Key result
Balloon-expandable valves show comparable 1-year mortality and stroke rates to self-expandable valves in TAVI.
Why the study?
Both balloon-expandable and self-expandable valves for TAVI are broadly used in clinical practice, but adequately powered randomized controlled trials comparing these two valve designs are lacking.
Does balloon-expandable valve compared to self-expandable valve improve one-year mortality and stroke rates in patients with severe aortic valve stenosis undergoing transfemoral TAVI?
Cohort (n=5,410)
Yes
Does balloon-expandable valve compared to self-expandable valve improve one-year mortality and stroke rates in patients with severe aortic valve stenosis undergoing transfemoral TAVI?
Relative Risk: 1.04 (95% CI 0.92–1.21)
Absolute Event Rate: 16.4% vs 17%
p-value: p=0.57
Balloon-expandable and self-expandable TAVI valves provide similar 1-year mortality and stroke outcomes, suggesting valve selection can be primarily tailored to individual patient anatomy and conduction block risks.
Background: Both balloon-expandable (BE) and self-expandable (SE) valves for transcatheter aortic valve implantation (TAVI) are broadly used in clinical practice. However, adequately powered randomized controlled trials comparing these two valve designs are lacking. Methods: The CENTER-study included 12,381 patients undergoing transfemoral TAVI. Patients undergoing TAVI with a BE-valve (n = 4096) were compared to patients undergoing TAVI with an SE-valve (n = 4096) after propensity score matching. Clinical outcomes including one-year mortality and stroke rates were assessed. Results: In the matched population of n = 5410 patients, the mean age was 81 ± 3 years, 60% was female, and the STS-PROM predicted 30-day mortality was 6.2% (IQR 4.0–12.4). One-year mortality was not different between patients treated with BE- or SE-valves (BE: 16.4% vs. SE: 17.0%, Relative Risk 1.04, 95%CI 0.02–1.21, p = 0.57). One-year stroke rates were also comparable (BE: 4.9% vs. SE: 5.3%, RR 1.09, 95%CI 0.86–1.37, p = 0.48). Conclusion: This study suggests that one-year mortality and stroke rates were comparable in patients with severe aortic valve stenosis undergoing TAVI with either BE or SE-valves.
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Nieuwkerk et al. (2021) conducted a cohort in severe aortic valve stenosis undergoing transfemoral TAVI (n=5,410). Balloon-expandable (BE) valve vs. Self-expandable (SE) valve was evaluated on One-year all-cause mortality (RR 1.04, 95% CI 0.92-1.21, p=0.57). Balloon-expandable valves resulted in comparable one-year mortality (16.4% vs 17.0%, RR 1.04) and stroke rates (4.9% vs 5.3%) compared to self-expandable valves in patients undergoing transcatheter aortic valve implantation.
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