ArticlesImplant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial
Introduction
In selected patients with heart failure and left ventricular systolic dysfunction, treatment with implantable cardioverter-defibrillators (ICDs) or cardiac resynchronisation therapy defibrillators (CRT-Ds) reduces all-cause mortality and hospital admissions for heart failure and other major cardiovascular events.1, 2 These devices afford the chance to automatically monitor physiological and technical data.3, 4, 5, 6, 7 Early detection of worsening heart failure, or of upstream factors predisposing to worsening heart failure, by a telemonitoring implant could enable pre-emptive medical intervention and improve outcomes beyond those achieved with stand-alone implantable devices, but the evidence is weak.3, 4, 5, 6, 7, 8, 9, 10, 11 The predisposing factors and precursors for poor clinical outcome or heart failure exacerbation include ventricular tachyarrhythmia, defibrillation shocks, onset of atrial fibrillation, low heart rate variability, low percentage of biventricular pacing, change in patient activity, abnormal sensing and other technical issues, lung fluid accumulation, and some haemodynamic variables.3, 4, 5, 6, 7, 8, 9, 10, 11
We did the INfluence of home moniToring on mortality and morbidity in heart failure patients with IMpaired lEft ventricular function (IN-TIME) trial to evaluate the incremental benefit of automatic multiparameter telemonitoring for patients with heart failure treated with an ICD or a CRT-D.
Section snippets
Study design and participants
We did this randomised controlled trial at 36 tertiary clinical centres, in Australia (one site), Europe (33 sites), and Israel (two sites; appendix). Details of the trial design have been published previously. 10 Consenting patients who were at least 18 years old were enrolled if they had chronic heart failure lasting for at least 3 months, New York Heart Association (NYHA) functional class II or III, a left ventricular ejection fraction of no more than 35%, and an indication for dual-chamber
Results
From July 24, 2007, to Dec 17, 2010, 716 patients were enrolled, of whom 664 were randomly assigned (figure 1 ): 333 to the telemonitoring group, 331 to the control group. Characteristics at enrolment were reasonably well balanced between the two groups (table 1 ). Mean age at enrolment was 65·5 years (SD 9·4), and 536 (81%) patients were men. Mean left ventricular ejection fraction was 26% (SD 7%). 582 (88%) of 664 patients completed follow-up, 37 died (6%), and 45 (7%) terminated the study
Discussion
In patients with heart failure treated with ICDs and CRT-Ds, automatic, daily, implant-based telemonitoring of rhythmic and technical parameters had a significantly beneficial effect on the composite clinical score and all-cause mortality. The favourable effect of telemonitoring seemed to arise from careful attention to various kinds of remote data without a single, typical scenario. In our opinion, three mechanisms contributed in parallel to the improved clinical outcome, but their relative
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