Romain Didier1, Hélène Eltchaninoff2, Patrick Donzeau-Gouge3, Karine Chevreul4, Jean Fajadet5, Pascal Leprince6, Alain Leguerrier7, Michel Lièvre8, Alain Prat9, Emmanuel Teiger4, Thierry Lefevre3, Didier Tchetché5, Didier Carrié10, Dominique Himbert11, Bernard Albat12, Alain Cribier2, Arnaud Sudre9, Didier Blanchard13, Gilles Rioufol8, Frederic Collet14, Remi Houel15, Pierre Dos Santos16, Nicolas Meneveau17, Said Ghostine18, Thibaut Manigold19, Philippe Guyon20, Thomas Cuisset21, Herve Le Breton7, Stephane Delepine22, Xavier Favereau23, Geraud Souteyrand24, Patrick Ohlmann25, Vincent Doisy26, Thérèse Lognoné27, Antoine Gommeaux28, Jean-Philippe Claudel29, Francois Bourlon30, Bernard Bertrand31, Bernard Iung11, Martine Gilard1. 1. Department of Cardiology, Brest University Hospital, France (R.D., M.G.). 2. Department of Cardiology, Rouen University Hospital, France (H.E., A.C.). 3. Department of Cardiology and Surgery, Institut Cardiovasculaire Paris Sud, Massy, France (P.D.-G., T.L.). 4. Department of Unité de Recherche Clinique en Économie de la Santé D'île-de-France and Cardiology, Creteil University, Paris, France (K.C., E.T.). 5. Department of Cardiology, Clinique Pasteur, Toulouse, France (J.F., D.T.). 6. Department of Surgery, Pitié Salpêtrière University Hospital, Paris, France (P.L.). 7. Department of Cardiology and Surgery, Rennes University Hospital, France (A.L., H.L.B.). 8. UMR and Department of Cardiology, Lyon University Hospital, France (M.L., G.R.). 9. Department of Cardiology and Surgery, Lille University Hospital, France (A.P., A.S.). 10. Department of Cardiology, Toulouse University Hospital, France (D.C.). 11. Department of Cardiology, AP-HP, Bichat Hospital, Paris-Diderot University, DHU Fire, France (D.H., B.I.). 12. Department of Surgery, Montpellier University Hospital, France (B.A.). 13. Department of Cardiology, Georges Pompidou European Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP), University Paris Descartes, France (D.B.). 14. Department of Surgery, Clairval Hospital, Marseille, France (F.C.). 15. Department of Cardiology, Saint Joseph Hospital, Marseille, France (R.H.). 16. Department of Cardiology, Bordeaux University Hospital, France (P.D.S.). 17. Department of Cardiology, Besancon University Hospital, France (N.M.). 18. Department of Cardiology, Centre Cardiologique Marie Lannelongue, Le Plessis-Robinson, France (S.G.). 19. Department of Cardiology, Nantes University Hospital, France (T.M.). 20. Department of Cardiology, Centre Cardiologique Nord, Saint Denis, France (P.G.). 21. Department of Cardiology, Marseille University Hospital, France (T.C.). 22. Department of Cardiology, Angers University Hospital, France (S.D.). 23. Department of Cardiology, Parly 2 Hospital, Le Chesnay, France (X.F.). 24. Department of Cardiology, Clermont Ferrand University Hospital, France (G.S.). 25. Department of Cardiology, Strasbourg University Hospital, France (P.O.). 26. Department of Surgery, Clinique du Tonkin, Lyon, France (V.D.). 27. Department of Cardiology, Saint-Malo Hospital, France (T.L.). 28. Department of Cardiology, Bois-Bernard Hospital, France (A.G.). 29. Department of Cardiology, Infirmerie Protestante, Lyon, France (J.-P.C.). 30. Department of Cardiology, Centre Cardio-Thoracique, Monaco (F.B.). 31. Department of Cardiology, Grenoble University Hospital, France (B.B.).
