title: 2-Year Outcomes After Iliofemoral Self-Expanding Transcatheter Aortic Valve Replacement in Patients With Severe Aortic Stenosis Deemed Extreme Risk for Surgery.
abstract: BACKGROUND
  We reported favorable 1-year outcomes in patients unsuitable for surgery who underwent self-expanding transcatheter aortic valve replacement (TAVR) compared with an objective performance goal. Longer-term outcomes in these patients are not known.
  
  
  OBJECTIVE
  This study sought to evaluate the 2-year safety and efficacy in patients with severe aortic stenosis (AS) at extreme risk of surgery treated with self-expanding TAVR.
  
  
  METHODS
  We performed a prospective, multicenter, controlled, nonrandomized investigation of self-expanding TAVR in patients with severe AS and prohibitive surgical risk. We report the 2-year clinical outcomes in these patients.
  
  
  RESULTS
  A total of 489 extreme-risk patients were treated transfemorally with a self-expanding aortic bioprosthesis at 41 centers. The rate of all-cause mortality or major stroke was 38.0% at 2 years (all-cause mortality, 36.5%; major stroke, 5.1%). The rates of all-cause mortality, cardiovascular mortality, and major stroke were 36.6%, 26.2%, and 5.1%, respectively, at 2 years. Between 1 and 2 years, the incremental all-cause mortality, cardiovascular mortality, and major stroke rates were 12.3%, 7.9%, and 0.8%, respectively. Multivariable predictors of all-cause mortality at 2 years included the presence of coronary artery disease and admission from an assisted living center. A Society of Thoracic Surgeons score >15% was also predictive of 2-year all-cause mortality. At 2 years, 94% of patients had New York Heart Association functional class I or II symptoms. The frequency of moderate or severe paravalvular regurgitation (4.3% at 1 year; 4.4% at 2 years) was unchanged between the first and second year.
  
  
  CONCLUSIONS
  Patients with severe AS at extreme surgical risk treated with self-expanding TAVR continued to show good clinical outcomes and hemodynamic valve performance at 2 years. The presence of comorbid conditions rather than valve performance affected 2-year outcomes in these patients. (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: Riverside Methodist Hospital, Columbus, Ohio. Electronic address: steven.yakubov@gmail.com.
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Yakubov
authors.affiliation: Mount Sinai Health System, New York, New York.
authors.forename: David H
authors.initials: DH
authors.lastname: Adams
authors.affiliation: Riverside Methodist Hospital, Columbus, Ohio.
authors.forename: Daniel R
authors.initials: DR
authors.lastname: Watson
authors.affiliation: Houston-Methodist-DeBakey Heart and Vascular Center, Houston, Texas.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Reardon
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 Heart Center of Indiana, Indianapolis, Indiana.
authors.forename: David
authors.initials: D
authors.lastname: Heimansohn
authors.affiliation: St. Vincent's Heart Center of Indiana, 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: 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: University of Michigan Medical Center, Ann Arbor, Michigan.
authors.forename: G Michael
authors.initials: GM
authors.lastname: Deeb
authors.affiliation: Medtronic, Minneapolis, Minnesota.
authors.forename: Jian
authors.initials: J
authors.lastname: Huang
authors.affiliation: Mayo Clinic Foundation, Rochester, Minnesota.
authors.forename: Jae
authors.initials: J
authors.lastname: Oh
authors.affiliation: Banner Good Samaritan Hospital, Phoenix, Arizona.
authors.forename: Timothy
authors.initials: T
authors.lastname: Byrne
authors.affiliation: Banner Good Samaritan Hospital, Phoenix, Arizona.
authors.forename: Michael
authors.initials: M
authors.lastname: Caskey
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000601:surgery*; D004452:Echocardiography; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation / Q000401:mortality*; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
keywords: extreme risk; self-expanding; severe aortic stenosis; transcatheter aortic valve replacement