title: Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery.
abstract: OBJECTIVE
  This study sought to evaluate the safety and efficacy of the CoreValve transcatheter heart valve (THV) for the treatment of severe aortic stenosis in patients at extreme risk for surgery.
  
  
  BACKGROUND
  Untreated severe aortic stenosis is a progressive disease with a poor prognosis. Transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis is a potentially effective therapy.
  
  
  METHODS
  We performed a prospective, multicenter, nonrandomized investigation evaluating the safety and efficacy of self-expanding TAVR in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery. The primary endpoint was a composite of all-cause mortality or major stroke at 12 months, which was compared with a pre-specified objective performance goal (OPG).
  
  
  RESULTS
  A total of 41 sites in the United States recruited 506 patients, of whom 489 underwent attempted treatment with the CoreValve THV. The rate of all-cause mortality or major stroke at 12 months was 26.0% (upper 2-sided 95% confidence bound: 29.9%) versus 43.0% with the OPG (p < 0.0001). Individual 30-day and 12-month events included all-cause mortality (8.4% and 24.3%, respectively) and major stroke (2.3% and 4.3%, respectively). Procedural events at 30 days included life-threatening/disabling bleeding (12.7%), major vascular complications (8.2%), and need for permanent pacemaker placement (21.6%). The frequency of moderate or severe paravalvular aortic regurgitation was lower 12 months after self-expanding TAVR (4.2%) than at discharge (10.7%; p = 0.004 for paired analysis).
  
  
  CONCLUSIONS
  TAVR with a self-expanding bioprosthesis was safe and effective in patients with symptomatic severe aortic stenosis at prohibitive risk for surgical valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, Massachusetts. Electronic address: jpopma@bidmc.harvard.edu.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
authors.affiliation: Mount Sinai Medical Center, New York, New York.
authors.forename: David H
authors.initials: DH
authors.lastname: Adams
authors.affiliation: Houston-Methodist-Debakey Heart and Vascular Center, Houston, Texas.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Reardon
authors.affiliation: Riverside Methodist Hospital, Columbus, Ohio.
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Yakubov
authors.affiliation: Houston-Methodist-Debakey Heart and Vascular Center, Houston, Texas.
authors.forename: Neal S
authors.initials: NS
authors.lastname: Kleiman
authors.affiliation: St. Vincent's Medical Center, Indianapolis, Indiana.
authors.forename: David
authors.initials: D
authors.lastname: Heimansohn
authors.affiliation: St. Vincent's Medical Center, Indianapolis, Indiana.
authors.forename: James
authors.initials: J
authors.lastname: Hermiller
authors.affiliation: Duke University Medical Center, Durham, North Carolina.
authors.forename: G Chad
authors.initials: GC
authors.lastname: Hughes
authors.affiliation: Duke University Medical Center, Durham, North Carolina.
authors.forename: J Kevin
authors.initials: JK
authors.lastname: Harrison
authors.affiliation: Texas Heart Institute at St. Luke's Medical Center, Houston, Texas.
authors.forename: Joseph
authors.initials: J
authors.lastname: Coselli
authors.affiliation: Texas Heart Institute at St. Luke's Medical Center, Houston, Texas.
authors.forename: Jose
authors.initials: J
authors.lastname: Diez
authors.affiliation: Detroit Medical Center, Detroit, Michigan.
authors.forename: Ali
authors.initials: A
authors.lastname: Kafi
authors.affiliation: Detroit Medical Center, Detroit, Michigan.
authors.forename: Theodore
authors.initials: T
authors.lastname: Schreiber
authors.affiliation: University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Gleason
authors.affiliation: Johns Hopkins Medical Center, Baltimore, Maryland.
authors.forename: John
authors.initials: J
authors.lastname: Conte
authors.affiliation: Palo Alto Veterans Administration Medical Center, Palo Alto, California.
authors.forename: Maurice
authors.initials: M
authors.lastname: Buchbinder
authors.affiliation: University of Michigan Medical Center, Ann Arbor, Michigan.
authors.forename: G Michael
authors.initials: GM
authors.lastname: Deeb
authors.affiliation: Baylor College of Medicine, Houston Texas.
authors.forename: Blasé
authors.initials: B
authors.lastname: Carabello
authors.affiliation: Thoraxcenter, Rotterdam, the Netherlands.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.affiliation: Medtronic, Inc., Minneapolis, Minnesota.
authors.forename: Sharla
authors.initials: S
authors.lastname: Chenoweth
authors.affiliation: Mayo Clinic Foundation, Rochester, Minnesota.
authors.forename: Jae K
authors.initials: JK
authors.lastname: Oh
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000601:surgery*; D001705:Bioprosthesis / Q000592:standards*; D006328:Cardiac Catheterization / Q000295:instrumentation* / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis / Q000592:standards*; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design / Q000592:standards; D012307:Risk Factors; D012720:Severity of Illness Index; D016896:Treatment Outcome
keywords: aortic stenosis; outcomes; transcatheter aortic valve replacement