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Clinical Trial
. 2023 Feb 27;16(4):429-440.
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

Taishi Okuno  1 , Daijiro Tomii  2 , Jonas Lanz  3 , Dik Heg  4 , Fabien Praz  5 , Stefan Stortecky  6 , David Reineke  7 , Stephan Windecker  3 , Thomas Pilgrim  8
Affiliations
Free article
Clinical Trial

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

Taishi Okuno et al. JACC Cardiovasc Interv. .
Free article

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.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Okuno has received speaker fees from Abbott. Dr Heg reports with CTU Bern, University of Bern, which has a staff policy of not accepting honoraria or consultancy fees. However, CTU Bern is involved in design, conduct, or analysis of clinical studies funded by not-for-profit and for-profit organizations. In particular, pharmaceutical and medical device companies provide direct funding to some of these studies. For an up-to-date list of CTU Bern’s conflicts of interest see http://www.ctu.unibe.ch/research/declaration_of_interest/index_eng.html. Dr Praz has received travel expenses from Abbott, Edwards Lifesciences, and Polares Medical. Dr Stortecky has received research grants to the institution from Edwards Lifesciences, Medtronic, Boston Scientifc, and Abbott; and has received personal fees from BTG, Teleflex, and Boston Scientific. Dr Windecker has received research and educational grants to the institution from Abbott, Amgen, AstraZeneca, Bristol Myers Squibb, Bayer, Biotronik, Boston Scientific, Cardinal Health, CardioValve, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Johnson & Johnson, Medicure, Medtronic, Novartis, Polares, OrPha Suisse, Pfizer, Regeneron, Sanofi-Aventis, Sinomed, Terumo, and V-Wave; and has served as an unpaid advisory board member and/or an unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bristol Myers Squibb, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Sinomed, V-Wave, and Xeltis but has not received personal payments by pharmaceutical companies or device manufacturers; is a member of the steering/executive committee group of several investigator-initiated trials that receive funding by industry without impact on his personal remuneration; and is an unpaid member of the Pfizer Research Award selection committee in Switzerland and of the Women as One Awards Committee. Dr Pilgrim has received research grants to the institution from Edwards Lifesciences, Boston Scientific, and Biotronik; and has received personal fees from Biotronik, Boston Scientific, Medtronic, Abbott, and HighLife SAS. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Comment in

  • When Anatomy Is Small, Does the Design Matter?
    Van Belle E, Delhaye C, Vincent F. Van Belle E, et al. JACC Cardiovasc Interv. 2023 Feb 27;16(4):441-443. doi: 10.1016/j.jcin.2023.01.004. JACC Cardiovasc Interv. 2023. PMID: 36858663 No abstract available.

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