Physicians may not be aware of such devices' intended use, with potential for misdiagnosis resulting in patient injury or death, the agency announced. 

Several late-breaking clinical trials at ACC.22 will likely impact clinical practice. Below are summaries of a few key trials and their takeaways for interventional cardiology and structural heart interventions. 

Sean Pokorney, MD, director of the arrhythmia core lab, Duke Clinical Research Institute, assistant professor of Medicine, Duke University, discusses a late-breaking ACC 2022 study that shows mortality is higher in patients with implantable electrophysiology (EP) device infections where the leads are not explanted.

A Chinese study of 2.8 million participants found that 94% of users flagged for AFib indeed have the heart rhythm disorder.

The study's authors examined data from the DANAMI-3 trial, focusing on such outcomes as all-cause mortality, recurrent MI and target vessel revascularization.

The company's flagship offering uses AI to evaluate 3D images of a patient's heart for signs of atherosclerotic plaque.

The increased risk of deep vein thrombosis lasts for up to three months, researchers found. 

Joanna Chikwe, MD, founding chair of the department of cardiac surgery at Cedars-Sinai Hospital, compares transcatheter edge-to-edge repair (TEER) to mitral valve surgery for primary mitral regurgitation.