Safety and Effectiveness of Sacubitril/Valsartan in Patients with a Left Ventricular Assist Device

Abstract

Purpose: This study evaluated the impact of early post-operative hyperlactatemia on outcomes after left ventricular assist device (LVAD) implantation. Methods: Adults undergoing contemporary LVAD implantation (Heart-Mate 3 or HeartWare HVAD) between 2009 to 2018 were included. Peak post-operative (within 24-hours) lactate level was analyzed. The cohort was stratified into patients with and without post-op hyperlactatemia, which was defined as peak >3.5 mMol/L. The primary outcome was survival, and secondary outcomes included post-implant adverse events. Subanalysis was performed to evaluate the impact of hours for lactate normalization, define as lactate <2 mMol/L. Multivariable cox regression was used for risk-adjustment. Results: 190 patients were included. 49.5% experienced post-operative hyperlactatemia. Patients with post-operative hyperlactatemia had significantly higher rates of post-implant complications including re-operation, renal failure, and hepatic dysfunction (all, p≤0.05). The post-operative hyperlactatemia group also had significantly higher 90-days and 1-year mortality rates following LVAD implantation (all, p≤0.05) (Table ). In multivariable analysis, post-operative hyperlactatemia (HR 1.69, 95% CI 1.09-2.60, p=0.02) was an independent predictor of overall mortality following LVAD implantation. Increased time for normalization of lactate also adversely impacted risk-adjusted overall mortality following implantation as a continuous variable (HR 1.02, 95% CI 1.01-1.03, p<.001). Conclusion:This study demonstrates post-operative hyperlactatemia is associated with increased morbidity and mortality following LVAD implantation. Even early post-operative lactate trends within the first 24 postoperative hours appear to have useful role in predicting longitudinal survival following implantation. Careful monitoring of post-operative lactate with measures to normalize levels should be considered in the early care of LVAD patients.