Risk Factors for Post-TAVI Bleeding According to the VARC-2 Bleeding Definition and Effect of the Bleeding on Short-Term Mortality: A Meta-analysis.

Background: In this study we investigated the effect of post-transcatheter aortic valve implantation (TAVI) bleeding (per Valve Academic Research Consortium-2 [VARC-2] bleeding criteria) on 30-day postoperative mortality and examined the correlation between pre- or intraoperative variables and bleeding.

Methods: Multiple electronic literature databases were searched using predefined criteria, with bleeding defined per Valve Academic Research Consortium-2 criteria. A total of 10 eligible articles with 3602 patients were included in the meta-analysis.

Results: The meta-analysis revealed that post-TAVI bleeding was associated with a 323% increase in 30-day postoperative mortality (odds risk [OR]; 4.23, 95% confidence interval [CI], 2.80-6.40; P < 0.0001) without significant study heterogeneity or publication bias. In subgroup analysis we found that patients with major bleeding/life-threatening bleeding showed a 410% increase in mortality compared with patients without bleeding (OR, 5.10; 95% CI, 3.17-8.19; P < 0.0001). Transapical access was associated with an 83% increase in the incidence of bleeding compared with transfemoral access (OR, 1.83; 95% CI, 1.43-2.33; P < 0.0001). Multiple logistic regression analysis revealed that atrial fibrillation (AF) was independently correlated with TAVI-associated bleeding (OR, 2.63; 95% CI, 1.33-5.21; P = 0.005). Meta-regression showed that potential modifiers like the Society of Thoracic Surgeons (STS) score, mortality, the logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE), aortic valve area, mean pressure gradient, left ventricular ejection fraction, preoperative hemoglobin and platelet levels, and study design had no significant effects on the results of the meta-analysis.

Conclusions: Post-TAVI bleeding, in particular, major bleeding/life-threatening bleeding, increased 30-day postoperative mortality. Transapical access was a significant bleeding risk factor. Preexisting AF independently correlated with TAVI-associated bleeding, likely because of AF-related anticoagulation. Recognition of the importance and determinants of post-TAVI bleeding should lead to strategies to improve outcomes.