title: Transcatheter aortic-valve replacement for inoperable severe aortic stenosis.
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.
  
  
  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.
  
  
  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.).
authors.affiliation: Cedars-Sinai Heart Institute, Los Angeles, USA.
authors.forename: Raj R
authors.initials: RR
authors.lastname: Makkar
authors.forename: Gregory P
authors.initials: GP
authors.lastname: Fontana
authors.forename: Hasan
authors.initials: H
authors.lastname: Jilaihawi
authors.forename: Samir
authors.initials: S
authors.lastname: Kapadia
authors.forename: Augusto D
authors.initials: AD
authors.lastname: Pichard
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Douglas
authors.forename: Vinod H
authors.initials: VH
authors.lastname: Thourani
authors.forename: Vasilis C
authors.initials: VC
authors.lastname: Babaliaros
authors.forename: John G
authors.initials: JG
authors.lastname: Webb
authors.forename: Howard C
authors.initials: HC
authors.lastname: Herrmann
authors.forename: Joseph E
authors.initials: JE
authors.lastname: Bavaria
authors.forename: Susheel
authors.initials: S
authors.lastname: Kodali
authors.forename: David L
authors.initials: DL
authors.lastname: Brown
authors.forename: Bruce
authors.initials: B
authors.lastname: Bowers
authors.forename: Todd M
authors.initials: TM
authors.lastname: Dewey
authors.forename: Lars G
authors.initials: LG
authors.lastname: Svensson
authors.forename: Murat
authors.initials: M
authors.lastname: Tuzcu
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Moses
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Williams
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Siegel
authors.forename: Jodi J
authors.initials: JJ
authors.lastname: Akin
authors.forename: William N
authors.initials: WN
authors.lastname: Anderson
authors.forename: Stuart
authors.initials: S
authors.lastname: Pocock
authors.forename: Craig R
authors.initials: CR
authors.lastname: Smith
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000601:surgery*; D001022:Aortic Valve Insufficiency / Q000209:etiology; D001024:Aortic Valve Stenosis / Q000150:complications / Q000401:mortality / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects; D002318:Cardiovascular Diseases / Q000209:etiology; D002404:Catheterization; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods*; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D011475:Prosthesis Failure; D020521:Stroke / Q000209:etiology; D014463:Ultrasonography
chemical_list: D000925:Anticoagulants; D010975:Platelet Aggregation Inhibitors