Wearable Self-Recording Device Can Detect the Earliest Phase of Acute Coronary Occlusion in Patients With CAD

October 8, 2019

By Eric Ramos

TALLINN, Estonia -- October 8, 2019 -- A self-recording wearable device can detect the earliest phase of acute coronary occlusion for most patients with coronary artery disease, thus, improving patient survival without overloading emergency services, researchers reported here at the inaugural European Society of Cardiology (ESC) Digital Summit 2019.

“Chest pain has many different causes, but it is the most frequent symptom of STEMI [ST-elevation myocardial infarction],” said Frederic Van Heuverswyn, MD, Ghent University, Ghent, Belgium. “Although immediate percutaneous coronary intervention is the cornerstone of treatment, no change in patient-to-ambulance time [has occurred] in the last 30 years.”

When illustrating the lifeline of chest pain, he noted that onset of chest pain is usually followed by a period of 60 to 210 minutes, on average, before first medical contact with the patient occurs.

“This can be due to doubts [from the patient], being afraid to call emergency services, or being uncertain about the symptoms [they are] feeling,” said Dr. Heuverswyn. “We also know that the first 10 to 15 minutes after the onset of chest pain is peak in primary ventricular fibrillation, so we lose many patients before they ever reach the hospital or emergency services.”

According to Dr. Heuverswyn, chest pain campaigns and patient education campaigns have proved futile.

“We tried to educate our patients, with limited effects,” he said. “Patients remain in doubt about what’s going on. We need to shape the future of medicine by patient empowerment.”

A wearable, self-recording device may just be the answer. The RELF device is a 3-lead detection system with an automatic algorithm built into a mobile handheld device. The system has Bluetooth capabilities and a dedicated mobile app. It is self-applied by patients during daily life conditions or before and during elective percutaneous coronary intervention.

“The device is capable of illustrating all occlusions that have any ECG change, with a higher sensitivity than a 12-lead ECG and with a low false positive rate,” said Dr. Heuverswyn.

The researchers tested the device on 58 patients and recently published their results in The Lancet Digital Health. Those results showed a mean false positive rate of 4.19% during daily life conditions. The sensitivity for the target conditions was 0.87 for acute coronary artery occlusion, 0.95 for acute coronary artery occlusion with ECG changes, and 1.00 for acute coronary artery occlusion with ECG changes and STEMI criteria.

The index test was more sensitive to detect a 60 s balloon occlusion than the STEMI criteria on 12-lead ECG (87% vs 56%; P

“Our RELF device is the first clinically validated device that can be used easily by patients with coronary artery disease to automatically self-detect acute coronary artery occlusion with greater sensitivity than 12-lead ECG,” said Dr. Heuverswyn.

“Automatic self-detection of STEMI can reduce patient-to-ambulance time by giving patients and emergency call centres an immediate and objective sign of an acute coronary occlusion associated with instantaneous advice,” he said. “Reducing patient-to-ambulance time can result in a significant reduction of STEMI mortality and increased myocardial salvage.”

[Presentation title: An Automated Decision Support Tool for Ongoing Chest Pain in Patients With Coronary Artery Disease]