Effect of Remote Monitoring on Clinical Outcomes in European Heart Failure Patients With an Implantable Cardioverter-Defibrillator

Secondary Results of the REMOTE-CIED Randomized Trial

Cheyenne S.L. Chiu; Ivy Timmermans; Henneke Versteeg; Edgar Zitron; Philippe Mabo; Susanne S. Pedersen; Mathias Meine

Disclosures

Europace. 2022;24(2):256-267. 

In This Article

Abstract and Introduction

Abstract

Aims: Remote patient monitoring (RPM) systems offer a promising alternative to conventional In-Clinic check-ups, hereby reducing unnecessary clinic visits. Especially with the rise of the COVID-19 pandemic, this reduction is of paramount importance. Regarding the association between RPM and clinical outcomes, findings of previous studies have been inconsistent. The aim of this study is to elucidate the effect of partly substituting In-Clinic visits by RPM on clinical outcomes in implantable cardioverter-defibrillator (ICD) patients.

Methods and Results: The study included 595 heart failure patients (LVEF ≤35%; NYHA Class II/III) implanted with an ICD compatible with the Boston Scientific LATITUDE™ system. Participants were randomized to RPM plus an annual In-Clinic visit or 3–6 months In-Clinic check-ups alone. The investigated endpoints after 2 years of follow-up included a composite of all-cause mortality and cardiac hospitalization, mortality and cardiac hospitalization as independent endpoints and ICD therapy. The incidence of mortality and hospitalization did not differ significantly as independent, nor as composite endpoint between the RPM and In-Clinic group (all Ps <0.05). The results were similar regarding ICD therapy, except for appropriate ICD therapy (odds ratio 0.50; 95% confidence interval 0.26–0.98; P = 0.04). Exploratory subgroup analyses indicated that the effect of RPM differs between patients with specific characteristics, i.e. ≥60 years and permanent atrial fibrillation (all Ps < 0.05).

Conclusion: RPM is non-inferior to conventional In-Clinic visits regarding clinical outcomes. Routine In-Clinic follow-up may partly be substituted by RPM without jeopardizing safety and efficiency, and thus reducing unnecessary In-Clinic visits.

ClinicalTrials.gov Identifier: NCT01691586.

Graphical Abstract

Introduction

Over the past decades, the number of patients suffering from heart failure has increased drastically and the indications for implantable cardioverter-defibrillators (ICDs) have expanded. In order to prevent death from life-threatening ventricular arrhythmias, heart failure patients are preferably treated with ICD therapy. The growing number of patients implanted with an ICD translates into an increasing demand for their follow-up.[1,2]

The introduction of remote patient monitoring (RPM) systems offer a promising alternative to conventional In-Clinic check-ups by sending disease- and ICD-related data to the hospital, hereby reducing unnecessary clinic visits.[3] The European Society of Cardiology (ESC) Guidelines on cardiac pacing and cardiac resynchronization therapy, developed in collaboration with the European Hearth Rhythm Association (EHRA) in 2013, recommend the use of RPM to provide earlier detection of clinical problems and technical issues.[4] Additionally, the ESC published a guidance document for the diagnosis and management of cardiovascular diseases during the COVID-19 pandemic in 2020. In this document, experts advocated substituting routine device interrogation clinic visits by RPM to the fullest extent as long as the pandemic status is maintained by the World Health Organization (WHO).[5] Furthermore, in a consensus statement in 2015, the Heart Rhythm Society (HRS) stated that remote monitoring should be offered to all patients implanted with a cardiac implantable electronic device (CIED) as part of the follow-up strategy.[6]

Large clinical trials and meta-analyses have already demonstrated that RPM is safe and effective in ICD patients. Regarding the association between RPM and clinical outcomes (e.g. mortality, hospitalization, and ICD therapy), findings of previous studies have been inconsistent. In the majority of the studies, RPM was used as an addition to conventional In-Clinic follow-up.[7–9] Those randomized controlled trials (RCTs) mostly reported neutral effects, whereas non-randomized clinical studies observed significantly reduced mortality and hospitalization rates.[10,11] The IN-TIME, TIM-HF2, and ECOST randomized trials reinforced these clinical benefits. The IN-TIME and TIM-HF2 study concluded that RPM leads to a reduction in all-cause and cardiovascular mortality rates.[7,8] Lastly, the ECOST study showed that both the total number of given shocks and patients receiving inappropriate shocks was reduced in remotely monitored patients.[12] In more recent studies, RPM was partly substituted In-Clinic visits and the results were again conflicting. The RESULT study observed a reduced hospitalization rate and composite event of cardiovascular hospitalization and all-cause mortality in the RPM group.[13] In contrast, the MORE-CARE found no difference in the primary endpoint, defined as all-cause mortality and hospitalization for cardiovascular or device-related reasons.[14]

The European REMOTE-CIED study was primarily designed to be the first and largest RCT to investigate the effect of RPM on patient-reported ICD acceptance and disease-specific health status.[15] Usual care was partly replaced by RPM and the study was performed under daily practice reflecting circumstances. This distinguishes the REMOTE-CIED trial from previously conducted trials, as those trials intensified follow-up by using RPM as an addition to conventional In-Clinic follow-up, daily data transmission, or integrating a central monitoring unit.[7–9] The results of the REMOTE-CIED study showed no difference in heart failure-specific health status or ICD acceptance between the remotely and In-Clinic monitored patients in the first 2 years after implantation.[16–18] The influence of replacing In-Clinic follow-up by RPM on mortality, hospitalization, and ICD therapy in heart failure patients with an implanted ICD/CRT-D was investigated as secondary outcomes during the REMOTE-CIED trial. The aim of this article is to elucidate the effect of substituting In-Clinic follow-up by RPM on these clinical outcomes.

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