Medtronic’s Evolut TAVR Studied for Patients with Small Annuli in SMART

March 12, 2025—Medtronic recently announced 2-year results from the SMART trial of transfemoral transcatheter aortic valve replacement (TAVR) in patients with symptomatic severe aortic stenosis and a small aortic annulus.

According to the company, 2-year results from the international, multicenter, randomized, postmarket SMART trial showed comparable composite outcomes of mortality, disabling stroke, and heart failure hospitalization. Results also demonstrated continued superior valve performance as measured by bioprosthetic valve dysfunction (BVD) for Medtronic’s Evolut self-expanding TAVR system versus the Sapien balloon-expandable TAVR system (Edwards Lifesciences).

The late-breaking science was presented at CRT 25, the Cardiovascular Research Technologies annual meeting held March 8-11 in Washington, DC.

As summarized in Medtronic’s press release, SMART randomized and treated 716 patients (87% women) at > 80 sites worldwide. Eligible patients had an aortic valve annulus area of ≤ 430 mm as measured by CT, as well as anatomy suitable for transfemoral TAVR with either an Evolut Pro/Pro+/FX device or a Sapien 3/3 Ultra device. Patients enrolled in the trial will continue to be followed out to 5 years.

The company reported that the SMART 2-year data demonstrated that Evolut TAVR continues to show “significantly less” BVD compared to Sapien TAVR. Additional results demonstrated that compared to Sapien, Evolut TAVR showed five times less prosthetic valve thrombosis (P = .0048) and nine times less hemodynamic structural valve dysfunction (defined by mean gradient ≥ 20 mm Hg; P < .001).

Medtronic noted that these results build on additional data of Evolut BVD performance in patients with small and large annuli presented as late-breaking science at CRT and in the Evolut BVD pooled analysis by Steven Yakobuv, MD, et al that was published March 9 online in the Journal of the American College of Cardiology.

The lead investigator of SMART is Howard C. Herrmann, MD, from Perelman School of Medicine at the University of Pennsylvania in Philadelphia, Pennsylvania.

“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,” commented Dr. Herrmann in Medtronic’s press release. “The 2-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.”