Yale leads test of new device that protects the brain during heart-valve procedure

March 15, 2015

New Haven, Conn. -- In the first multicenter trial of its kind, Yale researchers tested a new device that lowers the risk of stroke and cognitive decline in patients undergoing heart-valve replacement.

The preliminary findings of the DEFLECT III trial were presented by Alexandra Lansky, M.D., associate professor of medicine (cardiology) at Yale School of Medicine, on March 15 at the American College of Cardiology's 64th Annual Scientific Session in San Diego, CA.

Stroke is a devastating complication of transcatheter aortic valve replacement (TAVR), a minimally invasive procedure to repair a damaged heart valve without surgery. Up to 7% of TAVR patients suffer strokes due to the release of emboli, or particulate material such as a plaque, that travel in the blood from the heart to the brain during the valve procedure.

Led by co-principal investigators Lansky and Andreas Baumbach, M.D. of Bristol Heart Institute, the research team conducted a preliminary trial of the TriGuard, a device that is placed in the aortic arch during TAVR. The device has a mesh filter that covers the three major cerebral blood vessels, preventing the release of emboli from the aorta to the brain.

Conducted in centers in Europe and Israel, the exploratory trial enrolled 83 subjects and randomized them for TAVR with and without TriGuard protection. In patients with protection, the researchers observed fewer ischemic brain lesions and lesions of reduced volume.

"One of the major findings is, for the first time, we're showing that with protection, 55% more patients have completely clean brains -- with no ischemic brain lesions at all," said Lansky. Brain lesions increase risk of dementia and stroke two- to three-fold.

"What's more exciting are the neurocognitive findings," noted Lansky. The researchers used the Montreal Cognitive Assessment (MoCA) to evaluate the impact of TriGuard on cognitive factors such as language, memory, attention, recall, and orientation. "Whether we're looking at MoCA or looking at short-term memory or delayed memory, we're seeing an improvement in cognitive function as early as hospital discharge among protected patients, compared to controls," she explained.

These preliminary findings provide the basis to design a conclusive randomized clinical trial. "DEFLECT III is helping us design the next study, which will be definitive," Lansky noted.
-end-
Other authors include Joachim Schofer, Szilard Voros, Adam Brickman, Thomas Cuisset, Didier Tchetche, Pieter Stella, Daniel Blackman, Michael Cleman, John Forrest, Joseph Brennan, Abeel Mangi, Gil Bolotin, Jochen Reinöhl, Stefan Spitzer, Martine Gilard, David Hildick-Smith, Michael Haude, and Andreas Baumbach

The study was supported by Keystone Medical, Inc.

Yale University

Related Stroke Articles from Brightsurf:

Stroke alarm clock may streamline and accelerate time-sensitive acute stroke care
An interactive, digital alarm clock may speed emergency stroke care, starting at hospital arrival and through each step of the time-sensitive treatment process.

Stroke patients with COVID-19 have increased inflammation, stroke severity and death
Stroke patients who also have COVID-19 showed increased systemic inflammation, a more serious stroke severity and a much higher rate of death, compared to stroke patients who did not have COVID-19, according a retrospective, observational, cross-sectional study of 60 ischemic stroke patients admitted to UAB Hospital between late March and early May 2020.

'Time is vision' after a stroke
University of Rochester researchers studied stroke patients who experienced vision loss and found that the patients retained some visual abilities immediately after the stroke but these abilities diminished gradually and eventually disappeared permanently after approximately six months.

More stroke awareness, better eating habits may help reduce stroke risk for young adult African-Americans
Young African-Americans are experiencing higher rates of stroke because of health conditions such as high blood pressure, diabetes and obesity, yet their perception of their stroke risk is low.

How to help patients recover after a stroke
The existing approach to brain stimulation for rehabilitation after a stroke does not take into account the diversity of lesions and the individual characteristics of patients' brains.

Kids with headache after stroke might be at risk for another stroke
A new study has found a high incidence of headaches in pediatric stroke survivors and identified a possible association between post-stroke headache and stroke recurrence.

High stroke impact in low- and middle-income countries examined at 11th World Stroke Congress
Less wealthy countries struggle to meet greater need with far fewer resources.

Marijuana use might lead to higher risk of stroke, World Stroke Congress to be told
A five-year study of hospital statistics from the United States shows that the incidence of stroke has risen steadily among marijuana users even though the overall rate of stroke remained constant over the same period.

We need to talk about sexuality after stroke
Stroke survivors and their partners are not adequately supported to deal with changes to their relationships, self-identity, gender roles and intimacy following stroke, according to new research from the University of Sydney.

Standardized stroke protocol can ensure ELVO stroke patients are treated within 60 minutes
A new study shows that developing a standardized stroke protocol of having neurointerventional teams meet suspected emergent large vessel occlusion (ELVO) stroke patients upon their arrival at the hospital achieves a median door-to-recanalization time of less than 60 minutes.

Read More: Stroke News and Stroke Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.