Nav: Home

TAVR as good as surgery for patients at low surgical risk

March 18, 2019

NEW ORLEANS (March 17, 2019) -- A new trial comparing self-expanding transcatheter aortic valve replacement (TAVR) to standard open-heart surgery for valve replacement--this time in patients with severe aortic stenosis who are considered low surgical risk--found no difference in the combined rate of disabling stroke or death from any cause at two years. The findings were presented at the American College of Cardiology's 68th Annual Scientific Session. These events occurred in 5.3 percent of TAVR patients and 6.7 percent of patients undergoing traditional surgery.

TAVR, which involves threading a replacement valve through a catheter in the groin or chest, is at least as safe and effective as surgery in these patients; these results echo what was found in an earlier trial of intermediate risk patients, researchers said.

"We now have a minimally invasive procedure that is as good as or better than surgery, while at the same time allowing most patients to be out of the hospital within a few days and be back to their normal activities within a week, and that's pretty important," said Michael J. Reardon, MD, professor and Allison Family Distinguished Chair of Cardiovascular Research at Houston Methodist Hospital and the study's senior author.

Aortic stenosis--a problem that occurs when the valve in the heart's main artery doesn't open fully--forces the heart to work harder to pump blood and can be life-threatening. TAVR, which is 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 death and complications associated with surgery, appears to be a reasonable option in low-risk patients too.

This randomized, prospective study included 1,468 patients with severe, symptomatic aortic stenosis from 86 centers in Australia, Canada, France, Japan, the Netherlands, New Zealand and the United States who were deemed to be at low risk of surgery. Low risk was defined as a predicted 30-day mortality of 3 percent or less for 30 days post-surgery and was based on a combination of clinical judgment from the local heart team and an independent screening committee.

A total of 725 patients received TAVR with one of three types of self-expanding devices and 678 patients underwent surgical aortic valve replacement (SAVR) with bioprosthetic surgical valves. The TAVR arm of the trial started with first- and second-generation valves (3.6 percent received CoreValve and 74.1 percent Evolut R); the new third generation Evolut Pro valve was introduced late in the trial and was implanted in 22.3 percent of patients enrolled.

Both groups were well-matched in terms of baseline characteristics such as hypertension, coronary disease and lung disease. Unlike earlier intermediate- and high-risk trials that included a 50-50 split of men and women, this trial was two-thirds men and one-third women. Reardon said this might be because women tend to be smaller, require smaller surgical valves at surgery and are deemed at higher surgical risk.

At 30 days, TAVR was statistically superior to SAVR in terms of the combined rate of all-cause mortality or disabling stroke (0.8 vs. 2.6 percent). Taken by itself, death at one month was not statistically different between the groups, but there were fewer for TAVR; deaths occurred in 1.3 percent of surgical patients and 0.5 percent of TAVR patients, which Reardon said is clinically meaningful. TAVR patients also had significantly better quality of life and hemodynamics (a measure of how well the aortic stenosis is relieved) at 30 days, which are important factors, especially in younger, more active patients.

"TAVR beat surgery at 30 days for mortality or disabling stroke, quality of life and time in the hospital. In other words, you're more likely to be alive without a disabling stroke, get out of the hospital sooner--in half the time--and have a better quality of life one month after getting a new valve," Reardon said, adding that hospital stays were twice as long for patients undergoing surgery than they were for TAVR, 6.2 days vs 2.6 days on average. "The mean age of patients in this study was 74, so while this is still not a young group of patients, many of them are very active and whether it be in their professional or social lives, getting back to full range of daily activities is very important to them."

By 12 months, TAVR was still superior to open heart surgery for major stroke, occurring in 0.8 percent of TAVR patients and 2.4 percent of surgical patients. TAVR had lower rates of all-cause mortality (2.4 vs 3 percent), but it was not statistically significant. Hospitalization for heart failure occurred in 3.2 percent of TAVR patients and 6.5 percent of surgical patients at one year.

"At one year, patients with TAVR were more likely than surgery patients to be alive, without a disabling stroke and without a hospital admission for heart failure," Reardon said.

Quality of life assessments were done using the Kansas City Cardiomyopathy Questionnaire (KCCQ), allowing patients to report their functional ability and wellness. This was performed at baseline, one and six months, and yearly thereafter. For the KCCQ, a five-point increase is considered a small improvement in quality of life, 10 points is moderate, and 20 points is large. Patients receiving TAVR reported significantly better quality of life, 20 vs. 9.1 at one month post-procedure. By one year, both TAVR and surgery had similar improvements in quality of life, 22.2 and 20.9, respectively.

