Remote management of patients with heart failure—how long should it go on?
Remote management of patients with heart failure—how long should it go on? – The Lancet Digital Health Remote patient management (RPM) promises to improve patient care.1
- Varma N
- Ricci RP
Telemedicine and cardiac implants: what is the benefit?.Eur Heart J.2013; 34: 1885-1895
Previously, Friedrich Koehler and colleagues2
- Koehler F
- Koehler K
- Deckwart O
- et al.
Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial.Lancet.2018; 392: 1047-1057
showed a significant benefit of RPM in patients with heart failure compared with usual care over a 12-month study period. Patients assigned to remote patient management lost a mean of 17·8 days (95% CI 16·6–19·1) per year due to unplanned cardiovascular hospitalisations and all-cause mortality compared with patients assigned to usual care who lost a mean of 24·2 days (22·6–26·0) per year. The authors now present the results of the extended 12-month follow-up period after stopping the RPM intervention.3
- Koehler F
- Koehler K
- Prescher S
- et al.
Mortality and morbidity 1 year after stopping a remote patient management intervention: extended follow-up results from the telemedical interventional management in patients with heart failure II (TIM-HF2) randomised trial.Lancet Digital Health.2019; (published online Dec 12.)https://doi.org/10.1016/S2589-7500(19)30195-5
During this interval, there was no difference between RPM and usual care in the primary outcome, or recurrent heart failure hospitalisations and cardiovascular death. The authors concluded that the positive effect of RPM was lost when it was terminated, raising questions about the ideal duration of RPM for the patient group studied.There have been many observational studies on RPM in patients with heart failure and all have presented mixed results.4
- Ono M
- Varma N
Remote monitoring to Improve long-term prognosis in heart failure patients with implantable cardioverter-defibrillators.Expert Rev Med Devices.2017; 14: 335-342
In most studies, technology embedded in implantable devices was used. Analysis of remote monitoring databases of patients (ie, observational cohort studies) indicated large improvements in survival among those with networked implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy (CRT) devices, but these results could have been influenced by selection criteria and healthy-user bias.5
- Saxon LA
- Hayes DL
- Gilliam FR
- et al.
Long-term outcome after ICD and CRT implantation and influence of remote device follow-up: the ALTITUDE survival study.Circulation.2010; 122: 2359-2367
, 6
- Varma N
- Piccini JP
- Snell J
- Fischer A
- Dalal N
- Mittal S
The relationship between level of adherence to automatic wireless remote monitoring and survival in pacemaker and defibrillator patients.J Am Coll Cardiol.2015; 65: 2601-2610
Randomised trials have yielded non-significant results, except for the INTIME trial,7
- Hindricks G
- Taborsky M
- Glikson M
- et al.
Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial.Lancet.2014; 384: 583-590
which showed that treatments in response to alert notifications conveyed automatically by the remote monitoring technology (according to a prespecified protocol) improved survival among heart failure patients with ICDs and CRTDs. However, a puzzling result was that heart failure hospitalisations were not reduced.7
- Hindricks G
- Taborsky M
- Glikson M
- et al.
Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial.Lancet.2014; 384: 583-590
Several factors can reduce the ability of RPM to influence the course of heart failure, including frequency of transmission of the parameters being monitored (eg, daily, weekly, or monthly; daily appears to be better), dependence on patient activated systems, erratic connectivity, tracking parameters with little or no value to disease management, inability of a system to handle incoming data, and no treatment plan in response to those data. Several of these limitations were present in the REM-HF, which tested the effect of weekly downloads of all available diagnostic data in ICDS and CRTs, and TELEHF trial, which tested telephone-based interactive voice-response system that collected daily information about symptoms and weight that was reviewed by the patients’ clinicians. Therefore, these limitations might account for their non-significant results.8
- Morgan JM
- Kitt S
- Gill J
- et al.
Remote management of heart failure using implantable electronic devices.Eur Heart J.2017; 38: 2352-2360
, 9
- Chaudhry SI
- Mattera JA
- Curtis JP
- et al.
Telemonitoring in patients with heart failure.N Engl J Med.2010; 363: 2301-2309
By contrast, most of these did not affect the INTIME trial,7
- Hindricks G
- Taborsky M
- Glikson M
- et al.
Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial.Lancet.2014; 384: 583-590
and might have contributed to its positive results.Patients in the TIM-HF2 trial had heart failure, New York Heart Association functional class II or III, and had been hospitalised for heart failure within 12 months before randomisation. The TIMI-HF2 trial used non-implantable remote monitoring, daily transmissions from a patient’s home to the clinic, tracking a set of prespecified parameters (weight, blood pressure, heart rate, ECG, and peripheral oxygen saturation), generating patient risk profiles, adapting heart failure medication, and maintaining patient education and collaboration among managing physicians. This well-structured RPM plan resulted in positive findings in the randomised phase of the trial.2
- Koehler F
- Koehler K
- Deckwart O
- et al.
Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial.Lancet.2018; 392: 1047-1057
However, the results from the follow-up period3
- Koehler F
- Koehler K
- Prescher S
- et al.
Mortality and morbidity 1 year after stopping a remote patient management intervention: extended follow-up results from the telemedical interventional management in patients with heart failure II (TIM-HF2) randomised trial.Lancet Digital Health.2019; (published online Dec 12.)https://doi.org/10.1016/S2589-7500(19)30195-5
indicates that once the RPM was stopped, there was no further gain in the subsequent 12 months. At first glance, this observation seems to indicate that RPM needs to be continued to capitalise on its positive effects. This might be true; however, there are alternative explanations. During the 12-month randomised phase, tangible benefit of RPM manifested after 4–5 months, but reached an equilibrium after 8–9 months (study curves remained in parallel). These data might indicate that benefits with this particular RPM plan had peaked before the extended follow-up analysis commenced and further gain should not have been expected. There might be other parameters to follow or other interventions to consider that can increase the benefit of RPM (eg, haemodynamic monitoring).10
- Abraham WT
- Stevenson LW
- Bourge RC
- Lindenfeld JA
- Bauman JG
- Adamson PB
Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial.Lancet.2016; 387: 453-461
Importantly, the RPM group in the TIM-HF2 trial did not lose ground once remote contact ceased; at the beginning of extended follow-up phase, patients in the RPM group had a lower New York Heart Association functional class, fewer heart failure hospitalisations, and superior self-care status’. The maintenance during the extended phase of positive effects accrued earlier, possibly attributable to patient education and coordination of managing physicians, is encouraging.TIMI-HF22
- Koehler F
- Koehler K
- Deckwart O
- et al.
Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial.Lancet.2018; 392: 1047-1057
, 3
- Koehler F
- Koehler K
- Prescher S
- et al.
Mortality and morbidity 1 year after stopping a remote patient management intervention: extended follow-up results from the telemedical interventional management in patients with heart failure II (TIM-HF2) randomised trial.Lancet Digital Health.2019; (published online Dec 12.)https://doi.org/10.1016/S2589-7500(19)30195-5
is remarkable for revealing the benefits of RPM for heart failure management using a non-implantable technology, and their durability following cessation of remote support. This success is testament to a structured and well-defined RPM plan, which is vital to RPM. At the same time, the trial showed that a peak effect was reached. Increasing the gain of RPM further might require tracking other parameters and additional treatments (eg, haemodynamic monitoring).10
- Abraham WT
- Stevenson LW
- Bourge RC
- Lindenfeld JA
- Bauman JG
- Adamson PB
Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial.Lancet.2016; 387: 453-461
This could be important in patients with frequent recurrent heart failure.I declare no competing interests.
References
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- Varma N
- Ricci RP
- 2.
- Koehler F
- Koehler K
- Deckwart O
- et al.
- 3.
- Koehler F
- Koehler K
- Prescher S
- et al.
- 4.
- Ono M
- Varma N
- 5.
- Saxon LA
- Hayes DL
- Gilliam FR
- et al.
- 6.
- Varma N
- Piccini JP
- Snell J
- Fischer A
- Dalal N
- Mittal S
- 7.
- Hindricks G
- Taborsky M
- Glikson M
- et al.
- 8.
- Morgan JM
- Kitt S
- Gill J
- et al.
- 9.
- Chaudhry SI
- Mattera JA
- Curtis JP
- et al.
- 10.
- Abraham WT
- Stevenson LW
- Bourge RC
- Lindenfeld JA
- Bauman JG
- Adamson PB
Article Info
Publication History
Published: December 12, 2019
Identification
DOI: https://doi.org/10.1016/S2589-7500(19)30221-3
Copyright
© 2019 The Author(s). Published by Elsevier Ltd.