Daily Remote Monitoring and Outcomes in ICD Patients
Does home monitoring reduce all-cause mortality and the composite endpoint of all-cause mortality or worsening heart failure hospitalization in patients with implantable cardioverter-defibrillators (ICDs)?
This was a patient-level meta-analysis of the Biotronik’s TRUST, ECOST, and IN-TIME trials. Absolute risks of endpoints at 1-year follow-up for home monitoring vs. conventional follow-up were calculated. All-cause mortality analysis involved all three trials (2,405 patients). Other endpoints involved two trials, ECOST and IN-TIME (1,078 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 home monitoring group (95% confidence interval, 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 was significantly reduced (by 5.6%; p = 0.007; risk ratio, 0.64). The composite endpoint of all-cause mortality or cardiovascular hospitalization tended to be reduced by a similar degree (4.1%; p = 0.13; risk ratio, 0.85), but without statistical significance.
In a pooled analysis of the three trials, home monitoring reduced all-cause mortality and the composite endpoint of all-cause mortality or worsening heart failure hospitalization. The benefit of home monitoring is primarily due to the prevention of heart failure exacerbation.
Several nonrandomized studies found a substantial benefit of remote ICD monitoring in terms of mortality, but two of the three Biotronik randomized trials (TRUST and ECOST) mostly failed to confirm this. Only IN-TIME showed a significant positive effect of remote monitoring on the composite clinical score and on all-cause mortality. Notably, none of the individual trials was designed or powered to show a survival advantage. In addition to the potential hard endpoint benefit of reduced mortality, other benefits include earlier notification of hardware malfunction, clinical events like appropriate therapy and onset of atrial fibrillation, reductions in hospital use, and better adherence to follow-up. One should not assume that different proprietary systems may result in similar results, especially when it comes to the endpoint which drove the majority of the benefit—heart failure worsening. Multiparameter, automatic, and daily monitoring appears more advantageous than other platforms.
Clinical Topics: Arrhythmias and Clinical EP, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Prevention, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Acute Heart Failure
Keywords: Arrhythmias, Cardiac, Atrial Fibrillation, Defibrillators, Implantable, Geriatrics, Heart Failure, Ischemia, Primary Prevention, Risk, Treatment Outcome
< Back to Listings