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Pulmonary artery pressure technologies for remote monitoring of chronic heart failure

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2 Information about the technologies

2.1

Pulmonary artery pressure (PAP) monitoring systems use implantable sensors to collect data on PAP to remotely monitor chronic heart failure. The aim of PAP technologies is to detect increases in PAP at an early stage. PAP increases mean that fluid is beginning to accumulate because of worsening heart failure. So, early detection increases the possibility of optimising medication, and avoiding decompensation of heart failure and hospitalisation.

2.3

People take daily PAP measurements at home. Data, including on pressure trends and waveforms, is collected and transmitted to an external monitor in the home. The monitor securely forwards this information to a remote database that can be accessed by the person's healthcare team. The aim of PAP technologies is to supplement usual monitoring for chronic heart failure. The aim is not to replace any aspects of this monitoring, nor to make or confirm diagnosis of heart failure.

2.4

Two technologies were identified as relevant for inclusion in this evaluation:

  • CardioMEMS HF System (from here, CardioMEMS)

  • Cordella Pulmonary Artery Sensor System and Cordella Heart Failure System (from here, Cordella).

Table 1 Summary of pulmonary artery pressure monitoring technologies included in this evaluation

Technology

CardioMEMS HF System (from here, CardioMEMS; Abbott Medical)

Cordella Pulmonary Artery Sensor System and Cordella Heart Failure System (from here, Cordella; Endotronix/Edwards Life Sciences)

Intended use

CardioMEMS is indicated for wirelessly measuring and monitoring pulmonary artery pressure (PAP) and heart rate for people with chronic heart failure. In the UK, to have this technology, people need to have:

  • New York Heart Association (NYHA) class 3 symptoms, and

  • a prior hospitalisation for heart failure within the last 12 months, regardless of ejection fraction status.

Cordella is intended to measure, record and transmit PAP data for people with NYHA class 3 heart failure who:

  • are at home on diuretics and guideline-directed medical therapy, and

  • have been stable for 30 days.

Contraindications

CardioMEMS is contraindicated for people who are unable to take dual antiplatelet therapy or anticoagulants following implantation.

Cordella is contraindicated for people who are unable to take dual antiplatelet therapy or anticoagulants following implantation.

CE mark status

Class 3 CE mark

Class 3 CE mark

Description

A small pressure sensor is permanently implanted in the distal pulmonary artery during a minimally invasive right heart catheterisation procedure. The sensor is secured with nitinol wire loops. It measures PAP changes, which reflect fluid retention in the lungs because of worsening chronic heart failure.

At home, people use a portable electronics unit and a pillow with an embedded antenna. By lying down on the pillow and activating the technology, they take daily pressure readings by pressing a button. The data is sent wirelessly to a secure database for healthcare professionals to review. They can see trends and adjust medication and other treatments as needed, often before symptoms appear. This can potentially reduce the risk of decompensation of heart failure and hospitalisation.

A sensor is implanted in the pulmonary artery, and readings can be taken at home by holding a wireless handheld reader against the right pectoral region for 20 seconds. In addition to PAP data, this technology measures vital signs including blood pressure, heart rate, weight, and oxygen saturation.

Collected data is sent to the myCordella Hub, which guides people on how to use the technology, asks health-related questions, and transmits information to the myCordella Patient Management Portal for healthcare professionals to access. This technology aims to assist healthcare professionals in assessing and managing heart failure, potentially reducing hospitalisations.

NHS use

In the NHS in England, CardioMEMS has mostly been used in a trial setting and is not routinely used.

Cordella is not currently used in the NHS.

Price

£9,500

Not provided