Late Outcomes of Transcatheter Aortic Valve Replacement in High-Risk Patients: The FRANCE-2 Registry

M. Gilard; H. Eltchaninoff; P. Donzeau-Gouge; K. Chevreul; J. Fajadet; P. Leprince; A. Leguerrier; M. Lievre; A. Prat; E. Teiger; T. Lefevre; D. Tchetche; D. Carrie; D. Himbert; B. Albat; A. Cribier; A. Sudre; D. Blanchard; G. Rioufol; F. Collet; R. Houel; Santos P. Dos; N. Meneveau; S. Ghostine; T. Manigold; P. Guyon; D. Grisoli; Breton H. Le; S. Delpine; R. Didier; X. Favereau; G. Souteyrand; P. Ohlmann; V. Doisy; G. Grollier; A. Gommeaux; Claudel J. -P.; F. Bourlon; B. Bertrand; M. Laskar; B. Iung; M. Gilard; M. Laskar; H. Eltchaninoff; J. Fajadet; B. Iung; E. Teiger; P. Donzeau-Gouge; P. Leprince; A. Leguerrier; A. Prat; K. Chevreul; M. Lievre; M. Bertrand; J. Cassagne; J. Boschat; J. R. Lusson; P. Mathieu; Y. Logeais; Bessou J. -P.; T. Lefevre; B. Chevalier; A. Farge; P. Garot; T. Hovasse; M. C. Morice; M. Romano; P. D. Gouge; D. Tchetche; O. Vahdat; B. Farah; J. Fajadet; D. Carrie; N. Dumonteil; G. Fournial; B. Marcheix; D. Himbert; P. Nataf; A. Vahanian; B. Albat; F. Leclercq; C. Piot; L. Schmutz; P. Aubas; Cailar A. du; A. Dubar; N. Durrleman; F. Fargosz; G. Levy; E. Maupas; F. Rivalland; G. Robert; H. Eltchaninoff; Bessou J. -P.; A. Cribier; C. Tron; A. Sudre; F. Juthier; T. Modine; Belle E. Van; Carlo Banfi; D. Blanchard; T. Sallerin; O. Bar; C. Barbey; S. Chassaing; D. Chatel; Page O. Le; A. Tauran; G. Rioufol; D. Cao; R. Dauphin; de Gevigney G. Durand; G. Finet; O. Jegaden; Obadia J. -F.; P. Leprince; F. Beygui; Collet J. -P.; A. Pavie; F. Collet; Pecheux Bayet; A. Vaillant; J. Vicat; O. Wittenberg; R. Houel; P. Joly; R. Rosario; P. Bergeron; J. Bille; R. Gelisse; E. Teiger; Couetil J. -P.; Dubois Rande J. -L.; D. Hayat; E. Fougeres; Monin J. -L.; G. Mouillet; Santos P. Dos; F. Arsac; E. Choukroun; M. Dijos; Guibaud J. -P.; L. Leroux; N. Elia; N. Meneveau; Descotes Genon; S. Chocron; F. Schiele; C. Caussin; A. Azmoun; S. Ghostine; R. Nottin; A. Tirouvanziam; D. Crochet; R. Gaudin; Roussel J. -C.; P. Guyon; N. Bonnet; F. Digne; P. Mesnidrey; T. Royer; V. Stratiev; D. Grisoli; Bonnet J. -L.; T. Cuisset; D. Grisoli; Breton H. Le; I. Abouliatim; M. Bedossa; D. Boulmier; J. P. Verhoye; S. Delepine; Debrux J. -L.; A. Furber; F. Pinaud; M. Gilard; E. Bezon; J. Boschat; Choplain J. -N.; X. Favereau; O. Bical; G. Dambrin; P. Deleuze; A. Jegou; Lusson J. -R.; K. Azarnouch; N. Durel; A. Innorta; G. Souteyrand; V. Doisy; Y. Lienhart; R. Roriz; P. Staat; D. Blanchard; Fabiani J. -N.; A. Lafont; R. Zegdi; D. Heudes; P. Ohlmann; M. Kindo; Mazzucotelli J. -P.; M. Zupan; G. Grollier; C. Ivascau; T. Lognone; Massimo Massetti; R. Sabatier; B. Huret; A. Gommeaux; P. Hochart; null Pecheux; Claudel J. -P.; D. Bouchayer; F. Gabrielle; F. Pelissier; G. Tremeau; F. Bourlon; G. Dreyfus; A. Eker; Y. Habib; N. Hugues; C. Mialhe; B. Bertrand; O. Chavanon; P. Porcu; G. Vanzetto

