Left ventricular assist systems and infection-related outcomes: A comprehensive analysis of the MOMENTUM 3 trial

被引:60
|
作者
Patel, Chetan B. [1 ]
Blue, Laura [1 ]
Cagliostro, Barbara [2 ]
Bailey, Stephen H. [3 ]
Entwistle, John W. [4 ]
John, Ranjit [5 ]
Thohan, Vinay [6 ]
Cleveland, Joseph C. [7 ]
Goldstein, Daniel J. [8 ]
Uriel, Nir [2 ]
Su, Xiaolu [9 ]
Somo, Sami I. [9 ]
Sood, Poornima [9 ]
Mehra, Mandeep R. [10 ,11 ]
机构
[1] Duke Univ, Med Ctr, Durham, NC USA
[2] Columbia Univ, Med Ctr, New York Presbyterian, New York, NY USA
[3] Allegheny Gen Hosp, Pittsburgh, PA 15212 USA
[4] Thomas Jefferson Univ Hosp, Philadelphia, PA 19107 USA
[5] Univ Minnesota, Med Ctr, Minneapolis, MN 55455 USA
[6] Mission Hlth Syst, Asheville, NC USA
[7] Univ Colorado, Sch Med, Aurora, CO USA
[8] Montefiore Einstein Ctr Heart & Vasc Care, New York, NY USA
[9] Abbott, Abbott Pk, IL USA
[10] Brigham & Womens Hosp, 75 Francis St, Boston, MA 02115 USA
[11] Harvard Med Sch, Boston, MA 02115 USA
来源
关键词
LVAD; infection; prognosis; driveline; MCS; heart failure; DEVICE; IMPLANTATION; IMPACT;
D O I
10.1016/j.healun.2020.03.002
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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. J Heart Lung Transplant 2020;39:774-781 (C) 2020 The Author(s). Published by Elsevier Inc. on behalf of International Society for Heart and Lung Transplantation. This is an open access article under the CC BY-NC-ND license. (http://creativecommons.org/licenses/by-nc-nd/4.0)
引用
收藏
页码:774 / 781
页数:8
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