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Journal Articles Circulation Year : 2020

Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement

Julien Labreuche
  • Function : Author
Vincent Auffret
  • Function : Author
Nicolas Debry
  • Function : Author
Thierry Lefèvre
  • Function : Author
Helene Eltchaninoff
  • Function : Author
Thibaut Manigold
  • Function : Author
Martine Gilard
  • Function : Author
Jean-Phillipe Verhoye
  • Function : Author
Dominique Himbert
  • Function : Author
Rene Koning
  • Function : Author
Jean-Phillipe Collet
  • Function : Author
Pascal Leprince
  • Function : Author
Emmanuel Teiger
  • Function : Author
Alain Duhamel
  • Function : Author
Alessandro Cosenza
  • Function : Author
Guillaume Schurtz
  • Function : Author
Sina Porouchani
  • Function : Author
Benoit Lattuca
  • Function : Author
Emmanuel Robin
  • Function : Author
Augustin Coisne
  • Function : Author
Thomas Modine
  • Function : Author
Marjorie Richardson
  • Function : Author
Patrick Joly
  • Function : Author
Gilles Rioufol
  • Function : Author
Said Ghostine
  • Function : Author
Olivier Bar
  • Function : Author
Nicolas Amabile
  • Function : Author
Didier Champagnac
  • Function : Author
Patrick Ohlmann
  • Function : Author
Nicolas Meneveau
  • Function : Author
Thibaut Lhermusier
  • Function : Author
Lionel Leroux
  • Function : Author
Florence Leclercq
  • Function : Author
Thomas Gandet
  • Function : Author
Frédéric Pinaud
  • Function : Author
Thomas Cuisset
  • Function : Author
Pascal Motreff
  • Function : Author
Géraud Souteyrand
  • Function : Author
Bernard Iung
  • Function : Author
Philippe Commeau
  • Function : Author
Guillaume Cayla
  • Function : Author
Gilles Bayet
  • Function : Author
Olivier Darremont
  • Function : Author
Christian Spaulding
  • Function : Author
Hervé Le Breton
  • Function : Author
Cédric Delhaye
  • Function : Author

Abstract

Background: No randomized study powered to compare balloon expandable (BE) with self expanding (SE) transcatheter heart valves (THVs) on individual end points after transcatheter aortic valve replacement has been conducted to date. Methods: From January 2013 to December 2015, the FRANCE-TAVI nationwide registry (Registry of Aortic Valve Bioprostheses Established by Catheter) included 12 141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for treatment of native aortic stenosis. Long term mortality status was available in all patients (median 20 months; interquartile range, 14 to 30). Patients treated with BE-THV (n=3910) were successfully matched 1:1 with 3910 patients treated with SE-THV by using propensity score (25 clinical, anatomical, and procedural variables) and by date of the procedure (within 3 months). The first coprimary outcome was ≥ moderate occurrence of paravalvular regurgitation or in-hospital mortality, or both. The second coprimary outcome was 2-year all-cause mortality. Results: In propensity–matched analyses, the incidence of the first coprimary outcome was higher with SE-THV (19.8%) compared with BE-THV (11.9%; relative risk, 1.68 [95% CI, 1.46–1.91]; P <0.0001). Each component of the outcome was also higher in patients receiving SE-THV: ≥ moderate paravalvular regurgitation (15.5% versus 8.3%; relative risk, 1.90 [95% CI, 1.63–2.22]; P <0.0001) and in hospital mortality (5.6% versus 4.2%; relative risk, 1.34 [95% CI, 1.07–1.66]; P =0.01). During follow up, all cause mortality occurred in 899 patients treated with SE-THV (2-year mortality, 29.8%) and in 801 patients treated with BE-THV (2-year mortality, 26.6%; hazard ratio, 1.17 [95% CI, 1.06–1.29]; P =0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis. Conclusion: The present study suggests that use of SE-THV was associated with a higher risk of paravalvular regurgitation and higher in-hospital and 2-year mortality compared with use of BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare the latest generation of SE-THV and BE-THV. Clinical Trial Registration: https://www.clinicaltrials.gov . Unique identifier: NCT01777828.

Dates and versions

hal-04395626 , version 1 (15-01-2024)

Identifiers

Cite

Eric van Belle, Flavien Vincent, Julien Labreuche, Vincent Auffret, Nicolas Debry, et al.. Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement. Circulation, 2020, 141 (4), pp.243-259. ⟨10.1161/CIRCULATIONAHA.119.043785⟩. ⟨hal-04395626⟩
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