This article is more than 5 years old. Information may no longer be current.
Major late bleeding events after TAVR frequent, associated with increased mortality
Major late bleeding complications conferred a nearly fourfold risk for mortality after 30 days in a cohort of patients who underwent transcatheter aortic valve replacement in the PARTNER trial.
The new study was conducted to characterize the incidence, predictors and impact of major late bleeding complications at 30 days or later on long-term prognosis after TAVR. Researchers used pooled data from the PARTNER I trial, the randomized continued-access PARTNER trial and the nonrandomized continued-access PARTNER registry.
Researchers evaluated clinical and echocardiographic outcomes for 2,401 patients who underwent TAVR (Sapien, Edwards Lifesciences).
Among patients who survived to 30 days, the rate of major late bleeding complications was 5.9%. Of those, 40.8% were gastrointestinal complications, 15.5% neurological complications and 7.8% traumatic falls.
The median time to major late bleeding complications after the index procedure was 132 days (interquartile range, 71-230).
Low hemoglobin at baseline, atrial fibrillation or flutter at baseline or 30 days, moderate/severe paravalvular leak at 30 days and greater left ventricular mass at 30 days were identified as independent predictors of major late bleeding complications after TAVR.
Major late bleeding complications yielded a significant independent mortality risk from 30 days to 1 year (adjusted HR=3.91; 95% CI, 2.67-5.71), according to results of an adjusted analysis.
“The observed association between moderate or severe paravalvular leak and the occurrence of major late bleeding complications is interesting and deserves further investigation. Better individualized and risk-adjusted antithrombotic therapy after TAVR is urgently needed in this high-risk population,” the researchers concluded.
Disclosure: The researchers report associations with companies including Abbott Vascular, AstraZeneca, Biomet, Boston Scientific, Bristol-Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, GlaxoSmithKline, Janssen, Medtronic and Merck/Schering-Plough.