Cost-utility analysis of the EVOLVO study on remote monitoring for heart failure patients with implantable defibrillators: randomized controlled trial

Paolo Zanaboni, Maurizio Landolina, Maurizio Marzegalli, Maurizio Lunati, Giovanni B Perego, Giuseppe Guenzati, Antonio Curnis, Sergio Valsecchi, Francesca Borghetti, Gabriella Borghi, Cristina Masella, Paolo Zanaboni, Maurizio Landolina, Maurizio Marzegalli, Maurizio Lunati, Giovanni B Perego, Giuseppe Guenzati, Antonio Curnis, Sergio Valsecchi, Francesca Borghetti, Gabriella Borghi, Cristina Masella

Abstract

Background: 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.

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: Remote management of heart failure patients with implantable defibrillators appears to be cost-effective compared to the conventional method of in-person evaluations.

Trial registration: ClinicalTrials.gov NCT00873899; https://ichgcp.net/clinical-trials-registry/NCT00873899 (Archived by WebCite at http://www.webcitation.org/6H0BOA29f).

Keywords: cost-effectiveness; heart failure; implantable defibrillators; telemedicine.

Conflict of interest statement

Conflicts of Interest: Dr Landolina has speakers’ bureau appointments and an advisory board relationship with Medtronic and other device companies. Valsecchi and Borghetti are employees of Medtronic Inc. The other authors report no conflicts.

Figures

Figure 1
Figure 1
Medtronic CareLink home monitor.
Figure 2
Figure 2
Medtronic Carelink Network.
Figure 3
Figure 3
Consolidated Standards of Reporting Trials (CONSORT) diagram of the study.

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