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.

American Heart Association awards $10.6M to researchers investigating the long-term cardiovascular effects of COVID-19

The grants went to 11 different research teams in the United States and are expected to fund these projects for three years.

A view showing the close relationship between the mitral and aortic valves and how the overhang of a longer TAVR valve can interfere with the left ventricular outflow tract (LVOT). Image from a mitral echo assessment using Siemens eSie Valves software at ACC22.

The latest data on mitral valve infective endocarditis after TAVR

Self-expanding heart valves and the presence of significant PVL were both linked to a heightened risk of mitral valve infective endocarditis after TAVR.

Virtual reality specialists launch new training solutions for endovascular surgery

The virtual reality training sessions were designed to feature "the same sights, sound and sensations a surgeon would encounter during real procedures."

coronavirus COVID-19 vaccine vaccination

FDG PET/CT radiomics distinguishes between vaccine-related or metastatic breast cancer lymphadenopathy

The findings could help clinicians manage patients’ treatment when the origin of axillary lymphadenopathy is of concern, experts suggested.

FDA announces new insulin recall due to potential labeling issue

The recall is focused on a single batch distributed from December 2021 to March 2022.

Links to the ACC.22 late-breaking clinical trials

Learn more about the late-breaking studies presented at ACC.22 in Washington, D.C.

Drug-coated balloons comparable to drug-eluting stents when PCI patients have a high bleeding risk

Drug-coated balloons were associated with a lower risk of bleeding after PCI than drug-eluting stents, the study's authors reported.

VIDEO: TAVR durability outperforms surgical valves

Michael J. Reardon, MD, professor of cardiothoracic surgery and Allison Family Distinguished chair of cardiovascular research at Houston Methodist DeBakey Heart and Vascular Center, presented pooled data at ACC.22 from the CoreValve SURTAVI trials that found transcatheter aortic valve replacement (TAVR) was more durable than surgical aortic valve replacement (SAVR) devices.

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