Focus of the Report: This Health Technology Assessment focuses on the efficacy and safety of the CardioMEMS implantable hemodynamic monitor (CM-IHM) (Abbott) as an adjunct to the management of patients with heart failure (HF).
Technology Description: The CM-IHM system utilizes an implantable pulmonary artery pressure (PAP) sensor to allow patients to measure PAP remotely from home. Since elevated PAP is often an early indication of an impending HF exacerbation, data from CM-IHM can alert the patient and physician so that decisions regarding treatment can be made. Patients are instructed to obtain daily PAP readings, which are automatically uploaded to a database that can be accessed by the patient and caregivers. Physicians incorporate the PAP data into the HF treatment plan, often resulting in data-based dose changes to guideline-directed medical therapy (GDMT).
Controversy: Studies have consistently demonstrated that elevated PAP is a reliable prognostic indicator of acute HF exacerbation events, often increasing days or weeks prior to any clinical manifestation. The CM-IHM system aims to detect these subclinical warnings of decompensation, allowing for earlier intervention. However, it remains unclear whether early detection of PAP spikes can lead to changes in HF management that result in meaningful improvement of clinical outcomes and reduction of HFH event frequency.
Key Questions:
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Is the CardioMEMS HF System effective as an adjunct to standard care for the management of adults with symptomatic HF?
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How does monitoring with the CardioMEMS HF System compare with sham PAP monitoring or with standalone GDMT for managing patients with HF?
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Is the CardioMEMS HF System safe?
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Have definitive patient selection criteria been identified for the CardioMEMS HF System?
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