Key result
ALLEGRA transcatheter valve achieves ~92% VARC-2 device success with sustained 1-year hemodynamic performance.
Why the study?
Transcatheter aortic valve implantation for degenerated biological aortic valves has poorer results than in native aortic stenosis, and the Allegra device offers a new design to treat these patients.
Cohort (n=137)
Open-label
Yes
Supports ALLEGRA TAVR feasibility in native AS; leaves open randomized trials to guide adoption.
OBJECTIVES: The objective was to evaluate the results of valve-in-valve procedures performed with the Allegra device. BACKGROUND: Transcatheter aortic valve implantation to treat degenerated biological aortic valves (valve-in-valve) is an established procedure in most catheterization laboratories, but the results are poorer than procedures done in native aortic stenosis. The Allegra device (Biosensors, Morges, Switzerland) has an excellent design to treat these patients. METHODS: All patients with severely degenerated biological aortic valve treated with the Allegra device in centers from Spain until December 2020 were included (n = 29). Hemodynamic results and 30-day clinical outcomes were evaluated. The predominant hemodynamic failure was stenosis in 15, regurgitation in 11, and a combination of both in 3 cases. Time from aortic valve replacement to valve-in-valve procedure was 8.4 ± 3.9 years (range 3.3-22.1). RESULTS: After the procedure, maximum and mean trans-valvular gradients were 17.4 ± 12.3 and 8.4 ± 6.1 mmHg, respectively. Device success was obtained in 28 patients (96.6%). In one patient with a degenerated 19 mm prosthetic valve, mean gradient after the procedure was 22 mmHg. No patients had a para-valvular leak grade >1. There were no deaths during the hospitalization or at 30 days and one patient suffered a stroke. CONCLUSIONS: The Allegra trans-catheter aortic valve offers optimal hemodynamic results in patients with severely degenerated biological aortic valve.
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Moreno et al. (2021) conducted a cohort in Severe calcific aortic stenosis or degenerated surgical bioprosthesis (n=137). ALLEGRA transcatheter aortic valve with IMPERIA delivery system vs. Performance goal (from historical control) was evaluated on VARC-2 device success at discharge or 7 days post-implant (95% CI 83.5%-100.0%, p=<0.001).
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