Left Ventricular Assist Systems and Infection-Related Outcomes: A Comprehensive Analysis of the MOMENTUM 3 Trial

ABSTRACT Background In a randomized, controlled, trial (MOMENTUM 3), the HeartMate 3 (HM3) fully magnetically-levitated centrifugal-flow LVAD demonstrated superiority over the HeartMate II (HMII) axial-flow LVAD. These findings were driven by hemocompatibility-related outcomes, but infection-related outcomes were not altered by device choice. In this trial level analysis, we analyzed the clinical patterns of infection-related outcomes over two-years of support. Methods In MOMENTUM 3, 1020 patients were implanted with either the HM 3 (515) or HM II (505) pump. Clinical characteristics, morbidity and mortality related outcomes were evaluated to identify predictors associated with major infectious complications, using univariable and multivariable models. Results The cumulative number of infections at two-years was 1213 (634 HM3 and 579 HMII), and major infection occurred in 58% HM3 and 56% HMII patients (p=0.57). Infections of a local nature unrelated to pump components were most common (n=681/1213; 56%), followed by driveline-associated 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%); significant predictors of infection included gender (women vs. men; HR:1.38, p=0.003), pre-implant use of IABP (HR:1.33, p=0.02), preimplant history of cardiac surgery (HR:1.28, p=0.01), and BMI≥30 (HR:1.40, p Conclusion Infection is the most common adverse effect in patients implanted with contemporary continuous-flow LVADs with majority of such events unrelated to the pump or its peripheral components. Whether chronic mechanical circulatory devices confer an immunomodulatory effect predisposing to infection warrants closer scrutiny to understand and ameliorate this morbidity.