Infection-Related Morbidity with Continuous-Flow Left Ventricular Assist Systems: A Comprehensive Analysis of the Randomized MOMENTUM 3 Trial

Abstract

The MOMENTUM 3 trial established superiority of a fully magnetically-levitated HeartMate 3 (HM3) centrifugal pump over the axial flow HeartMate II (HMII) pump on hemocompatibility-related outcomes. Infection-related outcomes were no different between the two devices. We sought to understand the types of infection, temporal trends, clinical correlates and risk markers over 2-years of support. MOMENTUM 3 randomized 1020 patients to either the HM 3 (515) or HM II (505) groups. Morbidity and mortality related outcomes were analyzed between patients with or without major infection complications. Cox regression analyses were utilized to identify characteristics associated with major infectious complications. The cumulative number of infections was 1213 (634 HM3 and 579 HMII), and major infection occurred in 58% HM3 and 56% HMII patients (p=0.57). Localized infections unrelated to pump components were most common (n=681/1213; 56%), followed by driveline infection (n=329/1213; 27%), sepsis (n=194/1213; 16%), and other events (n=9/1213; 0.7%). Bacterial pathogens were implicated in 806/1213 events (66%) and significant predictors of infection included gender (men vs. women; HR:0.73, p=0.003), BUN (HR:1.12, p=0.01), preimplant history of cardiac surgery (HR:1.28, p=0.01), and BMI≥30 (HR:1.43, p<0.0001). Most deaths in those with infection ultimately occurred due to non-infectious causes (Figure). Infection is the commonest adverse effect in patients implanted with contemporary continuous-flow pumps with most such events presenting as events unrelated to the pump components. Whether mechanical circulatory devices confer an immunosuppressive effect leading to propensity for infection warrants closer scrutiny to understand and ameliorate this morbidity. (Funded by Abbott; MOMENTUM 3 NCT02224755).