Series

Heart Failure 4
Telemedicine and remote management of patients with
heart failure
Stefan D Anker, Friedrich Koehler, William T Abraham

Advances in telecommunication technologies have created new opportunities to provide telemedical care as an
adjunct to medical management of patients with heart failure. Meta-analyses suggest that telemedicine can reduce
morbidity and mortality in such patients; however, two prospective clinical trials not included in the analyses do not
support these ndings. Therefore, the eectiveness of telemedicine in heart failure is not established. Telemedicine
approaches range from computer-based support systems to programmes led by nurses and physicians.
Standardisation and appropriate classication of telemedical systems are needed to enable accurate interpretation
of clinical trials. Here we propose a classication of four generations of telemedicine in heart failure. Not all
approaches are the same and not every patient with heart failure will need telemedicine. Crisis prevention and
treatment, and stabilisation and self-empowerment of patients are focuses of telemedicine in heart failure. The
prole of patients who can potentially benet from telemedicine is unknown and should be investigated in
adequately powered randomised clinical trials. We are optimistic that telemedicine is an ecient approach and will
become an important feature of management in heart failure.

Introduction
Management of acute and chronic heart failure poses
substantial challenges to health-care systems worldwide.
Advances in modern telecommunication technologies
have created new opportunities to provide telemedical
care as an adjunct to the medical management of
patients with heart failure.1 Well structured outpatient
care could reduce the need for hospital admission,
facilitate early intervention, prevent crisis management,
and avoid complications or disease progression in these
patients.2 Remote telemedical management of heart
failure might be an option for future management
of patients.
Findings from four meta-analyses36 have shown that
telemedical monitoring in chronic heart failure can
reduce total mortality at a follow-up of 612 months,
and can reduce the number and duration of hospital
admissions for worsening heart failure. Since these
meta-analyses were published, two prospective randomised multicentre clinical trials of non-invasive
approaches7,8 have not corroborated these ndings for
morbidity-related and mortality-related endpoints. The
SENSE-HF trial9 used an invasive approach but also did
not nd benet. By contrast, the CHAMPION trial10
reported that wireless implantable haemodynamic
monitoring of pulmonary artery pressure used to guide
eorts for treatment optimisation signicantly reduced
the risk, compared with the control group, of hospital
admissions due to heart failure in patients with chronic
heart failure in New York Heart Association (NYHA)
functional class III.
These contrasting results pose a challenge to the
medical community for the potential of telemedical
monitoring in the management of patients with heart
failure; furthermore, the validity of meta-analyses is
www.thelancet.com Vol 378 August 20, 2011

questionable if prospective trials do not show similar

results.11 Because telemedical approaches vary, a
meta-analysis that combines dierent approaches is
probably inappropriate. In this review we summarise the
available telemedical interventions in heart failure,
discuss the systematic dierences between reported
clinical trials, and suggest a classication system for trials
of telemedical management and remote management of
patients to support future eorts for treatment development in this much needed specialty.

Chronic heart failure and telemedicine

Data transmission and processing

Lancet 2011; 378: 73139

This is the fourth in a Series of
four papers about heart failure
Applied Cachexia Research,
Department of Cardiology,
Charit Medical School,
Campus Virchow-Klinikum,
Berlin, Germany
(Prof S D Anker MD); Centre for
Clinical and Basic Research,
IRCCS San Raaele, Rome, Italy
(Prof S D Anker); Centre for
Cardiovascular Telemedicine
and Department of Cardiology
and Angiology, Charit
Universittsmedizin Berlin,
Campus Mitte, Berlin, Germany
(Prof F Koehler MD); and
Division of Cardiovascular
Medicine, Davis Heart and
Lung Research Institute, Ohio
State University, OH, USA
(Prof W T Abraham MD)
Correspondence to:
Prof Stefan D Anker, Applied
Cachexia Research, Department
of Cardiology, Charit
Universittsmedizin Berlin,
Campus Virchow-Klinikum,
D-13353 Berlin, Germany
s.anker@cachexia.de

The management of chronic heart failure is a medical

and economic challenge, exacerbated by the increasing
scarcity of physicians with expertise in heart failure and

