Key result
Large 34 mm self-expanding TAVI yields similar 5-year mortality to standard-size valves.
Why the study?
Patients with large aortic annuli undergoing TAVI represent a challenging subgroup with sparse data on long-term outcomes.
Does transcatheter aortic valve implantation with large self-expanding valves provide comparable short- and long-term outcomes compared to regular size valves in patients with native aortic stenosis?
Cohort (n=488)
Does transcatheter aortic valve implantation with large self-expanding valves provide comparable short- and long-term outcomes compared to regular size valves in patients with native aortic stenosis?
Hazard Ratio: 1.06 (95% CI 0.64–1.76)
p-value: p=0.8
TAVI with large self-expanding valves is associated with favorable technical success and long-term clinical outcomes that are comparable to those of regular-sized valves up to 5 years.
Large 34 mm valves show comparable 5-year mortality to smaller valves; extends observational data in large-annulus TAVI but leaves open randomized confirmation.
BACKGROUND: Patients with large aortic annuli are a more challenging subgroup for transcatheter aortic valve implantation (TAVI), and data on long-term outcomes are sparse. AIMS: Compare outcomes of patients with large annular anatomies to outcomes of patients with regular anatomies. METHODS: Between January 2015 and November 2025, 488 patients underwent TAVI with different generations of Evolut valves for the treatment of native aortic stenosis. Outcomes of large 34 mm valves were compared to regular size 23-29 mm valves. To account for the nonrandomized design, the primary comparison was performed in a 1:1 propensity score matching cohort. RESULTS: A total of 186 (38%) patients received large and 302 (62%) received regular size valves. Propensity score matching yielded 141 well-balanced pairs, in whom age (80 ± 6 vs. 81 ± 6 years), STS-PROM score (3.2 [2.0-4.9] vs. 3.6 [2.1-5.8]), and male sex (96% vs. 97%), were comparable. Procedural technical success (95% vs. 94%), device success (90% vs. 92%), and early safety (79% vs. 79%) were comparable. At 30 days, mortality (2.1% vs. 1.4%), stroke (2.1% vs. 3.5%), and new pacemaker implantation (12% vs. 11%) did not differ significantly. At 5 years, there were no significant differences between the groups in all-cause mortality (HR 1.06, 95% CI 0.64-1.76, p = 0.8), stroke (sHR 0.74, 95% CI 0.26-2.11, p = 0.6), heart failure rehospitalization (sHR 0.96, 95% CI 0.46-2.01, p=0.9), or new pacemaker implantation (sHR 1.02, 95% CI 0.57-1.82, p = 0.9). Structural valve deterioration stage 3 (0% vs. 1.6%), infective endocarditis (1.7% vs. 2.8%), and valve reintervention (0% vs. 0.9%) were infrequent in both groups. The findings were consistent in the whole-cohort analysis. CONCLUSION: Outcomes after TAVI with large self-expanding valves were comparable to regular size valves, demonstrating favorable results up to 5 years of follow-up.
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Alexiou et al. (2026) conducted a cohort in Native aortic stenosis (n=488). Large 34 mm self-expanding valves vs. Regular size 23-29 mm valves was evaluated on All-cause mortality at 5 years (HR 1.06, 95% CI 0.64-1.76, p=0.8). TAVI with large 34 mm self-expanding valves had similar 5-year all-cause mortality compared to regular size 23-29 mm valves (HR 1.06; 95% CI 0.64-1.76; P=0.8).
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