December 3, 2018Open Access

Telemonitoring with an implantable loop recorder in outpatient heart failure care

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Stable heart failure (n=30). Intervention: Implantable loop recorder (Reveal XT) vs. Routine clinic visits (standard care). Primary outcome: Therapeutic changes based on ILR-detected pre-specified arrhythmic events.

Key Result

Continuous monitoring with an implantable loop recorder detected arrhythmic events leading to therapeutic changes in 43.3% of stable heart failure patients, whereas routine clinical visits detected none of these events.

Study Design

Type

Observational (n=30)

Blinding

Single-blind

Multicenter

Yes

PICO

Population

30 stable heart failure patients (NYHA Class II and III) without a cardiac implantable device or oral anticoagulant therapy, followed for a median of 12 months to assess the utility of an implantable loop recorder.

Intervention / Comparator

Implantable loop recorder (Reveal XT) vs Routine clinic visits (standard care)

Primary Outcome

Therapeutic changes based on ILR-detected pre-specified arrhythmic events

Main Result

Absolute Event Rate: 43.3% vs 0%

Limitations

Therapy change was left to clinical judgment without a standardized protocol.
The study was not randomized, and patients essentially served as their own control group.
Treating physicians may have been biased knowing they would receive ILR findings if pre-specified events occurred.
Small sample size of only 30 patients included over several years.

Abstract

INTRODUCTION: In the care of heart failure patients, telemonitoring is receiving growing attention. The main purpose of this study was to determine the effect of continuous telemonitoring with an implantable loop recorder (ILR, Reveal XT), a novel strategy in the management of stable heart failure patients without a cardiac implantable device. Furthermore, little is known about the incidence of subclinical arrhythmias in this specific group of patients. MATERIALS AND METHODS: Stable heart failure patients, New York Heart Association Class II and III, without recent hospitalisation or upcoming intervention, were included. After implantation of the ILR there was regular contact with the research nurse on a pre-specified basis. Clinic visits and telephonic interviews were alternated for a minimum of 1 year. Parallel visits to their treating physician continued according to standard care. The treating physician was blinded for the ILR findings, accept for pre-specified, significant arrhythmic events. RESULTS: Thirty patients were included and followed for a median duration of 12 months. In 13 patients, data from the loop recorder led to therapeutic changes. One patient received a pacemaker. Eight patients developed atrial fibrillation, all subclinical, with a mean burden of 65.8 ± 173.2 min/day. CONCLUSION: The use of an ILR could potentially impact patient management. Additional study is needed in different patient populations (e. g. higher risk groups) to assess if an ILR could also impact on endpoints such as heart failure hospitalisation.

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