Search strategy and selection criteria

We searched PubMed and reference lists of relevant papers
from June, 2000, to June, 2011, with the search terms
telemedicine, telemedical monitoring, telemedical
management, telemonitoring, remote patient
management, remote patient care, remote patient
monitoring, ambient assisted living, and acute, chronic,
and congestive heart failure. We searched mostly for articles
containing meta-analyses of telemedicine and remote
patient management in patients with heart failure, and
recent peer-reviewed clinical trials of randomised controlled
studies not included in these meta-analyses. To identify such
clinical trials, we studied reports from recent important
congresses and relevant trial registration websites, including
www.ClinicalTrials.gov. We excluded publications not written
in English or German.

For a registry of clinical trials see

www.ClinicalTrials.gov

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Series

For more on personalised

health care see http://www.hhs.
gov/myhealthcare

732

cardiologists. This problem is not only present in the

developing world, but is also a substantial issue for
health-care planning in rural areas, particularly in
industrial countries, such as Germany or the UK. Heart
failure is therefore a main target for telemedical care to
reduce high rates of admission and readmission for
worsening heart failure, and to overcome the physical
distances between the patient and physician.
Three methods for delivery of telemedical care are
real-time (synchronous), store-and-forward (asynchronous), and hybrid systems.12 Synchronous telemedicine
involves real-time processing of the patients data
obtained remotely; the patient and care provider need
therefore to be simultaneously available. Asynchronous
telemedicine does not need such concurrent availability.
The history of telemedicine is several decades old if
simple approaches, such as blood glucose and Holter
monitoring, event recorders, and 24 h blood pressure
monitoring are classied as telemedical approaches.
Most non-invasive telemedical systems used for patients
with heart failure enable the transfer of physiological
data (eg, bodyweight, heart rate, blood pressure, body
temperature) to a telemedical centre. Advanced noninvasive systems enable the transfer of electrocardiograph
(ECG) tracings, oxygen saturation, and physical activity
(eg, pedometer) data. Other systems enable the transfer
of variables measured invasively, including impedance
and pulmonary and left atrial pressures.
Three distinct categories of technology are used in
telemedicine to obtain and transfer patients data:
portable medical imaging devices, personal digital
assistants (smart phones), and the wireless
communication infrastructure. In modern telemedical
settings, stable network availability for data transfer is
crucially important; it has reached 997% in some
systems,13 which (for comparison) is higher than the
system availability of online banking services. For the
data transfer characteristics of a given telemedical system,
the aerent arm (from patient to telemedical centre) and
the eerent arm (from telemedical centre to patient)
should be distinguished. Automatic algorithms, which
are increasingly used to manage the vast amounts of
data, can identify predictors of clinical deterioration
(crisis developments), and permit prioritisation of human
interaction with patients.
An important part of future research in telemedicine
will be towards the optimisation of these algorithms, for
which research is scarce.14 The clinically relevant size of
the change in bodyweight and the time period over which
it changes are uncertain, as is the level of precision
warranted in measurement of bodyweighteg, to the
nearest 50 g, 100 g, or 200 g. These questions are not only
clinically important, but also have an economic aspect
that cannot be neglected. The more precise a
measurement needs to be, the more sophisticated the
device to measure the parameter concerned should be,
therefore costs are aected.

How can telemedicine aect outcomes in patients with

heart failure?
Telemedicine provides the patient with a structured
disease management process and can be self
empowering. The mainstay of telemedicine is early
detection of disease deterioration and prompt medical
intervention. When telemedical solutions incorporate
human interactioneg, between the patient and
physician or nurse via telephonethis contact can also
detect depression, which is a known risk factor of poor
outcome in heart failure.15 Telemedical care should
generally be holistic; therefore, it should be provided in
a structured way with standard operating procedures
and guidelines for disease management. The most
eective approach for patients with heart failure is still
unclear. Ideally and logically, a telemedical system for
the management of these patients should incorporate
the synchronous transfer to a telemedical centre of
selected physiological measurements that indicate early
heart failure decompensation so the crisis state can be
averted. A fundamental characteristic of this approach
is that medical decisions for the management of
patients are made promptly, ideally by heart failure
nurses or physicians.
Telemedical management should oer patients the
opportunity to become actively involved in management
of their own health care. Management therefore shows
the movement towards personalised health care.16 The
key to success of this approach is the predictive value of
the monitored variables. Comorbidities, such as chronic
obstructive pulmonary disease, chronic kidney disease,
and anaemia can negatively aect outcome in patients
with heart failure. The assessment and measurement of
these comorbidities will need new sensory techniques.

