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

Abstract

BackgroundThe 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 ResultsBetween 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).ConclusionsThe 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.

Real‐world comparison of the new 34 mm self‐expandable transcatheter aortic prosthesis Evolut R to its 31 mm core valve predecessor

“…Acute kidney injury, as proposed by VARC‐2 criteria, was recorded according to the AKIN classification in three stages, based on the increase in serum creatinine levels and urine output, with stage 3 to be considered as a study endpoint. Finally, with regards to bleeding complications, the Bleeding Academic Research Consortium (BARC) classification was used for characterizing the bleeding severity …”

“…Finally, with regards to bleeding complications, the Bleeding Academic Research Consortium (BARC) classification was used for characterizing the bleeding severity. 21…”

Vascular complications associated with transcatheter aortic valve replacement

“…Patients who suffer minor vascular complications using either the VARC-1 or VARC-2 definitions have similar rates of mortality and other complications when compared with those without vascular complications. 38 However, both VARC-1 38 and VARC-2 major vascular complications are associated with increased length of hospital stay, longer procedural time 38,39 and mortality; VARC-2 definitions better predict survival than VARC-1 definitions. 40 …”

Comparison of dual antiplatelet therapy versus oral anticoagulation following transcatheter aortic valve replacement: A retrospective single-center registry analysis

“…Regardless of the underlying mechanisms, disabling or life-threatening bleeding is an important predictor of acute and late mortality in patients undergoing TAVR. Predictors of bleeding complications have been identified by several groups [30,31]. Among them, vascular or major intraprocedural complications, female sex, and baseline anemia have been most frequently reported.…”