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More research is needed on 3 technologies for algorithm-based remote monitoring in people with cardiac implantable electronic devices (CIEDs) who have or are at risk of developing heart failure, before they can be routinely used in the NHS. The technologies are:
HeartInsight
HeartLogic
TriageHF.
Access to the technology should be through company, research or non-core NHS funding, and clinical or financial risks should be appropriately managed.
This recommendation is not intended to affect monitoring with HeartInsight, HeartLogic or TriageHF that was started in the NHS before this draft guidance was published. People using these algorithms outside this recommendation may continue until they and their healthcare professional consider it appropriate to stop.
More 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.
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
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. CIEDs can also be used with algorithm-based remote monitoring, which automatically detects the early signs of worsening heart failure and sends an alert to a healthcare professional.
Evidence from accuracy studies for HeartLogic and TriageHF suggests that they may be able to predict the signs of worsening heart failure that could lead to hospitalisation or an unscheduled clinic visit (referred to as heart failure events). But this is uncertain because the studies have a high risk of bias (producing uncertain results because of the study's design) because of small numbers of people in the studies or a lack of controlling for other factors that could affect the results. There is also a lot of variation in the accuracy results. There are some concerns about risk of bias with the evidence showing how well CIEDs used with HeartLogic or TriageHF reduce heart failure events compared with CIEDs used with remote monitoring only. The key comparative study for HeartLogic has problems with the analysis and small participant numbers, and the key comparative study for TriageHF is unpublished and has some information missing on how the study was done.
Evidence for the HeartInsight algorithm suggests that it may fail to predict some early signs of worsening heart failure. But this is uncertain because the evidence comes from a single trial in a small number of people. There is also no evidence to show how well CIEDs that use HeartInsight reduce heart failure events compared with those that are only used with remote monitoring.
Because of the uncertainties in the evidence, HeartLogic, TriageHF and HeartInsight cannot be recommended for routine use in the NHS. But, they may be better at predicting worsening heart failure and reducing hospitalisations than CIEDs without algorithms, so more research is recommended.
Clinical trial evidence suggests that CorVue fails to predict 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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