title: Self-expanding transcatheter aortic valve replacement using alternative access sites in symptomatic patients with severe aortic stenosis deemed extreme risk of surgery.
abstract: OBJECTIVE
  The CoreValve Extreme Risk US Pivotal Trial enrolled patients with symptomatic severe aortic stenosis deemed unsuitable for surgical aortic valve replacement. Implants were attempted using transfemoral access (n = 489) or an alternative access (n = 150). In present analysis, we sought to examine the safety and efficacy of CoreValve transcatheter aortic valve replacement using alternative access.
  
  
  METHODS
  The present study included 150 patients with prohibitive iliofemoral anatomy who were treated with the CoreValve transcatheter heart valve delivered by way of the subclavian artery (n = 70) or a direct aortic approach (n = 80). The echocardiograms were read by an independent core laboratory. The primary endpoint was all-cause mortality or major stroke at 12 months.
  
  
  RESULTS
  The preoperative aortic valve area was 0.72 ± 0.27 cm(2) and mean aortic valve gradient was 49.5 ± 17.0 mm Hg. After the transcatheter aortic valve replacement, the effective aortic valve area was 1.82 ± 0.64 cm(2) at 1 month and 1.85 ± 0.51 cm(2) at 12 months. The mean aortic valve gradient was 9.7 ± 5.8 mm Hg at 30 days and 9.5 ± 5.7 mm Hg at 12 months. The death or major stroke rate was 15.3% at 30 days and 39.4% at 12 months. The individual rate of all-cause mortality and major stroke was 11.3% and 7.5% at 30 days and 36.0% and 9.1% at 12 months.
  
  
  CONCLUSIONS
  These data demonstrate that the CoreValve transcatheter heart valve delivered by an alternative access provides a suitable alternative for treatment of extreme risk patients with symptomatic severe aortic stenosis, who have prohibitive iliofemoral anatomy and no surgical options.
authors.affiliation: Houston-Methodist-Debakey Heart and Vascular Center, Houston, Tex. Electronic address: mreardon@houstonmethodist.org.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Reardon
authors.affiliation: Mount Sinai Medical Center, New York, NY.
authors.forename: David H
authors.initials: DH
authors.lastname: Adams
authors.affiliation: Texas Heart Institute, St Luke's Medical Center, Houston, Tex.
authors.forename: Joseph S
authors.initials: JS
authors.lastname: Coselli
authors.affiliation: University of Michigan Medical Center, Ann Arbor, Mich.
authors.forename: G Michael
authors.initials: GM
authors.lastname: Deeb
authors.affiliation: Houston-Methodist-Debakey Heart and Vascular Center, Houston, Tex.
authors.forename: Neal S
authors.initials: NS
authors.lastname: Kleiman
authors.affiliation: University of Michigan Medical Center, Ann Arbor, Mich.
authors.forename: Stan
authors.initials: S
authors.lastname: Chetcuti
authors.affiliation: Riverside Methodist Hospital, Columbus, Ohio.
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Yakubov
authors.affiliation: St Vincent's Medical Center, Indianapolis, Ind.
authors.forename: David
authors.initials: D
authors.lastname: Heimansohn
authors.affiliation: St Vincent's Medical Center, Indianapolis, Ind.
authors.forename: James
authors.initials: J
authors.lastname: Hermiller
authors.affiliation: Duke University Medical Center, Durham, NC.
authors.forename: G Chad
authors.initials: GC
authors.lastname: Hughes
authors.affiliation: Duke University Medical Center, Durham, NC.
authors.forename: J Kevin
authors.initials: JK
authors.lastname: Harrison
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, Mass.
authors.forename: Kamal
authors.initials: K
authors.lastname: Khabbaz
authors.affiliation: University of Kansas Hospital, Kansas City, Kan.
authors.forename: Peter
authors.initials: P
authors.lastname: Tadros
authors.affiliation: University of Kansas Hospital, Kansas City, Kan.
authors.forename: George L
authors.initials: GL
authors.lastname: Zorn
authors.affiliation: Spectrum Health Hospitals, Grand Rapids, Mich.
authors.forename: William
authors.initials: W
authors.lastname: Merhi
authors.affiliation: Spectrum Health Hospitals, Grand Rapids, Mich.
authors.forename: John
authors.initials: J
authors.lastname: Heiser
authors.affiliation: St Francis Hospital, Roslyn, NY.
authors.forename: George
authors.initials: G
authors.lastname: Petrossian
authors.affiliation: St Francis Hospital, Roslyn, NY.
authors.forename: Newell
authors.initials: N
authors.lastname: Robinson
authors.affiliation: Pinnacle Health, Harrisburg, Pa.
authors.forename: Brijeshwar
authors.initials: B
authors.lastname: Maini
authors.affiliation: Pinnacle Health, Harrisburg, Pa.
authors.forename: Mubashir
authors.initials: M
authors.lastname: Mumtaz
authors.affiliation: University of Pittsburgh Medical Center, Pittsburgh, Pa.
authors.forename: Joon Sup
authors.initials: JS
authors.lastname: Lee
authors.affiliation: University of Pittsburgh Medical Center, Pittsburgh, Pa.
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Gleason
authors.affiliation: Johns Hopkins University Hospital, Baltimore, Md.
authors.forename: Jon
authors.initials: J
authors.lastname: Resar
authors.affiliation: Johns Hopkins University Hospital, Baltimore, Md.
authors.forename: John
authors.initials: J
authors.lastname: Conte
authors.affiliation: Riverside Methodist Hospital, Columbus, Ohio.
authors.forename: Daniel
authors.initials: D
authors.lastname: Watson
authors.affiliation: Medtronic, Inc, Minneapolis, Minn.
authors.forename: Sharla
authors.initials: S
authors.lastname: Chenoweth
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, Mass.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001011:Aorta; D001021:Aortic Valve / Q000503:physiopathology*; D001024:Aortic Valve Stenosis / Q000150:complications / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006439:Hemodynamics; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D012720:Severity of Illness Index; D020521:Stroke / Q000209:etiology; D013348:Subclavian Artery; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States