EuroPCR 2026: Three-Year Follow-Up Data from SMART Trial—Largest TAVR Study in Women Highlights Superior Hemodynamics of Medtronic’s Evolut Platform

In patients with aortic stenosis, particularly among the female population (especially small-statured Asian patients), a "small annulus" is a common anatomical feature. When these patients undergo conventional TAVR procedures, they face two major challenges:

• Patient-Prosthesis Mismatch (PPM):Due to the patient's relatively small valve annular inner diameter, the available internal space is limited. Following prosthetic valve implantation, an insufficient effective orifice area (EOA) will lead to a significant increase in hemodynamic resistance, thereby elevating the patient's long-term risk of cardiovascular mortality.

• Valve Dysfunction (BVD) and Thrombosis:Within the confined annular space, the stent frame structure and materials used determine the long-term wear rate of the valve leaflets and the incidence of thrombosis. Once valve thrombosis occurs, it not only significantly increases the transvalvular pressure gradient but is also highly likely to induce heart failure, necessitating additional anticoagulation therapy for the patient.

While the SMART trial strongly validated the hemodynamic advantages of self-expanding valves, Medtronic addressed the real-world industry challenge of traditional self-expanding valves—where "tall stent frames hinder subsequent coronary access"—by implementing a foundational hardware upgrade to the fourth-generation Evolut FX and launching the latest Evolut FX+ system:

• Gold marker:The Evolut FX+ features gold markers that assist the operator in confirming "commissural alignment," which physically optimizes valve durability and primarily avoids the coronary ostia.

• Coronary ostium enlarged 4-fold:Due to the diverse anatomical variations in coronary arteries, it is difficult to completely avoid the coronary ostia. The Evolut FX+ incorporates an ultra-large coronary window within its core frame structure, which is four times larger than previous iterations. This enlarged open-cell design offers exceptional maneuverability for post-procedural catheter engagement with the left and right coronary arteries, without compromising the inherent radial strength and hemodynamics of the Medtronic Evolut platform.

The conference chair, expert panel, and discussants discussed this study: The participating experts noted that there was no statistically significant difference between the two groups in the 3-year composite clinical endpoint (death/stroke/rehospitalization for heart failure); the incidence of moderate-to-severe PPM in the Sapien group33.2%and incidence of bioprosthetic valve dysfunction (BVD)54.4%, with a statistically significant difference between the two groups. Given that female patients have a longer life expectancy than male patients, differences in hemodynamics and long-term survival rates may only become fully apparent 5 to 10 years postoperatively.

Study Principal Investigator: Professor Howard C. Herrmann

“Three-year sustained superior hemodynamic outcomes for the Evolut self-expanding valve in the treatment of patients with small aortic valvesIncidence of valve thrombosis, etc.These advantages provided evidence and yielded novel insights for clinical practice. We plan to continue follow-up for up to five years.”