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Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry
Abstract
AIMS: Transcatheter aortic valve implantation is a therapeutic alternative for high-surgical-risk patients with severe symptomatic aortic stenosis. Two models of prosthesis are currently commercialized in France, which can be implanted either via a transarterial or a transapical approach. The aim of the study was to evaluate in a national French registry the early safety and efficacy of transcatheter aortic valve replacement (AVR) using either the Edwards SAPIEN™ or CoreValve™ in high-surgical-risk patients with severe aortic stenosis. METHODS AND RESULTS: The multicentre national registry was conducted in 16 centres between February 2009 and June 2009, under the authority of the French Societies of Cardiology and Thoracic and Cardio-Vascular Surgery. The primary endpoint was mortality at 1 month. Two hundred and forty-four high-surgical-risk patients (logistic EuroSCORE ≥20%, STS ≥10%, or contra-indication to AVR) were enrolled. Mean age was 82 ± 7 years and 43.9% were female. Edwards SAPIEN and CoreValve were implanted in 68 and 32% of patients, respectively. The approaches used were transarterial (transfemoral: 66%; subclavian: 5%) or transapical in 29%. Device success rate was 98.3% and 30-day mortality was 12.7%. Severe complications included stroke (3.6%), tamponade (2%), acute coronary occlusion (1.2%), and vascular complications (7.3%). Pacemaker was required in 11.8%. At 1 month, 88% of patients were in NYHA class II or less. CONCLUSION: This prospective registry reflects the real-life experience of transcatheter aortic valve implantation in high-risk elderly patients in France. The early results are satisfactory in terms of feasibility, short-term haemodynamic and functional improvement, and safety. Longer term follow-up will be further assessed.
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Cited by
Guidelines on the management of valvular heart disease (version 2012)
Authors/Task Force Members, Vahanian, A., Alfieri, O., Andreotti, F., Antunes, M. J., Barón-Esquivias, G., Baumgartner, H., Borger, M. A., Carrel, T. P., De Bonis, M., et al. (2012) · European Heart Journal · doi:10.1093/eurheartj/ehs109 · Cited by 3,559
Self-citation2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease
Nishimura, R. A., Otto, C. M., Bonow, R. O., Carabello, B. A., Erwin, J. P., Guyton, R. A., O’Gara, P. T., Ruiz, C. E., Skubas, N. J., Sorajja, P., et al. (2014) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2014.02.536 · Cited by 3,523
Registry of Transcatheter Aortic-Valve Implantation in High-Risk Patients
Gilard, M., Eltchaninoff, H., Iung, B., Donzeau-Gouge, P., Chevreul, K., Fajadet, J., Leprince, P., Leguerrier, A., Lievre, M., Prat, A., et al. (2012) · New England Journal of Medicine · doi:10.1056/nejmoa1114705 · Cited by 1,228
Self-citationMoat, N. E., Ludman, P., de Belder, M. A., Bridgewater, B., Cunningham, A. D., Young, C. P., Thomas, M., Kovac, J., Spyt, T., MacCarthy, P. A., et al. (2011) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2011.08.050 · Cited by 884
Paravalvular Leak After Transcatheter Aortic Valve Replacement
Généreux, P., Head, S. J., Hahn, R., Daneault, B., Kodali, S., Williams, M. R., van Mieghem, N. M., Alu, M. C., Serruys, P. W., Kappetein, A. P., et al. (2013) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2012.08.1039 · Cited by 447
Metadata
- Authors
- Eltchaninoff, H., Prat, A., Gilard, M., Leguerrier, A., Blanchard, D., Fournial, G., Iung, B., Donzeau-Gouge, P., Tribouilloy, C., Debrux, J.-L., Pavie, A., Gueret, P., on behalf of the FRANCE Registry Investigators, Leprince, P., Beygui, F., Collet, J.-P., Himbert, D., Nataf, P., Vahanian, A., Lefevre, T., Romano, M., Eltchaninoff, H., Litzler, P.-Y., Bessou, J.-P., Cribier, A., Fajadet, J., Carrie, D., Berthoumieu, P., Dumonteil, N., Fournial, G., Teiger, E., Dubois Rande, J.-L., Kirsch, M., Blanchard, D., Fabiani, J.-N., Sudre, A., Modine, T., Dos Santos, P., Guibaud, J.-P., Roques, X., Gilard, M., Boschat, J., Bezon, E., Schiele, F., Chocron, S., Meneveau, N., Bassand, J., Rioufol, G., Obadia, J.-F., Tirouvanziam, A., Roussel, J.-C., Crochet, D., Collard, F., Bonnet, J.-L., Cuisset, T., Wolf, J.-E., Bouchot, O., Gueret, P., Pavie, A., Blanchard, D., Debrux, J.-L., Donzeau-Gouge, P., Eltchaninoff, H., Gilard, M., Iung, B., Leguerrier, A., Prat, A., Tribouilloy, C., & Chevreul, K.
- Venue
- European Heart Journal
- Publisher
- Oxford University Press (OUP)
- Published
- 2010-09-15
- Volume
- 32
- Issue
- 2
- Pages
- 191-197
- ISSN
- 0195-668X (ISSN-L)
- 1522-9645
- OpenAlex
- W1973814658
- Cited by
- 554
- References
- 0
- FWCI
- 56.41
- Type
- journal article
- Language
- en
- Open access
- closed
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- Eltchaninoff, H., Prat, A., Gilard, M., Leguerrier, A., Blanchard, D., Fournial, G., Iung, B., Donzeau-Gouge, P., Tribouilloy, C., Debrux, J.-L., Pavie, A., Gueret, P., on behalf of the FRANCE Registry Investigators, Leprince, P., Beygui, F., Collet, J.-P., Himbert, D., Nataf, P., Vahanian, A., . . . Chevreul, K. (2011). Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry. European Heart Journal. https://doi.org/10.1093/eurheartj/ehq261
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