Invasive versus non-invasive telemedical approaches

To assess important metrics and to treat patients,
measurements are needed that either show the patients
current clinical status, or predict future events (table 1).
Bodyweight is the traditional telemedical characteristic
used in heart failure. Although it is simple to measure,
there are several shortcomings because it is inuenced
by the clinical status of the patient and by changes in
food and uid intake and the degree of (possibly
inappropriately dosed) diuretic therapy. Advanced
telemedical systems can also non-invasively assess
oxygen saturation, body impedance, and physical activity,
and monitor falls. A new area of remote medical
monitoring involves the assessment of adherence with
treatment by use of special drug containers that send
signals when opened.17 Other methods label individual
pills and record when each dose is taken.
Telemedical home assessment units can also measure
concentrations of blood chemicals or biomarkers
ranging from blood glucose to brain natriuretic
peptide.18,19 For (already) implanted devices, telemedical
features can monitor device function and usage in
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Series

heart failure, (including implantable cardioverter

debrillator [ICD] shocks and status of pacemaker
batteries) and can monitor changes in various
physiological variables, such as heart rate.20 Finally,
some implantable devices can be designed solely or
predominantly for telemonitoring purposes, for
example implantable haemodynamic monitors that can
remotely monitor changes in intracardiac or pulmonary
artery pressures.21,22

Four generations of telemedical remote

management of patients
To enable comparisons between clinical studies, we
propose a classication based on denition of four
generations of telemedical remote management systems
in heart failure. The type of data transfer, the (eerent)
decision ability of the telemedical system, and the level
of integration of all systems with the patients primarycare structure are the main criteria used, rather than the
sensor platform. We suggest four system generations:
(1) non-reactive data collection and analysis systems,
such as event recorders. Here, no full telemedical care
system is developed, but measurements of interest are
transferred to the care provider (nurse or physician).
The care provider cannot respond immediately and data
transfer is generally asynchronous; (2) systems with
non-immediate analytical or decision-making structure.
These approaches use synchronous data transfer, and the
telemedical centre has medical sta that can recognise
important changes in essential measurements. Delays
can occur if the systems are active only during oce

hours; (3) remote patient management systems. These

telemedical systems provide constant analytical and
decision-making support. Telemedical centres directly
involve heart failure nurses, are physician-led, and have
full therapeutic authority outside oce hours; (4) fully
integrated remote management systems. These systems
are an extension of third-generation systems, and data
from invasive and non-invasive telemedical devices is
linked into the telemedical platform making them
available for the telemedical centre and the primary-care
provider. Because of the complexity of incoming
information and subsequent therapeutic decisions, these
services need continuous presence of a physician.

Results from clinical trials

Of the four published meta-analyses,36 the Cochrane
Collaboration review and meta-analysis provides the
most complete review of telemedical trials in heart failure
(gure 1).5 This meta-analysis distinguished between
systems that used structured telephone support and
telemedical systems and compared them with usual care
approaches. The investigators concluded that Structured
telephone support and telemonitoring are eective in
reducing the risk of all-cause mortality and CHF-related
hospitalizations in patients with CHF; they improve
quality of life, reduce costs, and evidence-based
prescribing.5 Since these meta-analyses were published,
results of the Tele-HF,7 TIM-HF,8 SENSE-HF,9 and
CHAMPION10 trials have become available. Figure 2
shows the main outcome-related results of these four
trials (that are not included in any of the meta-analyses)

Recommended assessment
frequency*

Methods of measurement

Systolic and diastolic blood pressure (mm Hg)

Daily

By the patient (via device)

Pulse rate (beats per min)

Daily

By the patient (via device)

3-lead ECG

Daily

By the patient (via device), electrode placement needed

Systolic time intervals

Daily

By the patient (via ECG)

