Impact of primary hemostasis disorders on late (> 30 days) major/life-threatening bleedings after TAVR

Abstract

Periprocedural and late (> 30 days) bleedings represent one of the major complications after transcatheter aortic valve replacement (TAVR) and have been identified as potential area for improved patient care. This study aimed to evaluate the impact of ongoing primary hemostasis disorders on late major/life-threatening bleeding complication (MLBCs). Bleedings were assessed according to the valve academic research consortium-2 (VARC-2) criteria. CT-ADP, a surrogate marker of high molecular weight von Willebrand multimers proteolysis was assessed 24 h after the procedure. Ongoing primary hemostasis disorders was defined by a CT-ADP > 180 s. Amongst 373 patients who survived at 30 days, MLBCs occurred in 42 patients (11.3%) at a median follow-up of 383 days (interquartile range: 188 to 574 days), MLBCs were mainly of gastrointestinal origin (42.9%) and were associated with increased mortality (45.2% vs. 9.7%; P < 0.001). A 3-fold elevation of MLBCs could be evidenced in patients with a CT-ADP > 180s (23.6% vs. 7.4%; P < 0.001). Multivariate regression analysis identified paravalvular leak (PVL) [HR: 6.313; 95% CI (3.437–11.595); P < 0.0001] and CT-ADP > 180 s [HR: 3.130; (1.653–5.929); P = 0.0005] as independent predictor of MLBCs ( Table 1 , Fig. 1 ). MLBCs after TAVR are frequent and associated with an increased morbidity and mortality. PVL and CT-ADP > 180 s were identified as strong predictors for MLBCs. Our findings strongly suggest that the missing link between PVL and the risk of MLBCs is a persistent high molecular weight Von Willebrand defect.