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  • Question on Consultation

    • Has all of the relevant evidence been taken into account?
  • Question on Consultation

    Are the summaries of clinical and resource savings reasonable interpretations of the evidence?
  • Question on Consultation

    • Are the recommendations sound and a suitable basis for guidance to the NHS?
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The content on this page is not current guidance and is only for the purposes of the consultation process.

1 Recommendations

More research is needed

1.1

More research is needed on the Cordella Pulmonary Artery Sensor System and the Cordella Heart Failure System (from here, Cordella) for remote monitoring of chronic heart failure in adults before it can be funded by the NHS.

What research is needed

More research is needed on:

  • the clinical effectiveness of the technology, including the impact on heart failure hospitalisations

  • the short-term impact of the technology on quality of life

  • defining which groups of people the technology is most suitable for.

Should not be used

1.2

CardioMEMS HF System (from here, CardioMEMS) should not be used for remote monitoring of chronic heart failure in adults.

What this means in practice

More research is needed

There is not enough evidence to support funding Cordella in the NHS.

Access to Cordella should be through company, research or non-core NHS funding, and clinical or financial risks should be managed appropriately.

Should not be used

CardioMEMS does not offer value for money and should not be used in the NHS.

Why the committee made these recommendations

Evidence from non-comparative studies suggests that Cordella may reduce heart failure hospitalisations but this needs confirming. There is some evidence from randomised controlled trials that CardioMEMS can reduce heart failure hospitalisations. But this is uncertain because the people included in the trials were younger than the people who would use the technology in the NHS. It is also uncertain whether using either technology affects how long people live, or their quality of life. There are no trials directly comparing CardioMEMS with Cordella. An indirect comparison suggests no difference in heart failure hospitalisations between the 2 technologies. But this is uncertain because of the data used in the comparison.

Ongoing monitoring could be reassuring for people with chronic heart failure and help to quickly identify any need for medication changes. Potential concerns about the technologies include:

  • that some people might not be able or willing to have a general anaesthetic, which is needed for this procedure

  • non-adherence to the monitoring schedule and changes to medication

  • how easy the technology is to use for the person with the condition and their carers.

The technologies could reduce resource use in the NHS by reducing the number of heart failure hospitalisations. But, the cost effectiveness of Cordella cannot be established because its cost is unknown. Also, because there is limited evidence on its clinical effectiveness, it can only be used in research. Results from the economic modelling of CardioMEMS show that it is not cost effective. So, it should not be used.