Clinical

This channel newsfeed includes clinical content on treating patients or the clinical implications in a variety of cardiac subspecialties and disease states. The channel includes news on cardiac surgery, interventional cardiology, heart failure, electrophysiology, hypertension, structural heart disease, use of pharmaceuticals, and COVID-19.

Medtronic recalls data management software, urging healthcare providers to run update
The error caused incorrect glucose data to be displayed to clinicians. According to Medtronic, any treatment decisions or recommendations based on those data need to be revisited.
Catheters recalled due to defect—FDA highlights risk of stroke or brain damage
The recall was put in place after a hydrophilic coating was discovered on the inside of the devices. According to the FDA, patients treated with the catheters could face a number of significant risks.
Abbott shares safety concerns with millions of CGM sensors—7 deaths reported
Approximately 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors need to be replaced due to a risk of incorrect glucose readings. Abbott has received reports of 736 severe adverse events and seven deaths that may be related to this issue.
Cardiology groups share new recommendations for performing safe, effective cardiac ablations in ASCs
The timing of this new guidance from the Heart Rhythm Society and American College of Cardiology could not have been better—the document went live just as CMS finalized its decision to cover cardiac ablation procedures performed in ASCs.
Adjustable interatrial shunt for heart failure shows promise in first-in-human trial
Gregg Stone, MD, spoke to Cardiovascular Business about early data from the ATHENS-HF trial. Ten heart failure patients were treated with the adjustable device, and each implant was a success.

How to encourage shared decision-making when treating aortic stenosis

Diagnosing, treating and managing aortic stenosis is often a challenging task, especially when the patient has a long life expectancy. Shared decision-making can make a significant impact, helping ensure the patient's values and preferences are taken into consideration.

The ReCor (left) and Medtronic Symplicity Spyral renal denervation systems.

FDA panel to review renal denervation system PMA submissions

The FDA Circulatory System Devices Panel is set to review the PMA submissions for the ReCor and Medtronic renal denervation systems to treat patients with uncontrolled hypertension.

artificial intelligence robot evaluates healthcare data

FDA grants breakthrough designation for new AI model to detect cardiac amyloidosis in ECG results

Anumana, Pfizer and Mayo Clinic all worked together to develop the advanced algorithm. The groups are now targeting full regulatory approval in the U.S., Europe and Japan.

Top 20 children’s hospitals for cardiology and heart surgery

Did your facility make the cut? For its 2023-2024 list, U.S. News and World Report evaluated data from 119 hospitals and surveyed thousands of pediatric specialists.

The Surdonics SurVeil drug-coated balloon to treat peripheral artery disease.

FDA approves next-gen DCB, earning the manufacturer a $27M payment from Abbott

The new-look DCB was designed to provide care with a significantly lower drug load than similar devices.

The U.S. Food and Drug Administration (FDA) priority review, the FDA has cleared the Agepha Pharma USA LLC's drug Lodoco (colchicine) as the first anti-inflammatory atheroprotective cardiovascular treatment.

FDA approves colchicine, the first anti-inflammatory drug for treating cardiovascular disease

The FDA's approval of colchicine, which is marketed and sold under the name Lodoco, is expected to have a big impact on cardiac care and outcomes.

A figure from the study shows a chest radiograph with an area of consolidation involving right lower lung consistent with pneumonia, as well as right pleural effusion. The deep-learning model predicted risk of 30-day mortality of 9%. Right: Gradient- weighted class activation map shows that model prediction was influenced by separate area of image corresponding with heart and liver (yellow and light blue colors). Patient’s CURB-65 score was 4. Patient recovered from pneumonia and remained alive. AJR Image

Deep learning predicts pneumonia mortality on chest X-rays

AI was able to predict 30-day mortality risk predictions more accurately that the current risk assessment.

A TAVR procedure being performed at Northwestern Medicine in Chicago. These structural heart procedures require a team approach.

Heart damage after TAVR: Follow-up imaging helps cardiologists anticipate problems

While cardiac damage reverses in many patients following treatment, it can actually continue to get worse in others.

Clinical

Medtronic recalls data management software, urging healthcare providers to run update

Catheters recalled due to defect—FDA highlights risk of stroke or brain damage

Abbott shares safety concerns with millions of CGM sensors—7 deaths reported

Cardiology groups share new recommendations for performing safe, effective cardiac ablations in ASCs

Adjustable interatrial shunt for heart failure shows promise in first-in-human trial