Left ventricular assist systems and infection-related outcomes: A comprehensive analysis of the MOMENTUM 3 trial.
Publication/Presentation Date
8-1-2020
Abstract
BACKGROUND: In a randomized controlled trial (MOMENTUM 3), the HeartMate 3 (HM3) fully magnetically levitated centrifugal-flow left ventricular assist device (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 2 years of support.
METHODS: In MOMENTUM 3, 1,020 patients were implanted with either the HM3 (n = 515) or HMII (n = 505) pump. Clinical characteristics and 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 2 years was 1,213 (634 HM3 and 579 HMII), and major infection occurred in 58% of patients with the HM3 and 56% of patients with the HMII (p = 0.57). Infections of a local nature unrelated to pump components were most common (n = 681/1,213; 56%), followed by driveline-associated infection (n = 329/1,213; 27%), sepsis (n = 194/1,213; 16%), and other events (n = 9/1,213; 0.7%). Bacterial pathogens were implicated in 806 of 1,213 events (66%); significant predictors of infection included sex (women vs men; hazard ratio [HR]: 1.38, p = 0.003), pre-implant use of intra-aortic balloon pump (HR: 1.33, p = 0.02), pre-implant history of cardiac surgery (HR: 1.28, p = 0.01), and body mass index ≥ 30 (HR: 1.40, p < 0.0001). Most deaths in those with infection occurred owing to non-infectious causes.
CONCLUSION: Infection is the most common adverse effect in patients implanted with contemporary continuous-flow LVADs, with most such events unrelated to the pump or its peripheral components. Whether chronic mechanical circulatory devices confer an immunomodulatory effect pre-disposing to infection warrants closer scrutiny to understand and ameliorate this morbidity.
Volume
39
Issue
8
First Page
774
Last Page
781
ISSN
1557-3117
Published In/Presented At
Patel, C. B., Blue, L., Cagliostro, B., Bailey, S. H., Entwistle, J. W., John, R., Thohan, V., Cleveland, J. C., Jr, Goldstein, D. J., Uriel, N., Su, X., Somo, S. I., Sood, P., & Mehra, M. R. (2020). Left ventricular assist systems and infection-related outcomes: A comprehensive analysis of the MOMENTUM 3 trial. The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation, 39(8), 774–781. https://doi.org/10.1016/j.healun.2020.03.002
Disciplines
Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods
PubMedID
32276809
Department(s)
Administration and Leadership
Document Type
Article