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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 (I² = 87.1%, chi² = 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.

SUBMITTER: Hajduczok AG

PROVIDER: S-EPMC8460850 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Heart failure patients with implantable defibrillators place a significant burden on health care systems. Remote monitoring allows assessment of device function and heart failure parameters, and may represent a safe, effective, and cost-saving method compared to conventional in-office follow-up.We hypothesized that remote device monitoring represents a cost-effective approach. This paper summarizes the economic evaluation of the Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators (EVOLVO) study, a multicenter clinical trial aimed at measuring the benefits of remote monitoring for heart failure patients with implantable defibrillators.Two hundred patients implanted with a wireless transmission-enabled implantable defibrillator were randomized to receive either remote monitoring or the conventional method of in-person evaluations. Patients were followed for 16 months with a protocol of scheduled in-office and remote follow-ups. The economic evaluation of the intervention was conducted from the perspectives of the health care system and the patient. A cost-utility analysis was performed to measure whether the intervention was cost-effective in terms of cost per quality-adjusted life year (QALY) gained.Overall, remote monitoring did not show significant annual cost savings for the health care system (€1962.78 versus €2130.01; P=.80). There was a significant reduction of the annual cost for the patients in the remote arm in comparison to the standard arm (€291.36 versus €381.34; P=.01). Cost-utility analysis was performed for 180 patients for whom QALYs were available. The patients in the remote arm gained 0.065 QALYs more than those in the standard arm over 16 months, with a cost savings of €888.10 per patient. Results from the cost-utility analysis of the EVOLVO study show that remote monitoring is a cost-effective and dominant solution.Remote management of heart failure patients with implantable defibrillators appears to be cost-effective compared to the conventional method of in-person evaluations.ClinicalTrials.gov NCT00873899; http://clinicaltrials.gov/show/NCT00873899 (Archived by WebCite at http://www.webcitation.org/6H0BOA29f).

Project description:BackgroundRemote monitoring of cardiac implantable electronic devices (CIEDs) has demonstrated substantial benefits. Treatment guidelines have therefore endorsed its use and is being increasingly adopted in the clinical setting, but the level of satisfaction they convey remains still unknown. We developed and validated a questionnaire to measure patient satisfaction with remote monitoring using Medtronic CareLink® Network and assessed its internal reliability and dimensional validity.MethodsAfter a thorough literature review, cognitive debriefing of 18 patients, and an expert panel discussion, a 30-item instrument was proposed and grouped into 5 dimensions (items): 1- Information on cardiac condition (3), 2- Device convenience (3), 3- Transmission process (6), 4- Satisfaction with medical monitoring (8), and 5- General opinions (10). Correlation with the visual analog scale (VAS), overall health related quality of life (HRQoL) measured by the EuroQoL-5D accompanied by the VAS as well as with the Medical Outcomes Study (MOS) SF-36 were assessed. Psychometric properties, exploratory factor analysis and a second order confirmatory factor analysis (a hierarchical CFA with a general common factor explaining the relations between the first order common factors, See Figure 1) were estimated. Models were assessed based on item loading size, sign and statistical significance, and goodness-of-fit statistics.ResultsA total of 186 patients (77% male) with a mean age of 66.03 (SD?=?13.94) years were assessed. 48% had implantable cardioverter-defibrillators, 24% had pacemakers, and 29% had cardiac resynchronization therapy devices. An overall Cronbach's ??=?0.893 was achieved, with acceptable reliabilities for isolated dimensions. Correlations with corresponding VAS scales were meaningful and significant (p?<?0.01). The second order factor solution yielded good goodness-of-fit indexes (?2/df?=?1.44, CFI?=?0.96, TLI?=?0.95, RMSEA?=?0.05). Satisfaction with remote monitoring was not related to HRQoL (r?<?0.05), except for the correlation between the SF-36 mental component and the information on cardiac condition dimension (r?=?0.263, p?<?0.001).ConclusionsThe 30-item questionnaire showed good reliability and validity to assess satisfaction with remote monitoring in patients with CIEDs.

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

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