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Implant-Based Multiparameter Telemonitoring of Patients With Heart Failure (IN-TIME): A Randomised Controlled Trial
Study Questions:
What is the incremental benefit of automatic multiparameter telemonitoring for patients with heart failure with reduced ejection fraction treated with an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D)?
Methods:
IN-TIME (INfluence of home moniToring on mortality and morbidity in heart failure patients with IMpaired lEft ventricular function) was a multicenter, international, randomized, controlled trial of patients with heart failure with reduced ejection fraction and New York Heart Association (NYHA) class II-III symptoms, who had received a recent dual-chamber ICD or CRT-D. Patients were randomized to either automatic, daily, implant-based, or multiparameter telemonitoring in addition to standard care, or usual care. Patients and investigators were not blinded. In the intervention group, devices transmitted data daily or on detection of tachyarrhythmia. Transmitted data were reviewed by study investigators; response to telemonitoring observations was at the discretion of the investigators. The primary outcome was worsening of a composite clinical score at 12 months; the score was a composite of all-cause death, overnight hospital admission for heart failure, change in NYHA class, and a change in patient global self-assessment. Funding was provided by Biotronik SE & Co. KG.
Results:
A total of 716 patients were enrolled and 664 were randomly assigned (333 to telemonitoring and 331 to control). At 1 year, 63 (18.9%) patients in the telemonitoring group versus 90 (27.2%) in the control group (p = 0.013) had worsened composite score (odds ratio [OR], 0.63; 95% confidence interval [CI], 0.43-0.90). This outcome was largely dominated by the lower mortality in the telemonitoring group (10 vs. 27 deaths; 1-year hazard ratio, 0.36; 95% CI, 0.17-0.74). Gap in data transmission of >3 days was the most frequent observation transmitted to the study investigators; other transmissions were for new-onset atrial tachyarrhythmia, suboptimal pacing in those with CRT-D, frequent ventricular ectopy, and sensing problems.
Conclusions:
In this randomized, controlled trial, automatic, daily, implant-based multiparameter telemonitoring improved clinical outcomes in patients with heart failure with reduced ejection fraction.
Perspective:
This study adds to the literature about telemonitoring implants for patients with heart failure. Although outcomes in the telemonitoring group were improved, the mechanism of this improvement is uncertain. The authors speculate that the intervention group may have benefitted from early detection of ventricular and/or atrial tachyarrhythmia, early recognition of suboptimal device function, or the outcome of the patient interview prompted by telemonitoring. Future studies should clarify the mechanism through which such telemonitoring improves outcomes. Ultimately, there may be benefit to creating systems and infrastructure through which to meaningfully address information transmitted from telemonitoring implants.
Keywords: Self-Assessment, Ventricular Function, Left, Heart Failure, Stroke Volume, Tachycardia
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