Get SMART: Cardiologist says new TAVR data changed his perspective on treating women with symptomatic severe AS
Physicians and researchers complete thousands of clinical trials each year, but some findings prove far more significant than others. For cardiologist Dharmesh Patel, MD, the results of the SMART (SMall Annuli Randomized To EvolutTM or SAPIENTM*) trial have changed the way he’s managing and recommending treatment for women with symptomatic severe aortic stenosis. “This is going to change a lot of things we do in our clinics every day,” says Patel, a cardiologist with Stern Cardiovascular Foundation in Memphis, Tennessee.
The SMART trial, is an in-depth analysis of transcatheter aortic valve replacement (TAVR) patients who presented with severe aortic stenosis (AS) and a small aortic annulus.[1]
SMART included one-year data from 737 TAVR patients with small annuli randomized to receive either a self-expanding Evolut valve from Medtronic or a balloon-expandable SAPIEN 3 valve from Edwards Lifesciences.
Lead researcher Howard C. Herrmann, MD, and colleagues presented the SMART data at ACC.24 in Atlanta. Overall, Medtronic’s self-expanding valves were associated with comparable safety and clinical outcomes and superior valve performance in bioprosthetic valve dysfunction (BVD) versus SAPIEN at one year. BVD is comprised of hemodynamic structural valve dysfunction, aortic valve gradient and prosthesis-patient mismatch (PPM) after one year. Based on these differences, the number need to treat (NNT) to avoid a poor outcome was approximately three patients—much lower than the NNTs often seen in clinical research. (2)
“This study absolutely represents the patients I treat in my clinic every single day,” says Patel. “And it will change my opinion when I treat these patients going forward. I don’t want BVD. I don’t want PPM. It’s really important to me for my patients not to have higher gradients after TAVR.”
SMART thrives where most other trials fall short
Because women are more likely to present with a small annulus than men, Herrmann et al. made it a priority to recruit as many female patients as possible for SMART. The study’s final patient population included 87% women, a proportion that is all but unheard of in modern cardiology trials.
Patel sees this high percentage of female recruits as one of the trial’s biggest strengths.
“We’ve done a very poor job of enrolling women in trials, in part because the perception is that heart disease affects men more than women,” he says. “People think breast cancer, for example, is more dangerous for women than heart disease. But one in three women die from heart disease while one in 33 women die from breast cancer. Maybe SMART is a good study to help change that perception and highlight that heart disease is as common in women as it has ever been.”
“A lot of us were really surprised by the differences between self-expanding and balloon-expandable TAVR valves. So yes, this is changing the way we practice. Cardiologists appreciate the nuances—knowing more information helps us do our jobs and take care of our patients.”
Dharmesh S. Patel, MD, Cardiologist, Stern Cardiovascular Foundation in Memphis, Tennessee.
What works for men, Patel says, doesn’t always work well for women. Even small nuances can make a big impact on the safety and effectiveness of treatment.
Another key difference between the two sexes is the fact that women do not always present with symptoms typically associated with AS. Their symptoms are often more generalized than men—they may not be complaining about specific feelings, for instance, but they will feel more tired than normal or like something “just isn’t right.”
“There’s the possibility that some women are just not reporting their symptoms,” Patel says. “I often talk to female patients who will do less in their daily lives to avoid feeling a certain way, because they don’t want to go to the hospital. Maybe they walk less at the supermarket or avoid going up and down stairs. These patients can say they feel OK, sure, but it is because they are going out of their way to do less. Does that really mean they are OK? I say, oftentimes, no.”
Differences between valve types a real surprise
According to one-year data from the SMART trial, BVD was seen in 8.4% of women with a self-expanding TAVR valve and 41.8% of women with a balloon-expandable valve. Hemodynamic structural valve dysfunction was seen in 3.2% of women with the self-expanding valve and 32.9% of women with the balloon-expandable valve. In addition, the aortic valve mean gradient was 7.7 mm Hg with the self-expanding valve and 15.8 mm Hg with the balloon-expandable valve.
Moderate or severe PPM, meanwhile, was seen in 9.2% of women with the self-expanding valve and 34. 1% of women with the balloon-expandable valve at 30 days
Patel, who was present at ACC.24 when the SMART results were first presented to attendees, says he did not expect self-expanding TAVR valves to be associated with so many clear advantages in terms of valve performance compared to balloon-expandable valves. The NNT data stood out as well, he says, because it made it clear just how impactful it could be to choose one type of valve over the other.
“To be honest with you, this is brand new information to a lot of cardiologists,” he says. “A lot of us were really surprised by the differences between self-expanding and balloon-expandable TAVR valves. So yes, this is changing the way we practice. Cardiologists appreciate the nuances—knowing more information helps us do our jobs and take care of our patients.”
How will these data influence Patel’s practice? For starters, he will work to ensure all patients with small annuli receive a self-expanding TAVR valve whenever possible. These may only be one-year data, but the differences are significant enough that he feels like he’s seen enough.
“I would actually want to challenge any colleagues who read these data and then proceed to use a balloon-expandable valve when treating a patient with a small annulus,” he says. “What could their rationale be?”
Positive outcomes highlight years of progress
Cardiac care continues to evolve at a rapid rate; yesterday’s dream is often today’s reality.
Patel notes that we are now seeing quicker recoveries, shorter hospital stays and fewer risks in TAVR compared to SAVR. Data from the SMART trial, he adds, continues to demonstrate positive and impactful valve performance in the TAVR space.
“Some 10 years ago, patients who needed a new valve would get their chest opened up for surgery, have the surgery and then stay in the hospital for five to seven days,” he says. “Now we have these advanced therapies where patients can get discharged the very next day or even the same day in some cases. These data further highlight just how far we have advanced in recent years; now we’re talking about which transcatheter heart valve would be the best fit for a certain subset of patients. That’s a reason to celebrate!”
Click here for indications, safety and warnings. Like any other procedure, TAVR risks can include death, stroke, bleeding.
™* Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.
Additional data about treating aortic stenosis in women is available here.
References:
Mehran R,et al. Small aortic annuli patients treated with TAVI: Outcomes in women in the SMART trial. Presented at EuroPCR; May 2024.
Medtronic Data on file.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.