Hospital Trust first in UK to implant novel heart failure device

University Hospital Southampton (UHS) is the first in the UK to fit a heart failure patient with a novel sensor that can give clinicians an early warning about a deterioration in their condition.

The procedure is part of a cutting-edge international research study which intends to prove this new way of monitoring and treating heart failure patients is safe and effective.

The unique technology, known as the FIRE1 System, is a sensor about the size of a pen lid which is designed to monitor the amount of fluid in the body – elevated levels can give an indication of worsening heart failure.

The device is implanted into the inferior vena cava (IVC) – the body's largest vein, located in the abdomen which carries oxygen-depleted blood back to the heart.

It works by continuously measuring the size of the IVC giving a marker of the amount of fluid in the body.

High levels can increase the risk of breathing difficulties and a build-up of fluid in the lungs which can lead to an emergency hospital admission.

The device is implanted during a simple 45-minute procedure using a small catheter which is placed in a vein at the top of the leg. It is collapsed on entry so it can be pushed up into the IVC where it expands to its full size.

After surgery patients are provided with an external detection belt worn across the abdomen for one to two minutes a day which powers the implanted sensor using radiofrequency energy.

Data is sent from a patient’s home to the heart failure team at UHS daily with the aim of alerting the team to early warning signs so they can intervene before their condition worsens significantly.

Heart failure occurs when the heart can’t pump blood around the body efficiently, causing fluid to build up. Around 700 patients are admitted to UHS with the condition every year.

Common causes include high blood pressure which puts strain on the heart, cardiomyopathy, which is a disease of the heart muscle, and long-term damage as a result of a heart attack.

Symptoms include shortness of breath, a persistent cough, swollen feet and ankles and fatigue. Patients may also feel light-headed, the heart may race quickly and they can occasionally faint.

It is estimated that more than 900,000 people in the UK are living with heart failure and this number is likely to rise due to an ageing population, more effective treatments and improved survival rates after a heart attack.

Heart failure admissions to hospital costs the NHS £2 billion per year and methods to reduce this are a key focus for researchers and doctors.

The procedure was performed by a team led by Dr Andrew Flett and Dr Peter Cowburn, both consultant cardiologists and heart failure specialists at UHS.

Dr Flett said: “This innovative new device has the potential to improve patient safety and outcomes in the management of patients with chronic heart failure and we are delighted to be the first site in the UK to implant as part of this ground-breaking study.

“We have now successfully implanted a second patient with the device and data is already being transmitted which we look forward to receiving so that we can intervene earlier in a bid to reduce hospital visits and keep patients well for longer.

“Heart failure is a significant burden on the NHS and so pioneering advances such as this could help to reduce that pressure.”

He added: “It is estimated that one in five people will develop heart failure and earlier intervention when patients start to deteriorate can make a huge difference and the hope is that this new FIRE1 device will do just that.

“It is an exciting new development for patients with this condition.”

FIRE1 has successfully completed its early phase of clinical trials and is now expanding its study to evaluate the feasibility and safety of implanting the FIRE1 System in heart failure patients.