What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Aortic stenosis (n=45947). Intervention: Balloon-expandable valves (BEVs) vs. Self-expanding valves (SEVs). Primary outcome: All-cause mortality at 30 days (OR 0.85, 95% CI 0.75-0.96).

November 10, 2023Open Access

Short- and Long-term Clinical Outcomes of Balloon-expandable Versus Self-expanding Valves in Patients Undergoing Transcatheter Aortic Valve Replacement: A Meta-analysis

Key Result

At 30 days, balloon-expandable valves significantly reduced all-cause mortality compared to self-expanding valves (OR 0.85), though there was no significant difference in mortality at 1 or 3 years.

Study Design

Type

Meta-Analysis (n=45,947)

Structured PICO

Do balloon-expandable valves improve short- and long-term clinical outcomes compared to self-expanding valves in patients undergoing transcatheter aortic valve replacement?

Population

46,000 patients undergoing transcatheter aortic valve replacement (TAVR) for aortic stenosis, pooled from 41 studies.

Intervention

Balloon-expandable valves (BEVs) (SAPIEN/SAPIEN 3/SAPIEN XT series)

Comparator

Self-expanding valves (SEVs) (CoreValve/Evolut R/Evolut PRO, ACURATE/ACURATE neo, and Portico series)

Outcome

All-cause mortality at short term (in-hospital or 30 days), intermediate term (1 year), and long term (3 years)hard clinical

In TAVR, balloon-expandable valves are associated with lower 30-day mortality, less paravalvular leak, and fewer pacemaker implantations compared to self-expanding valves, though self-expanding valves offer better hemodynamics and long-term mortality is similar.

Main Result

Effect estimate: OR 0.85 (95% CI 0.75-0.96)

Limitations

Most of the studies included were observational in nature.
Patients in this pooled analysis were not matched for their baseline characteristics.
Limited long-term data on the comparison of BEVs and SEVs.
The group of self-expandable valves is heterogeneous with potential differences in valve design.
Comparisons made across generations of transcatheter valves may affect the generalisability of the findings.

Abstract

Background: Distinct clinical differences exist between balloon-expandable valves (BEVs) and self-expanding valves (SEVs) used in transcatheter aortic valve replacement (TAVR) for aortic stenosis. However, randomised data on comparative outcomes are limited. The aim of this meta-analysis was to analyse the differences in short- and longer-term clinical outcomes between the two valve designs. Methods: A comprehensive literature search for all studies up to and including April 2020 on the clinical outcomes of BEVs versus SEVs was performed. Study outcomes were divided into short term (in-hospital or 30 days), intermediate term (1 year) and long term (3 years). The primary outcome was all-cause mortality. Secondary endpoints were stroke or transient ischaemic attack (TIA), life-threatening or major bleeding, at least moderate paravalvular leak (PVL), permanent pacemaker (PPM) implantation, aortic valve area (AVA) and aortic valve mean pressure gradient (AV MPG). Results: A total of 41 studies (BEV, n=23,892; SEV, n=22,055) were included. At in-hospital/30 days, all-cause mortality favoured BEV (OR 0.85; 95% CI 0.75–0.96). BEV had lower rates of PVL (OR 0.42; 95% CI 0.35–0.51) and PPM (OR 0.56; 95% CI 0.44–0.72), but smaller AVA (mean −0.09 cm2; 95% CI −0.17, 0.00) and higher AV MPG (mean 2.54 mmHg; 95% CI 1.84–3.23). There were no significant differences in the incidence of stroke/TIA or bleeding between the two valve designs. At 1 year a lower PPM implantation rate (OR 0.44; 95% CI 0.37–0.52), fewer PVLs (OR 0.26; 95% CI 0.09–0.77), smaller AVA (mean −0.23 cm2; 95% CI −0.35, −0.10) and higher AV MPG (mean 6.05 mmHg; 95% CI 1.74–10.36) were observed with BEV. No significant differences were observed in mortality, stroke/TIA or bleeding. There was no significant difference in mortality at 3 years between the two valve designs. Conclusion: In the short–intermediate term, SEVs had better valve haemodynamics but had higher PVL and PPM implantation rates than BEVs. However, there were no differences in intermediate–long-term mortality, stroke or TIA, or bleeding complications. A better understanding of these differences will enable TAVR operators to tailor their valve choice based on individual patient profile.

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