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Randomized Controlled Trial
. 2017 Aug 7;38(30):2352-2360.
doi: 10.1093/eurheartj/ehx227.

Remote management of heart failure using implantable electronic devices

John M Morgan  1 , Sue Kitt  2 , Jas Gill  3 , Janet M McComb  4 , Ghulam Andre Ng  5 , James Raftery  1 , Paul Roderick  1 , Alison Seed  6 , Simon G Williams  7 , Klaus K Witte  8 , David Jay Wright  9 , Scott Harris  1 , Martin R Cowie  10
Affiliations
Randomized Controlled Trial

Remote management of heart failure using implantable electronic devices

John M Morgan et al. Eur Heart J. .

Abstract

Aims: Remote management of heart failure using implantable electronic devices (REM-HF) aimed to assess the clinical and cost-effectiveness of remote monitoring (RM) of heart failure in patients with cardiac implanted electronic devices (CIEDs).

Methods and results: Between 29 September 2011 and 31 March 2014, we randomly assigned 1650 patients with heart failure and a CIED to active RM or usual care (UC). The active RM pathway included formalized remote follow-up protocols, and UC was standard practice in nine recruiting centres in England. The primary endpoint in the time to event analysis was the 1st event of death from any cause or unplanned hospitalization for cardiovascular reasons. Secondary endpoints included death from any cause, death from cardiovascular reasons, death from cardiovascular reasons and unplanned cardiovascular hospitalization, unplanned cardiovascular hospitalization, and unplanned hospitalization. REM-HF is registered with ISRCTN (96536028). The mean age of the population was 70 years (range 23-98); 86% were male. Patients were followed for a median of 2.8 years (range 0-4.3 years) completing on 31 January 2016. Patient adherence was high with a drop out of 4.3% over the course of the study. The incidence of the primary endpoint did not differ significantly between active RM and UC groups, which occurred in 42.4 and 40.8% of patients, respectively [hazard ratio 1.01; 95% confidence interval (CI) 0.87-1.18; P = 0.87]. There were no significant differences between the two groups with respect to any of the secondary endpoints or the time to the primary endpoint components.

Conclusion: Among patients with heart failure and a CIED, RM using weekly downloads and a formalized follow up approach does not improve outcomes.

Keywords: Heart failure; Implantable devices; Remote monitoring.

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Figures

Figure 1
Figure 1
Randomization, treatment, and follow-up of the patients. GP, general practitioner doctor.
Figure 2
Figure 2
Forest plot of the comparison of end point events by treatment group.
Figure 3
Figure 3
Cumulative incidence curves for the primary end point, death from any cause, and unplanned hospitalization for cardiovascular reasons. The primary endpoint was a composite of death from any cause and unplanned hospitalization for cardiovascular reasons.
See this image and copyright information in PMC

Comment in

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