Background: Severe device landing zone (DLZ) calcification in native aortic annuli is technically challenging and may affect procedural outcome of transcatheter aortic valve replacement (TAVR). Comparative data on self-expanding (SE) ACURATE neo2 (NEO2) and balloon-expandable (BE) SAPIEN 3 Ultra (ULTRA) in this subset with severe DLZ calcification are scarce.

Methods: A total of 1987 patients with severe native aortic stenosis treated with the SE NEO2 (n=1457) or BE ULTRA (n=530) from 01/2017 to 04/2023 were evaluated. The primary endpoint was procedural outcome according to the Valve Academic Research Consortium (VARC3) definitions. After exclusion of patients with low DLZ calcification (£75. percentile; calcium density cut-off 758 AU/cm²; n=1470), 1:1 propensity matching identified 219 matched pairs. 

Results: Technical success (91.3% vs. 91.8%, p=1.000) and device success at 30 days (83.1% vs. 75.8%, p=0.076) were comparable for NEO2 and ULTRA. Hemodynamic outcome with NEO2 was superior in terms of indicated aortic valve area (0.97cm²/m² vs. 0.82cm²/m², p<0.001), severe prosthesis-patient mismatch (1.1% vs. 10.1%, p<0.001), mean transvalvular gradient >20mmHg (2.8% vs. 14.3%, p<0.001) and lower incidence of major cardiac structural complications (0.0% vs. 2.7%, p=0.030). In contrast, the rate of relevant paravalvular regurgitation was significantly higher with NEO2 (4.6% vs. 0.0%, p=0.002) as well as tendency towards a higher rate of device embolization or migration (2.3% vs. 0.0%, p=0.061), see Figure 1.

Conclusion: In patients with severe calcified annuli supraannular NEO2 showed favorable hemodynamic advantages and a trend towards lower incidence of annulus ruptures and coronary obstructions of NEO2 compared to SAPIEN Ultra. Nevertheless, NEO2 was associated with significant higher incidence of relevant paravalvular leakage and trend towards a higher rate of device embolization compared to ULTRA in this particular patient group.