title: Transcatheter aortic valve replacement and vascular complications definitions.
abstract: OBJECTIVE
  Transcatheter aortic valve replacement (TAVR) requires large calibre catheters and is therefore associated with increased vascular complications. The aim of this study was to illustrate the impact of the different definitions of major vascular complications on their incidence and to underscore the importance of uniform reporting.
  
  
  RESULTS
  We pooled dedicated databases of consecutive patients undergoing TAVR from two tertiary care facilities and looked for the incidence of major vascular complications using various previously reported definitions. The level of agreement (Kappa statistic) between the respective definitions and the Valve Academic Research Consortium (VARC) consensus definition of vascular complications was assessed. A total of 345 consecutive patients underwent transfemoral TAVR and were included in this analysis. A completely percutaneous access and closure technique was applied in 96% of cases. Arterial sheath size ranged between 18 and 24 Fr, the majority being 18 Fr (60%). Procedural success was reached in 94.5%. Depending on the definition used, major vascular complications occurred in 5.2-15.9% of patients. According to the VARC definitions, the rate of major and minor vascular complications was 9.0% and 9.6%, respectively. Major vascular complications according to VARC criteria demonstrated at least a substantial level of agreement with the SOURCE registry (k 0.80), the UK registry (k 0.82) the Italian registry (k 0.72) and "FRANCE" registry (k 0.70) definitions, compared to a moderate level of agreement with the definitions used in the German registry ( 0.47) and the 18 Fr Safety and Efficacy study (k 0.42). Minor complications according to VARC demonstrated a moderate agreement only with vascular complications using the German registry definition (k 0.54).
  
  
  CONCLUSIONS
  Non-uniformity in how vascular complications are defined precludes any reliable comparison between previously reported TAVR registries. The VARC consensus document offers standardised endpoint definitions and should be universally adopted to obtain better insights into global TAVR experience.
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Nicolas M
authors.initials: NM
authors.lastname: Van Mieghem
authors.forename: Philippe
authors.initials: P
authors.lastname: Généreux
authors.forename: Robert M A
authors.initials: RM
authors.lastname: van der Boon
authors.forename: Susheel
authors.initials: S
authors.lastname: Kodali
authors.forename: Stuart
authors.initials: S
authors.lastname: Head
authors.forename: Matthew
authors.initials: M
authors.lastname: Williams
authors.forename: Benoit
authors.initials: B
authors.lastname: Daneault
authors.forename: Arie-Pieter
authors.initials: AP
authors.lastname: Kappetein
authors.forename: Peter P
authors.initials: PP
authors.lastname: de Jaegere
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D006328:Cardiac Catheterization; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects*; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000453:epidemiology*; D012042:Registries