Non-invasive variables

Heart-rate variability

Daily

By the patient (via ECG)

Bodyweight (kg)

Daily

By the patient (via device)

By the patient (via device with blood sample)

Blood glucose

Individually

Plasma concentrations of natriuretic peptides

Weeklymonthly

By the patient (via device with blood sample)

Oxygen saturation

In case of emergency

By the patient (via device)

Variables derived by acoustic cardiography

Daily

By the patient (via device)

Self-administered questions

Dailymonthly

By the patient (device-administered questionnaire [ie, device asks

the questions])

Invasive variables
Pulmonary artery pressure

Daily

Automatic (with patient-operated device interrogation)

Left atrial pressure

Daily

Automatic

Impedance

Daily

Detection of life-threatening arrhythmias in addition to Daily

atrial brillation or ventricular tachycardia

Fully automatic
Automatic

ECG=electrocardiograph. *Recommended assessment frequencies represent our opinion, but are mostly not evidence based.

Table 1: Variables for remote assessment in guidance approaches for telemedical treatment

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Intervention

Usual care

Events Total

Events

Risk ratio
MH, fixed, 95% CI

Weight

Total

A
Antonicelli, 2008

28

29

24%

062 (016236)

Balk, 2008

101

113

36%

126 (050314)

Capomolla, 2004

67

66

34%

070 (024211)

28

168

20

85

128%

071 (042118)

10

10

14%

067 (014317)

Giordano, 2009

21

230

32

230

155%

066 (039110)

Goldberg, 2003 (WHARF)

11

138

26

142

124%

044 (022085)

Kielblock, 2007

37

251

69

251

333%

054 (037077)

Mortara, 2009 (Telemon)

15

195

160

48%

137 (061304)

Soran, 2008

11

160

17

155

83%

063 (030129)

62

59

20%

119 (034422)

1300

1000%

Cleland, 2005 (Telemon)

de Lusignan, 2001

Woodend, 2008
Total (95% CI)
Total events

1410

066 (054081)

200

147

Heterogeneity: 2=884, df=10 (p=055); l2=0%

Test for overall eect: Z=407 (p<00001)

B
9

28

26

29

43%

036 (021062)

Cleland, 2005 (Telemon)

80

168

46

85

102%

088 (068113)

Giordano, 2009

67

230

96

230

160%

070 (054090)

Goldberg, 2003 (WHARF)

65

138

67

142

110%

100 (078128)

157

251

176

251

293%

089 (079101)

Mortara, 2009 (Telemon)

69

195

48

160

88%

118 (087160)

Soran, 2008

75

160

66

155

112%

110 (086141)

Woodend, 2008

60

63

54

59

92%

106 (097116)

1111

1000%

Antonicelli, 2008

Kielblock, 2007

1232

Total (95% CI)

Total events

091 (084099)

579

582

Heterogeneity: 2=3130, df=7 (p<00001); l2=78%

Test for overall eect: Z=229 (p=002)

C
Cleland, 2005 (Telemon)

40

168

24

85

146%

084 (055130)

Giordano, 2009

43

230

73

230

335%

059 (042082)

Kielblock, 2007

71

251

82

251

377%

087 (066113)

Mortara, 2009 (Telemon)

35

195

28

160

141%

103 (065161)

726

1000%

844

Total (95% CI)

Total events

189

079 (067094)

207

Heterogeneity: 2=488, df=3 (p=018); l2=39%

Test for overall eect: Z=266 (p=0008)

001

01

Favours experimental

10

100

Favours control

Figure 1: Eect of telemonitoring versus usual care in patients with chronic heart failure
Eect on all-cause mortality (A); all-cause hospital admission (B); and (C) hospital admission related to chronic heart failure. M-H= Mantel-Haenszel risk ratio. Data
are from full peer-reviewed publications only and reect the most recent meta-analysis of telemedicine in heart failure.5

and table 2 compares these results with those of the

Cochrane meta-analysis.

