Key result
Remote patient monitoring was non-inferior to conventional in-clinic visits for the composite of all-cause mortality and cardiac hospitalization (P<0.05).
Why the study?
Previous findings regarding the association between remote patient monitoring and clinical outcomes have been inconsistent, warranting evaluation of partly substituting in-clinic visits with remote monitoring in ICD patients.
Does remote patient monitoring plus an annual in-clinic visit improve clinical outcomes compared to 3-6 months in-clinic check-ups alone in heart failure patients with an ICD?
RCT (n=595)
randomized
Yes
Does remote patient monitoring plus an annual in-clinic visit improve clinical outcomes compared to 3-6 months in-clinic check-ups alone in heart failure patients with an ICD?
p-value: p=<0.05
Remote patient monitoring is non-inferior to conventional in-clinic visits regarding clinical outcomes and may reduce the incidence of appropriate ICD therapy in heart failure patients.
May allow RPM to replace some in-clinic visits now; confirms no harm and leaves open hard-outcome improvement.
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.
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Chiu et al. (2021) conducted an RCT in Heart failure with an implantable cardioverter-defibrillator (n=595). Remote patient monitoring (RPM) plus an annual In-Clinic visit vs. 3-6 months In-Clinic check-ups alone was evaluated on Composite of all-cause mortality and cardiac hospitalization (p=<0.05). Remote patient monitoring was non-inferior to conventional in-clinic visits for the composite of all-cause mortality and cardiac hospitalization (P<0.05).
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