Low major bleeding, pump thrombosis and death rates in continuous flow left ventricular assist devices patients with good anticoagulation control

Abstract

Abstract Background Continuous-flow left ventricular assist device (CF-LVAD) patients require anticoagulation with vitamin K antagonists (VKAs). Good versus suboptimal anticoagulation control expressed as high versus low time in target range (TTR) of international normalized ratio results in less clinical events in atrial fibrillation patients. However, data in CF-LVAD patients are lacking. Purpose To study the association between TTR and clinical events in patients with CF-LVAD as destination therapy. Methods Single-centre cohort study in patients receiving CF-LVAD between 2010–2021. Patients were followed from start of VKAs until outcome or end of follow-up. Outcomes were combined major adverse events, thromboembolisms, major bleedings, neurologic events and all-cause mortality. The TTR (low vs. high; <50% vs. >50%) was calculated during the overall study period and over 1-month periods by the Rosendaal-method. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated by Cox regression with time-dependent covariables, adjusted for confounding. Results 74 patients were included; median age 63 years [interquartile range 58–68], 77% males and 60%ischemic heart failure. During 191 years follow-up, 39 combined major adverse events, 14 thromboembolisms, 21 major bleeding, 22 neurologic events and 38 deaths occurred. For 1-month periods, high TTR was associated with less combined major adverse events (HR 0.3 95% CI 0.2–0.7), major bleeding (HR 0.4 95% CI 0.2–1.1), thromboembolism (HR 0.3 95% CI 0.1–1.3) and death (HR 0.2 95% CI 0.1–0.5) (Table 1). Results considering the overall study period were similar. Conclusion Good anticoagulation compared with suboptimal control during 1-month and the overall study period in CF-LVAD patients with destination therapy is associated with lower rates of combined major adverse events, major bleedings, pump thrombosis and death. Funding Acknowledgement Type of funding sources: None.