Non-invasive approaches
The Tele-HF trial7 randomly assigned patients who had
recently been admitted to hospital for heart failure either to
telemonitoring (n=826) or to usual care (n=827). The noninvasive telemonitoring system was an asynchronous,
telephone-based interactive voice-response system that
obtained information about symptoms and bodyweight
daily. The data were reviewed by the patients physician
every weekday (except holidays). All questions had
734

predetermined responses and those triggering variances

were brought to the attention of the patients clinician. The
primary endpoint was any readmission or death from any
cause within 180 days of inclusion in the trial. No signicant
dierence was noted between the telemonitoring and
control groups for the rate of the primary outcome, which
occurred in 432 patients (52%) in the telemonitoring
group, and in 426 (51%) in the usual-care group (hazard
ratio [HR] 104, 95% CI 091119). No signicant
dierences were noted for the secondary endpoints.
The TIM-HF trial8 in Germany randomly assigned
stable patients with chronic heart failure to either
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Series

A
40

Telemonitoring
Nurse support
Usual care
Incidence of readmission or death (%)

All-cause mortality (%)

32

24

16

Hazard ratio for readmission or death with telemonitoring

104 (95% CI 091119), p=058

75

50

25

0
0

10

15

Months

454
468

395
402

Months

Number at risk
Telemonitoring 826
Usual care 827

564
587

C
20

260

RTM
Usual care

Control group (253 hospital admissions for heart failure)

Treatment group (153 hospital admissions for heart failure)

240

18
Hazard ratio 097 (95% CI 067141), p=087

Hazard ratio 064 (95% CI 055075), p<00001

220
Cumulative hospital admissions

16
Patients with all-cause death (%)

Telemonitoring
Usual care

100

14
12
10
8
6
4

200
180
160
140
120
100
80
60
40

20

0
0

Number at risk
RTM 354
Usual care 356

352
352

340
344

330
336

12
15
Months

18

307
305

249
243

21

24

27

239
229

64
60

0
Control group 280
Treatment group 270

90

180

267
262

252
244

270
450
360
Time from implant (days)
215
210

179
169

138
131

540

630

105
108

67
82

Figure 2: Main outcomes of large-scale trials of telemedical treatment in patients with chronic heart failure
(A) TEN-HMS trial:23 total mortality in each randomised group. (B) Tele-HF trial:7 Kaplan-Meier time-to-event estimates for the primary endpoint of readmission for any reason or death from any cause.
(C) TIM-HF trial:8 Kaplan-Meier cumulative event curves for the primary endpoint of all-cause mortality. (D) CHAMPION:10 hospital admission due to cumulative heart failure during the entire period of
randomised single-blind follow-up. RTM=remote telemedical management.

telemonitoring (n=354) or usual care (n=356). The noninvasive, synchronous telemonitoring system was based
on a wireless bluetooth device together with a personal
digital assistant as the main structural element, and
data transfer to the telemedical centre was done with
cell-phone technologies. A three-lead ECG, a blood
pressure device, and weighing scales with 50 g precision
were part of the integrated sensor network. The patient
did a daily self-assessment with these devices and the
data were transferred to the telemedical centre, which
provided physician-led medical support continuously
for the total study period. Patients were contacted by
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the telemedical centre physician in accordance with the

standard operating procedures or when requested by
the patient. The centre contacted the patients local
physician at least every 3 months. No signicant
reductions were noted for the primary or secondary
outcomes for patients in the telemonitoring group. For
the primary outcome, the total mortality rate for the
primary outcome of death for any cause was 84 per
100 patient-years of follow-up in the telemedical group,
compared with 87 per 100 patient-years of follow-up in
the usual-care group (HR 097, 95% CI 067141;
p=087).
735

Series

Structured telephone support,

hazard ratio (95% CI)

Telemedicine, hazard ratio

(95% CI)

Overall

088 (076101)

066 (054081)

Studies with signicant ndings*

0 of 15

2 of 11

Follow-up >6 months*

087 (074102)

069 (055086)

Sensitivity analysis

096 (084109)

068 (057082)

All-cause mortality

Tele-HF7

097 (073130)

TIM-HF8

097 (067141)

CHAMPION10

Neutral

All-cause hospitalisation
Overall

092 (085099)

Studies with signicant ndings*

3 of 11

091 (084099)
2 of 8

Follow-up >6 months*

091 (083099)

087 (080095)

Sensitivity analysis

090 (084097)

094 (087101)

Tele-HF7

106 (093122)

TIM-HF8

112 (091137)

CHAMPION10

..

