Registry of Transcatheter Aortic-Valve Implantation in High-Risk Patients
Open accessAbstract
BACKGROUND: Transcatheter aortic-valve implantation (TAVI) is an emerging intervention for the treatment of high-risk patients with severe aortic stenosis and coexisting illnesses. We report the results of a prospective multicenter study of the French national transcatheter aortic-valve implantation registry, FRANCE 2. METHODS: All TAVIs performed in France, as listed in the FRANCE 2 registry, were prospectively included in the study. The primary end point was death from any cause. RESULTS: A total of 3195 patients were enrolled between January 2010 and October 2011 at 34 centers. The mean (±SD) age was 82.7±7.2 years; 49% of the patients were women. All patients were highly symptomatic and were at high surgical risk for aortic-valve replacement. Edwards SAPIEN and Medtronic CoreValve devices were implanted in 66.9% and 33.1% of patients, respectively. Approaches were either transarterial (transfemoral, 74.6%; subclavian, 5.8%; and other, 1.8%) or transapical (17.8%). The procedural success rate was 96.9%. Rates of death at 30 days and 1 year were 9.7% and 24.0%, respectively. At 1 year, the incidence of stroke was 4.1%, and the incidence of periprosthetic aortic regurgitation was 64.5%. In a multivariate model, a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation (EuroSCORE), New York Heart Association functional class III or IV symptoms, the use of a transapical TAVI approach, and a higher amount of periprosthetic regurgitation were significantly associated with reduced survival. CONCLUSIONS: This prospective registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis, in whom TAVI appeared to be a reasonable option. (Funded by Edwards Lifesciences and Medtronic.).
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Balloon-expandable and self-expanding transcatheter valves, specifically CoreValve and SAPIEN, have been the most rigorously studied to date.
“Balloon-expandable and self-expanding transcatheter valves have been the most rigorously studied to date, specifically the CoreValve (Medtronic, Dublin, Ireland) and SAPIEN (Edwards, Irvine CA, USA) valves”
From Calcific aortic stenosis (2016) · cites this paper as [226]
The Patients and Study Devices and Procedures sections identify SAPIEN as balloon-expandable and CoreValve as self-expanding; the Results section reports their use in 3,195 registry patients. The paper does not establish that these were the most rigorously studied transcatheter valves relative to other devices. (LLM, conf=0.85)
Experimental — accuracy not yet measuredApproximately two-thirds, or 56-75%, of TAVR procedures are performed using a transfemoral approach.
“Approximately two-thirds (56–75%) of TAVR procedures are performed via a transfemoral approach226–229.”
From Calcific aortic stenosis (2016) · cites this paper as [226]
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Self-citation
- Authors
- Gilard, M., Eltchaninoff, H., Iung, B., Donzeau-Gouge, P., Chevreul, K., Fajadet, J., Leprince, P., Leguerrier, A., Lievre, M., Prat, A., Teiger, E., Lefevre, T., Himbert, D., Tchetche, D., Carrié, D., Albat, B., Cribier, A., Rioufol, G., Sudre, A., Blanchard, D., Collet, F., Santos, P. D., Meneveau, N., Tirouvanziam, A., Caussin, C., Guyon, P., Boschat, J., Le Breton, H., Collart, F., Houel, R., Delpine, S., Souteyrand, G., Favereau, X., Ohlmann, P., Doisy, V., Grollier, G., Gommeaux, A., Claudel, J.-P., Bourlon, F., Bertrand, B., Van Belle, E., & Laskar, M.
- Affiliations
- Centre Hospitalier Régional Universitaire de Brest (FR)
- Inserm (FR)
- Hôpital Bichat-Claude-Bernard (FR)
- Centre Hospitalier Universitaire Henri-Mondor (FR)
- Clinique Pasteur (FR)
- Pitié-Salpêtrière Hospital (FR)
- Centre Hospitalier Universitaire de Rennes (FR)
- Centre Hospitalier Universitaire de Lille (FR)
- Centre Hospitalier Universitaire de Toulouse (FR)
- Centre Hospitalier Universitaire de Montpellier (FR)
- Hôpital privé Clairval (FR)
- Centre Hospitalier Universitaire de Besançon (FR)
- Centre Hospitalier Universitaire de Nantes (FR)
- Hôpital Marie Lannelongue (FR)
- Centre Cardiologique du Nord (FR)
- Centre Hospitalier Universitaire d'Angers (FR)
- Hôpitaux Universitaires de Strasbourg (FR)
- Centre Hospitalier Universitaire de Caen Normandie (FR)
- Infirmerie Protestante (FR)
- Centre Hospitalier Saint-Charles (FR)
- Centre Hospitalier Universitaire de Grenoble (FR)
- Hôpital Universitaire Dupuytren (FR)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2012-05-03
- Volume
- 366
- Issue
- 18
- Pages
- 1705-1715
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2108007523
- Cited by
- 1,228
- References
- 29
- Citations by year
- 2026: 14 · 2025: 21 · 2024: 22 · 2023: 18 · 2022: 35 · 2021: 36 · 2020: 60 · 2019: 68 · 2018: 103 · 2017: 115 · 2016: 150 · 2015: 174 · 2014: 153 · 2013: 196 · 2012: 54
- FWCI
- 117.77
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- HAL (submittedVersion)
- Funders
- Edwards Lifesciences
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Valve Diseases and Treatments
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Aortic Disease and Treatment Approaches
- Health Sciences › Medicine › Epidemiology › Infective Endocarditis Diagnosis and Management
- Keywords
- transcatheter aortic valve implantation, severe aortic stenosis, high surgical risk, elderly patients, mortality, stroke, transapical approach, transfemoral access, EuroSCORE, survival predictors, Edwards SAPIEN, Medtronic CoreValve
- MeSH terms
- Aged, Aged, 80 and over, Aortic Valve Stenosis, Female, France, Cardiac Catheterization, Heart Valve Prosthesis, Hemorrhage, Humans, Male, Prospective Studies, Registries, Incidence, Multivariate Analysis, Heart Valve Prosthesis Implantation, Stroke
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