Cardiac Surgery| Volume 287, P40-46, July 2023

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The Impact of MOMENTUM 3 Trial Eligibility on Left Ventricular Assist Device Outcomes: A Real-World Experience

Published:March 01, 2023DOI:



      Although the landmark MOMENTUM 3 trial was associated with excellent short-term left ventricular assist device (LVAD) outcomes, many end-stage heart failure patients would not have met the trial eligibility criteria. Moreover, the outcomes of trial ineligible patients are poorly characterized. Therefore, we undertook this study to compare MOMENTUM 3 eligible and ineligible patients.


      We conducted a retrospective review of all primary LVAD implants from 2017 to 2022. Primary stratification was according to MOMENTUM 3 inclusion and exclusion criteria. Primary outcome was survival. Secondary outcomes included complications and length of stay. Multivariable Cox proportional hazards regression models were constructed to further characterize outcomes.


      From 2017 to 2022, 96 patients underwent primary LVAD implantation. Thirty-seven (38.54%) patients were trial eligible while 59 (61.46%) were ineligible. When stratified by trial eligibility, patients who were trial eligible had higher 1-year (80.15% versus 94.52%, P = 0.04) and 2-year survival (70.17% versus 94.52%, P = 0.02). Multivariable analysis showed that trial eligibility was protective of mortality at both 1 y (HR: 0.19 [0.04-0.99], P = 0.049) and 2 y (HR: 0.17 [0.03-0.81], P = 0.03). Although the groups had similar rates of bleeding, stroke, and right ventricular failure, trial ineligibility was associated with a longer periprocedural length of stay.


      In conclusion, the majority of contemporary LVAD patients would not have been eligible for the MOMENTUM 3 trial. Ineligible patients have decreased but acceptable short-term survival. Our findings suggest that a simply reductionist approach to short-term mortality may improve outcomes but fail to capture the majority of patients who could benefit from therapy.


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        • Shah P.
        • Yuzefpolskaya M.
        • Hickey G.W.
        • et al.
        Twelfth interagency registry for mechanically assisted circulatory support report: readmissions after left ventricular assist device.
        Ann Thorac Surg. 2022; 113: 722-737
        • Rose E.A.
        • Gelijns A.C.
        • Moskowitz A.J.
        • et al.
        Long-term use of a left ventricular assist device for end-stage heart failure.
        N Engl J Med. 2001; 345: 1435-1443
        • Rogers J.G.
        • Butler J.
        • Lansman S.L.
        • et al.
        Chronic mechanical circulatory support for inotrope-dependent heart failure patients who are not transplant candidates: results of the INTrEPID trial.
        J Am Coll Cardiol. 2007; 50: 741-747
        • Slaughter M.S.
        • Rogers J.G.
        • Milano C.A.
        • et al.
        Advanced heart failure treated with continuous-flow left ventricular assist device.
        N Engl J Med. 2009; 361: 2241-2251
        • Mehra M.R.
        • Uriel N.
        • Naka Y.
        • et al.
        A fully magnetically levitated left ventricular assist device – final report.
        N Engl J Med. 2019; 380: 1618-1627
        • Mehra M.R.
        • Goldstein D.J.
        • Uriel N.
        • et al.
        Two-year outcomes with a magnetically levitated cardiac pump in heart failure.
        N Engl J Med. 2018; 378: 1386-1395
        • Mehra M.R.
        • Naka Y.
        • Uriel N.
        • et al.
        A fully magnetically levitated circulatory pump for advanced heart failure.
        N Engl J Med. 2017; 376: 440-450
        • Goldstein D.J.
        • Meyns B.
        • Xie R.
        • et al.
        Third annual report from the ISHLT mechanically assisted circulatory support registry: a comparison of centrifugal and axial continuous-flow left ventricular assist devices.
        J Heart Lung Transpl. 2019; 38: 352-363
        • Heatley G.
        • Sood P.
        • Goldstein D.
        • et al.
        Clinical trial design and rationale of the multicenter study of maglev technology in patients undergoing mechanical circulatory support therapy with heartmate 3 (MOMENTUM 3) investigational device exemption clinical study protocol.
        J Heart Lung Transpl. 2016; 35: 528-536
        • Goldstein D.J.
        • Naka Y.
        • Horstmanshof D.
        • et al.
        Association of clinical outcomes with left ventricular assist device use by bridge to transplant or destination therapy intent.
        JAMA Cardiol. 2020; 5: 411-419
        • Schmitto J.D.
        • Pya Y.
        • Krabatsch T.
        • et al.
        Long-term evaluation of a fully magnetically levitated circulatory support device for advanced heart failure – two-year results from the Heartmate 3 CE Mark study.
        Eur J Heart Fail. 2018; 21: 90-97
        • Zimpfer D.
        • Gustafsson F.
        • Potapov E.
        • et al.
        Two-year outcome after implantation of a full magnetically levitated left ventricular assist device: results from the ELEVATE registry.
        Eur Heart J. 2020; 41: 3801-3809
        • Netuka I.
        • Pya Y.
        • Zimpfer D.
        • et al.
        First 5-year multicentric clinical trial experience with the HeartMate 3 left ventricular assist system.
        J Heart Lung Transpl. 2021; 40: 247-250
        • Khush K.K.
        • Hsich E.
        • Potena L.
        • et al.
        The international thoracic organ transplant registry of the international society for heart and lung transplantation: thirty-eight adult heart transplantation report – 2021; focus on recipient characteristics.
        J Heart Lung Transpl. 2021; 40: 1035-1045
        • Kanwar M.K.
        • Pagani F.D.
        • Mehra M.R.
        • et al.
        Center variability in patient outcomes following HeartMate 3 implantation. An analysis of the MOMENTUM 3 trial.
        J Card Fail. 2022; 28: 1158-1168