Validation of the Valve Academic Research Consortium Bleeding Definition in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation.

Stortecky, Stefan; Stefanini, Giulio G; Pilgrim, Thomas; Heg, Dik; Praz, Fabien; Luterbacher, Fabienne; Piccolo, Raffaele; Khattab, Ahmed A; Räber, Lorenz; Langhammer, Bettina; Huber, Christoph; Meier, Bernhard; Jüni, Peter; Wenaweser, Peter Martin; Windecker, Stephan (2015). Validation of the Valve Academic Research Consortium Bleeding Definition in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation. Journal of the American Heart Association, 4(10), e002135. American Heart Association 10.1161/JAHA.115.002135

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology
04 Faculty of Medicine > Medical Education > Institute of General Practice and Primary Care (BIHAM)
04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiovascular Surgery
04 Faculty of Medicine > Pre-clinic Human Medicine > CTU Bern

UniBE Contributor:

Stortecky, Stefan; Stefanini, Giulio; Pilgrim, Thomas; Heg, Dierik Hans; Praz, Fabien; Khattab, Ahmed Aziz; Räber, Lorenz; Langhammer, Bettina; Huber, Christoph; Meier, Bernhard; Jüni, Peter; Wenaweser, Peter Martin and Windecker, Stephan

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

2047-9980

Publisher:

American Heart Association

Language:

English

Submitter:

Doris Kopp Heim

Date Deposited:

05 Nov 2015 11:14

Last Modified:

09 Nov 2015 15:18

Publisher DOI:

10.1161/JAHA.115.002135

PubMed ID:

26408014

Uncontrolled Keywords:

TAVI; Valve Academic Research Consortium; bleeding complication; transcatheter aortic valve implantation; transcatheter; aortic valve intervention

BORIS DOI:

10.7892/boris.72888

URI:

https://boris.unibe.ch/id/eprint/72888

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