Eric Van Belle1, Flavien Vincent1, Julien Labreuche2, Vincent Auffret3, Nicolas Debry1, Thierry Lefèvre4, Helene Eltchaninoff5, Thibaut Manigold6, Martine Gilard7, Jean-Phillipe Verhoye3, Dominique Himbert8, Rene Koning9, Jean-Phillipe Collet10, Pascal Leprince10, Emmanuel Teiger11, Alain Duhamel2, Alessandro Cosenza1, Guillaume Schurtz1, Sina Porouchani1, Benoit Lattuca12, Emmanuel Robin1, Augustin Coisne1, Thomas Modine1, Marjorie Richardson1, Patrick Joly13, Gilles Rioufol14, Said Ghostine15, Olivier Bar16, Nicolas Amabile17, Didier Champagnac18, Patrick Ohlmann19, Nicolas Meneveau20, Thibaut Lhermusier21, Lionel Leroux22, Florence Leclercq23, Thomas Gandet23, Frédéric Pinaud24, Thomas Cuisset25, Pascal Motreff26, Géraud Souteyrand26, Bernard Iung8, Thierry Folliguet27, Philippe Commeau28, Guillaume Cayla12, Gilles Bayet29, Olivier Darremont30, Christian Spaulding31, Hervé Le Breton3, Cédric Delhaye1. 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.
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.
Authors: Tsuyoshi Kaneko; Sreekanth Vemulapalli; Shun Kohsaka; Kazuo Shimamura; Amanda Stebbins; Hiraku Kumamaru; Adam J Nelson; Andrzej Kosinski; Koichi Maeda; Joseph E Bavaria; Shigeru Saito; Michael J Reardon; Toru Kuratani; Jeffrey J Popma; Taku Inohara; Vinod H Thourani; John D Carroll; Hideyuki Shimizu; Morimasa Takayama; Martin B Leon; Michael J Mack; Yoshiki Sawa Journal: J Am Heart Assoc Date: 2022-03-04 Impact factor: 6.106
Authors: Marko P O Virtanen; Markku Eskola; Mikko Savontaus; Tatu Juvonen; Matti Niemelä; Teemu Laakso; Annastiina Husso; Maina P Jalava; Tuomas Tauriainen; Tuomas Ahvenvaara; Pasi Maaranen; Eeva-Maija Kinnunen; Sebastian Dahlbacka; Mika Laine; Timo Mäkikallio; Antti Valtola; Peter Raivio; Stefano Rosato; Paola D'Errigo; Antti Vento; Juhani Airaksinen; Fausto Biancari Journal: J Cardiothorac Surg Date: 2020-06-29 Impact factor: 1.637
Authors: Simon C Y Chow; Randolph H L Wong; Gary S H Cheung; Alex P W Lee; Henry K L Chui; Kent C Y So; Eugene B Wu Journal: J Cardiothorac Surg Date: 2020-07-29 Impact factor: 1.637
Authors: Vinayak Kumar; Gurpreet S Sandhu; Charles M Harper; Henry H Ting; Charanjit S Rihal Journal: J Am Heart Assoc Date: 2020-04-17 Impact factor: 5.501