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 cardiologyheart failure, electrophysiologyhypertension, structural heart disease, use of pharmaceuticals, and COVID-19.   

Medtronic launches Evolut FX TAVR system aortic stenosis

Medtronic launches Evolut FX TAVR system for severe aortic stenosis

This is the fourth device in Medtronic's Evolut TAVR platform. The self-expanding valve gained FDA approval in 2021 for the treatment of high- and low-risk patients presenting with symptomatic severe aortic stenosis.

The U.S. Food and Drug Administration (FDA) has granted the first pediatric indication for use for an implantable cardiac monitor to Medtronic. The Linq II Insertable Cardiac Monitor (ICM) system is the first such device receive 510(k) clearance for use in pediatric patients over the age of 2 who have heart rhythm abnormalities and require long-term, continuous monitoring.

FDA grants new pediatric indication for Medtronic Linq II implantable cardiac monitor 

The FDA granted the first pediatric indication for an implantable cardiac monitor. The Linq II can be used in pediatric patients over the age of 2 for up to 4.5 years of long-term, continuous monitoring. 

The Pascal transcatheter mitral valve repair system. Similar to the latest version of the MitraClip, the Pascal can operate each leaflet independently to grasp the mitral valve leaflets. Results of the CLASP IID trial at #TCT2022.

Pascal transcatheter mitral repair device performs as well as MitraClip in late-breaking CLASP IID Trial 

Comparison between transcatheter edge-to-edge repair (TEER) devices found Pascal was non-inferior compared with MitraClip in the CLASP IID pivotal trial.

Use of ultrasound to guide needles used for femoral vascular access for cath lab procedures can help reduce bleeding and vascular complications. But the Universal Trial at TCT 2022 showed no difference. Image courtesy of Sonosite

Ultrasound guidance for femoral access did not reduce bleeding or vascular complications in TCT late-breaker

The UNIVERSAL Trial, one of the largest multicenter randomized trials comparing ultrasound with fluoroscopic guidance vs. fluoroscopic guidance alone, found there was no reduction in major vascular access complications. 

Positive data was presented on the first-generation Symplicity (left) long-term outcomes and from the Recor ultrasound renal denervation system pivotal trial at TCT 2022. #TCT #TCT2022

Renal denervation lowered blood pressure in two late-breaking TCT trials 

Results from the Medtronic SYMPLICITY HTN-3 trial long-term results and the pivotal RADIANCE II trial for the Recor ultrasound renal denervation system lowered blood pressure effectively in drug-resistant patients.

Sentinel Boston Scientific PROTECTED TAVR stroke disabling stroke

TAVR embolic protection devices fail to reduce stroke risk, but some cardiologists—and a leading vendor—remain encouraged

The PROTECTED TAVR results presented at TCT 2022 resulted in a mix of reactions. For some cardiologists, the slight reduction in the risk of a disabling stroke after TAVR is a positive result. For others, it was simply not enough. 

TCT 2022 Robert Califf FDA Commissioner

FDA Commissioner Robert Califf delivers fiery speech on innovation, healthcare disparities and misinformation at TCT 2022

“The United States is essentially inventing the technology and then the rest of the world is figuring out how to use it better,” he said.

he U.S. Food and Drug Administration (FDA) granted market clearance ion September 2022 for the Edwards Lifesciences Corp. Pascal Precision transcatheter valve repair system for transcatheter edge-to-edge repair (TEER). It is indicated for the treatment of patients with degenerative mitral regurgitation (DMR).

FDA clears Edwards Pascal device for transcatheter mitral valve repair

This is the second FDA-cleared transcatheter repair device for the mitral valve. Data from pivotal trial comparing Pascal vs. MitraClip will be presented at TCT 2022.

Around the web

Several key trends were evident at the Radiological Society of North America 2024 meeting, including new CT and MR technology and evolving adoption of artificial intelligence.

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