AccurKardia has announced the initiation of a multicentre clinical pilot study of AK+ Guard—a US Food and Drug Administration (FDA) Breakthrough Device designated, artificial intelligence (AI)-powered technology that enables the detection of hyperkalaemia using Lead I electrocardiograms (ECGs). The three-arm prospective pilot study will evaluate more than 150 patients across inpatient, outpatient and home settings in the USA.
A press release from the company notes that hyperkalaemia commonly affects patients with chronic kidney disease (CKD), end-stage renal disease, and heart failure, and can result in dangerous arrhythmias and sudden cardiac arrest. The release also states that, every year in the USA, hyperkalaemia results in more than one million hospitalisations, 10,000 deaths, and US$2 billion in annual core hospitalisation-related economic burden.
AccurKardia’s AK+ Guard software—which is compatible with a wide range of US FDA-cleared consumer and clinical wearables, including smartwatches—is designed to improve patient outcomes and reduce the burden of hyperkalaemia on the healthcare system through remote monitoring of the condition.
“Bringing accurate hyperkalaemia detection to common consumer and clinical grade wearables for the remote monitoring of hyperkalaemia in vulnerable CKD and heart failure populations would be a gamechanger,” said Wei Ling Lau (University of California, Irvine, USA). “If I saw a concerning result in a monitored patient, I could intervene immediately with a potassium-binding medication.”
In a 20,750-patient retrospective clinical validation study performed with data from Mayo Clinic, AK+ Guard achieved 89% accuracy for detecting moderate-to-severe hyperkalaemia, on par with many gold-standard diagnostics and remote patient monitoring solutions, AccurKardia claims.
“I frequently treat patients admitted for hyperkalaemia. It would be a huge benefit to patients and the healthcare system if we had an accurate way to detect and intervene before hyperkalaemia results in a costly hospitalisation,” said Omar Darwish (University of California, Irvine, USA).
Moin Hussaini, chief product officer of AccurKardia, added: “The goal of this pilot is to get an early demonstration of performance in the intended-use population and reproduce the impressive results from our retrospective validations in real-world settings.”
