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.
Bibliographical noteFunding Information:
CBP is a consultant for Abbott. LB is a consultant for Abbott and Medtronic. BC has no conflicts to disclose. SHB is a consultant for Abbott. JWE has no conflict to disclose. RJ is a consultant for Abbott and Medtronic and received research grants from Abbott. VT is a consultant and a trial steering committee member for Abbott. JCC received grant support during the conduct of the study. DJG received travel support from Abbott. NU received grant support, consulting fees, and honoraria from Abbott and Medtronic and serves on the advisory boards for Leviticus Cardio and Livemetric/Cormetric. XS, SIS, and PS are employees of Abbott. MRM is a consultant for Abbott (fees paid to Brigham and Women's Hospital), Portola, Bayer, Baim Institute for Clinical Research, and Triple Gene; a trial steering committee member for Medtronic and Janssen; a scientific advisory board member for Leviticus, NupulseCV, and FineHeart; and a Data and Safety Monitoring Board member for Mesoblast.
The study was funded by Abbott, Abbott Park, Illinois, MOMENTUM 3 ClinicalTrials.gov number, NCT02224755 .
© 2020 The Authors
- heart failure
PubMed: MeSH publication types
- Journal Article
- Multicenter Study
- Randomized Controlled Trial
- Research Support, Non-U.S. Gov't