番茄社区

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MUNICH -- Telemedicine monitoring in heart failure patients seemed to reduce the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause mortality, researchers reported here.

Patients assigned to remote management lost a mean of 17.8 days per year due to unplanned hospitalization compared with 24.2 days per year lost by patients assigned to usual care, for a relative risk reduction of 20% (P=0.046), according to Friedrich Koehler, MD, of the Center for Cardiovascular Telemedicine at Charite-Universitätsmedizin in Berlin, and colleagues.

In addition, the all-cause death rate was 11.34 per 100 patient-years versus 7.86 per 100 patient-years among the telemedicine patients (P=0.028), they stated in a presentation at the European Society of Cardiology annual meeting and in the .

However, cardiovascular mortality was not significantly different between the two groups (HR 0.671, 95% CI 0.45-1.01, P=0.0560), the authors noted.

"The Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial suggests 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," Koehler's group wrote. "To the best of our knowledge, this is the first randomized clinical trial 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."

From Aug. 13, 2013 to May 12, 2017, 1,571 patients were randomly assigned to remote patient management (n=796) or usual care (n=775). Of these, 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 authors noted.

Eligible patients had heart failure, were New York Heart Association class II or III, and had a left ventricular ejection fraction (LVEF) of ≤45%. They also had to have been admitted to hospital for heart failure within 12 months before randomization. Patients with an LVEF >45% had to be on prescribed oral diuretics.

Patients were randomly assigned (1:1) with a secure web-based system to either remote patient management plus usual care or to usual care only. They 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, while key secondary outcomes were all-cause and cardiovascular mortality.

The authors pointed out that "data transmitted to the telemedical center was not just monitored; the Fontane system (telemedical analysis software) enabled the telemedical center 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."

They noted that the telemedical center care concept did require the involvement of physicians and heart failure nurses. Ideally, such a service runs for 24 hours a day, 7 days a week, and has a "modern information technology infrastructure, including a self-adapting software algorithm with prioritization rules, to enable the tailored management of a large number of patients."

These elements set the TIM-HF2 trial apart from other telemedicine studies, said Mary Norine Walsh, MD, of St. Vincent's Hospital in Indianapolis.

"Telemedicine has a checkered past. Previous studies have left decision-making up to a doctor who was given reports and he or she decided what to do. This system recommends action be taken -- with the whole team on site day or night," Walsh, who is a a spokesperson for the American College of Cardiology, told 番茄社区.

But she pointed out that the system was set up under a German government grant. "Before I would advocate for such a system here, I would like to see a thorough cost analysis," she cautioned.

In an , John F. G. Cleland, MD, of the University of Glasgow, and colleague, noted that the result from TIM­-HF2 was similar to that of the , in which the proportion of days lost due to death or hospital admission >450 days with usual care was 37% versus 22.6% with remote management, for a difference between means of -65 days (95% CI -4 to -125).

"Neither study on its own has sufficient statistical power to be completely convincing but, despite much clinical skepticism and feeble support from most guidelines, in our view the growing weight of evidence suggests that home telemonitoring does reduce mortality for patients with heart failure, this effect might be substantial," they wrote.

They pointed out that some of the "key issues" with telemonitoring that need to be resolved are the development of sustainable business models, integration into existing health services, and overcoming the skepticism of health­care professionals who have no telemonitoring experience.

But they also stressed that "Home telemonitoring puts the patient back in the centre of healthcare, ensuring that they know what the health professional is trying to achieve and that they agree with those aims."