5-Year Outcomes With Self-Expanding vs Balloon-Expandable Transcatheter Aortic Valve Replacement in Patients With Small Annuli

Taishi Okuno; Daijiro Tomii; Jonas Lanz; Dik Heg; Fabien Praz; Stefan Stortecky; David Reineke; Stephan Windecker; Thomas Pilgrim

doi:10.1016/j.jcin.2022.11.032

5-Year Outcomes With Self-Expanding vs Balloon-Expandable Transcatheter Aortic Valve Replacement in Patients With Small Annuli

JACC Cardiovasc Interv. 2023 Feb 27;16(4):429-440. doi: 10.1016/j.jcin.2022.11.032.

Authors

Taishi Okuno¹, Daijiro Tomii², Jonas Lanz³, Dik Heg⁴, Fabien Praz⁵, Stefan Stortecky⁶, David Reineke⁷, Stephan Windecker³, Thomas Pilgrim⁸

Affiliations

¹ Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland. Electronic address: https://twitter.com/TaishiOkuno.
² Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland. Electronic address: https://twitter.com/DaijiroTomii.
³ Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland.
⁴ Clinical Trials Unit Bern, University of Bern, Bern, Switzerland.
⁵ Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland. Electronic address: https://twitter.com/FabienPraz.
⁶ Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland. Electronic address: https://twitter.com/StefanStortecky.
⁷ Department of Cardiac Surgery, Inselspital, University of Bern, Bern, Switzerland. Electronic address: https://twitter.com/DReineke76.
⁸ Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland. Electronic address: thomas.pilgrim@insel.ch.

PMID: 36858662
DOI: 10.1016/j.jcin.2022.11.032

Abstract

Background: Self-expanding transcatheter heart valves (THVs) are associated with better echocardiographic hemodynamic performance than balloon-expandable THVs and are considered preferable in patients with small annuli.

Objectives: This study sought to compare 5-year outcomes between self-expanding vs balloon-expandable THVs in severe aortic stenosis (AS) patients with small annuli.

Methods: Consecutive severe AS patients with an aortic valve annulus area <430 mm² who underwent transcatheter aortic valve replacement (TAVR) with either the CoreValve Evolut (Medtronic) or SAPIEN (Edwards Lifesciences) THV between 2012 and 2021 were enrolled from the Bern TAVI registry. A 1:1 propensity-matched analysis was performed to account for baseline differences between groups.

Results: A total of 723 patients were included, and propensity score matching resulted in 171 pairs. Technical success was achieved in over 85% of both groups with no significant difference. Self-expanding THVs were associated with a lower transvalvular gradient (8.0 ± 4.8 mm Hg vs 12.5 ± 4.5 mm Hg; P < 0.001), a larger effective orifice area (1.81 ± 0.46 cm² vs 1.49 ± 0.42 cm²; P < 0.001), and a lower incidence of prosthesis-patient mismatch (19.7% vs 51.8%; P < 0.001) than balloon-expandable THVs. At 5 years, there were no significant differences in mortality (50.4% vs 39.6%; P = 0.269) between groups. Disabling stroke occurred more frequently in patients with a self-expanding THV than those with a balloon-expandable THV (6.6% vs 0.6%; P = 0.030). Similar results were obtained using inverse probability of treatment weighting in the Bern TAVI registry and the nationwide Swiss TAVI registry.

Conclusions: The echocardiographic hemodynamic advantage of self-expanding THVs was not associated with better clinical outcomes compared with balloon-expandable THVs up to 5 years in patients with small annuli. (Swiss TAVI Registry; NCT01368250).

Keywords: aortic valve stenosis; prosthesis-patient mismatch; small annuli; transcatheter aortic valve replacement.

Publication types

Clinical Trial

MeSH terms

Echocardiography
Humans
Lymphatic Vessels*
Propensity Score
Transcatheter Aortic Valve Replacement*
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT01368250