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; Niraj Varma; Salem Kacet; Thorsten Lewalter; Peter Søgaard; Laurence Guédon-Moreau; Jochen Proff; Thomas A. Gerds; Stefan D. Anker; Christian Torp-Pedersen

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)

Gerhard Hindricks^*, Niraj Varma, Salem Kacet, Thorsten Lewalter, Peter Søgaard, Laurence Guédon-Moreau, Jochen Proff, Thomas A. Gerds, Stefan D. Anker, Christian Torp-Pedersen

^*Corresponding author for this work

54 Citations (Scopus)

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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.

Original language	English
Journal	European Heart Journal
Volume	38
Issue number	22
Pages (from-to)	1749-1755
Number of pages	7
ISSN	0195-668X
DOIs	https://doi.org/10.1093/eurheartj/ehx015
Publication status	Published - 7 Jun 2017

Keywords

Death
Heart failure
Hospitalization
Implantable cardioverter-defibrillator
Meta-analysis
Remote monitoring

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Daily remote monitoring of implantable cardioverter-defibrillators insights from the pooled patient-level data from three randomized controlled trials (IN-TIME, ECOST, TRUST)Final published version, 414 KBLicence: CC BY-NC

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Hindricks, G., Varma, N., Kacet, S., Lewalter, T., Søgaard, P., Guédon-Moreau, L., Proff, J., Gerds, T. A., Anker, S. D., & Torp-Pedersen, C. (2017). Daily remote monitoring of implantable cardioverter-defibrillators: Insights from the pooled patient-level data from three randomized controlled trials (IN-TIME, ECOST, TRUST). European Heart Journal, 38(22), 1749-1755. https://doi.org/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). / Hindricks, Gerhard; Varma, Niraj; Kacet, Salem et al.

In: European Heart Journal, Vol. 38, No. 22, 07.06.2017, p. 1749-1755.

Research output: Contribution to journal › Journal article › Research › peer-review

Hindricks, G, Varma, N, Kacet, S, Lewalter, T, Søgaard, P, Guédon-Moreau, L, Proff, J, Gerds, TA, Anker, SD & Torp-Pedersen, C 2017, 'Daily remote monitoring of implantable cardioverter-defibrillators: Insights from the pooled patient-level data from three randomized controlled trials (IN-TIME, ECOST, TRUST)', European Heart Journal, vol. 38, no. 22, pp. 1749-1755. https://doi.org/10.1093/eurheartj/ehx015

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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.",

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author = "Gerhard Hindricks and Niraj Varma and Salem Kacet and Thorsten Lewalter and Peter S{\o}gaard and Laurence Gu{\'e}don-Moreau and Jochen Proff and Gerds, {Thomas A.} and Anker, {Stefan D.} and Christian Torp-Pedersen",

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AU - Varma, Niraj

AU - Kacet, Salem

AU - Lewalter, Thorsten

AU - Søgaard, Peter

AU - Guédon-Moreau, Laurence

AU - Proff, Jochen

AU - Gerds, Thomas A.

AU - Anker, Stefan D.

AU - Torp-Pedersen, Christian

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N2 - 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.

AB - 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.

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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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