Key result
Transcatheter aortic valve implantation with the Allegra device achieved 98% device success and 96% procedural success, with no significant differences between early and later experience phases.
Why the study?
The authors sought to appraise the effectiveness of the Allegra, a new self-expandable TAVI device, and evaluate the impact of operator experience on procedural outcomes.
Does TAVI with the Allegra device provide safe and effective procedural and mid-term outcomes across different phases of operator experience in patients with aortic stenosis?
Observational (n=50)
No
Does TAVI with the Allegra device provide safe and effective procedural and mid-term outcomes across different phases of operator experience in patients with aortic stenosis?
p-value: p=>0.05
The Allegra TAVI device demonstrates high procedural success and a favorable short-to-midterm safety profile, even during the early phase of operator adoption.
Operator experience may enhance Allegra TAVI procedural results; leaves open need for randomized comparisons versus established valves.
BACKGROUND: Transcatheter aortic valve implantation (TAVI) has revolutionized the management of aortic stenosis. We aimed at appraising effectiveness of a new self-expandable TAVI device. METHODS: We retrospectively analyzed our institutional experience with Allegra (Biosensors, Morges, Switzerland) for TAVI, focusing on procedural outcomes and 1-month adverse events. We explored the impact of operator experience with this device, dividing patients according to their time of intervention. RESULTS: Between 2018 and 2021, a total of 50 patients underwent TAVI with Allegra, with average age of 81 years, 80% women, and 50% at low or intermediate surgical risk. No major significant difference in baseline patient features were found when comparing Phase 1 and Phase 2, except for baseline left ventricular ejection fraction and New York Heart Association, which were worse in Phase 1. All procedures were performed transfemorally and percutaneously, with predilation in 94% and postdilation in 36%, yielding device success in 98%, and procedural success in 96%. No significant differences in procedural features were found when comparing Phase 1 vs. Phase 2 (all P>0.05). One-month follow-up was also favorable, with no significant difference in adverse outcomes according to phase, and a total of 1 (4%) death, 1 (4%) myocardial infarction, 1 (4%) minor vascular complication, and 4 (8%) permanent pacemaker implantations. Consistent findings were obtained at exploratory 6-month follow-up. CONCLUSIONS: The Allegra TAVI device is associated with favorable short-to-midterm outcomes in experienced hands. Operators already proficient with other devices can achieve satisfactory results even in the early phase of adoption of Allegra.
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Corcione et al. (2022) conducted an observational in aortic stenosis (n=50). TAVI with Allegra vs. Early vs. late operator experience (Phase 1 vs. Phase 2) was evaluated on device success (p=>0.05). Transcatheter aortic valve implantation with the Allegra device achieved 98% device success and 96% procedural success, with no significant differences between early and later experience phases.
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