-
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 .).
Notes
Knowledge, pearl, summary or comment to share?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:

- 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.
.