Research in context
Evidence before this study
We reviewed randomised and non-randomised studies and meta-analyses published up to Dec 31, 2017, that addressed or discussed the use of telemedicine in patients with heart failure. We searched PubMed with the search terms “telemedicine”, “remote monitoring”, “telemonitoring” and “heart failure”. We restricted the search to articles published in English and German. One randomised controlled trial (RCT) of invasive telemonitoring found a significantly lower rate of readmissions to hospital for heart failure resulting from remote patient management based on pulmonary artery pressure than with usual care. Another RCT measured multiple variables acquired remotely from implanted devices (implantable cardioverter defibrillator [ICD] or ICD plus cardiac resynchronisation therapy [CRT]) to manage patients with heart failure. This RCT showed a benefit in mortality for patients with heart failure with an indication for ICD or ICD plus CRT. On the basis of the results of these two RCTs, the 2016 European Society of Cardiology guidelines for the diagnosis and treatment of acute and chronic heart failure gave remote patient monitoring of patients with heart failure (with these two specific devices) a grade IIb recommendation, level of evidence B. No such recommendation exists for non-invasive remote patient management interventions. Within the past 10 years, non-invasive remote patient management strategies have been studied in several RCTs investigating the effect of remote patient management on mortality, morbidity, and quality of life in patients with heart failure. These RCTs have reported conflicting results because of major differences in the precise study populations investigated, the durations of the remote patient management interventions, the type of home-care devices used, and the interaction methods (including intensity and timing) between the patients, local physicians, heart failure specialists, and telemedical caregivers. Subgroup analyses of the TIM-HF trial suggested that remote patient management has a potential beneficial effect for patients with heart failure in functional New York Heart Association class II and III who were admitted to hospital for decompensated heart failure no more than 12 months before starting the remote patient management intervention and who did not have major depression, which is a common comorbidity in patients with heart failure.
Added value of this study
To the best of our knowledge, this is the first RCT to use a structured remote patient management intervention that was designed to be a true holistic approach for the management of patients with heart failure, involving cardiologists, general practitioners, nurses, other health-care providers, and the patient. The data transmitted to the telemedical centre was not just monitored; the Fontane system (telemedical analysis software) enabled the telemedical centre staff to provide tailored patient support and management using predefined algorithms and biomarker values obtained during follow-up visits. This approach enabled a risk profile to be defined for each patient and the subsequent individual patient care was tailored around this risk profile accordingly. Applying such a care concept, the telemedical centre was the central point for patient management, and such a unit requires physicians and heart failure nurses, and preferably a service that runs for 24 h a day, 7 days a week, and a modern information technology infrastructure, including a self-adapting software algorithm with prioritisation rules, to enable the tailored management of a large number of patients.
Implications of all the available evidence
Our study, along with findings from some of the previous RCTs, has shown that if a patient with heart failure is carefully chosen according to their profile (ie, they have had a recent admission to hospital for heart failure and do not show evidence of major depression) and a structured remote patient management intervention is used, the proportion of days lost due to unplanned cardiovascular hospital admissions or all-cause death during 1 year of follow-up is reduced compared with usual care. The key element in this holistic care concept is a telemedical centre with physicians and heart failure nurses available 24 h a day, every day, and able to act promptly according to the individual patient risk profile. The actions taken by the telemedical centre staff include changes in medication and admission to hospital, if needed, but also educational activities. Moreover, the study results were not influenced by geographical location. As a result, regional differences in the access to appropriate heart failure care might be reduced.