Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement-Reference-Cited by-同舟云学术

Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement

Published:2020-01-28 Issue:4 Volume:141 Page:243-259
ISSN:0009-7322
Container-title:Circulation
language:en
Short-container-title:Circulation

Author:

Van Belle Eric¹,Vincent Flavien¹,Labreuche Julien²,Auffret Vincent³,Debry Nicolas¹,Lefèvre Thierry⁴,Eltchaninoff Helene⁵,Manigold Thibaut⁶,Gilard Martine⁷,Verhoye Jean-Phillipe³,Himbert Dominique⁸,Koning Rene⁹,Collet Jean-Phillipe¹⁰,Leprince Pascal¹⁰,Teiger Emmanuel¹¹,Duhamel Alain²,Cosenza Alessandro¹,Schurtz Guillaume¹,Porouchani Sina¹,Lattuca Benoit¹²,Robin Emmanuel¹,Coisne Augustin¹,Modine Thomas¹,Richardson Marjorie¹,Joly Patrick¹³,Rioufol Gilles¹⁴,Ghostine Said¹⁵,Bar Olivier¹⁶,Amabile Nicolas¹⁷,Champagnac Didier¹⁸,Ohlmann Patrick¹⁹,Meneveau Nicolas²⁰,Lhermusier Thibaut²¹,Leroux Lionel²²,Leclercq Florence²³,Gandet Thomas²³,Pinaud Frédéric²⁴,Cuisset Thomas²⁵,Motreff Pascal²⁶,Souteyrand Géraud²⁶,Iung Bernard⁸,Folliguet Thierry²⁷,Commeau Philippe²⁸,Cayla Guillaume¹²,Bayet Gilles²⁹,Darremont Olivier³⁰,Spaulding Christian³¹,Le Breton Hervé³,Delhaye Cédric¹

Affiliation:

1. Département de Cardiologie, Institut Coeur Poumon, Inserm U1011, Institut Pasteur de Lille, EGID (E.V.B., F.V., N.D., A. Cosenza, G. Schurtz, S.P., E.R., A. Coisne, T. Modine, M.R., C.D.)

2. Department of Biostatistics, EA 2694-Santé Publique: épidémiologie et Qualité des Soins (J.L., A.D.)

3. CHU de Lille, Université de Lille, France. CHU Pontchaillou, Service de Cardiologie et Maladies Vasculaires, CIC-IT 804, Université de Rennes 1, Laboratoire de Traitement du Signal et de l’Image, Inserm U1099, Rennes, France (V.A., J.P.-V., H.L.B.).

4. Institut Cardiovasculaire Paris-Sud, Hôpital Privé Jacques-Cartier, Massy, France (T. Lefèvre).

5. CHU Rouen–Charles-Nicolle, Service de Cardiologie, Inserm U644, Rouen, France (H.E.).

6. CHU Guillaume et René Laennec, Institut du Thorax, Service de Cardiologie, Nantes, France (T. Manigold).

7. CHU La Cavale Blanche, Département de Cardiologie, Optimisation des Régulations Physiologiques, UFR Sciences et Techniques, Brest, France (M.G.).

8. AP–HP, Hôpital Bichat, Département de Cardiologie, Université Paris-Diderot, France (D.H., B.I.).

9. Clinique Saint-Hilaire, Service de Cardiologie, Rouen, France (R.K.).

10. AP–HP, CHU La Pitié-Salpêtrière, Service de Cardiologie, Paris, France (J.-P.C., P.L.).

11. Hôpital Henri-Mondor Assistance Publique Hôpitaux de Paris, Département de Cardiologie, Créteil, France (E.T.).

12. CHU Nîmes, Cardiologie, Université Montpellier, Nimes, France (B.L., G.C.).

13. Hopital Saint-Joseph, Fédération de Cardiologie, Marseille, France (P.J.).

14. CHU Louis Pradel, Division de Cardiologie, Centre d’Investigation Clinique de Lyon (CIC), Bron, France (G.R.).

15. Centre Marie Lannelongue, Département de Cardiologie, Le Plessis Robinson, France (S.G.).

16. Clinique Saint Gatien, Service de Cardiologie, Tours, France (O.B.).

17. Institut Mutualiste Montsouris, Département de Cardiologie, Paris, France (N.A.).

18. Clinique du Tonkin, Service de Cardiologie, Villeurbanne, France (D.C.).

19. CHU de Strasbourg, Nouvel Hôpital Civil, Département de Cardiologie, Université de Strasbourg, France (P.O.).

20. CHU Besançon, Cardiologie, Hopital Jean Minjoz, Besançon, France (N.M.).

21. CHU de Toulouse, Département de Cardiologie, Inserm U1048, Université de Toulouse 3, France (T. Lhermusier).

22. Hôpital Cardiologique du Haut-Lévêque, Département de Cardiologie Interventionnelle, Université de Bordeaux, Pessac, France (L.L.).

23. CHU Arnaud de Villeneuve, Service de Cardiologie, Montpellier, France (F.L., T.G.).

24. CHU d’Angers, Service de Chirurgie Cardiaque, CNRS UMR 6214, INSERM 1083, Université d’Angers, France (F.P.).

25. CHU La Timone Assistance Publique Hôpitaux de Marseille, Département de Cardiologie, Inserm UMR1062, INRA UMR 1260, Université d’Aix-Marseille, France (T.C.).

26. CHU Gabriel Montpied, Département de Cardiologie, ISIT, CaVITI, CNRS (UMR-6284), Université d’Auvergne, Clermont-Ferrand, France (P.M., G. Souteyrand).

27. CHU de Nancy, Service de Chirurgie Cardiovasculaire, Vandoeuvre-lès-Nancy, France (T.F.).

28. Polyclinique les Fleurs, Cardiologie, Ollioules, France (P.C.).

29. Hôpital Privé Clairval, Service de Cardiologie, Marseille, France (G.B.).

30. Clinique Saint Augustin, Service de Cardiologie, Bordeaux, France (O.D.).

31. Hôpital Européen Georges Pompidou, Paris, France (C.S.).

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Physiology (medical),Cardiology and Cardiovascular Medicine

Reference32 articles.

1. Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery

2. Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients

3. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients

4. Transcatheter Aortic Valve Replacement Using a Self-Expanding Bioprosthesis in Patients With Severe Aortic Stenosis at Extreme Risk for Surgery

5. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients

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