Heinz Völler, Dominik Bindl, Klaus Nagels, Reiner Hofmann, Eik Vettorazzi, Karl Wegscheider, Eckart Fleck, Stefan Störk, Eckhard Nagel

• Introduction: Remote telemonitoring (RTM) for patients with chronic heart failure (HF) holds promise to improve prognosis and well-being beyond the standard of care (SoC). The CardioBBEAT trial assessed the health economic and clinical impact of an interactive bidirectional RTM system (Motiva(R)) versus SoC for patients with HF and a reduced ejection fraction (HFrEF), in Germany.Methods: This multicenter, randomized controlled trial enrolled 621 patients with HFrEF (mean age 63.0 +/- 11.5 years, 88% men). The primary endpoint was the integrated effect of the intervention on total costs and nonhospitalized days alive after 12 months, reported as incremental cost-effectiveness ratio (ICER). Costs (in keuro) were based on actual charges of patients' statutory health insurance. Among secondary outcome measures were mortality and disease-specific quality of life.Results: We found a neutral effect on nonhospitalized days alive (RTM mean 341 +/- 59 days, SoC 346 +/- 45 days; p = 0.298) associated with increased total costs (RTM 18.5 +/- 39.5Introduction: Remote telemonitoring (RTM) for patients with chronic heart failure (HF) holds promise to improve prognosis and well-being beyond the standard of care (SoC). The CardioBBEAT trial assessed the health economic and clinical impact of an interactive bidirectional RTM system (Motiva(R)) versus SoC for patients with HF and a reduced ejection fraction (HFrEF), in Germany.Methods: This multicenter, randomized controlled trial enrolled 621 patients with HFrEF (mean age 63.0 +/- 11.5 years, 88% men). The primary endpoint was the integrated effect of the intervention on total costs and nonhospitalized days alive after 12 months, reported as incremental cost-effectiveness ratio (ICER). Costs (in keuro) were based on actual charges of patients' statutory health insurance. Among secondary outcome measures were mortality and disease-specific quality of life.Results: We found a neutral effect on nonhospitalized days alive (RTM mean 341 +/- 59 days, SoC 346 +/- 45 days; p = 0.298) associated with increased total costs (RTM 18.5 +/- 39.5 keuro, SoC 12.8 +/- 22.0 keuro; p = 0.046). This yielded an ICER of -1.15 keuro/day. RTM did not impact mortality risk. All quality of life scales were consistently and meaningfully improved in the RTM group at 12 months compared to SoC (all p < 0.01).Conclusions: The first 12 months of RTM were not cost-effective compared to SoC in patients with HFrEF, but associated with a relevant improvement in disease-specific quality of life. The balanced assessment of the potential benefit of RTM requires integration of both the societal and patient perspective.ClinTrials.gov (NCT02293252).…