doi:10.1016/j.jacc.2016.07.747

Late Outcomes of Transcatheter Aortic Valve Replacement in High-Risk Patients: The FRANCE-2 Registry

M. Gilard^*, H. Eltchaninoff, P. Donzeau-Gouge, K. Chevreul, J. Fajadet, P. Leprince, A. Leguerrier, M. Lievre, A. Prat, E. Teiger, T. Lefevre, D. Tchetche, D. Carrie, D. Himbert, B. Albat, A. Cribier, A. Sudre, D. Blanchard, G. Rioufol, F. ColletR. Houel, Santos P. Dos, N. Meneveau, S. Ghostine, T. Manigold, P. Guyon, D. Grisoli, Breton H. Le, S. Delpine, R. Didier, X. Favereau, G. Souteyrand, P. Ohlmann, V. Doisy, G. Grollier, A. Gommeaux, Claudel J. -P., F. Bourlon, B. Bertrand, M. Laskar, B. Iung, M. Gilard^*, M. Laskar, H. Eltchaninoff, J. Fajadet, B. Iung, E. Teiger, P. Donzeau-Gouge, P. Leprince, A. Leguerrier, A. Prat, K. Chevreul, M. Lievre, M. Bertrand, J. Cassagne, J. Boschat, J. R. Lusson, P. Mathieu, Y. Logeais, Bessou J. -P., T. Lefevre, B. Chevalier, A. Farge, P. Garot, T. Hovasse, M. C. Morice, M. Romano, P. D. Gouge, D. Tchetche, O. Vahdat, B. Farah, J. Fajadet, D. Carrie, N. Dumonteil, G. Fournial, B. Marcheix, D. Himbert, P. Nataf, A. Vahanian, B. Albat, F. Leclercq, C. Piot, L. Schmutz, P. Aubas, Cailar A. du, A. Dubar, N. Durrleman, F. Fargosz, G. Levy, E. Maupas, F. Rivalland, G. Robert, H. Eltchaninoff, Bessou J. -P., A. Cribier, C. Tron, A. Sudre, F. Juthier, T. Modine, Belle E. Van, Carlo Banfi, D. Blanchard, T. Sallerin, O. Bar, C. Barbey, S. Chassaing, D. Chatel, Page O. Le, A. Tauran, G. Rioufol, D. Cao, R. Dauphin, de Gevigney G. Durand, G. Finet, O. Jegaden, Obadia J. -F., P. Leprince, F. Beygui, Collet J. -P., A. Pavie, F. Collet, Pecheux Bayet, A. Vaillant, J. Vicat, O. Wittenberg, R. Houel, P. Joly, R. Rosario, P. Bergeron, J. Bille, R. Gelisse, E. Teiger, Couetil J. -P., Dubois Rande J. -L., D. Hayat, E. Fougeres, Monin J. -L., G. Mouillet, Santos P. Dos, F. Arsac, E. Choukroun, M. Dijos, Guibaud J. -P., L. Leroux, N. Elia, N. Meneveau, Descotes Genon, S. Chocron, F. Schiele, C. Caussin, A. Azmoun, S. Ghostine, R. Nottin, A. Tirouvanziam, D. Crochet, R. Gaudin, Roussel J. -C., P. Guyon, N. Bonnet, F. Digne, P. Mesnidrey, T. Royer, V. Stratiev, D. Grisoli, Bonnet J. -L., T. Cuisset, D. Grisoli, Breton H. Le, I. Abouliatim, M. Bedossa, D. Boulmier, J. P. Verhoye, S. Delepine, Debrux J. -L., A. Furber, F. Pinaud, M. Gilard^*, E. Bezon, J. Boschat, Choplain J. -N., X. Favereau, O. Bical, G. Dambrin, P. Deleuze, A. Jegou, Lusson J. -R., K. Azarnouch, N. Durel, A. Innorta, G. Souteyrand, V. Doisy, Y. Lienhart, R. Roriz, P. Staat, D. Blanchard, Fabiani J. -N., A. Lafont, R. Zegdi, D. Heudes, P. Ohlmann, M. Kindo, Mazzucotelli J. -P., M. Zupan, G. Grollier, C. Ivascau, T. Lognone, Massimo Massetti, R. Sabatier, B. Huret, A. Gommeaux, P. Hochart, Pecheux, Claudel J. -P., D. Bouchayer, F. Gabrielle, F. Pelissier, G. Tremeau, F. Bourlon, G. Dreyfus, A. Eker, Y. Habib, N. Hugues, C. Mialhe, B. Bertrand, O. Chavanon, P. Porcu, G. Vanzetto

