Remote monitoring for heart failure using implantable devices: a systematic review, meta-analysis, and meta-regression of randomized controlled trials

Abstract

In heart failure (HF) patients, remote monitoring using implantable devices may be used to predict and reduce HF exacerbations and mortality. Data from randomized controlled trials (RCTs) was assessed to determine the effectiveness of implantable remote monitoring on the improvement of outcomes in HF patients. A systematic review and meta-analysis of RCTs testing remote monitoring versus standard of care for management of HF patients was performed. Primary endpoints were all-cause mortality and a composite of cardiovascular (CV) and HF hospitalizations. Rate ratios (RRs) and 95% confidence intervals (CI) were calculated. A secondary analysis tested for heterogeneity of treatment effect (HTE) comparing right ventricular/pulmonary pressure monitoring versus impedance-based monitoring on hospitalization. A regression analysis was performed using the mean follow-up time as the moderator on each primary endpoint. Eleven RCTs (n = 6196) were identified with a mean follow-up of 21.9 months. The mean age and reported ejection fraction were 64.1 years and 27.7%, respectively. Remote monitoring did not reduce mortality (RR 0.89 [95% CI 0.77, 1.03]) or the composite of CV and HF hospitalizations (RR 0.98 [0.81, 1.19]). Subgroup analysis found significant HTE for hospitalizations between those studies that used right ventricular/pulmonary pressure monitoring versus impedance-based monitoring (I 2 = 87.1%, chi 2 = 7.75, p = 0.005). Regression analysis found no relationship between the log rate ratio of remote monitoring's effect on mortality, CV hospitalization or HF hospitalization, and mean follow-up time. Compared to standard of care, remote monitoring using implantable devices did not reduce mortality, CV, or HF hospitalizations. However, right ventricular/pulmonary pressure monitoring may reduce HF hospitalizations, which will need to be explored in future studies. Keywords Heart failure • Remote monitoring • Implantable devices • Systematic review • Meta-analysis • Randomized controlled trials Abbreviations HF Heart failure CV Cardiovascular RCT Randomized controlled trial CRT-D Cardiac resynchronization therapy defibrillator ICD Implantable cardioverter-defibrillator Highlights • Standard of care in heart failure outpatient monitoring is centered on patient-reported symptoms. • New methods of monitoring physiologic markers with implantable devices such as cardiac resynchronization therapy device and pulmonary artery pressure sensors have been developed. • Several randomized controlled trials (RCTs) have been conducted examining whether use of remote monitoring has an effect on mortality and hospitalizations. • This systematic review and meta-analysis examined 11 RCTs and showed no significant effect with implantable remote monitoring on mortality, heart failure (HF) hospitalizations, or cardiovascular hospitalizations when compared to standard of care. • A decrease in HF hospitalizations was observed in RCTs using implantable continuous cardiac/pulmonary artery pressure monitoring compared to thoracic impedance-based m...

Letter to the editor to update the article “Remote monitoring for heart failure using implantable devices: a systematic review, meta-analysis, and meta-regression of randomized controlled trials”

“…The findings from GUIDE-HF are consistent with our prior conclusion that right ventricular/pulmonary pressure monitoring may reduce HF hospitalizations [1]. Overall the addition of the GUIDE-HF results to our previously published meta-analysis tightened the confidence interval and had minimally affected the point estimate for reduction of HF hospitalizations.…”

“…We would like to update our recently published manuscript (Hajduczok et al [1]) due to the emergence of new data from the GUIDE-HF randomized controlled trial (RCT) that meets the inclusion criteria of our systematic review and meta-analysis [1,2].…”

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Our recently published systematic review and meta-analysis of heart failure (HF) remote monitoring using implantable devices 1) has been updated to reflected new data from the GUIDE-HF trial (Lindenfeld et al in Lancet 398(10304):991-1001, 2). Data from randomized controlled trials (RCTs) was assessed to determine the effectiveness of implantable remote monitoring on the improvement of outcomes in HF patients.

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“…In Hajduczok et al, we reported data from 11 RCTs that tested implantable remote monitoring versus standard of care for management of heart failure (HF) patients [1]. Primary endpoints were all-cause mortality and a composite of cardiovascular (CV) and HF hospitalizations.…”

Current status of reimbursement practices for remote monitoring of cardiac implantable electrical devices across Europe

“…In patients with CIEDs affected by HF, RM using signals detected by implantable devices may be used for disease management, with the aim to predict and reduce HF exacerbations, consequent HF hospitalization and cardiovascular mortality. 24 , 25 Indeed, the clinical role of RM has evolved by the trends to move the focus from the ‘device carried by the patient’ to the ‘patient carrying a device’, thus with the aim to detect signals suggesting the risk of worsening HF that could lead to appropriate clinical decisions and to reduce hospital admissions in patients with HF. 5 , 26–30 Today, many physiologic variables can be monitored through CIEDs in patients with HF and with multi-parametric algorithms found to be more effective in assessing the risk of worsening or impending HF.…”