What is the clinical evidence from this study?

Study design: Cohort. Population: severe aortic valve stenosis (n=12381). Intervention: Balloon-expandable (BE) valves vs. Self-expandable (SE) valves. Primary outcome: One-year mortality (RR 1.04, 95% CI 0.02-1.21, p=0.57).

September 4, 2021Open Access

Balloon-Expandable versus Self-Expandable Valves in Transcatheter Aortic Valve Implantation: Complications and Outcomes from a Large International Patient Cohort

ANAstrid van NieuwkerkInterventional Cardiology RSRaquel B. SantosUniversidade do Porto LALeire AndrakaHospital de Basurto

Key Result

Balloon-expandable valves were associated with similar one-year mortality compared to self-expandable valves in patients undergoing TAVI (16.4% vs. 17.0%; RR 1.04; 95% CI 0.02-1.21; p=0.57).

Study Design

Type

Cohort (n=12,381)

Multicenter

Yes

Structured PICO

Does TAVI with a balloon-expandable valve compared to a self-expandable valve improve one-year mortality and stroke rates in patients with severe aortic valve stenosis?

Population

12,381 patients with severe aortic valve stenosis undergoing transfemoral TAVI, analyzed via a propensity-matched cohort of 5,410 patients followed for one year.

Exposure

Transcatheter aortic valve implantation (TAVI) with a balloon-expandable (BE) valve

Comparator

Transcatheter aortic valve implantation (TAVI) with a self-expandable (SE) valve

Outcome

One-year mortalityhard clinical

Balloon-expandable and self-expandable valves for TAVI demonstrate comparable one-year mortality and stroke rates in a large, propensity-matched international cohort.

Main Result

Relative Risk: 1.04 (95% CI 0.02–1.21)

Absolute Event Rate: 16.4% vs 17%

p-value: p=0.57

Abstract

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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