NA

Hospital admission for CHF

Overall

077 (068087)

Studies with signicant ndings*

3 of 13

079 (067094)
1 of 4

Follow-up >6 months*

076 (065089)

079 (067094)

Sensitivity analysis

077 (068087)

076 (064089)

Tele-HF7

Neutral (true event rate

275% vs 270%)

TIM-HF8

084 (060118)

CHAMPION10

070 (060084)||

Data shown are for the Cochrane Collaboration meta-analysis and selected trials that were not included in the
meta-analysis.7,8,10 NA=not available. CHF=chronic heart failure. *Based on full peer-reviewed publications only.
Selected trials done after the Cochrane analyses. 15 deaths (6%) versus 20 deaths (7%) within 6 months (did not
dier signicantly). Based on full peer-reviewed publications and abstracts. Rates are true event rates; a correct
hazard ratio is not available. 227 readmissions for heart failure (28%) versus 223 readmissions for heart failure (27%)
within 6 months (p=081). ||Based on 6-month follow-up (primary endpoint); in the entire follow-up period (mean
15 months [SD 7]) hazard ratio 064, 95% CI 055075.
5

Table 2: Hazard ratios and 95% CIs for telemedicine or structured telephone support versus usual care in
patients with chronic heart failure

Invasive approaches
The SENSE-HF trial9 enrolled 501 patients with chronic
heart failure with a newly implanted ICD or debrillator
device (CRT-D). The study used the OptiVol feature of
the newly implanted devices for monitoring of
intrathoracic uid to predict heart failure events. In
phase 1, the uid monitoring data were concealed from
patients and physicians. In phases 2 and 3 (unmasked,
18-month duration), the positive predictive value (PPV)
of the rst OptiVol Patient Alert for detection of
worsening heart failure status with signs or symptoms of
pulmonary congestion was identied. Impedance was
assessed daily, and data for the rst 30 days after
implantation were excluded to allow for wound healing.
In phase 3, clinical intervention was planned on the basis
of the obtained data. During the rst 6 months,
12 of 58 adjudicated hospital admissions for heart failure
were predicted by OptiVol (sensitivity 207%). A
worsening status was reported for 80 patients
736

(PPV 381%). These results show that much work is

needed to bring the impedance technology (which had
promising results in specialist centres) to the multicentre
daily-routine level.
In the CHAMPION study,10 patients with NYHA
class III heart failure, irrespective of the left ventricular
ejection fraction, and a previous hospital admission for
heart failure, were randomly allocated to either a
centralised electronic system with a wireless implantable
haemodynamic monitoring system (W-IHM, Champion,
CardioMEMS, Atlanta, GA, USA; n=270), or to usual care
(n=280). In the intervention group, patients were managed
with daily measurement of pulmonary artery pressures
and standard of care. Patients were unaware of their
group assignment. After implantation of the CardioMEMS
Heart Sensor system24a passive, wireless, radiofrequency
sensor with no batteriespatients stayed overnight, and
if they were not taking warfarin were given aspirin (81 mg
or 325 mg once daily) and clopidogrel (75 mg once daily)
for a month, and continued with aspirin alone thereafter.
Compared with usual care, W-IHM signicantly
reduced the primary endpoint rate of hospital admissions
related to heart failure by 30% up to 6 months (p<00001),
and to 36% in the entire follow-up period (p<00001,
table 2). The duration of hospital stays was also shorter in
the W-IHM group than in the usual care group. These
benets were achieved through a greater number of
changes in drug therapy for heart failure in the
intervention group than in the usual-care group
(91 vs 38 per patient; p<00001).

