New device from Birmingham, U.K., to provide early diagnosis for cardiac tamponade

Patients recovering from heart surgery can be at risk from a life-threatening condition where fluid builds up around the heart, strangling its ability to beat properly. Now, a company formed by Birmingham cardiothoracic surgeon Mr Hazem Fallouh has received a £500k grant from Innovate UK to develop a new device for early diagnosis of the life-threatening condition.

Fallouh Healthcare is developing the device to monitor cardiac patients after surgery, which is when the condition, called cardiac tamponade, usually strikes.

Typically, this happens late at night when the patient is in intensive care, and as blood clots accumulate, they compress the heart, reducing its ability to pump blood around the body.

Around 45,000 patients in the UK undergo cardiac surgery each year, and it is usually safe. However cardiac tamponade can come on quickly, and diagnosis is difficult as it can be confused with other causes of heart failure. As high as 3 in 10 of all deaths that immediately follow post-cardiac surgery are thought to be due to cardiac tamponade.

If missed, cardiac tamponade can lead to cardiac arrest which is resistant to CPR and requires immediate opening of the patient’s chest in the uncontrolled environment of the intensive care unit – a procedure that has a mortality rate (30-70%), and poor outcomes for those patients who survive.

Consultant surgeon Mr Fallouh, who has worked in many centres of excellence in the UK, invented the device to provide early diagnosis of tamponade, allowing a planned return to surgery to drain fluid and clots around the heart.

Called PerDeCT (Pericardial Device to monitor Cardiac output and diagnose Tamponade), it is the only device to diagnose cardiac tamponade, and provide cardiac monitoring at no extra cost.

In 2021, Dr Fallouh, who has previously commercialized two award-winning inventions in cardiac surgery, received the prestigious Techno-College Innovation Award at the 35th Annual Meeting of European Society of Cardiothoracic Surgery for PerDeCT, which was against 11 technologies by panels of expert surgeons, cardiologists and medical devices and investment specialists.

The device consists of a probe and a balloon, which is placed in the pericardium (the sac around the heart) during initial surgery, and measures cardiac efficiency (cardiac output) as well as predicting the development of tamponade, by looking at the trend in the relationship between balloon inflation and cardiac efficiency. It can be withdrawn through the skin after the patient is recovered.

The intellectual property in the form of a patent is assigned to Fallouh Healthcare Limited.

Fallouh Healthcare is a startup with a mission to deliver smart solutions to unmet needs in order to deliver safer and more effective cardiothoracic surgery.

The company has now taken up residency in Unit 9, a short-term medical technology incubator funded by University of Birmingham Enterprise, the Greater Birmingham & Solihull Local Enterprise Growth Hub and the West Midlands Combined Authority to provide flexible, low-cost facilities for medical research, proof of concept and prototyping activity.

The delivery of the Innovate UK project is in collaboration with University Hospitals Birmingham NHS Foundation Trust (UHB) and the University of Sheffield. The funding from Innovate UK will allow Fallouh Healthcare to build a prototype and conduct a usability study at UHB’s Queen Elizabeth Hospital site, the Medical Device – Testing and Evaluation Centre (MD-TEC).