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Randomized Controlled Trial
. 2019 Oct;108(10):1117-1127.
doi: 10.1007/s00392-019-01447-5. Epub 2019 Mar 14.

Implant-based multi-parameter telemonitoring of patients with heart failure and a defibrillator with vs. without cardiac resynchronization therapy option: a subanalysis of the IN-TIME trial

Johann Christoph Geller  1   2 , Thorsten Lewalter  3   4 , Niels Eske Bruun  5 , Milos Taborsky  6   7 , Frank Bode  8   9 , Jens Cosedis Nielsen  10 , Christoph Stellbrink  11 , Steffen Schön  12 , Holger Mühling  13 , Hanno Oswald  14 , Sebastian Reif  15 , Stefan Kääb  16 , Peter Illes  17 , Jochen Proff  18 , Nikolaos Dagres  19 , Gerhard Hindricks  19 ; IN-TIME Study Group
Collaborators, Affiliations
Randomized Controlled Trial

Implant-based multi-parameter telemonitoring of patients with heart failure and a defibrillator with vs. without cardiac resynchronization therapy option: a subanalysis of the IN-TIME trial

Johann Christoph Geller et al. Clin Res Cardiol. 2019 Oct.

Abstract

Aims: In the IN-TIME trial, automatic daily implant-based multiparameter telemonitoring significantly improved clinical outcomes in patients with chronic systolic heart failure and implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D). We compared IN-TIME results for ICD and CRT-D subgroups.

Methods: Patients with LVEF ≤ 35%, NYHA class II/III, optimized drug treatment, no permanent atrial fibrillation, and a dual-chamber ICD (n = 274) or CRT-D (n = 390) were randomized 1:1 to telemonitoring or no telemonitoring for 12 months. Primary outcome measure was a composite clinical score, classified as worsened if the patient died or had heart failure-related hospitalization, worse NYHA class, or a worse self-reported overall condition.

Results: The prevalence of worsened score at study end was higher in CRT-D than ICD patients (26.4% vs. 18.2%; P = 0.014), as was mortality (7.4% vs. 4.1%; P = 0.069). With telemonitoring, odds ratios (OR) for worsened score and hazard ratios (HR) for mortality were similar in the ICD [OR = 0.55 (P = 0.058), HR = 0.39 (P = 0.17)] and CRT-D [OR = 0.68 (P = 0.10), HR = 0.35 (P = 0.018)] subgroups (insignificant interaction, P = 0.58-0.91).

Conclusion: Daily multiparameter telemonitoring has a potential to reduce clinical endpoints in patients with chronic systolic heart failure both in ICD and CRT-D subgroups. The absolute benefit seems to be higher in higher-risk populations with worse prognosis.

Keywords: Remote monitoring of cardiac resynchronization therapy defibrillators; Remote monitoring of implantable cardioverter-defibrillators; Telemonitoring of patients with heart failure.

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Conflict of interest statement

JCG is a consultant for Abbott/St. Jude Medical, Biosense Webster, Boston Scientific, Medtronic, AstraZeneca, Bayer Pharma, Boehringer Ingelheim, DaiichiSankyo, and Pfizer, and has received speaker fees and research support from Abbott/St. Jude Medical, Boston Scientific, Medtronic, Biotronik, AstraZeneca, Bayer Pharma, Boehringer Ingelheim, DaiichiSankyo, Novartis, Pfizer/BMS and Sanofi Aventis. PS is a consultant for Biotronik and has received equipment from GE Health Care and from EBR Systems. JP is employee of Biotronik. GH is a member of the advisory board/consultant of Biotronik, Biosense, St. Jude Medical, Stereotaxis, and Cyberheart, and has received honoraria for lectures from these companies except for Cyberheart. Boston Scientific, Biosense Webster, Hansen Medical, Medtronic, and St. Jude Medical. The other authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Percentage of patients with worsened composite clinical score. For the number of patients in each group, see Table 2. CRT-D cardiac resynchronization therapy defibrillator, ICD implantable cardioverter-defibrillator, OR odds ratio, telemon. telemonitoring
Fig. 2
Fig. 2
Kaplan–Meier curves of patient survival. CI confidence interval, CRT-D cardiac resynchronization therapy defibrillator, ICD implantable cardioverter-defibrillator
See this image and copyright information in PMC

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