Pre-Operative Risk Factors of Bleeding and Stroke During Left Ventricular Assist Device Support

• Published in: Journal of the American College of Cardiology Vol. 63; no. 9; pp. 880 - 888
• Main Authors: Boyle, Andrew J., MD, Jorde, Ulrich P., MD, Sun, Benjamin, MD, Park, Soon J., MD, Milano, Carmelo A., MD, Frazier, O. Howard, MD, Sundareswaran, Kartik S., PhD, Farrar, David J., PhD, Russell, Stuart D., MD
• Format: Journal Article
• Language: English
• Published: New York Elsevier Inc 11-03-2014; Elsevier Limited
• Subjects: bleeding; Body mass index; Cardiology; Cardiomyopathy; Cardiovascular; Clinical trials; Drug therapy; heart failure; HeartMate II; Internal Medicine; LVAD; pump thrombosis; Risk factors; Stroke; Studies; Thrombosis; heart failure; destination therapy; bleeding; BTT; HMII; CF-LVAD; body mass index; HeartMate II; HR; stroke; LVAD; continuous flow left ventricular assist device; DT; bridge to transplantation; EPPY; events per patient-year; pump thrombosis; hazard ratio; left ventricular assist device; BMI
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2013.08.1656

Objectives This study sought to determine the pre-operative risk factors related to late bleeding, stroke, and pump thrombosis in patients with HeartMate II (HMII) left ventricular assist devices (LVADs) (Thoratec Corporation, Pleasanton, California) that might influence tailored improvements in patient management. Background Adverse events in LVAD patients remain high. It is unclear whether pre-operative characteristics influence the likelihood of the development of post-operative hemorrhagic or thrombotic complications. Knowing which patients are at greater risk might assist in tailoring anticoagulation therapy for certain patients. Methods Advanced heart failure patients (n = 956) discharged from the hospital after LVAD implantation in the HMII bridge to transplantation (n = 405) and destination therapy (n = 551) clinical trials were retrospectively evaluated. Bleeding requiring surgery or transfusion of >2 U of packed red blood cells, stroke (hemorrhagic and ischemic), and pump thrombosis were tracked from hospital discharge until patient outcome. Results Adverse event rates for post-discharge bleeding (0.67 events/patient-year) were higher than those for hemorrhagic stroke (0.05), ischemic stroke (0.04), and pump thrombosis (0.03). The main sites of bleeding included gastrointestinal (45% of events), wound (12%), and epistaxis (4%). Older age (>65 years) (hazard ratio [HR]: 1.31), lower pre-operative hematocrit (≤31%) (HR: 1.31), ischemic etiology (HR: 1.35), and female (HR: 1.45) were statistically significant multivariable risk factors for bleeding. Female (HR: 1.92) and 65 years of age and younger (HR: 1.94) were multivariable risk factors for hemorrhagic stroke, whereas female (HR: 1.84) and history of diabetes (HR: 1.99) were risk factors for ischemic stroke. Female (HR: 1.90) and higher body mass index (HR: 1.71/10 kg/m2 increase) were also multivariable risk factors for pump thrombosis. Conclusions The risk of bleeding and thrombotic events during LVAD support differs by patient demographics, including sex, age, body mass index, and etiology of heart failure. Further studies should focus on the potential of tailored anticoagulation strategies in these subgroups.