Key result
Balloon-expandable valves linked to higher gradients but ~58% less moderate-to-severe paravalvular leak versus self-expandable valves.
Why the study?
The comparative performance of contemporary balloon-expandable valves and self-expandable valves in real-world practice remains debated.
Does transcatheter aortic valve replacement with balloon-expandable valves compared to self-expandable valves improve procedural and in-hospital outcomes in patients with symptomatic severe aortic stenosis and high surgical risk?
Cohort (n=366)
No
Does transcatheter aortic valve replacement with balloon-expandable valves compared to self-expandable valves improve procedural and in-hospital outcomes in patients with symptomatic severe aortic stenosis and high surgical risk?
Absolute Event Rate: 11.7% vs 8.5%
p-value: p=<0.0001
In a real-world cohort of high-risk patients with severe aortic stenosis, balloon-expandable TAVR valves demonstrated superior sealing with fewer paravalvular leaks, while self-expandable valves provided lower postoperative transvalvular gradients.
Background: Transcatheter aortic valve replacement (TAVR) is rapidly becoming the preferred treatment for patients with severe aortic stenosis across different surgical risk profiles. However, the comparative performance of contemporary balloon-expandable valves (BEVs) and self-expandable valves (SEVs) in real-world practice remains debated. Objectives: To evaluate procedural and postoperative outcomes associated with different contemporary TAVR systems in a consecutive cohort of patients treated at a single center. Methods: We retrospectively analyzed 366 consecutive patients with symptomatic severe aortic stenosis and high surgical risk who underwent TAVR at Casa di Cura San Michele (Maddaloni, Italy) between January 2019 and October 2024. Patient baseline characteristics, procedural data, and in-hospital outcomes were collected and compared across different TAVR systems. Results: < 0.0001) but a lower incidence of moderate-to-severe paravalvular leak (2.9% vs. 6.9%). The need for permanent pacemaker implantation was more frequent in the BEV group (11.4% vs. 6.5%). Overall in-hospital mortality was 2.7%. Device success was achieved in 93.2% of procedures. Conclusion: In a real-world, single-center cohort, both BEVs and SEVs provided favorable outcomes. While BEVs demonstrated superior sealing properties with fewer paravalvular leaks, SEVs were associated with lower postoperative gradients. Careful consideration of anatomical and procedural factors remains essential for optimizing outcomes with contemporary TAVR systems.
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Vinciguerra et al. (2026) conducted a cohort in symptomatic severe aortic stenosis (n=366). Balloon-expandable valves (BEVs) vs. Self-expandable valves (SEVs) was evaluated on Post-procedural mean transvalvular gradient (mmHg) (p=<0.0001). Balloon-expandable valves resulted in significantly higher post-procedural transvalvular gradients (11.7 vs. 8.5 mmHg, p < 0.0001) but a lower incidence of moderate-to-severe paravalvular leak (2.9% vs. 6.9%) compared to self-expandable valves.
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