Evolut FX was associated with lower early safety and higher mild or greater paravalvular leakage (29.0% vs. 13.6%, p<0.001) than SAPIEN 3 Ultra RESILIA, despite comparable 1-year clinical outcomes.
Cohort (n=1,068)
Yes
Does the Evolut FX valve improve early clinical outcomes and hemodynamic performance compared to the SAPIEN 3 Ultra RESILIA valve in patients undergoing TAVI for severe aortic stenosis?
In real-world TAVI, the SAPIEN 3 Ultra RESILIA valve demonstrated better early safety and less paravalvular leak, whereas the Evolut FX valve provided superior hemodynamics with lower gradients and larger effective orifice areas.
Abstract Backgrounds Transcatheter aortic valve implantation (TAVI) is a well-established treatment for severe aortic stenosis, with continuous advancements in valve technology aimed at improving clinical outcomes. However, real-world data comparing the latest-generation Evolut FX and SAPIEN 3 Ultra RESILIA (S3 UR) valves remain limited. Purpose This study aimed to evaluate and compare early clinical outcomes and hemodynamic performance between the Evolut FX and S3 UR valves. Methods A multicenter registry analysis included 4,921 patients who underwent TAVI, of whom 1,068 received either an Evolut FX or S3 UR valve. Among these, 414 patients (38.7%) were treated with the Evolut FX, while 654 (61.2%) received the S3 UR (Figure 1). A 1:1 propensity score matching was performed, adjusting for key baseline variables, including age, sex, body surface area, and aortic valve area. Primary endpoints included device success and 30-day early safety, defined according to the Valve Academic Research Consortium-2 (VARC-2) criteria. Results In the matched cohort, the mean age was 85 years, and 63.9% of patients were female. Device success rates were comparable between the two valve groups. However, early safety was significantly higher in the S3 UR group (Figure 2). Post-procedural echocardiography revealed a higher incidence of mild or greater paravalvular leakage in the Evolut FX group (29.0% vs. 13.6%, p0.001), whereas the mean pressure gradient was lower in Evolut FX compared to S3 UR 7.3 (5.0–10.5) mmHg vs. 8.7 (7.0–11.3) mmHg, p0.001. Additionally, the indexed effective orifice area (EOAi) was significantly larger in the Evolut FX group than in the S3 UR group 1.28 (1.07–1.54) vs. 1.23 (1.04–1.44), p=0.021. At one year, the composite outcome of all-cause mortality and heart failure hospitalization was comparable between groups (5.0% vs. 3.4%, p=0.32). Conclusions Both the Evolut FX and S3 UR valves demonstrated comparable device success rates. The S3 UR valve was associated with a higher early safety profile, whereas the Evolut FX valve exhibited a lower transvalvular pressure gradient and larger EOAi but had a higher incidence of mild or greater paravalvular leakage. The long-term clinical significance of these findings requires further investigation.
Takahashi et al. (Sat,) conducted a cohort in severe aortic stenosis (n=1,068). Evolut FX valve vs. SAPIEN 3 Ultra RESILIA valve was evaluated on Device success and 30-day early safety (VARC-2 criteria). Evolut FX was associated with lower early safety and higher mild or greater paravalvular leakage (29.0% vs. 13.6%, p<0.001) than SAPIEN 3 Ultra RESILIA, despite comparable 1-year clinical outcomes.