Abstract
BACKGROUND: The FRANCE-2 registry (French Aortic National Corevalve and Edwards) previously reported good early- and medium-term clinical and echocardiographic efficacy for transcatheter aortic valve replacement. We here report 5-year follow-up results from the registry. METHODS: The registry includes all consecutive patients undergoing transcatheter aortic valve replacement for severe aortic stenosis in France. Follow-up is scheduled at 30 days, 6 months, then annually from 1 to 5 years. Clinical events were defined according to the Valve Academic Research Consortium criteria, and hemodynamic structural valve deterioration (SVD) was defined according to the consensus statement by the European Association of Percutaneous Cardiovascular Interventions. RESULTS: Between January 2010 and January 2012, 4201 patients were enrolled in 34 centers. Five-year vital status was available for 95.5% of patients; 88.1% had clinical evaluation or died. Overall, at 5 years, all-cause mortality was 60.8% (n=2478; 95% CI, 59.3% to 62.3%). The majority of cardiovascular events occurred in the first month after valve implantation, and incidence remained low thereafter, at <2% per year up to 5 years, except for heart failure. The rate of heart failure was 14.3% at 1 year, then decreased over time to <5% per year. In cumulative incidence function, the rates of severe SVD and moderate/severe SVD at 5 years were 2.5% and 13.3%, respectively. Mortality did not differ between patients with or without severe SVD (hazard ratio, 0.71; 95% CI, 0.47-1.07; P=0.1). Finally, in the population of patients with severe SVD, 1 patient (1.7%) experienced a stroke, and 8 patients presented ≥1 heart failure event (13.3%). CONCLUSIONS: The 5-year follow-up results of the FRANCE-2 registry represent the largest long-term data set available in a high-risk population. In surviving patients, the low rate of clinical events and the low level of SVD after 1 year support the long-term efficacy of transcatheter aortic valve replacement in both types of transcatheter prosthesis featuring in the registry.
BACKGROUND: The FRANCE-2 registry (French Aortic National Corevalve and Edwards) previously reported good early- and medium-term clinical and echocardiographic efficacy for transcatheter aortic valve replacement. We here report 5-year follow-up results from the registry. METHODS: The registry includes all consecutive patients undergoing transcatheter aortic valve replacement for severe aortic stenosis in France. Follow-up is scheduled at 30 days, 6 months, then annually from 1 to 5 years. Clinical events were defined according to the Valve Academic Research Consortium criteria, and hemodynamic structural valve deterioration (SVD) was defined according to the consensus statement by the European Association of Percutaneous Cardiovascular Interventions. RESULTS: Between January 2010 and January 2012, 4201 patients were enrolled in 34 centers. Five-year vital status was available for 95.5% of patients; 88.1% had clinical evaluation or died. Overall, at 5 years, all-cause mortality was 60.8% (n=2478; 95% CI, 59.3% to 62.3%). The majority of cardiovascular events occurred in the first month after valve implantation, and incidence remained low thereafter, at <2% per year up to 5 years, except for heart failure. The rate of heart failure was 14.3% at 1 year, then decreased over time to <5% per year. In cumulative incidence function, the rates of severe SVD and moderate/severe SVD at 5 years were 2.5% and 13.3%, respectively. Mortality did not differ between patients with or without severe SVD (hazard ratio, 0.71; 95% CI, 0.47-1.07; P=0.1). Finally, in the population of patients with severe SVD, 1 patient (1.7%) experienced a stroke, and 8 patients presented ≥1 heart failure event (13.3%). CONCLUSIONS: The 5-year follow-up results of the FRANCE-2 registry represent the largest long-term data set available in a high-risk population. In surviving patients, the low rate of clinical events and the low level of SVD after 1 year support the long-term efficacy of transcatheter aortic valve replacement in both types of transcatheter prosthesis featuring in the registry.
Authors: Marie-Isabel K Murray; Eileen Hofmann; Roberta De Rosa; Silvia Mas-Peiro; Philipp Seppelt; Thomas Walther; Andreas M Zeiher; Stephan Fichtlscherer; Mariuca Vasa-Nicotera Journal: J Interv Cardiol Date: 2019-10-01 Impact factor: 2.279
Authors: Isaac Pascual; Marcel Almendárez; Rut Álvarez Velasco; Antonio Adeba; Daniel Hernández-Vaquero; Rebeca Lorca; Rocío Díaz; Alberto Alperi; Héctor Cubero-Gallego; Jose Rozado; César Morís; Pablo Avanzas Journal: Ann Transl Med Date: 2020-08
Authors: Daniela Haase; Laura Bäz; Marcus Franz; P Christian Schulze; Tarek Bekfani; Sophie Neugebauer; Michael Kiehntopf; Sven Möbius-Winkler Journal: Clin Res Cardiol Date: 2020-10-14 Impact factor: 5.460