title: Procedural and 30-day outcomes following transcatheter aortic valve implantation using the third generation (18 Fr) corevalve revalving system: results from the multicentre, expanded evaluation registry 1-year following CE mark approval.
abstract: OBJECTIVE
  To describe the procedural performance and 30-day outcomes following implantation using the 18 Fr CoreValve Revalving System (CRS) as part of the multicentre, expanded evaluation registry, 1-year after obtaining CE mark approval.
  
  
  RESULTS
  Patients with symptomatic severe aortic stenosis and logistic Euroscore > or =15%, or age > or =75 years, or age > or =65 years associated with pre-defined risk factors, and for whom a physician proctor and a clinical specialist were in attendance during the implantation and who collected the clinical data, were included. From April 2007, to April 2008, 646 patients with a mean age of 81 +/- 6.6 years, mean aortic valve area 0.6 +/- 0.2 cm2, and logistic EuroSCORE of 23.1 +/- 13.8% were recruited. After valve implantation, the mean transaortic valve gradient decreased from 49.4 +/- 13.9 to 3 +/- 2 mmHg. All patients had paravalvular aortic regurgitation < or = grade 2. The rate of procedural success was 97%. The procedural mortality rate was 1.5%. At 30 days, the all-cause mortality rate (i.e, including procedural) was 8% and the combined rate of death, stroke and myocardial infarction was 9.3%.
  
  
  CONCLUSIONS
  The results of this study demonstrate the high rate of procedural success and a low 30-day mortality in a large cohort of high-risk patients undergoing transcatheter aortic valve implantation (TAVI) with the CRS.
authors.affiliation: Thoraxcenter, Rotterdam, The Netherlands.
authors.forename: Nicolo
authors.initials: N
authors.lastname: Piazza
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
authors.forename: Ulrich
authors.initials: U
authors.lastname: Gerckens
authors.forename: Peter
authors.initials: P
authors.lastname: den Heijer
authors.forename: Axel
authors.initials: A
authors.lastname: Linke
authors.forename: Olev
authors.initials: O
authors.lastname: Luha
authors.forename: Angelo
authors.initials: A
authors.lastname: Ramondo
authors.forename: Giampaolo
authors.initials: G
authors.lastname: Ussia
authors.forename: Peter
authors.initials: P
authors.lastname: Wenaweser
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Laborde
authors.forename: Peter
authors.initials: P
authors.lastname: de Jaegere
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001022:Aortic Valve Insufficiency / Q000000981:diagnostic imaging / Q000401:mortality* / Q000601:surgery*; D002423:Cause of Death; D018795:Device Approval; D004452:Echocardiography; D005260:Female; D006350:Heart Valve Prosthesis / Q000706:statistics & numerical data*; D019918:Heart Valve Prosthesis Implantation / Q000401:mortality*; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000401:mortality; D011474:Prosthesis Design; D012042:Registries; D012308:Risk Management; D012720:Severity of Illness Index; D016896:Treatment Outcome