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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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; Lewalter, Thorsten; Søgaard, Peter; Guédon-Moreau, Laurence; Proff, Jochen; Gerds, Thomas A.; Anker, Stefan D.; Torp-Pedersen, Christian.
In: European Heart Journal, Vol. 38, No. 22, 07.06.2017, p. 1749-1755.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Daily remote monitoring of implantable cardioverter-defibrillators
T2 - Insights from the pooled patient-level data from three randomized controlled trials (IN-TIME, ECOST, TRUST)
AU - Hindricks, Gerhard
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
PY - 2017/6/7
Y1 - 2017/6/7
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.
KW - Death
KW - Heart failure
KW - Hospitalization
KW - Implantable cardioverter-defibrillator
KW - Meta-analysis
KW - Remote monitoring
UR - http://www.scopus.com/inward/record.url?scp=85020008329&partnerID=8YFLogxK
U2 - 10.1093/eurheartj/ehx015
DO - 10.1093/eurheartj/ehx015
M3 - Journal article
C2 - 29688304
AN - SCOPUS:85020008329
VL - 38
SP - 1749
EP - 1755
JO - European Heart Journal
JF - European Heart Journal
SN - 0195-668X
IS - 22
ER -
ID: 188963938