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Validation of the Valve Academic Research Consortium Bleeding Definition in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation
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Titel: |
Validation of the Valve Academic Research Consortium Bleeding Definition in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation |
In: | Journal of the American Heart Association, 4, 2015, 10 |
veröffentlicht: |
Ovid Technologies (Wolters Kluwer Health)
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ISSN: |
2047-9980 |
DOI: | 10.1161/jaha.115.002135 |
Zusammenfassung: | <jats:sec xml:lang="en"> <jats:title>Background</jats:title> <jats:p xml:lang="en"> The Valve Academic Research Consortium ( <jats:styled-content style="fixed-case">VARC</jats:styled-content> ) has proposed a standardized definition of bleeding in patients undergoing transcatheter aortic valve interventions ( <jats:styled-content style="fixed-case">TAVI</jats:styled-content> ). The <jats:styled-content style="fixed-case">VARC</jats:styled-content> 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 <jats:styled-content style="fixed-case">VARC</jats:styled-content> bleeding events with established bleeding definitions. </jats:p> </jats:sec> <jats:sec xml:lang="en"> <jats:title>Methods and Results</jats:title> <jats:p xml:lang="en"> Between August 2007 and April 2012, 489 consecutive patients with severe aortic stenosis were included into the Bern‐ <jats:styled-content style="fixed-case">TAVI</jats:styled-content> ‐Registry. Every bleeding complication was adjudicated according to the definitions of <jats:styled-content style="fixed-case">VARC</jats:styled-content> , <jats:styled-content style="fixed-case">BARC</jats:styled-content> , <jats:styled-content style="fixed-case">TIMI</jats:styled-content> , and <jats:styled-content style="fixed-case">GUSTO</jats:styled-content> . Periprocedural blood loss was added to the definition of <jats:styled-content style="fixed-case">VARC</jats:styled-content> , providing a modified <jats:styled-content style="fixed-case">VARC</jats:styled-content> definition. A total of 152 bleeding events were observed during the index hospitalization. Bleeding severity according to <jats:styled-content style="fixed-case">VARC</jats:styled-content> was associated with a gradual increase in mortality, which was comparable to the <jats:styled-content style="fixed-case">BARC</jats:styled-content> , <jats:styled-content style="fixed-case">TIMI</jats:styled-content> , <jats:styled-content style="fixed-case">GUSTO</jats:styled-content> , and the modified <jats:styled-content style="fixed-case">VARC</jats:styled-content> classifications. The predictive precision of a multivariable model for mortality at 30 days was significantly improved by adding the most serious bleeding of <jats:styled-content style="fixed-case">VARC</jats:styled-content> (area under the curve [ <jats:styled-content style="fixed-case">AUC</jats:styled-content> ], 0.773; 95% confidence interval [ <jats:styled-content style="fixed-case">CI</jats:styled-content> ], 0.706 to 0.839), <jats:styled-content style="fixed-case">BARC</jats:styled-content> ( <jats:styled-content style="fixed-case">AUC</jats:styled-content> , 0.776; 95% <jats:styled-content style="fixed-case">CI</jats:styled-content> , 0.694 to 0.857), <jats:styled-content style="fixed-case">TIMI</jats:styled-content> ( <jats:styled-content style="fixed-case">AUC</jats:styled-content> , 0.768; 95% <jats:styled-content style="fixed-case">CI</jats:styled-content> , 0.692 to 0.844), and <jats:styled-content style="fixed-case">GUSTO</jats:styled-content> ( <jats:styled-content style="fixed-case">AUC</jats:styled-content> , 0.791; 95% <jats:styled-content style="fixed-case">CI</jats:styled-content> , 0.714 to 0.869), with the modified <jats:styled-content style="fixed-case">VARC</jats:styled-content> definition resulting in the best predictivity ( <jats:styled-content style="fixed-case">AUC</jats:styled-content> , 0.814; 95% <jats:styled-content style="fixed-case">CI</jats:styled-content> , 0.759 to 0.870). </jats:p> </jats:sec> <jats:sec xml:lang="en"> <jats:title>Conclusions</jats:title> <jats:p xml:lang="en"> The <jats:styled-content style="fixed-case">VARC</jats:styled-content> 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 <jats:styled-content style="fixed-case">VARC</jats:styled-content> may increase the sensitivity and the predictive power of this classification. </jats:p> </jats:sec> |
Format: | E-Article |
Quelle: | Ovid Technologies (Wolters Kluwer Health) (CrossRef) |
Sprache: | Englisch |