Current trials
Several other trials are underway, including DOT-HF,25
LAPTOP-HF,26 HOME study,27 and HABIT.28 HOME and
HABIT are studies of biomarker-based approaches; this
device type could also become routine in heart-failure
care. The results of the three most recent meta-analyses46
are similar because they are based on (almost) the same
set of published studies. These analyses were done
because no suciently powered randomised controlled
trial was available; however, several randomised trials
have now been done and conclusions have become
unclear. An important factor in the discrepancy is the
denition of usual care, and that trials are done in
patients with heart failure who vary in clinical status,
stability, and degree of previous treatment. The metaanalyses might therefore need to be done in greater detail
in terms of these features. Other limitations include
variations in quality of endpoint assessments, such as
data completeness and adjudication.
The biggest studies have the biggest eect on the quality
of a meta-analysis. The Cochrane Collaboration metaanalysis5 accepted the study by Kielblock and colleagues29
for inclusion as a controlled trial, and gave it 26% to
43% weight in the analyses, but this study was in fact a
cohort study. The study was done in collaboration with a
health insurance company, and the intervention group
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Series

(n=251) was self selected and signicantly younger than

the control group (n=251) (median 73 years vs 78 years,
p<0001). Mortality was lower in the intervention than in
the usual-care group (144% vs 271%, p<0001) as were
rates of hospital admission (10 vs 15, p=004). This
report should not have been included in the meta-analysis
and its conclusions are therefore unreliable.
Approaches for telemedical management rely on the
principle that regular observation of carefully selected
physiological data will enable early detection of clinical
deterioration and timely intervention to prevent poor
outcomes. A focus on keeping patients with heart failure
alive and out of hospital is probably more clinically and
economically appropriate than a focus on mortality alone.
Hospital admissions for heart failure are a substantial
burden to society and the patients because of the adverse
eect on quality of life. An endpoint focusing on days lost
because of death or hospital admission is a measure of
survival adjusted for quality of life, and is perhaps an
appropriate study outcome to assess the eectiveness of
telemedical management in these patients. A consensus
needs to be reached on most appropriate endpoint to use,
from clinical and economic perspectives, in clinical trials
of telemedicine and to establish the gold standard outcome
to allow fair comparisons between clinical trials.
In telemedical trials, the nature of the intervention is
known and the study group allocation cannot be concealed
from the investigators, patients, and data management
groups; bias is therefore possible. The only outcome that
cannot be subject to bias is all-cause mortality. Changes in
neurohormonal variables as surrogate markers (such as
plasma concentrations of natriuretic peptides) can be used
as supportive evidence for eectiveness, but they are not
sucient. Another limitation of telemedical trials is the
comparator group. Patients allocated to the intervention
group will have daily contact with the telemedical centre,
which could inuence outcome and treatment eect
might be overestimated. Patients allocated to usual care
will have less frequent contact with the medical profession,
and events might be underestimated. The TEN-HMS
study23 aimed to compare a telemedical approach with
nurse-led telephone support and usual care. Telemedicine
and nurse-led care both reduced rates of death and hospital
admission, but duration of hospital stay was lower in the
telemedical group than in the nurse-led group. In addition
to telemedical systems showing eectiveness compared
with usual care, evidence that they are better than nurseled support systems with an increased number of visits
will be necessary. Further three-group studies would be
needed to address this need.
Inadequate sample size can aect any trial. The
COMPASS-HF study30 investigated a management
strategy based on continuous monitoring of intracardiac
pressures in patients with heart failure already on
optimum medical care. All patients transmitted
monitoring data at least once a week via a home-based
monitoring system (Chronicle device), but data from the
www.thelancet.com Vol 378 August 20, 2011

device for patients in the control group were not available

to physicians. The device measured absolute right
ventricular pressures and applied an algorithm to
estimate diastolic pressures in the pulmonary artery. The
primary ecacy outcome was a composite of hospital
admissions because of heart failure, and emergency
room and urgent clinic visits for intravenous intervention.
The 6-month event rate was 070 in the Chronicle group
and 089 in the control group (p=033). The intervention
did not reduce the rate of events related to heart failure.
Because the study was underpowered, clear conclusions
cannot be made, but the strategy to reduce peak pressures
seems insucient. TIM-HF8 was also underpowered.
When the feasibility of undertaking a telemedical
clinical trial is assessed, technical details need adequate
investigation because they could result in problems with
data transfers during the trial, and thus aect compliance.
Examples of issues for consideration are accessibility to
a mobile telephone network, the time to install
telemedical systems in patients homes and to train
patients to use them, and response times from the
recording of the assessment to when medical action is
taken (if needed). Systems should also avoid false alerts
because they might make patients (and physicians)
nervous and lead to non-compliance.

