Clinical Research

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. 

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.

A structural heart Presentation during the TVT 2022 conference. #TCT #TCT22 #TCT2022

TCT 2022 late-breaking clinical presentations announced

The Cardiovascular Research Foundation (CRF) announced the 32 late-breaking studies being presented at the Transcatheter Cardiovascular Therapeutics 2022 annual meeting at in Boston, Sept. 16-19.

Thermedical SERF thermal ablation system for VT.

FDA approves trial for new type of thermal-ablation system to treat ventricular arrhythmias

The FDA has approved a clinical trial to evaluate the safety and efficacy of a new type of ablation catheter for patients with ventricular tachycardia (VT) resistant to conventional anti-arrhythmic drugs or standard ablation procedures.

Christine Albert, MD, MPH, cardiology chair for the Smidt Heart Institute at Cedars-Sinai Medical Center

Rethinking arrhythmias: Women may face a higher AFib risk than men

New research, published in JAMA Cardiology, challenges the common belief that AFib is more likely to develop among men than women. The key problem, it seems, is that prior research teams did not understand the significance of certain risk factors.

Balloon expansion deployment of an Edwards Lifesciences Sapien 3 transcatheter aortic valve replacement (TAVR) device.

VIDEO: TAVR for asymptomatic patients with severe calcific aortic stenosis

Philippe Genereux, MD, medical director of the Structural Heart Disease Program at Morristown Medical Center, discusses the use of transcatheter aortic valve replacement (TAVR) procedures in patients with severe, calcific aortic stenosis who are asymptomatic. 

Around the web

Tom Price, MD, former secretary of Health and Human Services (HHS), said one way to address the growing shortage of physicians is to expand medical resident positions, but these are tied to Medicare spending so alternative means may be needed.

"Domestic radiopharmaceutical suppliers, who receive isotopes from abroad, would be impacted by price changes and uncertainty caused by additional tariffs,” SNMMI President Cathy Cutler, PhD, wrote in a letter to the U.S. Department of Commerce this week.