Key result
Allegra TAVI yields ~92% technical success across native and valve-in-valve aortic stenosis procedures.
Why the study?
Limited data were available on the safety and outcomes of TAVI using the self-expanding Allegra transcatheter heart valve in daily practice.
Does transcatheter aortic valve implantation using the self-expanding Allegra valve provide safe periprocedural outcomes, acute hemodynamic improvement, and favorable 1- and 3-year survival in patients with severe native aortic stenosis or degenerated aortic bioprostheses?
Observational (n=142)
No
Does transcatheter aortic valve implantation using the self-expanding Allegra valve provide safe periprocedural outcomes, acute hemodynamic improvement, and favorable 1- and 3-year survival in patients with severe native aortic stenosis or degenerated aortic bioprostheses?
Absolute Event Rate: 91.5% vs 92%
In real-world practice, TAVI with the self-expanding Allegra valve demonstrates high technical success (~92%), significant acute hemodynamic improvement, and ~73–75% 3-year survival in both native aortic stenosis and valve-in-valve procedures, though caution is warranted during postdilatation due to the risk of valve embolization.
Allegra TAVI supports feasibility in native AS and ViV; leaves comparative efficacy versus other valves open for randomized trials.
Background: Limited data are available of the self-expanding Allegra transcatheter heart valve (THV). The aim of this study was to investigate the safety and outcome of transcatheter aortic valve implantation (TAVI) using the Allegra THV in daily practice. Methods: Between February 2018 and September 2024, 142 consecutive patients underwent Allegra TAVI at the Heart and Vascular Center, Bad Bevensen, Germany, either for native aortic stenosis (AS) (n = 117, median 82 (interquartile range 80–86) years) or degenerated aortic bioprostheses (n = 25, 80 (73–84) years) as valve-in-valve (ViV) procedures. Endpoints were defined according to Valve Academic Research Consortium-3 criteria. Results: The logistic EuroSCORE II was significantly higher in the cohort of patients with degenerated aortic bioprostheses than in those with native AS (14.4% (6.6–25.3%) versus 3.3% (2.5–5.7%), P < 0.01). Technical success was nearly identical in both cohorts (91.5% of patients with native AS and 92.0% of patients with ViV TAVI). Postinterventional aortic regurgitation ≥ moderate was found in 4.5% of patients with native AS and was not present in any patient with ViV TAVI. In the native AS cohort, mean and maximal aortic pressure gradients decreased from 44 (36–54) mm Hg and 72 (60–87) mm Hg before the intervention to 6 (5–9) mm Hg and 12 (9–15) mm Hg after Allegra TAVI. In the ViV cohort, mean and maximal transvalvular pressure gradients decreased from 34 (27–43) mm Hg and 59 (44–70) mm Hg to 9 (7–11) mm Hg and 16 (14–23) mm Hg, respectively. Periprocedural mortality rates (≤ 30 days) were 6.8% and 12.0% in the native AS and ViV cohorts, respectively. One-year and 3-year survival rates were 87.2% and 73.2% in the native AS cohort and 89.8% and 75.1% in the ViV cohort, respectively. Conclusions: TAVI using the self-expanding Allegra THV system is safe and leads to acute hemodynamic improvements in patients with native AS or degenerated aortic bioprostheses.
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Zemaite et al. (2026) conducted an observational in Severe native aortic stenosis or degenerated aortic bioprosthesis (n=142). Allegra transcatheter heart valve (THV) TAVI in native aortic stenosis vs. Allegra THV valve-in-valve (ViV) TAVI in degenerated aortic bioprostheses was evaluated on Technical success (VARC-3 criteria). TAVI using the self-expanding Allegra valve achieved 91.5% technical success in native aortic stenosis and 92.0% in valve-in-valve procedures, with 3-year survival of 73.2% and 75.1%.
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