title: 3-Year Outcomes in High-Risk Patients Who Underwent Surgical or Transcatheter Aortic Valve Replacement.
abstract: BACKGROUND
  In patients with severe aortic stenosis at increased risk for surgery, self-expanding transcatheter aortic valve replacement (TAVR) is associated with improved 2-year survival compared with surgery.
  
  
  OBJECTIVE
  This study sought to determine whether this clinical benefit was sustained over time.
  
  
  METHODS
  Patients with severe aortic stenosis deemed at increased risk for surgery by a multidisciplinary heart team were randomized 1:1 to TAVR or open surgical valve replacement (SAVR). Three-year clinical and echocardiographic outcomes were obtained in those patients with an attempted procedure.
  
  
  RESULTS
  A total of 797 patients underwent randomization at 45 U.S. centers; 750 patients underwent an attempted procedure. Three-year all-cause mortality or stroke was significantly lower in TAVR patients (37.3% vs. 46.7% in SAVR; p = 0.006). Adverse clinical outcome components were also reduced in TAVR patients compared with SAVR patients, including all-cause mortality (32.9% vs. 39.1%, respectively; p = 0.068), all stroke (12.6% vs. 19.0%, respectively; p = 0.034), and major adverse cardiovascular or cerebrovascular events (40.2% vs. 47.9%, respectively; p = 0.025). At 3 years aortic valve hemodynamics were better with TAVR patients (mean aortic valve gradient 7.62 ± 3.57 mm Hg vs. 11.40 ± 6.81 mm Hg in SAVR; p < 0.001), although moderate or severe residual aortic regurgitation was higher in TAVR patients (6.8% vs. 0.0% in SAVR; p < 0.001). There was no clinical evidence of valve thrombosis in either group.
  
  
  CONCLUSIONS
  Patients with severe aortic stenosis at increased risk for surgery had improved 3-year clinical outcomes after TAVR compared with surgery. Aortic valve hemodynamics were more favorable in TAVR patients without differences in structural valve deterioration. (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: University of Michigan Medical Center, Ann Arbor, Michigan. Electronic address: mdeeb@med.umich.edu.
authors.forename: G Michael
authors.initials: GM
authors.lastname: Deeb
authors.affiliation: Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Reardon
authors.affiliation: University of Michigan Medical Center, Ann Arbor, Michigan.
authors.forename: Stan
authors.initials: S
authors.lastname: Chetcuti
authors.affiliation: University of Michigan Medical Center, Ann Arbor, Michigan.
authors.forename: Himanshu J
authors.initials: HJ
authors.lastname: Patel
authors.affiliation: University of Michigan Medical Center, Ann Arbor, Michigan.
authors.forename: P Michael
authors.initials: PM
authors.lastname: Grossman
authors.affiliation: Riverside Methodist Hospital, Columbus, Ohio.
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Yakubov
authors.affiliation: Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas.
authors.forename: Neal S
authors.initials: NS
authors.lastname: Kleiman
authors.affiliation: Texas Heart Institute at St. Luke's Medical Center, Houston, Texas.
authors.forename: Joseph S
authors.initials: JS
authors.lastname: Coselli
authors.affiliation: University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Gleason
authors.affiliation: University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
authors.forename: Joon Sup
authors.initials: JS
authors.lastname: Lee
authors.affiliation: St. Vincent Medical Center, Indianapolis, Indiana.
authors.forename: James B
authors.initials: JB
authors.lastname: Hermiller
authors.affiliation: Spectrum Health Hospitals, Grand Rapids, Michigan.
authors.forename: John
authors.initials: J
authors.lastname: Heiser
authors.affiliation: Spectrum Health Hospitals, Grand Rapids, Michigan.
authors.forename: William
authors.initials: W
authors.lastname: Merhi
authors.affiliation: The University of Kansas Hospital, Kansas City, Kansas.
authors.forename: George L
authors.initials: GL
authors.lastname: Zorn
authors.affiliation: The University of Kansas Hospital, Kansas City, Kansas.
authors.forename: Peter
authors.initials: P
authors.lastname: Tadros
authors.affiliation: St. Francis Hospital, Roslyn, New York.
authors.forename: Newell
authors.initials: N
authors.lastname: Robinson
authors.affiliation: St. Francis Hospital, Roslyn, New York.
authors.forename: George
authors.initials: G
authors.lastname: Petrossian
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: Pinnacle Health, Wormleysburg, Pennsylvania.
authors.forename: Brijeshwar
authors.initials: B
authors.lastname: Maini
authors.affiliation: Pinnacle Health, Wormleysburg, Pennsylvania.
authors.forename: Mubashir
authors.initials: M
authors.lastname: Mumtaz
authors.affiliation: The Johns Hopkins Hospital, Baltimore, Maryland.
authors.forename: John
authors.initials: J
authors.lastname: Conte
authors.affiliation: The Johns Hopkins Hospital, Baltimore, Maryland.
authors.forename: Jon
authors.initials: J
authors.lastname: Resar
authors.affiliation: Kaiser Permanente-Los Angeles Medical Center, Los Angeles, California.
authors.forename: Vicken
authors.initials: V
authors.lastname: Aharonian
authors.affiliation: Kaiser Permanente-Los Angeles Medical Center, Los Angeles, California.
authors.forename: Thomas
authors.initials: T
authors.lastname: Pfeffer
authors.affiliation: Mayo Clinical Foundation, Rochester, Minnesota.
authors.forename: Jae K
authors.initials: JK
authors.lastname: Oh
authors.affiliation: Medtronic, Minneapolis, Minnesota.
authors.forename: Hongyan
authors.initials: H
authors.lastname: Qiao
authors.affiliation: Mount Sinai Health System, New York, New York.
authors.forename: David H
authors.initials: DH
authors.lastname: Adams
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
mesh_terms: D058186:Acute Kidney Injury / Q000209:etiology; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000601:surgery*; D001022:Aortic Valve Insufficiency / Q000453:epidemiology; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000601:surgery*; D004452:Echocardiography; D004696:Endocarditis / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D006439:Hemodynamics; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D010138:Pacemaker, Artificial / Q000706:statistics & numerical data; D011446:Prospective Studies; D012086:Reoperation; D015607:Stents; D020521:Stroke / Q000453:epidemiology; D065467:Transcatheter Aortic Valve Replacement; D014481:United States / Q000453:epidemiology
keywords: aortic stenosis; outcomes; surgical aortic valve replacement; transcatheter aortic valve replacement