^*Corresponding author

Research output: Contribution to journal › Article

74 Citations (Scopus)

Abstract

Background Transcatheter aortic valve replacement (TAVR) has revolutionized management of high-risk patients with severe aortic stenosis. However, survival and the incidence of severe complications have been assessed in relatively small populations and/or with limited follow-up. Objectives This report details late clinical outcome and its determinants in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry. Methods The FRANCE-2 registry prospectively included all TAVRs performed in France. Follow-up was scheduled at 30 days, at 6 months, and annually from 1 to 5 years. Standardized VARC (Valve Academic Research Consortium) outcome definitions were used. Results A total of 4,201 patients were enrolled between January 2010 and January 2012 in 34 centers. Approaches were transarterial (transfemoral 73%, transapical 18%, subclavian 6%, and transaortic or transcarotid 3%) or, in 18% of patients, transapical. Median follow-up was 3.8 years. Vital status was available for 97.2% of patients at 3 years. The 3-year all-cause mortality was 42.0% and cardiovascular mortality was 17.5%. In a multivariate model, predictors of 3-year all-cause mortality were male sex (p < 0.001), low body mass index, (p < 0.001), atrial fibrillation (p < 0.001), dialysis (p < 0.001), New York Heart Association functional class III or IV (p < 0.001), higher logistic EuroSCORE (p < 0.001), transapical or subclavian approach (p < 0.001 for both vs. transfemoral approach), need for permanent pacemaker implantation (p = 0.02), and post-implant periprosthetic aortic regurgitation grade ≥2 of 4 (p < 0.001). Severe events according to VARC criteria occurred mainly during the first month and subsequently in <2% of patients/year. Mean gradient, valve area, and residual aortic regurgitation were stable during follow-up. Conclusions The FRANCE-2 registry represents the largest database available on late results of TAVR. Late mortality is largely related to noncardiac causes. Incidence rates of severe events are low after the first month. Valve performance remains stable over time.

Original language	English
Pages (from-to)	1637-1647
Number of pages	11
Journal	Journal of the American College of Cardiology
Volume	68
Issue number	15
DOIs	https://doi.org/10.1016/j.jacc.2016.07.747
Publication status	Published - 2016

All Science Journal Classification (ASJC) codes

Cardiology and Cardiovascular Medicine

Keywords

80 and over
Aged
Aortic Valve Stenosis
Female
France
Humans
Male
Prospective Studies
Registries
Risk Assessment
Time Factors
Transcatheter Aortic Valve Replacement
Treatment Outcome
aortic stenosis
predictive analysis
risk score

Access to Document

10.1016/j.jacc.2016.07.747

Cite this

Gilard, M., Eltchaninoff, H., Donzeau-Gouge, P., Chevreul, K., Fajadet, J., Leprince, P., Leguerrier, A., Lievre, M., Prat, A., Teiger, E., Lefevre, T., Tchetche, D., Carrie, D., Himbert, D., Albat, B., Cribier, A., Sudre, A., Blanchard, D., Rioufol, G., ... Vanzetto, G. (2016). Late Outcomes of Transcatheter Aortic Valve Replacement in High-Risk Patients: The FRANCE-2 Registry. Journal of the American College of Cardiology, 68(15), 1637-1647. https://doi.org/10.1016/j.jacc.2016.07.747

