In light of the recently presented results from REM-HF and MORE-CARE trials, Gerhard Hindricks and Nikolaos Dagres, both from Leipzig University Heart Center, Leipzig, Germany, share their views on the value of remote monitoring.
At the European Society of Cardiology (ESC) congress in Rome (27‒31 August 2016), the results of two randomised clinical trials investigating the effect of remote monitoring in patients with cardiac implantable electronic devices were announced.
These were the REM-HF trial that included more than 1,600 patients with implantable cardioverter defibrillator (ICD), or cardiac resynchronisation therapy device with defibrillator (CRT-D) or with pacemaker (CRT-P)1 and the MORE-CARE trial that included heart failure patients with a CRT-D device.2 The latter trial was planned to recruit more than 1,700 patients but was terminated early due to slow recruitment. The primary endpoint in the two trials was similar: death from any cause or unplanned hospitalisation for cardiovascular reason (in REM-HF) and mortality and hospitalisations for cardiovascular or device-related reasons (in MORE-CARE).
The design of the two trials was also similar. REM-HF compared in a randomised fashion usual care plus weekly remote monitoring with usual care alone (which included remote monitoring of the device every three or six months). In MORE-CARE, patients were randomised to undergo remote checks alternating with in-office follow-ups or in-office follow-ups alone.
The results of both trials were very comparable. There was no significant difference in the primary endpoint between the groups of remotely monitored patients and the ones receiving standard of care.
These results are a further addition to the ongoing debate regarding the value of remote monitoring in patients with devices but also in other fields of cardiology. Indeed, contradictory results have been published up to now. Some trials have observed a significant benefit achieved by remote monitoring of device patients as in the IN-TIME trial3 or by other means, eg. by wireless pulmonary artery haemodynamic monitoring as in the CHAMPION trial4. Other trials such as REM-HF and MORE-CARE or the OptiLink HF,5 which monitored the fluid status in patients with heart failure and an ICD failed to show any significant benefit.
How can these contradictory results be explained?
In order to achieve a benefit by remote monitoring, a complete chain is needed beginning with the correct choice of the remotely monitored parameter going through adequate technology for its monitoring, reliable and regular transmission and, importantly, tailored actions and adaptation of patient’s therapy after receiving the information. If there is a gap in any of these steps, then technology will be of little help. Indeed, there is evidence that daily transmissions may achieve benefit that is otherwise not evident. In a recent meta-analysis6 of nine randomised controlled trials comparing remote monitoring with in-office follow-up of patients with ICDs, there was no difference in clinical endpoints such as all-cause mortality, cardiovascular mortality and hospitalisation between these two follow-up strategies. However, in the three trials that used home monitoring with daily verification of transmission, a significant reduction of all-cause mortality was observed. In REM-HF, remote monitoring was weekly. Whether this explains partially the different results, is unknown.
Thus, we believe that there are two key points that shape the benefit achieved by remote monitoring and may finally explain the contradictory results: a) the frequency of the data transmission that must be high and b) the existence of a predefined set of actions following the acquired data ensuring that patient’s therapy is timely adapted to the changed haemodynamic situation.
However, it seems that we still have a long way to go and more trials to conduct before we completely understand the mechanisms of benefit provided by remote monitoring.
- Cowie M. REM-HF trial results presented at ESC 2016
- Boriani G et al. Effects of remote monitoring on clinical outcomes and use of healthcare resources in heart failure patients with biventricular defibrillators: results of the MORE-CARE multicentre randomized controlled trial. Eur J Heart Fail. 2016 Aug 28. doi: 10.1002/ejhf.626. [Epub ahead-of-print]
- Hindricks G et al. Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial. Lancet 2014;384:583–590
- Abraham WT. 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
- Böhm M et al. Fluid status telemedicine alerts for heart failure: a randomized controlled trial. Eur Heart J 2016;37:3154–3163
- Parthiban N et al. Remote monitoring of implantable cardioverter-defibrillators: a systematic review and meta-analysis of clinical outcomes. J Am Coll Cardiol 2015;65:2591–2600
Gerhard Hindricks is director of the Department of Electrophysiology, University Leipzig – Heart Center, Leipzig, Germany and Nikolaos Dagres is consultant electrophysiologist at the same institution. They report research grants from St Jude Medical, Boston Scientific and Biotronik to the institution.