{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T21:23:22Z","timestamp":1790371402123,"version":"4.1.0"},"reference-count":32,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"4","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circulation"],"published-print":{"date-parts":[[2020,1,28]]},"abstract":"<jats:sec>\n            <jats:title>Background:<\/jats:title>\n            <jats:p>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.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods:<\/jats:title>\n            <jats:p>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 \u2265 moderate occurrence of paravalvular regurgitation or in-hospital mortality, or both. The second coprimary outcome was 2-year all-cause mortality.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results:<\/jats:title>\n            <jats:p>\n              In propensity\u2013matched 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\u20131.91];\n              <jats:italic>P<\/jats:italic>\n              &lt;0.0001). Each component of the outcome was also higher in patients receiving SE-THV: \u2265 moderate paravalvular regurgitation (15.5% versus 8.3%; relative risk, 1.90 [95% CI, 1.63\u20132.22];\n              <jats:italic>P<\/jats:italic>\n              &lt;0.0001) and in hospital mortality (5.6% versus 4.2%; relative risk, 1.34 [95% CI, 1.07\u20131.66];\n              <jats:italic>P<\/jats:italic>\n              =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\u20131.29];\n              <jats:italic>P<\/jats:italic>\n              =0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusion:<\/jats:title>\n            <jats:p>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.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Clinical Trial Registration:<\/jats:title>\n            <jats:p>\n              <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n              . Unique identifier: NCT01777828.\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/circulationaha.119.043785","type":"journal-article","created":{"date-parts":[[2019,11,16]],"date-time":"2019-11-16T22:31:48Z","timestamp":1573943508000},"page":"243-259","update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":151,"title":["Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement"],"prefix":"10.1161","volume":"141","author":[{"given":"Eric","family":"Van Belle","sequence":"first","affiliation":[{"name":"D\u00e9partement 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.)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Flavien","family":"Vincent","sequence":"additional","affiliation":[{"name":"D\u00e9partement 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.)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julien","family":"Labreuche","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, EA 2694-Sant\u00e9 Publique: \u00e9pid\u00e9miologie et Qualit\u00e9 des Soins (J.L., A.D.)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincent","family":"Auffret","sequence":"additional","affiliation":[{"name":"CHU de Lille, Universit\u00e9 de Lille, France. CHU Pontchaillou, Service de Cardiologie et Maladies Vasculaires, CIC-IT 804, Universit\u00e9 de Rennes 1, Laboratoire de Traitement du Signal et de l\u2019Image, Inserm U1099, Rennes, France (V.A., J.P.-V., H.L.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Debry","sequence":"additional","affiliation":[{"name":"D\u00e9partement 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.)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thierry","family":"Lef\u00e8vre","sequence":"additional","affiliation":[{"name":"Institut Cardiovasculaire Paris-Sud, H\u00f4pital Priv\u00e9 Jacques-Cartier, Massy, France (T. Lef\u00e8vre)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helene","family":"Eltchaninoff","sequence":"additional","affiliation":[{"name":"CHU Rouen\u2013Charles-Nicolle, Service de Cardiologie, Inserm U644, Rouen, France (H.E.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thibaut","family":"Manigold","sequence":"additional","affiliation":[{"name":"CHU Guillaume et Ren\u00e9 Laennec, Institut du Thorax, Service de Cardiologie, Nantes, France (T. Manigold)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martine","family":"Gilard","sequence":"additional","affiliation":[{"name":"CHU La Cavale Blanche, D\u00e9partement de Cardiologie, Optimisation des R\u00e9gulations Physiologiques, UFR Sciences et Techniques, Brest, France (M.G.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Phillipe","family":"Verhoye","sequence":"additional","affiliation":[{"name":"CHU de Lille, Universit\u00e9 de Lille, France. CHU Pontchaillou, Service de Cardiologie et Maladies Vasculaires, CIC-IT 804, Universit\u00e9 de Rennes 1, Laboratoire de Traitement du Signal et de l\u2019Image, Inserm U1099, Rennes, France (V.A., J.P.-V., H.L.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dominique","family":"Himbert","sequence":"additional","affiliation":[{"name":"AP\u2013HP, H\u00f4pital Bichat, D\u00e9partement de Cardiologie, Universit\u00e9 Paris-Diderot, France (D.H., B.I.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rene","family":"Koning","sequence":"additional","affiliation":[{"name":"Clinique Saint-Hilaire, Service de Cardiologie, Rouen, France (R.K.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Phillipe","family":"Collet","sequence":"additional","affiliation":[{"name":"AP\u2013HP, CHU La Piti\u00e9-Salp\u00eatri\u00e8re, Service de Cardiologie, Paris, France (J.-P.C., P.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pascal","family":"Leprince","sequence":"additional","affiliation":[{"name":"AP\u2013HP, CHU La Piti\u00e9-Salp\u00eatri\u00e8re, Service de Cardiologie, Paris, France (J.-P.C., P.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmanuel","family":"Teiger","sequence":"additional","affiliation":[{"name":"H\u00f4pital Henri-Mondor Assistance Publique H\u00f4pitaux de Paris, D\u00e9partement de Cardiologie, Cr\u00e9teil, France (E.T.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alain","family":"Duhamel","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, EA 2694-Sant\u00e9 Publique: \u00e9pid\u00e9miologie et Qualit\u00e9 des Soins (J.L., A.D.)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandro","family":"Cosenza","sequence":"additional","affiliation":[{"name":"D\u00e9partement de Cardiologie, Institut Coeur Poumon, Inserm U1011, Institut Pasteur de Lille, EGID (E.V.B., F.V., N.D., A. 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