@article{3903be0109054a5badfb9e17aa674041,

title = "Late Outcomes of Transcatheter Aortic Valve Replacement in High-Risk Patients: The FRANCE-2 Registry",

abstract = "Background Transcatheter aortic valve replacement (TAVR) has revolutionized management of high-risk patients with severe aortic stenosis. However, survival and the incidence of severe complications have been assessed in relatively small populations and/or with limited follow-up. Objectives This report details late clinical outcome and its determinants in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry. Methods The FRANCE-2 registry prospectively included all TAVRs performed in France. Follow-up was scheduled at 30 days, at 6 months, and annually from 1 to 5 years. Standardized VARC (Valve Academic Research Consortium) outcome definitions were used. Results A total of 4,201 patients were enrolled between January 2010 and January 2012 in 34 centers. Approaches were transarterial (transfemoral 73%, transapical 18%, subclavian 6%, and transaortic or transcarotid 3%) or, in 18% of patients, transapical. Median follow-up was 3.8 years. Vital status was available for 97.2% of patients at 3 years. The 3-year all-cause mortality was 42.0% and cardiovascular mortality was 17.5%. In a multivariate model, predictors of 3-year all-cause mortality were male sex (p < 0.001), low body mass index, (p < 0.001), atrial fibrillation (p < 0.001), dialysis (p < 0.001), New York Heart Association functional class III or IV (p < 0.001), higher logistic EuroSCORE (p < 0.001), transapical or subclavian approach (p < 0.001 for both vs. transfemoral approach), need for permanent pacemaker implantation (p = 0.02), and post-implant periprosthetic aortic regurgitation grade ≥2 of 4 (p < 0.001). Severe events according to VARC criteria occurred mainly during the first month and subsequently in <2% of patients/year. Mean gradient, valve area, and residual aortic regurgitation were stable during follow-up. Conclusions The FRANCE-2 registry represents the largest database available on late results of TAVR. Late mortality is largely related to noncardiac causes. Incidence rates of severe events are low after the first month. Valve performance remains stable over time.",

keywords = "80 and over, Aged, Aortic Valve Stenosis, Female, France, Humans, Male, Prospective Studies, Registries, Risk Assessment, Time Factors, Transcatheter Aortic Valve Replacement, Treatment Outcome, aortic stenosis, predictive analysis, risk score, 80 and over, Aged, Aortic Valve Stenosis, Female, France, Humans, Male, Prospective Studies, Registries, Risk Assessment, Time Factors, Transcatheter Aortic Valve Replacement, Treatment Outcome, aortic stenosis, predictive analysis, risk score",

