Telemedicine in Heart Failure Patients (TIM-HF2)
What is the efficacy of a remote patient management intervention on mortality and morbidity in a well-defined heart failure population?
The TIM-HF2 (Telemedical Interventional Management in Heart Failure II) trial investigators conducted a prospective, randomized, controlled, parallel-group, unmasked, multicenter trial, with pragmatic elements introduced for data collection. The trial was done in Germany, and patients were recruited from hospitals and cardiology practices. Eligible patients had heart failure, were in New York Heart Association class II or III, had been admitted to hospital for heart failure within 12 months before randomization, and had a left ventricular ejection fraction (LVEF) of ≤45% (or if >45%, oral diuretics were being prescribed). Patients with major depression were excluded. Patients were randomly assigned (1:1) using a secure web-based system to either remote patient management plus usual care or to usual care only, and were followed up for a maximum of 393 days. The primary outcome was percentage of days lost due to unplanned cardiovascular hospital admissions or all-cause death, analyzed in the full analysis set. Key secondary outcomes were all-cause and cardiovascular mortality. All survival analyses were done on a time-to-first event basis. Cumulative incidence curves for all-cause mortality were constructed according to the Kaplan-Meier method, and the differences between curves were examined by the log-rank statistic.
A total of 1,571 patients were randomly assigned to remote patient management (n = 796) or usual care (n = 775). Of these 1,571 patients, 765 in the remote patient management group and 773 in the usual care group started their assigned care, and were included in the full analysis set. The percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause death was 4.88% (95% confidence interval [CI], 4.55-5.23) in the remote patient management group and 6.64% (6.19-7.13) in the usual care group (ratio, 0.80; 95% CI, 0.65-1.00; p = 0.0460). Patients assigned to remote patient management lost a mean of 17.8 days (95% CI, 16.6-19.1) per year compared with 24.2 days (22.6-26.0) per year for patients assigned to usual care. The all-cause death rate was 7.86 (95% CI, 6.14-10.10) per 100 person-years of follow-up in the remote patient management group compared with 11.34 (9.21-13.95) per 100 person-years of follow-up in the usual care group (hazard ratio [HR], 0.70; 95% CI, 0.50-0.96; p = 0.0280). Cardiovascular mortality was not significantly different between the two groups (HR, 0.671; 95% CI, 0.45-1.01; p = 0.0560).
The authors concluded that a structured remote patient management intervention, when used in a well-defined heart failure population, could reduce the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause mortality.
This study reports that remote patient management in a well-defined heart failure population results in fewer days lost due to unplanned cardiovascular hospitalizations and all-cause mortality compared with the usual care. The primary outcome composite was driven mainly by reduction in mortality, and in particular cardiovascular mortality, rather than in unplanned cardiovascular hospital admissions. The key component in this care strategy is a telemedical center with physicians and heart failure nurses available 24 hours a day, every day, and able to act promptly according to the individual patient risk profile. The actions taken by the telemedical center staff include changes in medication and admission to hospital, if needed, but also educational activities. These data, along with several other studies, strongly supports the role of telemedicine with 24-hour availability to improve outcomes in selected heart failure patients.
Keywords: ESC Congress, ESC18, Diuretics, Heart Failure, Hospitalization, Internet, Primary Prevention, Stroke Volume, Telemedicine
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