1.1
Use HeartLogic and TriageHF as options for algorithm-based remote monitoring in people with cardiac implantable electronic devices (CIEDs) who have heart failure. They should be used with specialist review of alerts.
DIAGNOSTICS ASSESSMENT PROGRAMME
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1 Recommendations
Use as an option
For people with heart failure
1.2
Companies should work with the NHS to collect registry data for HeartLogic and TriageHF on:
hospitalisation rates
heart-failure-related mortality rates
rates of emergency department or primary care visits
patient-reported outcomes.
Can only be used in research
More research
1.5
More research for the technologies in sections 1.3 and 1.4 is needed in the populations outlined. This research is needed on:
prognostic accuracy
rates of false positives or unexplained alerts
hospitalisation rates
heart-failure-related mortality rates
rates of emergency department or primary care visits
patient-reported outcomes.
1.6
Access to the technologies in sections 1.3 and 1.4 in the populations outlined should be through company, research or non-core NHS funding, and clinical or financial risks should be appropriately managed.
Do not use
1.7
CorVue should not be used for algorithm-based remote monitoring in people with CIEDs who have or are at risk of developing heart failure.
Why the committee made these recommendations
Algorithm-based remote monitoring automatically detects the early signs of worsening heart failure and sends an alert to the healthcare professional. People who have or are at risk of developing heart failure can be offered CIEDs, which healthcare professionals can use to remotely monitor the person's heart function. Algorithm-based remote monitoring may be activated in a person's CIED.
Evidence for HeartLogic and TriageHF shows that they can detect the signs of worsening heart failure that could lead to hospitalisation or an unscheduled clinic visit (referred to as heart failure events). Evidence shows that CIEDs used with HeartLogic or TriageHF reduce hospitalisations compared with CIEDs used with remote monitoring only. Collection of registry data is recommended for these algorithms to confirm the extent of the benefit seen in the studies.
It is uncertain whether the HeartInsight algorithm can detect early signs of worsening heart failure. There is also no evidence to show how well CIEDs that use HeartInsight reduce heart failure events. HeartInsight may be better at predicting worsening heart failure and reducing hospitalisations than CIEDs without algorithms, so more research is recommended.
More research is also recommended for HeartInsight, HeartLogic and TriageHF in people at risk of developing heart failure because there is very limited evidence in this population.
Clinical trial evidence suggests that CorVue fails to detect some signs of worsening heart failure and has a high rate of false-positive alerts (alerts that are not followed by a heart failure event). So CorVue is not recommended for use in the NHS.
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