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Registry of transcatheter aortic-valve implantation in high-risk patients
- Source :
- New England Journal of Medicine, New England Journal of Medicine, Massachusetts Medical Society, 2012, 366 (18), pp.1705-15. ⟨10.1056/NEJMoa1114705⟩, New England Journal of Medicine, 2012, 366 (18), pp.1705-15. ⟨10.1056/NEJMoa1114705⟩
- Publication Year :
- 2012
- Publisher :
- HAL CCSD, 2012.
-
Abstract
- International audience; 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.).
- Subjects :
- Male
Cardiac Catheterization
MESH: Registries
medicine.medical_treatment
Periprosthetic
030204 cardiovascular system & hematology
0302 clinical medicine
MESH: Aged, 80 and over
Prospective Studies
Registries
030212 general & internal medicine
MESH: Incidence
Settore MED/23 - CHIRURGIA CARDIACA
Prospective cohort study
Stroke
MESH: Aortic Valve Stenosis
Cardiac catheterization
Aged, 80 and over
Heart Valve Prosthesis Implantation
MESH: Aged
High risk patients
Framingham Risk Score
MESH: Cardiac Catheterization
Incidence
General Medicine
3. Good health
Heart Valve Prosthesis
Aortic valve stenosis
Cardiology
Female
France
MESH: Hemorrhage
Medtronic corevalve
MESH: Heart Valve Prosthesis Implantation
medicine.medical_specialty
Transcatheter aortic
MESH: Heart Valve Prosthesis
Hemorrhage
MESH: Multivariate Analysis
MESH: Stroke
03 medical and health sciences
Internal medicine
medicine
[SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO]
Humans
Aged
MESH: Humans
business.industry
EuroSCORE
Aortic Valve Stenosis
medicine.disease
MESH: Prospective Studies
MESH: Male
Surgery
MESH: France
Stenosis
Multivariate Analysis
business
MESH: Female
Subjects
Details
- Language :
- English
- ISSN :
- 00284793 and 15334406
- Database :
- OpenAIRE
- Journal :
- New England Journal of Medicine, New England Journal of Medicine, Massachusetts Medical Society, 2012, 366 (18), pp.1705-15. ⟨10.1056/NEJMoa1114705⟩, New England Journal of Medicine, 2012, 366 (18), pp.1705-15. ⟨10.1056/NEJMoa1114705⟩
- Accession number :
- edsair.doi.dedup.....da38fb42fb0985b4b8c075b2275c5f2c
- Full Text :
- https://doi.org/10.1056/NEJMoa1114705⟩