Based on an analysis of echocardiograms, Reardon said there was some indication that the TAVR valve worked better; TAVR had a better orifice--how big the opening of the valve is--(2.2 cm2 vs 2.0 cm2) and lower mean gradients than surgery at all time points in the trial. Similar to earlier studies, TAVR has more pacemakers and more moderate to severe paravalvular leak (leakage around the valve). The TAVR group also had major vascular injury, including dissection, cardiac perforation or access site injury. There were more cases of atrial fibrillation, transfusions and acute kidney injury in the surgery arm.

"We've now looked at a broad risk spectrum of patients--those at high, intermediate and low surgical risk--and these series of trials have shown that TAVR is better than or as good as surgery in terms of disabling strokes and deaths from all causes. When we look at secondary outcomes of quality of life and functional recovery, these seem to favor TAVR at this point," Reardon said. "Given this data, it now seems reasonable to consider moving TAVR in low risk patients to a class I guideline indication on par with surgery for patients with severe aortic stenosis."

Reardon said this and PARTNER 3 are probably the final trials that will randomize TAVR against surgery given the positive outcomes and patient preference for less invasive therapy. His team plans to follow patients for 10 years, which should yield important long-term data about TAVR compared with surgically implanted valves, as well as the valves themselves. They will also do a cost-effectiveness analysis.

A key study limitation is the relatively short follow up time. Because patients with bicuspid aortic valves and those with anatomic incompatibility for TAVR valves were excluded, as were patients needing other major cardiac surgical procedures such as mitral valve repair, researchers cannot say how these patients might fare.
The study received funding from Medtronic.

This study was simultaneously published online in the New England Journal of Medicine at the time of presentation.

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

American College of Cardiology

Related Heart Failure Articles:

New hope for treating heart failure
Heart failure patients who are getting by on existing drug therapies can look forward to a far more effective medicine in the next five years or so, thanks to University of Alberta researchers.
Activated T-cells drive post-heart attack heart failure
Chronic inflammation after a heart attack can promote heart failure and death.
ICU care for COPD, heart failure and heart attack may not be better
Does a stay in the intensive care unit give patients a better chance of surviving a chronic obstructive pulmonary disease (COPD) or heart failure flare-up or even a heart attack, compared with care in another type of hospital unit?
Tissue engineering advance reduces heart failure in model of heart attack
Researchers have grown heart tissue by seeding a mix of human cells onto a 1-micron-resolution scaffold made with a 3-D printer.
Smoking may lead to heart failure by thickening the heart wall
Smokers without obvious signs of heart disease were more likely than nonsmokers and former smokers to have thickened heart walls and reduced heart pumping ability.
After the heart attack: Injectable gels could prevent future heart failure (video)
During a heart attack, clots or narrowed arteries block blood flow, harming or killing cells in the heart.
Heart failure after first heart attack may increase cancer risk
People who develop heart failure after their first heart attack have a greater risk of developing cancer when compared to first-time heart attack survivors without heart failure, according to a study today in the Journal of the American College of Cardiology.
Scientists use 'virtual heart' to model heart failure
A team of researchers have created a detailed computational model of the electrophysiology of congestive heart failure, a leading cause of death.
Increase in biomarker linked with increased risk of heart disease, heart failure, death
In a study published online by JAMA Cardiology, Elizabeth Selvin, Ph.D., M.P.H., of the Johns Hopkins Bloomberg School of Public Health, Baltimore, and colleagues examined the association of six-year change in high-sensitivity cardiac troponin T with incident coronary heart disease, heart failure and all-cause mortality.
1 in 4 patients develop heart failure within 4 years of first heart attack
One in four patients develop heart failure within four years of a first heart attack, according to a study in nearly 25,000 patients presented today at Heart Failure 2016 and the 3rd World Congress on Acute Heart Failure by Dr.

Related Heart Failure Reading:

Best Science Podcasts 2019

We have hand picked the best science podcasts for 2019. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Do animals grieve? Do they have language or consciousness? For a long time, scientists resisted the urge to look for human qualities in animals. This hour, TED speakers explore how that is changing. Guests include biological anthropologist Barbara King, dolphin researcher Denise Herzing, primatologist Frans de Waal, and ecologist Carl Safina.
Now Playing: Science for the People

#SB2 2019 Science Birthday Minisode: Mary Golda Ross
Our second annual Science Birthday is here, and this year we celebrate the wonderful Mary Golda Ross, born 9 August 1908. She died in 2008 at age 99, but left a lasting mark on the science of rocketry and space exploration as an early woman in engineering, and one of the first Native Americans in engineering. Join Rachelle and Bethany for this very special birthday minisode celebrating Mary and her achievements. Thanks to our Patreons who make this show possible! Read more about Mary G. Ross: Interview with Mary Ross on Lash Publications International, by Laurel Sheppard Meet Mary Golda...