Issues of telemedicine in heart failure

Medicolegal issues
Telemedicine is an underdeveloped specialty in medicolegal
terms. When potentially important clinical data are
obtained but not analysed instantly, who is responsible and
what degree of time delay is acceptable, particularly at
night, weekends, or holidays? These important issues
cause people to doubt telemedical systems and contribute
to the increasing drive to develop dedicated telemedical
centres including a physician-led service that operates 24 h
a day, 7 days a week. These legal issues lead to a preference
for developments that favour management by exception
approaches, whereby clinicians are alerted only to changes
in measured variables above or below preset thresholds;
thus, the need to review data daily is eliminated. A
physician-directed, self-management approach would also
shift the day-to-day responsibility for telemedicine away
from health-care providers to the patient, such as in the
use of glucose meters for diabetes management. This
approach is being tested in the LAPTOP-HF trial.26
Telemedical care should adhere to the same fundamental
legal principles of medicine as when a physician is
physically seeing a patient, including needs for informed
consent, condentiality, personal responsibility for medical
care, and insurance-related issues. A risk of telemedical
services is non-availability of data transfer because of
technical issues in mobile phone services. Patients should
be informed about these issues. For telemedicine (as for
any branch of medicine), national law takes priority, which
might have implications for ownership of the data. Patients
do not own their data in every country.
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Financial issues
With development of telemedicine for heart failure,
reimbursement questions become relevant. Costs are
associated with the telemedical systems and services.
Provision and implantation of telemedical devices generate
device-related and procedural expenses. That costs are
incurred is normal, but complexity arises when the device
provider or implanter is dierent from the people
analysing the data and providing clinical care on the basis
of this acquired information. Further complexity develops
when devices are provided for restricted periods and
reused for other patients. No reimbursement strategies
for telemedicine in heart failure have been developed, but
they will probably substantially aect the uptake of these
systems at the population level. Telemedicine might be
most benecial for patients with worsening heart failure,
which is costly and dicult to manage.
Financial issues might also facilitate selection of
appropriate endpoints for telemedical trials. In North
America, great emphasis is placed on reduction of
readmission rates because these have important
implications for the reimbursement of hospitals caring
for patients with heart failure. In a society with dierent
economic stimuli, reductions in length of hospital stay
might become more important. An important area of
further development will be automated decision systems
and a key metric of service eectiveness (and economic
feasibility) will be the number of patients one nurse or
physician can care for. In telephone support structures,
one nurse cares for 50 patients, and modern remote
management systems employ one sta member per
200300 patients (during daytime).

The future
Approaches for the management of patients with heart
failure include second or third generation telemedical
systems and are mostly non-invasive. Few trials have
investigated invasive approaches (COMPASS-HF,
SENSE-HF, CHAMPION). In the future, most systems
will be in generation three or four, combining non-invasive
and invasive approaches with daily monitoring and
management. Telemedical management in heart failure
should also incorporate the monitoring and management
of comorbidities. The organisational approach will
probably be via dedicated telemedical service centres. In
all these technological developments, systems should
favour a partnership between patients and physicians and
make use of the self-care abilities of patients.31 Successful
future systems will probably enable patients to interpret
and respond to some of the physiological information they
have generated about themselves.11
We are optimistic that telemedicine for heart failure
will become proven and ecient as an important part of
management in heart failure that evolves as the
organisation of medical care systems is redened.
Contributors
All authors contributed to writing the nal version of the review.

738

Conicts of interest
SDA has received fees for consultancy from Robert Bosch Healthcare
GmbH, SHL Telemedicine, Thermo Fisher Scientic, and St Jude Medical
GmbH, and honoraria for speaking from Thermo Fisher Scientic, SHL
Telemedicine, and St Jude Medical GmbH. FK has received grant support
for development of telemedical technology and treatment trials from the
German Federal Ministry of Economics and Technology (grant number
01MG531). WTA has received fees for consultancy from Biotronik,
CardioMEMS, Medtronic, and St Jude Medical.
Acknowledgments
We thank Bridget-Anne Kirwan for contributing to the paper.
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