title: Transcatheter aortic valve implantation (TAVI) outcome according to standardized endpoint definitions by the Valve Academic Research Consortium (VARC).
abstract: BACKGROUND
  Transcatheter aortic valve implantation (TAVI) has become an accepted treatment option for severe aortic stenosis (AS) in high-risk individuals. Yet, current results are difficult to compare given the lack of standardized definitions.
  
  
  RESULTS
  TAVI was performed in 130 high-risk individuals. The Edwards SAPIEN (n = 50) and the Medtronic CoreValve (n = 80) prostheses were implanted by transfemoral (75%) or transapical (25%) access. Outcomes at 30 days and 1 year are reported according to the newly established Valve Academic Research Consortium (VARC) criteria. Median follow-up was 235 days (range, 44-490 days). Thirty-day device success was high (91.5%). Combined safety endpoint at 30 days was 20.8%, with an all-cause mortality of 11.5%. Major vascular complications (11.5%), life-threatening or disabling bleeding (8.5%), and acute kidney injury (6.2%) were further major adverse events. At 1-year follow-up, valve performance was accurate in 94.7% of patients. However, prosthetic-valve associated complications, such as new left bundle branch block (20.0%) or permanent pacemaker implantation (34.7%), were common; cumulative prosthetic-valve associated complications were significantly more frequent in patients treated with a Medtronic CoreValve prosthesis (p = 0.0012). Overall 1-year survival was 80%, with the VARC combined efficacy endpoint (composite of survival, freedom from therapy failure, and accurate valve performance) met in 70.2%. In particular, at 1 year, 68.5% of the patients were living independently at home.
  
  
  CONCLUSIONS
  The newly established VARC standardized definitions are useful for TAVI outcome reporting.
authors.affiliation: Department of Cardiology, Cardiovascular Center, University Hospital Zürich, Rämistress 100, 8091 Zürich, Switzerland.
authors.forename: Barbara E
authors.initials: BE
authors.lastname: Stähli
authors.forename: Reto
authors.initials: R
authors.lastname: Bünzli
authors.forename: Jürg
authors.initials: J
authors.lastname: Grünenfelder
authors.forename: Ines
authors.initials: I
authors.lastname: Bühler
authors.forename: Christian
authors.initials: C
authors.lastname: Felix
authors.forename: Dominique
authors.initials: D
authors.lastname: Bettex
authors.forename: Patric
authors.initials: P
authors.lastname: Biaggi
authors.forename: Felix C
authors.initials: FC
authors.lastname: Tanner
authors.forename: Dan Linh
authors.initials: DL
authors.lastname: Nguyen-Kim
authors.forename: André
authors.initials: A
authors.lastname: Plass
authors.forename: Heng
authors.initials: H
authors.lastname: Ge
authors.forename: Volkmar
authors.initials: V
authors.lastname: Falk
authors.forename: Thomas F
authors.initials: TF
authors.lastname: Lüscher
authors.forename: Roberto
authors.initials: R
authors.lastname: Corti
authors.forename: Willibald
authors.initials: W
authors.lastname: Maier
authors.forename: Lukas A
authors.initials: LA
authors.lastname: Altwegg
mesh_terms: D058186:Acute Kidney Injury / Q000453:epidemiology / Q000209:etiology; D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000379:methods*; D023381:Endpoint Determination / Q000592:standards*; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis / Q000009:adverse effects; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D015994:Incidence; D008297:Male; D009203:Myocardial Infarction / Q000453:epidemiology / Q000209:etiology; D019106:Postoperative Hemorrhage / Q000453:epidemiology / Q000209:etiology; D016896:Treatment Outcome