Heart Rhythm

Hearts should have normal rhythm to their beats, but when these beats are out of synch, it causes inefficient pumping of blood. Irregular heart arrhythmias occur when the electrical signals that coordinate the heart's beats do not work properly. This can cause beats that are too fast (tachycardia), or too slow (bradycardia). Tachycardias include atrial fibrillation (AFib), supraventricular tachycardia, ventricular fibrillation, and ventricular tachycardia (VT). Bradycardias include sick sinus syndrome and conduction block. Electrophysiology arrhythmia treatments include medications, life style changes, and the EP lab interventions of catheter ablation, and implantable pacemakers or defibrillators.

The U.S. Food and Drug Administration (FDA) has announced that Defibtech, a Nihon Kohden company, is recalling its RMU-2000 ARM XR Chest Compression Device due to significant safety concerns. This is a Class I recall, which means the FDA believes using the device “may cause serious injury or death.”

Automated chest compression device recalled after patient death

Regulators emphasized that these devices should not be used due to significant safety risks. 

Left atrial appendage occlusion (LAAO) with the Watchman FLX device from Boston Scientific is associated with positive outcomes and limited adverse events after one year, according to new findings published in Circulation: Cardiovascular Interventions.[1] Many prior Watchman FLX studies, including PINNACLE FLX, had focused on the device’s performance in a controlled setting. The study’s authors hoped to gain a better understanding of its real-world impact by reviewing registry data from more than 97,000 U.S

LAAO with Watchman FLX associated with positive 1-year outcomes, real-world data confirm

Researchers hoped to gain a better understanding of the device's real-world impact by reviewing registry data from more than 97,000 U.S. patients. Overall, the Watchman FLX was linked to positive data and limited adverse events one year after treatment. 

Huxley Medical, an Atlanta-based medical device company, has secured U.S. Food and Drug Administration (FDA) clearance for its new Sansa device, a chest-worn patch designed to help diagnose sleep apnea in addition to tracking patient data with electrocardiograms (ECGs) a variety of sensors.

FDA clears chest-worn patch for simultaneous ECG, sleep apnea monitoring

The new device from Huxley Medical offers care teams a way to monitor patients for signs of sleep apnea while also keeping a close eye on their heart health. 

Treating mitral regurgitation with transcatheter mitral edge-to-edge repair (TEER) using the MitraClip device is associated with a low risk of cerebrovascular accidents (CVAs) such as stroke and transient ischemic attack (TIA), according to new data published in The American Journal of Cardiology.[1]

TEER with Abbott’s MitraClip linked to low stroke risk, new study confirms

Treating severe MR with the popular device does not appear to increase a patient's risk of stroke or transient ischemic attack. When patients present with AFib, however, care teams may want to make certain adjustments to optimize outcomes. 

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Stroke after TAVR in AFib patients: Key risk factors cardiologists should know

Reviewing a patient's medical history can help care teams select the optimal post-TAVR oral anticoagulation strategy.

Anne Kroman, DO, PhD, director of lead management and the device clinic, and assistant professor at Medical University of South Carolina (MUSC), explains more women need to be included in clinical trials to help better understand sex differences in electrophysiology presentations.

Why electrophysiology trials need to include more women

Most EP clinical study data are from men, Anne Kroman, DO, explained in an interview. This is a significant problem, she said, because heart rhythm issues look quite different in women. 

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Pharmacists help lower stroke risk in patients with undiagnosed, undertreated AFib

Researchers described pharmacies as an “attractive setting for community-based AFib screening."

FibriCheck, a Belgium-based healthcare technology company, has gained U.S. Food and Drug Administration (FDA) for its artificial intelligence-powered digital platform that uses smartphone cameras to obtain heart rhythm measurements.

FDA clears heart rhythm AI that turns smartphones into medical devices

FibriCheck has been increasing its presence in the United States in anticipation of this approval, opening a new office and partnering with U.S. hospitals. 

Around the web

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

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