title: Validation of the Valve Academic Research Consortium Bleeding Definition in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation.
abstract: BACKGROUND
  The Valve Academic Research Consortium (VARC) has proposed a standardized definition of bleeding in patients undergoing transcatheter aortic valve interventions (TAVI). The VARC bleeding definition has not been validated or compared to other established bleeding definitions so far. Thus, we aimed to investigate the impact of bleeding and compare the predictivity of VARC bleeding events with established bleeding definitions.
  
  
  RESULTS
  Between August 2007 and April 2012, 489 consecutive patients with severe aortic stenosis were included into the Bern-TAVI-Registry. Every bleeding complication was adjudicated according to the definitions of VARC, BARC, TIMI, and GUSTO. Periprocedural blood loss was added to the definition of VARC, providing a modified VARC definition. A total of 152 bleeding events were observed during the index hospitalization. Bleeding severity according to VARC was associated with a gradual increase in mortality, which was comparable to the BARC, TIMI, GUSTO, and the modified VARC classifications. The predictive precision of a multivariable model for mortality at 30 days was significantly improved by adding the most serious bleeding of VARC (area under the curve [AUC], 0.773; 95% confidence interval [CI], 0.706 to 0.839), BARC (AUC, 0.776; 95% CI, 0.694 to 0.857), TIMI (AUC, 0.768; 95% CI, 0.692 to 0.844), and GUSTO (AUC, 0.791; 95% CI, 0.714 to 0.869), with the modified VARC definition resulting in the best predictivity (AUC, 0.814; 95% CI, 0.759 to 0.870).
  
  
  CONCLUSIONS
  The VARC bleeding definition offers a severity stratification that is associated with a gradual increase in mortality and prognostic information comparable to established bleeding definitions. Adding the information of periprocedural blood loss to VARC may increase the sensitivity and the predictive power of this classification.
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland (S.S., G.G.S., T.P., F.P., F.L., R.P., A.A.K., L., B.M., P.W., S.W.).
authors.forename: Stefan
authors.initials: S
authors.lastname: Stortecky
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland (S.S., G.G.S., T.P., F.P., F.L., R.P., A.A.K., L., B.M., P.W., S.W.).
authors.forename: Giulio G
authors.initials: GG
authors.lastname: Stefanini
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland (S.S., G.G.S., T.P., F.P., F.L., R.P., A.A.K., L., B.M., P.W., S.W.).
authors.forename: Thomas
authors.initials: T
authors.lastname: Pilgrim
authors.affiliation: Department of Clinical Research, Clinical Trials Unit, Bern, Switzerland (D.H., S.W.).
authors.forename: Dik
authors.initials: D
authors.lastname: Heg
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland (S.S., G.G.S., T.P., F.P., F.L., R.P., A.A.K., L., B.M., P.W., S.W.).
authors.forename: Fabien
authors.initials: F
authors.lastname: Praz
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland (S.S., G.G.S., T.P., F.P., F.L., R.P., A.A.K., L., B.M., P.W., S.W.).
authors.forename: Fabienne
authors.initials: F
authors.lastname: Luterbacher
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland (S.S., G.G.S., T.P., F.P., F.L., R.P., A.A.K., L., B.M., P.W., S.W.).
authors.forename: Raffaele
authors.initials: R
authors.lastname: Piccolo
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland (S.S., G.G.S., T.P., F.P., F.L., R.P., A.A.K., L., B.M., P.W., S.W.).
authors.forename: Ahmed A
authors.initials: AA
authors.lastname: Khattab
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland (S.S., G.G.S., T.P., F.P., F.L., R.P., A.A.K., L., B.M., P.W., S.W.).
authors.forename: Lorenz
authors.initials: L
authors.lastname: Räber
authors.affiliation: Department of Cardiovascular Surgery, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland (B.L., C.H.).
authors.forename: Bettina
authors.initials: B
authors.lastname: Langhammer
authors.affiliation: Department of Cardiovascular Surgery, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland (B.L., C.H.).
authors.forename: Christoph
authors.initials: C
authors.lastname: Huber
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland (S.S., G.G.S., T.P., F.P., F.L., R.P., A.A.K., L., B.M., P.W., S.W.).
authors.forename: Bernhard
authors.initials: B
authors.lastname: Meier
authors.affiliation: Institute of Primary Health Care, University of Bern, Switzerland (P.).
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland (S.S., G.G.S., T.P., F.P., F.L., R.P., A.A.K., L., B.M., P.W., S.W.).
authors.forename: Peter
authors.initials: P
authors.lastname: Wenaweser
authors.affiliation: Department of Cardiology, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland (S.S., G.G.S., T.P., F.P., F.L., R.P., A.A.K., L., B.M., P.W., S.W.) Department of Clinical Research, Clinical Trials Unit, Bern, Switzerland (D.H., S.W.).
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D019540:Area Under Curve; D006328:Cardiac Catheterization / Q000009:adverse effects* / Q000379:methods / Q000401:mortality; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects* / Q000379:methods / Q000401:mortality; D006470:Hemorrhage / Q000145:classification* / Q000175:diagnosis* / Q000209:etiology / Q000401:mortality / Q000628:therapy; D006801:Humans; D008297:Male; D015999:Multivariate Analysis; D011237:Predictive Value of Tests; D016016:Proportional Hazards Models; D012372:ROC Curve; D012042:Registries; D015203:Reproducibility of Results; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013557:Switzerland; D009626:Terminology as Topic; D016896:Treatment Outcome
keywords: TAVI; Valve Academic Research Consortium; bleeding; complication; transcatheter aortic valve implantation; transcatheter aortic valve intervention