TIM-HF2: Remote Patient Management May Improve Outcomes in HF

Marlene Busko

August 28, 2018

MUNICH — Nondepressed patients with chronic heart failure (HF) who received remote patient management added to usual care had fewer "days lost" due to cardiovascular hospital admissions and lower all-cause mortality than patients who received only usual care, researchers report.  

Professor Friedrich Köhler, from the Charité–Universitätsmedizin Berlin, Germany, presented these findings from the randomized Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial — including more than 1500 patients at 16 centers in Germany — here at the European Society of Cardiology (ESC) Congress 2018, with results simultaneously published online in The Lancet.

In addition to careful patient selection, "a well-structured telemedical center providing 24/7 service is a key element with the remote patient management intervention," Köhler reported.

This study shows that "remote patient management — not just monitoring, not just watching — will be part of the doctor's work in the future," Köhler told theheart.org | Medscape Cardiology. Doctors will soon be treating inpatients, outpatients, and remote patients, he said.

Moreover, even the oldest patient in the trial, at age 92 years, found that collecting and submitting daily data, including electrocardiogram readings, was easy to do, he noted.

However, "it's not possible to [just] outsource [patient management] to a call center," Köhler emphasized. "You need to see the big picture from incoming data and then develop a plan for the patient, instead of only looking at crossing thresholds," he said.

The nurses and physicians at the call center worked closely with the patients' own general practitioners and local cardiologists, he added.

At 1 year, the proportion of days lost due to unplanned cardiovascular hospital admissions or all-cause mortality (the primary endpoint) was lower with telemonitoring, at 4.88% vs 6.64% (ratio, 0.80; 95% confidence interval [95% CI], 0.65 - 1.00; P = .0460).

"Importantly, home telemonitoring triggered some potentially life-saving hospital admissions, although, overall, it slightly reduced the number of days that patients were hospitalized due to heart failure," Professor John F.G. Cleland, Imperial College London, United Kingdom, and Professor Robin A. Clark, Flinders University, Adelaide, Australia, write in an editorial that accompanied the article.

They note that the primary outcome was similar to the outcome in one of the first large trials of home telemonitoring for HF; in TEN-HMS, lost days for this outcome were 23% vs 37% for patients with vs without telemonitoring, during 450 days — with most benefit coming from reduced mortality.

"Neither study on its own has sufficient statistical power to be completely convincing," Cleland and Clark write, "but, despite much clinical scepticism 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, and this effect might be substantial."

Moreover, the "proportion of days lost due to hospital admission is small compared with those lost due to death," so survival is probably a better outcome to study rather than hospital admission for HF.  

"Clearly, home telemonitoring might not work for every patient," Cleland and Clark note, "but no intervention does."

However, "home telemonitoring systems provide a valuable organisational structure for maintaining and improving the quality of care for long-term medical conditions such as heart failure; we should use them and learn," they conclude.

Limited Recommendations for Telemonitoring  

The recent ESC guidelines on heart failure management give only limited recommendations for telemonitoring for patients with HF, based on two device-related telemonitoring solutions, Köhler and colleagues write.

However, remote patient management (as opposed to telemonitoring alone) goes beyond early detection of clinical deterioration; it also allows "prompt initiation of the appropriate treatment and care before a full manifestation of a heart failure decompensation," they stress.

In this study, they aimed to investigate morbidity and mortality in patients with HF who were randomly assigned to receive remote patient management or usual care.

On the basis of their findings from a smaller earlier trial, TIM-HF, they enrolled patients in TIM-HF2 who were free of major depression (ie, Patient Health Questionnaire score < 10), had been hospitalized for HF in the past 12 months, and had New York Heart Association class II or III HF.  

Between 2013 and 2017, 765 patients received remote patient management and 773 patients received usual care.   

Patients in the telemonitoring group received devices to measure blood pressure, electrocardiography, weight, and oxygen saturation, and they were given a mobile phone to be able to contact the telemonitoring center in emergency situations.

The patients received an initial half-hour training from nurses, followed by monthly phone calls

Patients in both groups had a visit with their cardiologist or general practitioner at baseline and then at 3, 6, and 9 months.

At 1 year, mortality was 7.9 vs 11.3 per 100 years of follow-up (hazard ratio, 0.70; 95% CI, 0.50 - 0.96; P = .028) for patients in the remote monitoring vs usual care groups.

Cardiovascular death, however, did not differ between groups (hazard ratio, 0.671; 95% CI, 0.45 - 1.01; P = .0560).

During the presentation here, assigned discussant, Jelena Celutkiene, MD, PhD, associate professor of medicine, Vilnius University, Lithuania, wanted to know how many patients were excluded from this trial because of a high depression score.

Köhler replied that "around a third of the eligible [recruited] patients had a score over 10," but other patients may not have been referred for the study because of depression.

"Why is heart failure treatment not effective in patients with depression?" the other discussant, Ewa Piotrowicz, MD, PhD, Telecardiology Center Cardinal Wyszynski National Institute of Cardiology, Warsaw, Poland, wanted to know.

"We need an active patient who is able to make daily measurements, and communicate between the telemonitoring center and local caregivers," Köhler replied, but a very depressed patient might prefer to lie in bed.

The TIM-HF2 study was a part of the Gesundheitsregion der Zukunft Nordbrandenburg – Fontane (Fontane) research and development project, funded by the German Federal Ministry of Education and Research and industry; data collection was supported by two German health insurance funds. K ö hler has received research grants from the German Federal Ministry of Education and Research and lecture fees from Novartis and Medtronic and was on an advisory board for Abbott. The disclosures of the other authors are listed with the article. Cleland reports personal fees from AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Myokardia, Sanofix, and Servier; grants and personal fees from Amgen, Bayer, Bristol-Myers Squibb, Philips, Stealth Biopharmaceuticals, and Torrent Pharmaceuticals; grants, personal fees, and nonfinancial support from Medtronic, Novartis, and Vifor; and grants and nonfinancial support from Pharmacosmos and PharmaNord, outside the area of work commented on here. Clark has disclosed no relevant financial relationships.

European Society of Cardiology (ESC) Congress 2018. Presentation 370. Presented August 25, 2018.

Lancet. Published online August 25, 2018. AbstractComment

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