Self-expanding TAVR valves still linked to superior durability in patients with small annuli after 2 years
Researchers have shared an update to one of the most noteworthy transcatheter aortic valve replacement (TAVR) studies in recent years, presenting the new data at the Cardiovascular Research Technologies (CRT) 2025 conference in Washington, D.C.
The SMART trial is a head-to-head comparison of self-expanding Evolut TAVR valves from Medtronic and balloon-expandable Sapien 3 TAVR valves from Edwards Lifesciences in patients with a small aortic annulus. One-year data found that the self-expanding Evolut devices outperformed the balloon-expandable Sapien 3 devices in terms of bioprosthetic valve dysfunction, prosthesis-patient mismatch and aortic valve mean gradient.
Now, new two-year data presented at CRT 2025 show that self-expanding TAVR valves are still associated with superior valve performance after an additional year of clinical surveillance. The risk of prosthetic valve thrombosis is significantly lower with the self-expanding valves, for example, as is the rate of hemodynamic structural valve dysfunction.
“Valve performance is critical for all patients, but the impact of poor valve performance is magnified in patients with a small aortic annulus, who are at risk of receiving a valve that is not adequate for their cardiac requirements,” lead investigator Howard C. Herrmann, MD, with the Perelman School of Medicine at the University of Pennsylvania, said in a statement. “The two-year results highlight the continued superior performance of the Evolut TAVR valve in these patients. While we would not yet expect to see a significant difference in the composite clinical outcomes at this early stage, valve performance provides important data that operators can use to inform and personalize treatment decisions to enhance patient outcomes.”
“The SMART Trial is a groundbreaking, head-to-head comparison that, for the first time, highlights how a patient with a small annulus can benefit from Evolut's differentiated valve design,” added Kendra J. Grubb, MD, MHA, MSc, vice president and chief medical officer of Medtronic’s structural heart portfolio. “At two years, we continue to see superior valve performance that we will follow to assess long-term outcomes.”
Additional background on the SMART trial
The SMART trial included data from 716 patients randomized to receive either a self-expanding Evolut TAVR valve or a balloon-expandable Sapien 3 valve. All patients presented with symptomatic severe aortic stenosis and a small aortic annulus. Eighty-seven percent of patients were women, a statistic that is practically unheard of in TAVR research. Evolut models implanted for the study included the Evolut PRO, Evolut PRO+ and Evolut FX. Sapien 3 models included the Sapien 3 and Sapien 3 Ultra.
Overall, one-year data showed that the two valve types were linked to comparable clinical outcomes. However, the self-expanding valves were associated with a much lower BVD rate (9.4% vs. 41.6%), a lower rate of moderate or severe prosthesis patient mismatch (11.2% vs 35.3%) and a lower aortic valve mean gradient (7.7 mm Hg vs. 15.7 mm Hg).
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.