Early Hemodynamic Performance of the SAPIEN 3 Ultra Resilia and Evolut Valves: A Propensity-Matched Analysis

Limited data are available on early hemodynamic outcomes of the balloon-expandable SAPIEN 3 Ultra Resilia (S3UR) (Edwards Lifesciences, Irvine, CA) compared with the self-expandable Evolut (Medtronic, Minneapolis, MN) transcatheter heart valves. In this study we aimed to compare the hemodynamic performance of the S3UR with contemporary Evolut platforms (Evolut PRO, PRO+, FX) in a propensity-matched study.

A total of 307 patients who received an S3UR valve were matched with 488 patients who received Evolut valves (mean age, 80.1 ± 7 years; 46.2% women). The primary end point was valve hemodynamics (aortic mean gradient, effective orifice area [EOA], severe prosthesis-patient mismatch [PPM], and moderate to severe aortic regurgitation [AR]) at 1-3 months after transcatheter aortic valve replacement. Secondary end points included clinical outcomes.

Evolut valves were associated with lower mean gradients (8.0 ± 3.1 mm Hg vs 9.8 ± 3.8 mm Hg; P < 0.001) but higher rates of residual AR (mild AR, 10.7% vs 4.1%; moderate to severe AR, 4.2% vs 1.4%; P < 0.001). EOA values and PPM rates were comparable. In patients with small aortic annulus (< 430 mm²), Evolut valves showed larger EOA (1.94 ± 0.3 cm² vs 1.83 ± 0.4 cm²; P = 0.038) and lower gradients (7.8 ± 2.4 mmHg vs 10.9 ± 4.5 mmHg; P < 0.010). Moderate to severe AR and PPM were similar between groups. Despite comparable device success, early safety outcomes favoured the S3UR (81.8% vs 60.5%; P < 0.010 for S3UR and Evolut, respectively), because of higher rates of pacemaker implantation, atrial fibrillation, major vascular complication, and type 2-3 bleeding in the Evolut cohort.

Evolut valves showed lower transprosthetic gradients but a higher rate of residual AR compared with the S3UR. Further studies are needed to validate these findings and investigate their effect on long-term outcomes.