author = "M. Gilard and H. Eltchaninoff and P. Donzeau-Gouge and K. Chevreul and J. Fajadet and P. Leprince and A. Leguerrier and M. Lievre and A. Prat and E. Teiger and T. Lefevre and D. Tchetche and D. Carrie and D. Himbert and B. Albat and A. Cribier and A. Sudre and D. Blanchard and G. Rioufol and F. Collet and R. Houel and Dos, {Santos P.} and N. Meneveau and S. Ghostine and T. Manigold and P. Guyon and D. Grisoli and Le, {Breton H.} and S. Delpine and R. Didier and X. Favereau and G. Souteyrand and P. Ohlmann and V. Doisy and G. Grollier and A. Gommeaux and -P., {Claudel J.} and F. Bourlon and B. Bertrand and M. Laskar and B. Iung and M. Gilard and M. Laskar and H. Eltchaninoff and J. Fajadet and B. Iung and E. Teiger and P. Donzeau-Gouge and P. Leprince and A. Leguerrier and A. Prat and K. Chevreul and M. Lievre and M. Bertrand and J. Cassagne and J. Boschat and Lusson, {J. R.} and P. Mathieu and Y. Logeais and -P., {Bessou J.} and T. Lefevre and B. Chevalier and A. Farge and P. Garot and T. Hovasse and Morice, {M. C.} and M. Romano and Gouge, {P. D.} and D. Tchetche and O. Vahdat and B. Farah and J. Fajadet and D. Carrie and N. Dumonteil and G. Fournial and B. Marcheix and D. Himbert and P. Nataf and A. Vahanian and B. Albat and F. Leclercq and C. Piot and L. Schmutz and P. Aubas and du, {Cailar A.} and A. Dubar and N. Durrleman and F. Fargosz and G. Levy and E. Maupas and F. Rivalland and G. Robert and H. Eltchaninoff and -P., {Bessou J.} and A. Cribier and C. Tron and A. Sudre and F. Juthier and T. Modine and Van, {Belle E.} and Carlo Banfi and D. Blanchard and T. Sallerin and O. Bar and C. Barbey and S. Chassaing and D. Chatel and Le, {Page O.} and A. Tauran and G. Rioufol and D. Cao and R. Dauphin and Durand, {de Gevigney G.} and G. Finet and O. Jegaden and -F., {Obadia J.} and P. Leprince and F. Beygui and -P., {Collet J.} and A. Pavie and F. Collet and Pecheux Bayet and A. Vaillant and J. Vicat and O. Wittenberg and R. Houel and P. Joly and R. Rosario and P. Bergeron and J. Bille and R. Gelisse and E. Teiger and -P., {Couetil J.} and -L., {Dubois Rande J.} and D. Hayat and E. Fougeres and -L., {Monin J.} and G. Mouillet and Dos, {Santos P.} and F. Arsac and E. Choukroun and M. Dijos and -P., {Guibaud J.} and L. Leroux and N. Elia and N. Meneveau and Descotes Genon and S. Chocron and F. Schiele and C. Caussin and A. Azmoun and S. Ghostine and R. Nottin and A. Tirouvanziam and D. Crochet and R. Gaudin and -C., {Roussel J.} and P. Guyon and N. Bonnet and F. Digne and P. Mesnidrey and T. Royer and V. Stratiev and D. Grisoli and -L., {Bonnet J.} and T. Cuisset and D. Grisoli and Le, {Breton H.} and I. Abouliatim and M. Bedossa and D. Boulmier and Verhoye, {J. P.} and S. Delepine and -L., {Debrux J.} and A. Furber and F. Pinaud and M. Gilard and E. Bezon and J. Boschat and -N., {Choplain J.} and X. Favereau and O. Bical and G. Dambrin and P. Deleuze and A. Jegou and -R., {Lusson J.} and K. Azarnouch and N. Durel and A. Innorta and G. Souteyrand and V. Doisy and Y. Lienhart and R. Roriz and P. Staat and D. Blanchard and -N., {Fabiani J.} and A. Lafont and R. Zegdi and D. Heudes and P. Ohlmann and M. Kindo and -P., {Mazzucotelli J.} and M. Zupan and G. Grollier and C. Ivascau and T. Lognone and Massimo Massetti and R. Sabatier and B. Huret and A. Gommeaux and P. Hochart and Pecheux and -P., {Claudel J.} and D. Bouchayer and F. Gabrielle and F. Pelissier and G. Tremeau and F. Bourlon and G. Dreyfus and A. Eker and Y. Habib and N. Hugues and C. Mialhe and B. Bertrand and O. Chavanon and P. Porcu and G. Vanzetto",

year = "2016",

doi = "10.1016/j.jacc.2016.07.747",

language = "English",

volume = "68",

pages = "1637--1647",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

publisher = "Attuale:ELSEVIER SCIENCE INC, 360 PARK AVE SOUTH, NEW YORK, USA, NY, 10010-1710 W B Saunders Company:Fulfillment Department, The Curtis Center, Independence Square West:Philadelphia, PA 19106:(800)654-2452, (215)238-7800, EMAIL: [email protected], INTERNET: http://elsevierhealth.com, Fax: (215)238-6445",

