Validation of the Valve Academic Research Consortium Bleeding Definition in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation.
- Stortecky S 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.).
- Stefanini GG 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.).
- Pilgrim T 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.).
- Heg D Department of Clinical Research, Clinical Trials Unit, Bern, Switzerland (D.H., S.W.).
- Praz F 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.).
- Luterbacher F 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.).
- Piccolo R 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.).
- Khattab AA 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.).
- Räber L 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.).
- Langhammer B Department of Cardiovascular Surgery, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland (B.L., C.H.).
- Huber C Department of Cardiovascular Surgery, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland (B.L., C.H.).
- Meier B 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.).
- Jüni P Institute of Primary Health Care, University of Bern, Switzerland (P.).
- Wenaweser P 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.).
- Windecker S 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.).
- 2015-09-27
Published in:
- Journal of the American Heart Association. - 2015
TAVI
Valve Academic Research Consortium
bleeding
complication
transcatheter aortic valve implantation
transcatheter aortic valve intervention
Aged
Aged, 80 and over
Aortic Valve Stenosis
Area Under Curve
Cardiac Catheterization
Female
Heart Valve Prosthesis Implantation
Hemorrhage
Humans
Male
Multivariate Analysis
Predictive Value of Tests
Proportional Hazards Models
ROC Curve
Registries
Reproducibility of Results
Risk Assessment
Risk Factors
Severity of Illness Index
Switzerland
Terminology as Topic
Treatment Outcome
English
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.
METHODS AND 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.
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.
METHODS AND 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.
- Language
-
- English
- Open access status
- gold
- Identifiers
-
- DOI 10.1161/JAHA.115.002135
- PMID 26408014
- Persistent URL
- https://sonar.ch/global/documents/185188
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