title: Adherence to patient selection criteria in patients undergoing transcatheter aortic valve implantation with the 18F CoreValve ReValving System.
abstract: BACKGROUND
  Anecdotal evidence suggests that transcatheter aortic valve implantation (TAVI) is being used beyond pre-market label indications.
  
  
  METHODS
  To assess the frequency and outcomes associated with "off-label" use of TAVI, we conducted a retrospective study, examining adherence to patient selection criteria in 63 patients undergoing implantation with the 18F CoreValve ReValving System (CRS). Label status (on-label vs off-label) was determined by following (1) inclusion/exclusion criteria indicated in the 18F CRS safety and efficacy trial and (2) a patient selection matrix indicating anatomical boundaries to guide patient selection. Off-label use was defined as the presence of at least one exclusion criterion or "non-acceptable" criteria based on the patient selection matrix.
  
  
  RESULTS
  Off-label implantation was identified in 42 patients (67%)-40% had one, 19% had two and 8% had three or more off-label criteria. Baseline demographics were similar between the groups except for a higher logistic EuroSCORE in the on-label group (19.8 (11.2) vs 14.5 (7.3), p = 0.029). There was no significant difference in the procedural success rates between the on-label and off-label groups (91% vs 95%, respectively, p = 0.47). The frequency of angiographic moderate-severe aortic regurgitation, post-implant dilatation or implantation of a second valve was also similar between the groups. At 30 days, the cumulative death rate was 10%; there were four deaths in the "on-label" and three deaths in the "off-label" group.
  
  
  CONCLUSIONS
  In this study we found that "off-label" implantation of the CRS was common. Further studies are needed to evaluate the consequences of "label status" for patients undergoing TAVI.
authors.affiliation: Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: N
authors.initials: N
authors.lastname: Piazza
authors.forename: A
authors.initials: A
authors.lastname: Otten
authors.forename: C
authors.initials: C
authors.lastname: Schultz
authors.forename: Y
authors.initials: Y
authors.lastname: Onuma
authors.forename: H M
authors.initials: HM
authors.lastname: Garcia-Garcia
authors.forename: E
authors.initials: E
authors.lastname: Boersma
authors.forename: P
authors.initials: P
authors.lastname: de Jaegere
authors.forename: P W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000601:surgery*; D018795:Device Approval; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006801:Humans; D008297:Male; D018579:Patient Selection; D015996:Survival Rate; D016896:Treatment Outcome