number = "15",

}

Gilard, M, Eltchaninoff, H, Donzeau-Gouge, P, Chevreul, K, Fajadet, J, Leprince, P, Leguerrier, A, Lievre, M, Prat, A, Teiger, E, Lefevre, T, Tchetche, D, Carrie, D, Himbert, D, Albat, B, Cribier, A, Sudre, A, Blanchard, D, Rioufol, G, Collet, F, Houel, R, Dos, SP, Meneveau, N, Ghostine, S, Manigold, T, Guyon, P, Grisoli, D, Le, BH, Delpine, S, Didier, R, Favereau, X, Souteyrand, G, Ohlmann, P, Doisy, V, Grollier, G, Gommeaux, A, -P., CJ, Bourlon, F, Bertrand, B, Laskar, M, Iung, B, Gilard, M, Laskar, M, Eltchaninoff, H, Fajadet, J, Iung, B, Teiger, E, Donzeau-Gouge, P, Leprince, P, Leguerrier, A, Prat, A, Chevreul, K, Lievre, M, Bertrand, M, Cassagne, J, Boschat, J, Lusson, JR, Mathieu, P, Logeais, Y, -P., BJ, Lefevre, T, Chevalier, B, Farge, A, Garot, P, Hovasse, T, Morice, MC, Romano, M, Gouge, PD, Tchetche, D, Vahdat, O, Farah, B, Fajadet, J, Carrie, D, Dumonteil, N, Fournial, G, Marcheix, B, Himbert, D, Nataf, P, Vahanian, A, Albat, B, Leclercq, F, Piot, C, Schmutz, L, Aubas, P, du, CA, Dubar, A, Durrleman, N, Fargosz, F, Levy, G, Maupas, E, Rivalland, F, Robert, G, Eltchaninoff, H, -P., BJ, Cribier, A, Tron, C, Sudre, A, Juthier, F, Modine, T, Van, BE, Banfi, C, Blanchard, D, Sallerin, T, Bar, O, Barbey, C, Chassaing, S, Chatel, D, Le, PO, Tauran, A, Rioufol, G, Cao, D, Dauphin, R, Durand, DGG, Finet, G, Jegaden, O, -F., OJ, Leprince, P, Beygui, F, -P., CJ, Pavie, A, Collet, F, Bayet, P, Vaillant, A, Vicat, J, Wittenberg, O, Houel, R, Joly, P, Rosario, R, Bergeron, P, Bille, J, Gelisse, R, Teiger, E, -P., CJ, -L., DRJ, Hayat, D, Fougeres, E, -L., MJ, Mouillet, G, Dos, SP, Arsac, F, Choukroun, E, Dijos, M, -P., GJ, Leroux, L, Elia, N, Meneveau, N, Genon, D, Chocron, S, Schiele, F, Caussin, C, Azmoun, A, Ghostine, S, Nottin, R, Tirouvanziam, A, Crochet, D, Gaudin, R, -C., RJ, Guyon, P, Bonnet, N, Digne, F, Mesnidrey, P, Royer, T, Stratiev, V, Grisoli, D, -L., BJ, Cuisset, T, Grisoli, D, Le, BH, Abouliatim, I, Bedossa, M, Boulmier, D, Verhoye, JP, Delepine, S, -L., DJ, Furber, A, Pinaud, F, Gilard, M, Bezon, E, Boschat, J, -N., CJ, Favereau, X, Bical, O, Dambrin, G, Deleuze, P, Jegou, A, -R., LJ, Azarnouch, K, Durel, N, Innorta, A, Souteyrand, G, Doisy, V, Lienhart, Y, Roriz, R, Staat, P, Blanchard, D, -N., FJ, Lafont, A, Zegdi, R, Heudes, D, Ohlmann, P, Kindo, M, -P., MJ, Zupan, M, Grollier, G, Ivascau, C, Lognone, T, Massetti, M, Sabatier, R, Huret, B, Gommeaux, A, Hochart, P, Pecheux, -P., CJ, Bouchayer, D, Gabrielle, F, Pelissier, F, Tremeau, G, Bourlon, F, Dreyfus, G, Eker, A, Habib, Y, Hugues, N, Mialhe, C, Bertrand, B, Chavanon, O, Porcu, P & Vanzetto, G 2016, 'Late Outcomes of Transcatheter Aortic Valve Replacement in High-Risk Patients: The FRANCE-2 Registry', Journal of the American College of Cardiology, vol. 68, no. 15, pp. 1637-1647. https://doi.org/10.1016/j.jacc.2016.07.747

