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J Am Coll Cardiol. 2016 Oct 11;68(15):1637-1647. doi: 10.1016/j.jacc.2016.07.747.

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

Collaborators (187)

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, Bessou JP, 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 Cailar A, Dubar A, Durrleman N, Fargosz F, Levy G, Maupas E, Rivalland F, Robert G, Eltchaninoff H, Bessou JP, Cribier A, Tron C, Sudre A, Juthier F, Modine T, Van Belle E, Banfi C, Blanchard D, Sallerin T, Bar O, Barbey C, Chassaing S, Chatel D, Le Page O, Tauran A, Rioufol G, Cao D, Dauphin R, Durand de Gevigney G, Finet G, Jegaden O, Obadia JF, Leprince P, Beygui F, Collet JP, Pavie A, Collet F, Pecheux, Bayet, Vaillant A, Vicat J, Wittenberg O, Houel R, Joly P, Rosario R, Bergeron P, Bille J, Gelisse R, Teiger E, Couetil JP, Dubois Rande JL, Hayat D, Fougeres E, Monin JL, Mouillet G, Dos Santos P, Arsac F, Choukroun E, Dijos M, Guibaud JP, Leroux L, Elia N, Meneveau N, Descotes Genon, Chocron S, Schiele F, Caussin C, Azmoun A, Ghostine S, Nottin R, Tirouvanziam A, Crochet D, Gaudin R, Roussel JC, Guyon P, Bonnet N, Digne F, Mesnidrey P, Royer T, Stratiev V, Grisoli D, Bonnet JL, Cuisset T, Grisoli D, Le Breton H, Abouliatim I, Bedossa M, Boulmier D, Verhoye JP, Delepine S, Debrux JL, Furber A, Pinaud F, Gilard M, Bezon E, Boschat J, Choplain JN, Favereau X, Bical O, Dambrin G, Deleuze P, Jegou A, Lusson JR, Azarnouch K, Durel N, Innorta A, Souteyrand G, Doisy V, Lienhart Y, Roriz R, Staat P, Blanchard D, Fabiani JN, Lafont A, Zegdi R, Heudes D, Ohlmann P, Kindo M, Mazzucotelli JP, Zupan M, Grollier G, Ivascau C, Lognone T, Massetti M, Sabatier R, Huret B, Gommeaux A, Hochart P, Pecheux, Claudel JP, 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.

Author information

1
Department of Cardiology, Brest University Hospital, Brest, France. Electronic address: martine.gilard@chu-brest.fr.
2
Department of Cardiology, Rouen University Hospital, Rouen, France.
3
Department of Cardiology and Surgery, Institut Cardiovasculaire Paris Sud, Massy, France.
4
Department of URC-ECO and Cardiology, Creteil University Hospital, Paris, France.
5
Department of Cardiology, Clinique Pasteur, Toulouse, France.
6
Department of Surgery, Pitié Salpetrière University Hospital, Paris, France.
7
Department of Cardiology and Surgery, Rennes University Hospital, Rennes, France.
8
UMR and Department of Cardiology, Lyon University Hospital, Lyon, France.
9
Department of Cardiology and Surgery, Lille University Hospital, Lille, France.
10
Department of Cardiology, Toulouse University Hospital, Toulouse, France.
11
Department of Cardiology, Bichat University Hospital, Paris, France.
12
Department of Surgery, Montpellier University Hospital, Montpellier, France.
13
Department of Cardiology, Clinique St. Gatien, Tours, France.
14
Department of Surgery, Hospital Clairval, Marseille, France.
15
Department of Surgery, Hospital Saint Joseph, Marseille, France.
16
Department of Cardiology, Bordeaux University Hospital, Bordeaux, France.
17
Department of Cardiology, Besancon University Hospital, Besancon, France.
18
Department of Cardiology, Centre Cardiologique Marie Lannelongue, Le Plessis Robinson, France.
19
Department of Cardiology, Nantes University Hospital, Nantes, France.
20
Department of Cardiology, Centre Cardiologique du Nord, Saint Denis, France.
21
Department of Surgery, Marseille University Hospital, Marseille, France.
22
Department of Cardiology, Angers University Hospital, Angers, France.
23
Department of Cardiology, Brest University Hospital, Brest, France.
24
Department of Cardiology, Parly 2 Hospital, Le Chesnay, France.
25
Department of Cardiology, Clermont Ferrand University Hospital, Clermont Ferrand, France.
26
Department of Cardiology, Strasbourg University Hospital, Strasbourg, France.
27
Department of Surgery, Clinique du Tonkin, Lyon, France.
28
Department of Cardiology, Caen University Hospital, Caen, France.
29
Department of Cardiology, Hôpital Bois Bernard, Bois Bernard, France.
30
Department of Cardiology, Infirmerie Protestante, Lyon, France.
31
Department of Cardiology, Centre Cardio-Thoracique, Monaco.
32
Department of Cardiology, Grenoble University Hospital, Grenoble, France.
33
Department of Surgery, Limoges University Hospital, Limoges, France.

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:

aortic stenosis; predictive analysis; risk score

PMID:
27712776
DOI:
10.1016/j.jacc.2016.07.747
[Indexed for MEDLINE]
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