title: Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and current third-generation self-expanding CoreValve prosthesis: device success and 30-day clinical outcome.
abstract: OBJECTIVE
  We sought to determine both the procedural performance and safety of percutaneous implantation of the second (21-French [F])- and third (18-F)-generation CoreValve aortic valve prosthesis (CoreValve Inc., Irvine, California).
  
  
  BACKGROUND
  Percutaneous aortic valve replacement represents an emerging alternative therapy for high-risk and inoperable patients with severe symptomatic aortic valve stenosis.
  
  
  METHODS
  Patients with: 1) symptomatic, severe aortic valve stenosis (area <1 cm2); 2) age > or =80 years with a logistic EuroSCORE > or =20% (21-F group) or age > or =75 years with a logistic EuroSCORE > or =15% (18-F group); or 3) age > or =65 years plus additional prespecified risk factors were included. Introduction of the 18-F device enabled the transition from a multidisciplinary approach involving general anesthesia, surgical cut-down, and cardiopulmonary bypass to a truly percutaneous approach under local anesthesia without hemodynamic support.
  
  
  RESULTS
  A total of 86 patients (21-F, n = 50; 18-F, n = 36) with a mean valve area of 0.66 +/- 0.19 cm2 (21-F) and 0.54 +/- 0.15 cm2 (18-F), a mean age of 81.3 +/- 5.2 years (21-F) and 83.4 +/- 6.7 years (18-F), and a mean logistic EuroSCORE of 23.4 +/- 13.5% (21-F) and 19.1 +/- 11.1% (18-F) were recruited. Acute device success was 88%. Successful device implantation resulted in a marked reduction of aortic transvalvular gradients (mean pre 43.7 mm Hg vs. post 9.0 mm Hg, p < 0.001) with aortic regurgitation grade remaining unchanged. Acute procedural success rate was 74% (21-F: 78%; 18-F: 69%). Procedural mortality was 6%. Overall 30-day mortality rate was 12%; the combined rate of death, stroke, and myocardial infarction was 22%.
  
  
  CONCLUSIONS
  Treatment of severe aortic valve stenosis in high-risk patients with percutaneous implantation of the CoreValve prosthesis is feasible and associated with a lower mortality rate than predicted by risk algorithms.
authors.affiliation: HELIOS Heart Center Siegburg, Siegburg, Germany. GrubeE@aol.com
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schuler
authors.forename: Lutz
authors.initials: L
authors.lastname: Buellesfeld
authors.forename: Ulrich
authors.initials: U
authors.lastname: Gerckens
authors.forename: Axel
authors.initials: A
authors.lastname: Linke
authors.forename: Peter
authors.initials: P
authors.lastname: Wenaweser
authors.forename: Barthel
authors.initials: B
authors.lastname: Sauren
authors.forename: Friedrich-Wilhelm
authors.initials: FW
authors.lastname: Mohr
authors.forename: Thomas
authors.initials: T
authors.lastname: Walther
authors.forename: Bernfried
authors.initials: B
authors.lastname: Zickmann
authors.forename: Stein
authors.initials: S
authors.lastname: Iversen
authors.forename: Thomas
authors.initials: T
authors.lastname: Felderhoff
authors.forename: Raymond
authors.initials: R
authors.lastname: Cartier
authors.forename: Raoul
authors.initials: R
authors.lastname: Bonan
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D001705:Bioprosthesis; D006328:Cardiac Catheterization; D005260:Female; D005500:Follow-Up Studies; D019918:Heart Valve Prosthesis Implantation / Q000379:methods* / Q000401:mortality*; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D018570:Risk Assessment; D012720:Severity of Illness Index; D016037:Single-Blind Method; D015996:Survival Rate; D016896:Treatment Outcome