An Observational Single‐Center Study: Comparison of the 29‐mm Sapien 3 With the 34‐mm Evolut‐R in Patients With a Large Aortic Annulus

Introduction: Currently, there are 2 types of third generation bioprostheses that can be used in patients with aortic stenosis with a large aortic annulus (LAA): the 29‐mm Sapien 3 (S3; Edwards Lifesciences LLC, Irvine, CA) and the 34‐mm Evolut‐R (ER; Medtronic, Inc, Dublin, Ireland). The objective of this trial was to compare long‐term hemodynamic and clinical outcomes of these two valves in patients with LAA and to determine the effect of aortic annulus size on these two outcomes. Method: We conducted a retrospective, monocentric study (CHU Rangueil–Toulouse) in patients who underwent transcatheter aortic valve implantation (TAVI) for aortic stenosis between 04/01/2018 and 31/12/2020. We included all patients with severe aortic stenosis (SAS) who were diagnosed based on clinical and echocardiographic criteria. All clinical, anatomical, and procedural characteristics were recorded. Results: We included 172 patients: 110 received a 29‐mm S3 prosthesis and 62 patients a 34‐mm ER prosthesis. The average area of the aortic annulus was 595 ± 67 mm 2 . The average aortic perimeter was 87.5 ± 5.1 cm for the S3 and 584 ± 72 mm 2 and 86.4 ± 6.3 cm for the ER. The aortic regurgitation (AR) rate was higher with the ER than with the S3 (18.3% vs. 3.9%; p = 0.002) but the mean transvalvular gradient was lower with the ER (7.1 ± 2.8 mmHg vs. 9.9 ± 3.8 mmHg; p < 0.001). At Day 30, there were 4 deaths in the S3 group and 1 death in the ER group. The mean duration of follow‐up was 22.7 months. No differences in cardiovascular mortality were observed between the two devices, with a rate of 2.7 deaths per 100 person‐years for the ER vs. 3.9 deaths per person‐years for the S3 group ( p = 0.208). Subgroup analysis according to the LAA size showed a higher rate of AR in patients with the largest annulus dimensions. Conclusion: In patients with a LAA who require a TAVI, the 34‐mm ER and 29‐mm S3 prostheses demonstrate significant differences in hemodynamics with no impact on cardiovascular mortality.