An Investigation on the Factors that Affect Sizing in Two Generations of Self-Expandable Transcatheter Valves and Their Influence on Paravalvular Regurgitation (PVR)

Background: Aim of the present study is to investigate the impact of sizing on paravalvular regurgitation (PVR) in two generations of self-expandable transcatheter heart valves.

Method: A total of 2,865 patients with severe aortic stenosis underwent transfemoral TAVI using the NEO (n = 2,055) or NEO-2 (n = 810) prosthesis between 2012 and 2021 at two high-volume centers. Mean age was 81.6 ± 5.6 years, 1,073 male, median EuroSCORE II 3.4 (IQR: 2.3–5.2).

Results: The following factors were independently associated with increased probability for relevant PVR: calcium density OR: 1.122/100 AU/cm² (1.066–1.180; p < 0.001), presence of eccentric calcification OR: 4.255 (2.820–6.420; p < 0.001), cover index OR: 0.902 (0.839–0.970; p = 0.005), STJ-to-annulus index OR: 1.030 (1.011–1.049; p = 0.002), and the interaction of CI with THV generation (NEO2) OR: 0.858 (0.769–0.957; p = 0.006).

In borderline sizing ranges (within 0.5 mm of the upper recommended annulus diameter for each valve size, n = 314), upsizing to one size larger than the official recommendation decreased the risk of relevant PVR.

Conclusion: Our study shows that oversizing especially in borderline sizes may further reduce the incidence of PVR. It is important to consider several anatomical and sizing-related factors that influence the incidence of PVR in the NEO/NEO2 self-expanding transcatheter heart valve platform.

Publication History

Article published online:
28 January 2023