Researchers study new heart valve that doesn't require open-heart surgery

October 9, 2013, Northwestern Memorial Hospital

Northwestern's Bluhm Cardiovascular Institute has enrolled its first participant in SALUS, a clinical trial studying the effectiveness of a prosthetic aortic heart valve that can be placed without open-heart surgery. The heart valve under study, the Direct Flow Medical Transcathether Aortic Valve System manufactured by Direct Flow Medical, Inc., is a non-metallic, investigational device specifically designed to be placed inside the heart using a catheter that is inserted through a blood vessel in the groin and then navigated into the aorta to the heart. The study valve is also designed to have the unique ability to be repositioned or even replaced with a different size after the valve's initial placement to achieve a better fit if one is needed.

SALUS is the first U.S. clinical trial of the Direct Flow Medical Transcathether Aortic Valve System, and will seek to evaluate how well the test valve can be delivered and its effectiveness once it is in use. Northwestern's enrollment is the first in Illinois and the fourth institute in the country to enroll subjects.

"Aortic stenosis is a condition that commonly affects older individuals. The leaflets of the aortic valve become thick and calcified and ultimately can limit the ability of blood from being pumped out of the heart," said James D. Flaherty, MD, Northwestern Medicine cardiologist and Northwestern's principal investigator for SALUS. "When the narrowing becomes severe, patients develop symptoms such as shortness of breath, fatigue, lightheadedness and chest pain. If uncorrected, their life expectancy is also significantly shortened."

Open-heart surgery has been the gold standard treatment for aortic stenosis since the 1960's. However, many patients are considered high-risk or inoperable for traditional heart surgery. Transcatheter Aortic Valve Replacement (TAVR) is a technique to insert a new through catheters instead of open . The only transcatheter heart valve that is commercially available in the United States requires larger catheters than the study valve, sits within a metal ring, and cannot be repositioned or replaced once it is released from the catheter.

"Aortic valve replacement is a life saving procedure for patients with severe symptomatic . TAVR, which is done without the need of a cardiopulmonary bypass machine, may also prove to be life saving in patients who are not eligible for cardiac surgery," said Flaherty, who is also an Associate Professor of Medicine in Interventional Cardiology at the Feinberg School of Medicine of Northwestern University. "This study valve is inserted through smaller catheters and its unique design allows it to be repositioned or replaced until the Heart Team is satisfied that it is in the optimal position. It is also expected that this design will prove to cut down or even eliminate any leaking, called aortic regurgitation, around the implanted valve."

Instead of using a metal stent frame, the Direct Flow Medical Transcathether Aortic Valve System's polymer support structure uses an inflatable, conformable cuff that has the ability to provide a better seal and prevent leaking. The study valve is composed of two inflatable rings at each end that are connected by multiple inflatable bars, all of which are covered with a polyester fabric sleeve and surround the heart valve itself. During a procedure, the study valve's inflatable rings and connecting bars are filled with a liquid plastic polymer that hardens to a solid after it has been fitted to further help prevent leakage around the valve.

Explore further: Approval expanded for sapien artificial heart valve

Related Stories

Approval expanded for sapien artificial heart valve

October 22, 2012
(HealthDay)—U.S. Food and Drug Administration approval for the Sapien Transcatheter Heart Valve has been expanded to include additional people with aortic valve stenosis, the medical term for a narrowing of the aortic valve ...

UofL physicians, Jewish Hospital first in Kentucky to offer new aortic valve replacement

January 3, 2012
Some individuals with severe aortic stenosis – also known as narrowing of the aortic valve in the heart – who are not well enough to undergo open heart surgery have a new treatment option thanks to a new procedure ...

MDCT helps better determine valve implant size for transcatheter aortic valve in patients with aortic stenosis

April 13, 2013
MDCT is a better way to measure annular size in patients with aortic stenosis who are candidates for transcatheter aortic valve implantation (TAVI) than two dimensional echocardiography, a new study indicates.

Family history doubles aortic stenosis risk

September 1, 2013
The risk of aortic stenosis doubles when a first degree relative had the disease, according to research presented at ESC Congress 2013 today by Dr. Mattis F. Ranthe from Denmark. The study of 4.2 million people from Danish ...

TAVI is safe alternative to redo cardiac surgery

September 2, 2013
TAVI is a safe alternative to redo cardiac surgery for failing bioprosthetic valves, according to research presented at the ESC Congress today by Dr. Spyridon Katsanos from the Netherlands. The findings suggest that transcatheter ...

UCLA uses new device to replace aortic valve in patients who can't have open-heart surgery

August 16, 2012
(Medical Xpress) -- UCLA has performed its first transcatheter aortic valve replacement (TAVR), using a new device approved by the U.S. Food and Drug Administration to replace an aortic valve in a patient who ...

Recommended for you

Heart researchers develop a new, promising imaging technique for cardiac arrhythmias

February 22, 2018
Every five minutes in Germany alone, a person dies of sudden cardiac arrest or fibrillation, the most common cause of death worldwide. This is partly due to the fact that doctors still do not fully understand exactly what ...

Scientists use color-coded tags to discover how heart cells develop

February 22, 2018
UCLA researchers used fluorescent colored proteins to trace how cardiomyocytes—cells in heart muscle that enable it to pump blood—are produced in mouse embryos. The findings could eventually lead to methods for regenerating ...

Beetroot juice supplements may help certain heart failure patients

February 22, 2018
Beetroot juice supplements may help enhance exercise capacity in patients with heart failure, according to a new proof-of-concept study. Exercise capacity is a key factor linked to these patients' quality of life and even ...

'Beetroot pill' could help save patients from kidney failure after heart X-ray

February 22, 2018
Beetroot may reduce the risk of kidney failure in patients having a heart x-ray, according to research led by Queen Mary University of London.

Women once considered low risk for heart disease show evidence of previous heart attack scars

February 20, 2018
Women who complain about chest pain often are reassured by their doctors that there is no reason to worry because their angiograms show that the women don't have blockages in the major heart arteries, a primary cause of heart ...

Can your cardiac device be hacked?

February 20, 2018
Medical devices, including cardiovascular implantable electronic devices could be at risk for hacking. In a paper publishing online today in the Journal of the American College of Cardiology, the American College of Cardiology's ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.