Nav: Home

Analysis looks at role type of valve plays in patient outcomes post-TAVR

May 12, 2017

For patients who undergo transcatheter aortic valve replacement (TAVR), their risk factors, not the type of valve used, determined their 30-day post-TAVR outcomes. Results from "Impact of valve design and bivalirudin vs. unfractionated heparin for anticoagulation in transcatheter aortic valve replacement: Results from the BRAVO-3 trial" were presented today as a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 2017 Scientific Sessions in New Orleans.

TAVR is performed in intermediate or high-risk patients with significant symptomatic aortic valve stenosis, who are deemed suitable for the procedure following heart team assessment. In the past 10 years, more than 100,000 TAVR valves have been implanted with several device improvements during that time.

This pre-specified subgroup analysis from the BRAVO-3 trial included 500 patients undergoing transfemoral TAVR with balloon expandable valves (BE) and 282 patients with non-BE valves. Although selection of valve type was at operator's discretion, randomization to bivalirudin (BIV) or unfractionated heparin (UFH) was stratified by valve type.

Results demonstrated that the two-thirds of TAVR patients receiving BE valves had a different baseline profile than patients treated with non-BE valves. Non-BE valve patients were older, had a higher euroSCORE I, but had lower rates of diabetes. They also had a trend for higher prevalence of chronic obstructive lung disease, lower left ventricular ejection fraction and lower body weight. Within the BE valve patient group, 251 were treated with BIV and 249 with UFH. Among non-BE patients, 140 were treated with BIV and 142 with UFH.

Although non-BE valve patients were more likely to require a second implant during the procedure, there were no significant differences in the adjusted endpoints between the groups. "This is not a one size fits all situation," said Roxana Mehran, MD, professor of medicine and director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Weiner Cardiovascular Institute at Icahn School of Medicine at Mount Sinai. "It is not the differences in the valves, but differences in the patients. When we select the valve based on the patient's characteristics, the outcomes are positive."

Thirty day clinical outcomes for BE patients were stroke (3.0 percent), death (3.8 percent), BARC major bleeding (9.0 percent), major vascular complications (8.4 percent), MACE (6.8 percent) and NACE (14.2 percent). Those treated with non-BE valves were stroke (3.6 percent), death (7.1 percent), BARC major bleeding (10.6 percent), major vascular complications (11.0 percent), MACE (10.6 percent) and NACE (17.7 percent).

The patients with non-BE valves exhibited a trend for higher adjusted risk of major vascular complications (OR 1.78, 95 percent CI 0.97-3.26, p = 0.062), which researchers note may be a function of available device generation during the study period. There was a borderline interaction noted between valve type and anticoagulation treatment for the occurrence of major vascular complications, suggesting that bivalirudin might be associated with lower risk in patients treated with non-BE valves.
Mehran's disclosures are as follows: Grants/Research support: The Medicines Company, BMS, Astra Zeneca, Lilly/Daiichi Sankyo, Abbott Vascular, Boston Scientific, CSL Behring, Janssen (J+J), Claret Consulting fees: Advisory board for Janssen (J+J), Medscape, Osprey.

Mehran presented "Impact of valve design and bivalirudin vs. unfractionated heparin for anticoagulation in transcatheter aortic valve replacement: Results from the BRAVO-3 trial" on Friday, May 12, 2017, 11:00 a.m. CDT.

For more information about the SCAI 2017 Scientific Sessions, visit

About SCAI

The Society for Cardiovascular Angiography and Interventions is a 4,300-member professional organization representing invasive and interventional cardiologists in approximately 70 nations. SCAI's mission is to promote excellence in invasive/interventional cardiovascular medicine through physician education and representation, and advancement of quality standards to enhance patient care. SCAI's public education program, Seconds Count, offers comprehensive information about cardiovascular disease. For more information about SCAI and Seconds Count, visit or Follow @SCAI on Twitter for the latest heart health news.

Society for Cardiovascular Angiography and Interventions

Related Stroke Articles:

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.
Stroke affects more than just the physical
A new study looks at what problems affect people most after a stroke and it provides a broader picture than what some may usually expect to see.
Stroke journal features women's studies on how gender influences stroke risk, treatment and outcomes
Many aspects of strokes affect women and men differently, and four articles in the American Heart Association's journal Stroke highlight recent research and identify future research needs.
Too few with stroke of the eye are treated to reduce future stroke
Only one-third of 5,600 patients with retinal infarction, or stroke in the eye, underwent basic stroke work-up, and fewer than one in 10 were seen by a neurologist.
Juvenile stroke: Causes often not known
Strokes without a definitive identifiable cause account for up to 50 percent of juvenile strokes.
More Stroke News and Stroke Current Events

Top Science Podcasts

We have hand picked the top science podcasts of 2019.
Now Playing: TED Radio Hour

Why do we revere risk-takers, even when their actions terrify us? Why are some better at taking risks than others? This hour, TED speakers explore the alluring, dangerous, and calculated sides of risk. Guests include professional rock climber Alex Honnold, economist Mariana Mazzucato, psychology researcher Kashfia Rahman, structural engineer and bridge designer Ian Firth, and risk intelligence expert Dylan Evans.
Now Playing: Science for the People

#540 Specialize? Or Generalize?
Ever been called a "jack of all trades, master of none"? The world loves to elevate specialists, people who drill deep into a single topic. Those people are great. But there's a place for generalists too, argues David Epstein. Jacks of all trades are often more successful than specialists. And he's got science to back it up. We talk with Epstein about his latest book, "Range: Why Generalists Triumph in a Specialized World".
Now Playing: Radiolab

Dolly Parton's America: Neon Moss
Today on Radiolab, we're bringing you the fourth episode of Jad's special series, Dolly Parton's America. In this episode, Jad goes back up the mountain to visit Dolly's actual Tennessee mountain home, where she tells stories about her first trips out of the holler. Back on the mountaintop, standing under the rain by the Little Pigeon River, the trip triggers memories of Jad's first visit to his father's childhood home, and opens the gateway to dizzying stories of music and migration. Support Radiolab today at