TY - JOUR

T1 - Late Outcomes of Transcatheter Aortic Valve Replacement in High-Risk Patients: The FRANCE-2 Registry

AU - Gilard, M.

AU - Eltchaninoff, H.

AU - Donzeau-Gouge, P.

AU - Chevreul, K.

AU - Fajadet, J.

AU - Leprince, P.

AU - Leguerrier, A.

AU - Lievre, M.

AU - Prat, A.

AU - Teiger, E.

AU - Lefevre, T.

AU - Tchetche, D.

AU - Carrie, D.

AU - Himbert, D.

AU - Albat, B.

AU - Cribier, A.

AU - Sudre, A.

AU - Blanchard, D.

AU - Rioufol, G.

AU - Collet, F.

AU - Houel, R.

AU - Dos, Santos P.

AU - Meneveau, N.

AU - Ghostine, S.

AU - Manigold, T.

AU - Guyon, P.

AU - Grisoli, D.

AU - Le, Breton H.

AU - Delpine, S.

AU - Didier, R.

AU - Favereau, X.

AU - Souteyrand, G.

AU - Ohlmann, P.

AU - Doisy, V.

AU - Grollier, G.

AU - Gommeaux, A.

AU - -P., Claudel J.

AU - Bourlon, F.

AU - Bertrand, B.

AU - Laskar, M.

AU - Iung, B.

AU - Gilard, M.

AU - Laskar, M.

AU - Eltchaninoff, H.

AU - Fajadet, J.

AU - Iung, B.

AU - Teiger, E.

AU - Donzeau-Gouge, P.

AU - Leprince, P.

AU - Leguerrier, A.

AU - Prat, A.

AU - Chevreul, K.

AU - Lievre, M.

AU - Bertrand, M.

AU - Cassagne, J.

AU - Boschat, J.

AU - Lusson, J. R.

AU - Mathieu, P.

AU - Logeais, Y.

AU - -P., Bessou J.

AU - Lefevre, T.

AU - Chevalier, B.

AU - Farge, A.

AU - Garot, P.

AU - Hovasse, T.

AU - Morice, M. C.

AU - Romano, M.

AU - Gouge, P. D.

AU - Tchetche, D.

AU - Vahdat, O.

AU - Farah, B.

AU - Fajadet, J.

AU - Carrie, D.

AU - Dumonteil, N.

AU - Fournial, G.

AU - Marcheix, B.

AU - Himbert, D.

AU - Nataf, P.

AU - Vahanian, A.

AU - Albat, B.

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PY - 2016

Y1 - 2016

N2 - Background Transcatheter aortic valve replacement (TAVR) has revolutionized management of high-risk patients with severe aortic stenosis. However, survival and the incidence of severe complications have been assessed in relatively small populations and/or with limited follow-up. Objectives This report details late clinical outcome and its determinants in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry. Methods The FRANCE-2 registry prospectively included all TAVRs performed in France. Follow-up was scheduled at 30 days, at 6 months, and annually from 1 to 5 years. Standardized VARC (Valve Academic Research Consortium) outcome definitions were used. Results A total of 4,201 patients were enrolled between January 2010 and January 2012 in 34 centers. Approaches were transarterial (transfemoral 73%, transapical 18%, subclavian 6%, and transaortic or transcarotid 3%) or, in 18% of patients, transapical. Median follow-up was 3.8 years. Vital status was available for 97.2% of patients at 3 years. The 3-year all-cause mortality was 42.0% and cardiovascular mortality was 17.5%. In a multivariate model, predictors of 3-year all-cause mortality were male sex (p < 0.001), low body mass index, (p < 0.001), atrial fibrillation (p < 0.001), dialysis (p < 0.001), New York Heart Association functional class III or IV (p < 0.001), higher logistic EuroSCORE (p < 0.001), transapical or subclavian approach (p < 0.001 for both vs. transfemoral approach), need for permanent pacemaker implantation (p = 0.02), and post-implant periprosthetic aortic regurgitation grade ≥2 of 4 (p < 0.001). Severe events according to VARC criteria occurred mainly during the first month and subsequently in <2% of patients/year. Mean gradient, valve area, and residual aortic regurgitation were stable during follow-up. Conclusions The FRANCE-2 registry represents the largest database available on late results of TAVR. Late mortality is largely related to noncardiac causes. Incidence rates of severe events are low after the first month. Valve performance remains stable over time.

