Transcatheter aortic-valve replacement for inoperable severe aortic stenosis.[Erratum appears in N Engl J Med. 2012 Aug 30;367(9):881]
Citation: New England Journal of Medicine. 366(18):1696-704, 2012 May 3.PMID: 22443478Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | Multicenter Study | Randomized Controlled Trial | Research Support, Non-U.S. Gov'tSubject headings: *Aortic Valve Stenosis/th [Therapy] | *Aortic Valve/su [Surgery] | *Cardiac Catheterization | *Catheterization | *Heart Valve Prosthesis Implantation/mt [Methods] | Anticoagulants/ae [Adverse Effects] | Anticoagulants/tu [Therapeutic Use] | Aortic Valve Insufficiency/et [Etiology] | Aortic Valve Stenosis/co [Complications] | Aortic Valve Stenosis/mo [Mortality] | Aortic Valve/us [Ultrasonography] | Cardiac Catheterization/ae [Adverse Effects] | Cardiovascular Diseases/et [Etiology] | Female | Follow-Up Studies | Heart Valve Prosthesis Implantation/ae [Adverse Effects] | Heart Valve Prosthesis | Hospitalization/sn [Statistics & Numerical Data] | Humans | Kaplan-Meier Estimate | Male | Platelet Aggregation Inhibitors/ae [Adverse Effects] | Platelet Aggregation Inhibitors/tu [Therapeutic Use] | Prosthesis Failure | Stroke/et [Etiology]Local holdings: Available online from MWHC library: 1993 - present, Available in print through MWHC library: 1980 - presentISSN:- 0028-4793
Item type | Current library | Collection | Call number | Status | Date due | Barcode |
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Journal Article | MedStar Authors Catalog | Article | Available | 22443478 |
Available online from MWHC library: 1993 - present, Available in print through MWHC library: 1980 - present
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.
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.).
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.
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.
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