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Review
. 2017 Jun 7;38(22):1749-1755.
doi: 10.1093/eurheartj/ehx015.

Daily Remote Monitoring of Implantable Cardioverter-Defibrillators: Insights From the Pooled Patient-Level Data From Three Randomized Controlled Trials (IN-TIME, ECOST, TRUST)

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Free PMC article
Review

Daily Remote Monitoring of Implantable Cardioverter-Defibrillators: Insights From the Pooled Patient-Level Data From Three Randomized Controlled Trials (IN-TIME, ECOST, TRUST)

Gerhard Hindricks et al. Eur Heart J. .
Free PMC article

Abstract

Aims: Remote monitoring of implantable cardioverter-defibrillators may improve clinical outcome. A recent meta-analysis of three randomized controlled trials (TRUST, ECOST, IN-TIME) using a specific remote monitoring system with daily transmissions [Biotronik Home Monitoring (HM)] demonstrated improved survival. We performed a patient-level analysis to verify this result with appropriate time-to-event statistics and to investigate further clinical endpoints.

Methods and results: Individual data of the TRUST, ECOST, and IN-TIME patients were pooled to calculate absolute risks of endpoints at 1-year follow-up for HM vs. conventional follow-up. All-cause mortality analysis involved all three trials (2405 patients). Other endpoints involved two trials, ECOST and IN-TIME (1078 patients), in which an independent blinded endpoint committee adjudicated the underlying causes of hospitalizations and deaths. The absolute risk of death at 1 year was reduced by 1.9% in the HM group (95% CI: 0.1-3.8%; P = 0.037), equivalent to a risk ratio of 0.62. Also the combined endpoint of all-cause mortality or hospitalization for worsening heart failure (WHF) was significantly reduced (by 5.6%; P = 0.007; risk ratio 0.64). The composite endpoint of all-cause mortality or cardiovascular (CV) hospitalization tended to be reduced by a similar degree (4.1%; P = 0.13; risk ratio 0.85) but without statistical significance.

Conclusion: In a pooled analysis of the three trials, HM reduced all-cause mortality and the composite endpoint of all-cause mortality or WHF hospitalization. The similar magnitudes of absolute risk reductions for WHF and CV endpoints suggest that the benefit of HM is driven by the prevention of heart failure exacerbation.

Figures

Figure 1
Figure 1
Time to all-cause death for pooled TRUST, ECOST, and IN-TIME patients. The shaded areas indicate the 95% CIs. The numbers below panel are patients at risk. The 1.9% reduction in the absolute risk of death in the HM group was statistically significant (95% CI: 0.1–3.8%; P = 0.037). Abbreviations: HM, Home Monitoring; ECOST/IN-TIME/TRUST as in Table 1.
Figure 2
Figure 2
Forest plot of the absolute risk differences (in %) for all endpoints at 12 months. A negative value (reduction) is in favour of HM. Abbreviations: CI, confidence interval; CV, cardiovascular; hosp, hospitalization; WHF, worsening heart failure; ECOST/IN-TIME/TRUST as in Table 1.
Figure 3
Figure 3
Time to occurrence of composite endpoints for pooled ECOST and IN-TIME patients. Upper panel: Composite of all-cause death and a CV hospitalization, excluding device related or procedure-related hospitalizations. The 4.1% absolute risk reduction in the HM group was not statistically significant (P = 0.13). Lower panel: Composite of all-cause death and a hospitalization due to WHF. The 5.6% absolute risk reduction in the HM group was statistically significant (P = 0.007). For confidence intervals, see Figure 2. Abbreviations as in Figures 1 and .

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