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The cardiology team at Galway University Hospitals (GUH) and NUI Galway researchers have carried out a first-in-man clinical trial for a sensor which detects changes in the health of patients with heart failure and securely transmits the information to the care team for review, allowing for clinical intervention to prevent a heart failure flare-up resulting in urgent hospitalisation.

This technology is particularly relevant now during restricted movements when patients with underlying conditions are cocooning to minimise the chances of contracting COVID-19.

Over the past 18 months, seven patients with advanced heart failure have had a Cordella Sensor implanted in their right pulmonary artery to monitor their heart pressure. Using a secure cloud-based system, the physiological data from the sensor can be read daily by the clinical team in the hospital who can identify if there is a change in the patients’ condition and modify their medication and make other decisions on their care.

Dr Faisal Sharif, Consultant Cardiologist at GUH and Director of Cardiovascular Research and Innovation Centre at NUI Galway is the lead for the clinical trial. He said, “Patients with advanced heart failure usually have 3 or 4 hospital admissions per year with each stay lasting between 2 and 3 weeks in order to get their flare-up under control. However, there are changes in the pressure of the pulmonary artery around a week before a flare-up and if these changes are detected in time, myself or my colleague Dr John Barton can make changes to the patients’ medication which will prevent the flare-up and the subsequent hospital admission.

“To monitor the pressure in the pulmonary artery we insert a tiny sensor into the artery – it is a simple procedure that just requires an overnight in hospital. We can then receive the data from the patients when they are at home via a hand-held reader which they hold over the sensor and this in turns transmits the information directly to our clinic by wifi.

“In addition, the Cordella System includes Bluetooth-enabled devices to measure blood pressure, weight, heart rate and oxygen saturation which all connect to our clinic. We then have all the data we need to assess the patient without the patient having to leave home.

“Since the clinical trial started 18 months ago, none of the patients who have taken part have been admitted to hospital with heart-related illnesses. Also, they no longer need to travel to outpatient clinics which would typically involve 6 or 8 visits per year. This greatly improves the quality of life for our patients and during this time of cocooning, it is one less worry for them.

“Besides the convenience of being able to check their condition at home, this new technology allows the patient to become actively involved in their treatment. The patients become part of the team and are empowered and motivated to get involved in managing their own care themselves.”

John O’Connor, a patient from Galway City said, “This technology gives me peace of mind that my heart pressures are being monitored constantly by hospital staff without the need for me to go into the hospital. Since I’ve had the sensor I’ve had no hospital admissions for almost two years. I would highly recommend this to other patients.”

Dr Pat Nash, Consultant Cardiologist at GUH and Chief Clinical Director, Saolta University Health Care Group added, “This pandemic is forcing us to look at new and innovative ways to deliver high quality care to our patients while also taking precautions against the risks that are associated with close contact that is the normal part of a clinical examination. The success of this clinical trial can be measured in the improvements in the patients’ quality of life, the dramatic reduction in the need for hospitalisation and the enhanced role that the patients are able to play in their own care. All of these successes are even more significant in light of the current public health measures and the need to protect patients with long-term underlying conditions.”

Ms Chris Kane, General Manager, Galway University Hospitals said, “As we continue to contend with the challenges of resuming to a new-normal, we will need to embrace technology where it is appropriate for the clinical setting and our patients. This is an excellent example of providing quality care in a patient’s own home environment to a level as close as possible to a hospital visit.”

The second phase of the clinical trial has just commenced and is open for patients with heart failure, who meet certain criteria and are being treated at the Heart Failure Clinic in GUH. The technology has been developed by a US-based company called Endotronix. The trial has been running simultaneously in Ireland and Genk, Belgium.

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