Key result
Evolut TAVI increases effective orifice area by ~1.2 cm² with zero permanent pacemaker implantations.
Why the study?
This study aimed to evaluate the procedural outcomes, safety, and clinical efficacy of TAVI using the Evolut self-expanding valve system in patients with severe aortic stenosis at E Hospital.
Does transcatheter aortic valve implantation using the Evolut self-expanding valve system improve hemodynamic parameters and provide safe clinical outcomes in patients with severe symptomatic aortic stenosis at high surgical risk?
Observational (n=21)
No
Does transcatheter aortic valve implantation using the Evolut self-expanding valve system improve hemodynamic parameters and provide safe clinical outcomes in patients with severe symptomatic aortic stenosis at high surgical risk?
This single-center Vietnamese cohort demonstrates that TAVI using the self-expanding Evolut valve in complex severe aortic stenosis (including 33.3% bicuspid and 19.0% Valve-in-Valve) achieves substantial hemodynamic improvement with zero permanent pacemaker requirement, though careful Heart Team anatomical screening is critical to avoid early mortality in hostile anatomy.
Objectives: To evaluate the procedural outcomes, safety, and clinical efficacy of Transcatheter Aortic Valve Implantation (TAVI) using the Evolut self-expanding valve system in patients with severe aortic stenosis at E Hospital. Methods: A descriptive, longitudinal study was conducted on 21 patients undergoing TAVI from December 2019 to December 2025. Results: The mean age was 72.2 ± 8.3 years; males accounted for 52.4%. Complex characteristics included bicuspid aortic valves (33.3%), degenerated bioprosthetic valves (Valve-in-Valve) (19.0%), and concomitant coronary artery disease requiring Chimney stenting (23.8%). The mean EuroSCORE II was 5.2 ± 1.8%, and the STS Score was 4.1 ± 1.5%. Regarding hemodynamics, the effective orifice area (EOA) increased from 0.65 ± 0.15 cm² to 1.85 ± 0.45 cm²; the mean pressure gradient decreased from 55 ± 12 mmHg to 8.5 ± 3.2 mmHg. The procedural volume increased over time, peaking with 9 cases in 2025. In-hospital mortality was 9.5% (2 cases); both occurred in the early phase (2020 and 2023) associated with highly complex anatomy. Moderate paravalvular leak was observed in 1 case (4.8%), and there were no cases of conduction disorders requiring a permanent pacemaker (0%). No major complications were recorded in the 2024–2025 period. At the 6-month follow-up, left ventricular ejection fraction (EF) improved from 57.38 ± 12.1% to 60.15 ± 9.8%. Conclusion: TAVI using Evolut self-expanding valves is a feasible and effective procedure at E Hospital. Despite initial challenges related to the learning curve, the current protocol has been standardized with high safety outcomes. The role of the Heart Team in patient selection and thorough anatomical assessment is the key factor in improving treatment outcomes.
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Phan et al. (2026) conducted an observational in Severe symptomatic aortic stenosis (including native valve stenosis and degenerated bioprosthetic valves) (n=21). Transcatheter Aortic Valve Implantation (TAVI) using Evolut self-expanding valve vs. Baseline (pre-procedure) was evaluated on Effective orifice area (EOA, cm²) (p=<0.001). TAVI using Evolut self-expanding valves increased effective orifice area from 0.65 to 1.85 cm² (p<0.001) with 9.5% in-hospital mortality and 0% permanent pacemaker implantation.
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