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Transcatheter aortic-valve replacement for inoperable severe aortic stenosis.
- Source :
-
The New England journal of medicine [N Engl J Med] 2012 May 03; Vol. 366 (18), pp. 1696-704. Date of Electronic Publication: 2012 Mar 26. - Publication Year :
- 2012
-
Abstract
- Background: Transcatheter aortic-valve replacement (TAVR) is the recommended therapy for patients with severe aortic stenosis who are not suitable candidates for surgery. The outcomes beyond 1 year in such patients are not known.<br />Methods: We randomly assigned patients to transfemoral TAVR or to standard therapy (which often included balloon aortic valvuloplasty). Data on 2-year outcomes were analyzed.<br />Results: A total of 358 patients underwent randomization at 21 centers. The rates of death at 2 years were 43.3% in the TAVR group and 68.0% in the standard-therapy group (P<0.001), and the corresponding rates of cardiac death were 31.0% and 62.4% (P<0.001). The survival advantage associated with TAVR that was seen at 1 year remained significant among patients who survived beyond the first year (hazard ratio, 0.58; 95% confidence interval [CI], 0.36 to 0.92; P=0.02 with the use of the log-rank test). The rate of stroke was higher after TAVR than with standard therapy (13.8% vs. 5.5%, P=0.01), owing, in the first 30 days, to the occurrence of more ischemic events in the TAVR group (6.7% vs. 1.7%, P=0.02) and, beyond 30 days, to the occurrence of more hemorrhagic strokes in the TAVR group (2.2% vs. 0.6%, P=0.16). At 2 years, the rate of rehospitalization was 35.0% in the TAVR group and 72.5% in the standard-therapy group (P<0.001). TAVR, as compared with standard therapy, was also associated with improved functional status (P<0.001). The data suggest that the mortality benefit after TAVR may be limited to patients who do not have extensive coexisting conditions. Echocardiographic analysis showed a sustained increase in aortic-valve area and a decrease in aortic-valve gradient, with no worsening of paravalvular aortic regurgitation.<br />Conclusions: Among appropriately selected patients with severe aortic stenosis who were not suitable candidates for surgery, TAVR reduced the rates of death and hospitalization, with a decrease in symptoms and an improvement in valve hemodynamics that were sustained at 2 years of follow-up. The presence of extensive coexisting conditions may attenuate the survival benefit of TAVR. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).
- Subjects :
- Anticoagulants adverse effects
Anticoagulants therapeutic use
Aortic Valve diagnostic imaging
Aortic Valve Insufficiency etiology
Aortic Valve Stenosis complications
Aortic Valve Stenosis mortality
Cardiovascular Diseases etiology
Female
Follow-Up Studies
Heart Valve Prosthesis
Heart Valve Prosthesis Implantation adverse effects
Hospitalization statistics & numerical data
Humans
Kaplan-Meier Estimate
Male
Platelet Aggregation Inhibitors adverse effects
Platelet Aggregation Inhibitors therapeutic use
Prosthesis Failure
Stroke etiology
Ultrasonography
Aortic Valve surgery
Aortic Valve Stenosis therapy
Cardiac Catheterization adverse effects
Catheterization
Heart Valve Prosthesis Implantation methods
Subjects
Details
- Language :
- English
- ISSN :
- 1533-4406
- Volume :
- 366
- Issue :
- 18
- Database :
- MEDLINE
- Journal :
- The New England journal of medicine
- Publication Type :
- Academic Journal
- Accession number :
- 22443478
- Full Text :
- https://doi.org/10.1056/NEJMoa1202277