Nav: Home

TAVR outperforms surgery in younger, low risk patients with AS

March 17, 2019

NEW ORLEANS (March 17, 2019) -- Among patients with severe, symptomatic aortic stenosis who were at low surgical risk, transcatheter aortic valve replacement (TAVR) using the SAPIEN 3 valve compared with conventional surgery significantly reduced the primary endpoint of death, stroke and re-hospitalizations by 46 percent at one year, according to data from the latest PARTNER trial presented at the American College of Cardiology's 68th Annual Scientific Session. In addition, the rates of death from any cause, stroke and repeat hospitalizations independently favored TAVR at 30 days and at one year, researchers said.

Unlike open surgery, TAVR involves threading a replacement valve through a catheter in the groin. TAVR is currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of severe aortic valve stenosis in patients at intermediate and high risk for complications associated with surgery.

PARTNER 3 is the fifth randomized trial of the PARTNER series of studies, which collectively includes over 9,000 patients with severe aortic stenosis, a problem that occurs when the valve in the heart's main artery doesn't open fully, forcing the heart to work harder to pump blood. The earliest trials evaluated TAVR in the "sickest" patients--many of whom cannot be treated with surgery--with subsequent research moving down the spectrum of risk. This study was performed in patients at low surgical risk, which comprise the majority of patients who are candidates for surgery to have their aortic valve replaced.

"This is a landmark study because it involves 80 percent of the people who are currently being treated with surgery for aortic stenosis. Our hope was that TAVR would be non-inferior or comparable to surgery, and we were surprised to find an almost 50 percent reduction in the primary endpoint, from 15.1 percent in the surgical group to 8.5 percent with TAVR," said Martin B. Leon, MD, director of the Center for Interventional Vascular Therapy at New York-Presbyterian/Columbia University Irving Medical Center, professor of medicine at Columbia University Vagelos College of Physicians and Surgeons and lead author of the study. "This is beyond anything we could have expected, mostly because surgery is so good in treating aortic stenosis in these low risk patients."

PARTNER 3 included 1,000 patients with severe aortic stenosis at 71 centers in the U.S. and several other countries with over 95 percent of patients enrolled at U.S. sites. Participants were carefully screened to be low risk for either TAVR or surgery and were randomly assigned to receive the SAPIEN 3 TAVR valve, the newest generation technology, or surgical valve replacement. Compared with the earlier PARTNER trials with intermediate- and high-risk surgical patients, this low-risk group was younger (73 years on average), had fewer co-morbid conditions and had fewer symptoms. There were also more men than women enrolled (67.5 percent vs. 32.5 percent, respectively).

The primary endpoint was the combined rate of all-cause death, any stroke and re-hospitalizations (those related to the valve, the procedure or heart failure) at one year after the procedure.

"Taken by themselves, each component of the primary endpoint also favored TAVR, which is confirmatory evidence of the outcome," Leon said.

A total of 16 patients died during follow up. Of these, 11 were in the surgery group and five were in the TAVR group, so the one-year mortality rate was 1 percent for TAVR and 2.5 percent for surgery. Twenty patients suffered a stroke, 14 of which occurred in the surgery group (3.1 percent) and six in TAVR (1.2 percent). Patients in the surgical group were also more likely to go back to the hospital compared with those in the TAVR group (11 percent and 7.3 percent, respectively).

Several secondary endpoints were also analyzed. The length of hospital stay was reduced from seven to three days with TAVR. Patients in the TAVR group also had more rapid 30-day functional recovery based on six-minute walk tests and other self-reported quality of life measures.

"Surgery eventually catches up to TAVR in terms of functional recovery and quality of life, but it takes several months," Leon said. "TAVR is a less invasive procedure, so we expect an earlier return to normal daily activities compared with surgery. There has also been an evolution of TAVR technology, increased operator experience and enhanced procedural techniques, all of which combine to lower complications after TAVR especially in the lowest risk patients."

Post-operative or new onset atrial fibrillation was found in almost 40 percent of the surgical patients compared with only 5 percent of those receiving TAVR. Major vascular complications were similar between the groups, as was the need for new permanent pacemakers (4 percent after surgery vs 6.5 percent after TAVR). However, Leon said that the incidence of new left bundle block was higher with TAVR, which may be a predictor of needing a new pacemaker in future. Moderate or severe paravalvular leaks, leaks around the valve, were similar in the two groups.

"The results of this trial in low risk patients indicates that the choice of TAVR versus surgery for severe aortic stenosis should be independent of surgical risk profile assessments," Leon said. "The combined rate of death and disabling stroke at one year was only 1 percent with TAVR, which was an unexpectedly favorable outcome. Based on these findings, the choice of TAVR versus surgery should be a shared decision-making process that respects patient preferences and considers some of the knowledge gaps, especially in treating young patients."

There are two major limitations to the PARTNER 3 trial. First, the data are limited to one-year follow-up and longer-term follow-up is needed to be certain that the transcatheter valves are as durable as surgical valves. The patients in this trial will be followed for 10 years. Second, certain patients were excluded in this study, such as patients with bicuspid aortic valve disease and those with poor anatomy such that the valve couldn't be threaded through the femoral artery in the groin.

The study was funded by Edwards Lifesciences.

This study was simultaneously published online in the New England Journal of Medicine at the time of presentation.
-end-
The ACC's Annual Scientific Session will take place March 16-18, 2019, in New Orleans, bringing together cardiologists and cardiovascular specialists from around the world to share the newest discoveries in treatment and prevention. Follow @ACCinTouch, @ACCMediaCenter and #ACC19 for the latest news from the meeting.

The American College of Cardiology envisions a world where innovation and knowledge optimize cardiovascular care and outcomes. As the professional home for the entire cardiovascular care team, the mission of the College and its more than 52,000 members is to transform cardiovascular care and to improve heart health. The ACC bestows credentials upon cardiovascular professionals who meet stringent qualifications and leads in the formation of health policy, standards and guidelines. The College also provides professional medical education, disseminates cardiovascular research through its world-renowned JACC Journals, operates national registries to measure and improve care, and offers cardiovascular accreditation to hospitals and institutions. For more, visit acc.org.

American College of Cardiology

Related Stroke Articles:

'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.
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.
More Stroke News and Stroke Current Events

Trending Science News

Current Coronavirus (COVID-19) News

Top Science Podcasts

We have hand picked the top science podcasts of 2020.
Now Playing: TED Radio Hour

Processing The Pandemic
Between the pandemic and America's reckoning with racism and police brutality, many of us are anxious, angry, and depressed. This hour, TED Fellow and writer Laurel Braitman helps us process it all.
Now Playing: Science for the People

#568 Poker Face Psychology
Anyone who's seen pop culture depictions of poker might think statistics and math is the only way to get ahead. But no, there's psychology too. Author Maria Konnikova took her Ph.D. in psychology to the poker table, and turned out to be good. So good, she went pro in poker, and learned all about her own biases on the way. We're talking about her new book "The Biggest Bluff: How I Learned to Pay Attention, Master Myself, and Win".
Now Playing: Radiolab

Invisible Allies
As scientists have been scrambling to find new and better ways to treat covid-19, they've come across some unexpected allies. Invisible and primordial, these protectors have been with us all along. And they just might help us to better weather this viral storm. To kick things off, we travel through time from a homeless shelter to a military hospital, pondering the pandemic-fighting power of the sun. And then, we dive deep into the periodic table to look at how a simple element might actually be a microbe's biggest foe. This episode was reported by Simon Adler and Molly Webster, and produced by Annie McEwen and Pat Walters. Support Radiolab today at Radiolab.org/donate.