Temporary mechanical circulatory support (tMCS) devices are used for the management of cardiogenic shock. The Impella 5.0 (Abiomed; Danvers, MA) (IMP5) is a commonly used, surgically implanted, tMCS device that requires systemic anticoagulation and purge solution to avoid pump failure. To avoid heparin-induced thrombocytopenia (HIT) from unfractionated heparin (UFH) use, our program has explored the utility of bivalirudin (BIV) for systemic anticoagulation in IMP5. This single center, retrospective study included patients supported on IMP5 with BIV based AC. The efficacy and safety end points were recovery, bridge to left ventricular assist device (LVAD), cardiac transplant (HTX), or death as well as clinically significant bleeding, incidence of Tissue Plasminogen Activator (tPA) use for suspected pump thrombosis, stroke, and device failure. There were 31 patients included, and 26 (84%) received BIV purge solutions. The median duration of IMP5 was 6 (IQR 4–10) days. Most patients were bridged to LVAD (39%, 12); 16% (5) were bridged to HTX, 16% (5) recovered, and 29% (9) died. One patient (3%) suffered from ischemic stroke and 12% (4) patients developed clinically significant bleeding. tPA was administered to 8 (26%) patients. Logistic regression analysis demonstrated that duration of IMP5 was a significant predictor of tPA use (OR 1.28; 95% Confidence Interval 1.04–1.56). There were no cases of pump failure. Our experience highlights the feasibility of utilizing BIV for routine AC use in IMP5.
Advances have allowed left ventricular assist devices (LVAD) to be used with greater success, however, optimal medical management of LVAD patients remains unclear. Methods: We performed a single-center retrospective cohort study at the University of Florida to evaluate 1-year outcomes of mortality and major adverse events in LVAD recipients. All recipients of a continuous flow LVAD between April 2005 and November 2019 were included (n=293). Demographic data, pre-operative laboratory values and medication use on discharge were collected. Patients were followed up to one year postimplantation or to time of death, transplant, or pump exchange. Cox hazards-proportional regression analysis was performed to test predictors of mortality and major adverse events of INTERMACS major bleeding and thromboembolic events . Results: Patients were followed up for a median time of 12 months. Mortality occurred in 16% (n=48). There was a trend to lower mortality with time, with a HR of 0.91 for every additional year across our study period (p=0.017). On univariate analysis, predictors of a higher mortality were older age, male sex, white race, ischemic cardiomyopathy and elevated serum creatinine, while predictors of a lower mortality were use of an ACEI/ARB/ARNI on discharge and use of an aspirin dose greater than 325mg. In a multivariable model including all these variables, only older age independently predicted a higher mortality (HR 1.06 for each additional year, p-value <0.001), while use of an ACEI/ARB/ARNI on discharge was associated with a 91% reduction in mortality (HR 0.09, pvalue <0.001). INTERMACS major bleeding occurred in 33% of patients, and older age was the only independent predictor of it (HR 1.02 for each additional year, p-value 0.010). Thromboembolic events occurred in 15% of patients with no identifiable predictors. Conclusion: Addition of an ACE/ARB/ARNI to LVAD recipients may lead to an overall reduction in one-year mortality. Older age is associated with worse outcomes of mortality and major bleeding events.
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