title: Clinical outcomes after transcatheter aortic valve replacement using valve academic research consortium definitions: a weighted meta-analysis of 3,519 patients from 16 studies.
abstract: OBJECTIVE
  This study sought to perform a weighted meta-analysis to determine the rates of major outcomes after transcatheter aortic valve replacement (TAVR) using Valve Academic Research Consortium (VARC) definitions and to evaluate their current use in the literature.
  
  
  BACKGROUND
  Recently, the published VARC definitions have helped to add uniformity to reporting outcomes after TAVR.
  
  
  METHODS
  A comprehensive search of multiple electronic databases from January 1, 2011, through October 12, 2011, was conducted using predefined criteria. We included studies reporting at least 1 outcome using VARC definitions.
  
  
  RESULTS
  A total of 16 studies including 3,519 patients met inclusion criteria and were included in the analysis. The pooled estimate rates of outcomes were determined according to VARC's definitions: device success, 92.1% (95% confidence interval [CI]: 88.7% to 95.5%); all-cause 30-day mortality, 7.8% (95% CI: 5.5% to 11.1%); myocardial infarction, 1.1% (95% CI: 0.2% to 2.0%); acute kidney injury stage II/III, 7.5% (95% CI: 5.1% to 11.4%); life-threatening bleeding, 15.6% (95% CI: 11.7% to 20.7%); major vascular complications, 11.9% (95% CI: 8.6% to 16.4%); major stroke, 3.2% (95% CI: 2.1% to 4.8%); and new permanent pacemaker implantation, 13.9% (95% CI: 10.6% to 18.9%). Medtronic CoreValve prosthesis use was associated with a significant higher rate of new permanent pacemaker implantation compared with the Edwards prosthesis (28.9% [95% CI: 23.0% to 36.0%] vs. 4.9% [95% CI: 3.9% to 6.2%], p < 0.0001). The 30-day safety composite endpoint rate was 32.7% (95% CI: 27.5% to 38.8%) and the 1-year total mortality rate was 22.1% (95% CI: 17.9% to 26.9%).
  
  
  CONCLUSIONS
  VARC definitions have already been used by the TAVR clinical research community, establishing a new standard for reporting clinical outcomes. Future revisions of the VARC definitions are needed based on evolving TAVR clinical experiences.
authors.affiliation: Columbia University Medical Center/New York-Presbyterian Hospital, The Cardiovascular Research Foundation, New York, USA.
authors.forename: Philippe
authors.initials: P
authors.lastname: Généreux
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Head
authors.forename: Nicolas M
authors.initials: NM
authors.lastname: Van Mieghem
authors.forename: Susheel
authors.initials: S
authors.lastname: Kodali
authors.forename: Ajay J
authors.initials: AJ
authors.lastname: Kirtane
authors.forename: Ke
authors.initials: K
authors.lastname: Xu
authors.forename: Craig
authors.initials: C
authors.lastname: Smith
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: A Pieter
authors.initials: AP
authors.lastname: Kappetein
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
mesh_terms: D001021:Aortic Valve / Q000601:surgery; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000601:surgery*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000401:mortality; D015986:Confounding Factors, Epidemiologic; D006350:Heart Valve Prosthesis / Q000009:adverse effects; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000401:mortality; D006801:Humans; D015994:Incidence; D009203:Myocardial Infarction / Q000453:epidemiology* / Q000209:etiology; D010138:Pacemaker, Artificial / Q000706:statistics & numerical data*; D020521:Stroke / Q000453:epidemiology* / Q000209:etiology; D016019:Survival Analysis; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome