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.

Blood filtration company fined $5.7M, executive charged, for covering up patient deaths
The U.S. Department of Justice said ExThera cooperated with the investigation into a failure to file adverse event notices with the Food and Drug Administration after two cancer patients who used its blood filtration systems in Antigua died shortly after returning home. The California-based company’s former chief regulatory officer has agreed to plead guilty and could serve prison time.
Tenaya Therapeutics could earn up to $1.1B for new heart disease research
Tenaya Therapeutics and Alnylam Pharmaceuticals have agreed to collaborate on identifying potential new gene therapies for the treatment of cardiovascular disease. Tenaya will receive an upfront payment of $10 million, but stands to earn much more.
Cardiology now has more than 200 FDA-cleared AI algorithms
Cardiology is No. 2 behind radiology when it comes to FDA-cleared AI algorithms. Neurology, meanwhile, is a distant No. 3.
FDA shares details about reprocessed catheter recall
Back in February, the FDA expanded a recall of several reprocessed EP and ultrasound catheters due to a risk of contamination. The agency is now sharing additional information with the public.
High-sensitivity troponin protocol most successful at freestanding EDs
Freestanding EDs demonstrated meaningful operational advantages over hospitals when using an accelerated troponin pathway. This included earlier discharges for low-risk chest pain patients.

Comic illustrations enhance informed consent before coronary angiography

A new pilot study out of Germany suggests a comic-style graphic supplement can improve the informed consent process before coronary angiography by putting patients at ease and helping them understand the procedure.

Socioeconomic factors may impact the chances of getting an LVAD

A study of nearly 900,000 patients with heart failure or cardiogenic shock revealed their race, insurance coverage and ZIP code were associated with their odds of receiving a left ventricular assist device (LVAD).

Medtronic, Blue Cross ink outcomes-based agreement for glucose monitor

Medtronic has struck a value-based agreement with Blue Cross and Blue Shield of Minnesota in which the medical device company will pay back the insurer if patients using the Guardian Connect continuous glucose monitoring (CGM) system fail to keep their blood sugar levels within a specified range.

Real-world Watchman results hold up at 2 years

Left atrial appendage (LAA) closure with the Watchman device was associated with low rates of stroke and bleeding events in high-risk atrial fibrillation patients over a two-year follow-up period, according to a real-world analysis published April 3 in Circulation: Electrophysiology and Arrhythmia.

Genetic variants may guard against heart disease

Rare protein-truncating variants in the apolipoprotein B (APOB) gene are linked to lower triglycerides and LDL cholesterol levels and also appear to be protective against coronary heart disease (CHD), according to a study published in Circulation: Genomic and Precision Medicine.

Registry analysis finds link between TAVR volume, mortality

With CMS just months away from an updated national coverage determination for transcatheter aortic valve replacement (TAVR), a new analysis in the New England Journal of Medicine suggests the relationship between procedural volume and TAVR outcomes remains important in the United States.

FDA approves therapy to reduce infarct size in LAD STEMI after PCI

Once the artery has been opened with PCI, the treatment involves mixing a patient’s own blood with oxygenated saline and then infusing that superoxygenated mixture to the targeted ischemic area for 60 minutes.

Colorado 2nd state to require surgical smoke evacuation systems

Colorado became the second state to pass legislation requiring surgical smoke evacuation systems at hospitals and ambulatory surgical centers on March 28, when Gov. Jared Polis signed the bill into law. Rhode Island passed a similar law in June 2018.

Clinical

Blood filtration company fined $5.7M, executive charged, for covering up patient deaths

Tenaya Therapeutics could earn up to $1.1B for new heart disease research

Cardiology now has more than 200 FDA-cleared AI algorithms

FDA shares details about reprocessed catheter recall

High-sensitivity troponin protocol most successful at freestanding EDs