• N. Engl. J. Med. · Apr 2018

    Randomized Controlled Trial Comparative Study

    Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure.

    • Mandeep R Mehra, Daniel J Goldstein, Nir Uriel, Joseph C Cleveland, Melana Yuzefpolskaya, Christopher Salerno, Mary N Walsh, Carmelo A Milano, Chetan B Patel, Gregory A Ewald, Akinobu Itoh, David Dean, Arun Krishnamoorthy, William G Cotts, Antone J Tatooles, Ulrich P Jorde, Brian A Bruckner, Jerry D Estep, Valluvan Jeevanandam, Gabriel Sayer, Douglas Horstmanshof, James W Long, Sanjeev Gulati, Eric R Skipper, John B O'Connell, Gerald Heatley, Poornima Sood, Yoshifumi Naka, and MOMENTUM 3 Investigators.
    • From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (M.R.M.); Montefiore Einstein Center for Heart and Vascular Care (D.J.G., U.P.J.) and Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital (M.Y., Y.N.), New York; University of Chicago School of Medicine and Medical Center (N.U., V.J., G.S.) and Abbott (J.B.O., G.H., P.S.), Chicago, and Advocate Christ Medical Center, Oak Lawn (W.G.C., A.J.T.) - all in Illinois; University of Colorado School of Medicine, Aurora (J.C.C.); St. Vincent Heart Center, Indianapolis (C.S., M.N.W.); Duke Heart Center, Duke University, Durham (C.A.M., C.B.P.), and Carolinas Medical Center, Charlotte (S.G., E.R.S.) - both in North Carolina; Washington University School of Medicine, St. Louis (G.A.E., A.I.); Piedmont Hospital, Atlanta (D.D., A.K.); Houston Methodist Hospital, Houston (B.A.B., J.D.E.); and Integris Baptist Medical Center, Oklahoma City (D.H., J.W.L.).
    • N. Engl. J. Med. 2018 Apr 12; 378 (15): 1386-1395.

    BackgroundIn an early analysis of this trial, use of a magnetically levitated centrifugal continuous-flow circulatory pump was found to improve clinical outcomes, as compared with a mechanical-bearing axial continuous-flow pump, at 6 months in patients with advanced heart failure.MethodsIn a randomized noninferiority and superiority trial, we compared the centrifugal-flow pump with the axial-flow pump in patients with advanced heart failure, irrespective of the intended goal of support (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke (with disabling stroke indicated by a modified Rankin score of >3; scores range from 0 to 6, with higher scores indicating more severe disability) or survival free of reoperation to replace or remove a malfunctioning device. The noninferiority margin for the risk difference (centrifugal-flow pump group minus axial-flow pump group) was -10 percentage points.ResultsOf 366 patients, 190 were assigned to the centrifugal-flow pump group and 176 to the axial-flow pump group. In the intention-to-treat population, the primary end point occurred in 151 patients (79.5%) in the centrifugal-flow pump group, as compared with 106 (60.2%) in the axial-flow pump group (absolute difference, 19.2 percentage points; 95% lower confidence boundary, 9.8 percentage points [P<0.001 for noninferiority]; hazard ratio, 0.46; 95% confidence interval [CI], 0.31 to 0.69 [P<0.001 for superiority]). Reoperation for pump malfunction was less frequent in the centrifugal-flow pump group than in the axial-flow pump group (3 patients [1.6%] vs. 30 patients [17.0%]; hazard ratio, 0.08; 95% CI, 0.03 to 0.27; P<0.001). The rates of death and disabling stroke were similar in the two groups, but the overall rate of stroke was lower in the centrifugal-flow pump group than in the axial-flow pump group (10.1% vs. 19.2%; hazard ratio, 0.47; 95% CI, 0.27 to 0.84, P=0.02).ConclusionsIn patients with advanced heart failure, a fully magnetically levitated centrifugal-flow pump was superior to a mechanical-bearing axial-flow pump with regard to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755 .).

      Pubmed     Free full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…

Want more great medical articles?

Keep up to date with a free trial of metajournal, personalized for your practice.
1,706,642 articles already indexed!

We guarantee your privacy. Your email address will not be shared.