost was 5.4% vs. 7.6% for HFrEF (IRR 0.72, 95% CI 0.54-0.97), 3.3% vs. 5.9% for HFmrEF (0.85, 95% CI 0.48-1.50) and 4.7% vs. 5.4% for HFpEF (0.93, 95% CI 0.64-1.36). No interaction between left ventricular EF and the randomized group became apparent. All-cause and cardiovascular mortality were also reduced by RPM in each subgroup with hazard ratios <1.0 across the EF spectrum for both endpoints.

Conclusion: In the clinical set-up deployed in the TIM-HF2 trial, RPM appeared effective irrespective of the EF-based HF phenotype.