Key result
Non-invasive telemonitoring significantly reduced the composite endpoint of death or heart failure hospitalization (HR 0.2) compared to standard care in patients with severe heart failure and an implanted cardiac resynchronization therapy system.
Why the study?
Heart failure remains a disease with poor prognosis, and the clinical relevance of non-invasive telemonitoring devices in these patients needed identification.
Does the addition of a non-invasive telemonitoring device to standard medical care reduce the composite of death or heart failure hospitalization in patients with severe heart failure and an implanted CRT system?
RCT (n=60)
Open-label
1:1
No
Does the addition of a non-invasive telemonitoring device to standard medical care reduce the composite of death or heart failure hospitalization in patients with severe heart failure and an implanted CRT system?
Effect estimate: HR 0.2 (95% CI 0.07-0.7)
Absolute Event Rate: 21.4% vs 46.8%
p-value: p=0.004
In patients with severe heart failure receiving CRT, the addition of daily non-invasive telemonitoring to standard care significantly reduced the risk of death or heart failure hospitalization over 2 years.
BACKGROUND: Heart failure (HF) remains a disease with a poor prognosis. Telemonitoring is a medical service aimed at remote monitoring of patients. AIM: The study aimed to identify the clinical relevance of non-invasive telemonitoring devices in HF patients. METHODS: Sixty patients aged 66.1 (11) years, with left ventricular ejection fraction (LVEF) 26.3 (6.8)% underwent cardiac resynchronization therapy (CRT) implantation. They were randomly allocated to the control (standard medical care) or study (standard medical care + telemonitoring device) groups. During the follow-up (24 months), the patients in the study group provided body mass and blood pressure, along with electrocardiogram on a daily basis. The data were transferred to themonitoring center and consulted with a cardiologist. Transthoracic echocardiography and a 6-minute walk test were performed before and 24 months after CRT implantation. RESULTS: During the two-year observation, the composite endpoint (death or HF hospitalization) occurred in 21 patients, more often in the control group (46.8% vs. 21.4%; P = 0.026). Inunivariate analysis: the use of telemetry (hazard ratio [HR], 0.2; 95% confidence interval [CI], 0.07-0.7; P=0.004), thepresence of coronary heart disease (HR, 41.4; 95% CI, 3.1-567.7; P=0.005), hypertension (HR, 0.24; 95% CI, 0.07-0.90; P = 0.035), and patient's body mass (HR, 0.36; 95% CI, 0.14-0.92; P = 0.03) were related to the occurrence of the composite endpoint. CONCLUSIONS: The use of a telemonitoring device in CRT recipients improved theprognosis in2-year observation and contributed to the reduction of HF hospitalization.
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Wita et al. (2022) conducted an RCT in Severe heart failure with reduced ejection fraction (HFrEF) (n=60). Non-invasive telemonitoring device vs. Standard medical care was evaluated on Composite of all-cause death or first-time emergency hospitalization for decompensated heart failure (HR 0.2, 95% CI 0.07-0.7, p=0.004). Non-invasive telemonitoring significantly reduced the composite endpoint of death or heart failure hospitalization (HR 0.2) compared to standard care in patients with severe heart failure and an implanted cardiac resynchronization therapy system.
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