AB - Background Transcatheter aortic valve replacement (TAVR) has revolutionized management of high-risk patients with severe aortic stenosis. However, survival and the incidence of severe complications have been assessed in relatively small populations and/or with limited follow-up. Objectives This report details late clinical outcome and its determinants in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry. Methods The FRANCE-2 registry prospectively included all TAVRs performed in France. Follow-up was scheduled at 30 days, at 6 months, and annually from 1 to 5 years. Standardized VARC (Valve Academic Research Consortium) outcome definitions were used. Results A total of 4,201 patients were enrolled between January 2010 and January 2012 in 34 centers. Approaches were transarterial (transfemoral 73%, transapical 18%, subclavian 6%, and transaortic or transcarotid 3%) or, in 18% of patients, transapical. Median follow-up was 3.8 years. Vital status was available for 97.2% of patients at 3 years. The 3-year all-cause mortality was 42.0% and cardiovascular mortality was 17.5%. In a multivariate model, predictors of 3-year all-cause mortality were male sex (p < 0.001), low body mass index, (p < 0.001), atrial fibrillation (p < 0.001), dialysis (p < 0.001), New York Heart Association functional class III or IV (p < 0.001), higher logistic EuroSCORE (p < 0.001), transapical or subclavian approach (p < 0.001 for both vs. transfemoral approach), need for permanent pacemaker implantation (p = 0.02), and post-implant periprosthetic aortic regurgitation grade ≥2 of 4 (p < 0.001). Severe events according to VARC criteria occurred mainly during the first month and subsequently in <2% of patients/year. Mean gradient, valve area, and residual aortic regurgitation were stable during follow-up. Conclusions The FRANCE-2 registry represents the largest database available on late results of TAVR. Late mortality is largely related to noncardiac causes. Incidence rates of severe events are low after the first month. Valve performance remains stable over time.

KW - 80 and over

KW - Aged

KW - Aortic Valve Stenosis

KW - Female

KW - France

KW - Humans

KW - Male

KW - Prospective Studies

KW - Registries

KW - Risk Assessment

KW - Time Factors

KW - Transcatheter Aortic Valve Replacement

KW - Treatment Outcome

KW - aortic stenosis

KW - predictive analysis

KW - risk score

KW - 80 and over

KW - Aged

KW - Aortic Valve Stenosis

KW - Female

KW - France

KW - Humans

KW - Male

KW - Prospective Studies

KW - Registries

KW - Risk Assessment

KW - Time Factors

KW - Transcatheter Aortic Valve Replacement

KW - Treatment Outcome

KW - aortic stenosis

KW - predictive analysis

KW - risk score

UR - https://publicatt.unicatt.it/handle/10807/169123

UR - https://www.scopus.com/inward/citedby.uri?partnerID=HzOxMe3b&scp=84994156598&origin=inward

UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84994156598&origin=inward

U2 - 10.1016/j.jacc.2016.07.747

DO - 10.1016/j.jacc.2016.07.747

M3 - Article

SN - 0735-1097

VL - 68

SP - 1637

EP - 1647

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 15

ER -

Late Outcomes of Transcatheter Aortic Valve Replacement in High-Risk Patients: The FRANCE-2 Registry

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