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N Engl J Med. 2019 Mar 17. doi: 10.1056/NEJMoa1900486. [Epub ahead of print]

A Fully Magnetically Levitated Left Ventricular Assist Device - Final Report.

Author information

1
From Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (M.R.M.); University of Chicago School of Medicine and Medical Center, Chicago (N.U., V.J., G.S.), Advocate Christ Medical Center, Oak Lawn (W.G.C., A.J.T.), and Abbott, Abbott Park (J.C., I.T., P.S.) - all in Illinois; Columbia University College of Physicians and Surgeons and New York-Presbyterian Hospital (Y.N., M.Y.) and Montefiore Einstein Center for Heart and Vascular Care (D.J.G.), New York; University of Colorado School of Medicine, Aurora (J.C.C.); St. Vincent Heart Center, Indianapolis (C.T.S., M.N.W.); Duke University Medical Center, Durham (C.A.M., C.B.P.), and the University of North Carolina, Chapel Hill (J.N.K., P.B.T.) - both in North Carolina; Baptist Health Medical Center, Little Rock, AR (S.W.H., J.R.); Washington University School of Medicine, St. Louis (G.A.E., A.I.); Advent Health Transplant Institute, Orlando, FL (N.Y.R., S.C.S.); University of Minnesota, Minneapolis (R.C., R.J.); Houston Methodist Hospital, Houston (A. Bhimaraj, B.A.B.); University of Nebraska Medical Center, Omaha (B.D.L., J.Y.U.); Yale Medical School, New Haven, CT (A.A.M.); MedStar Washington Hospital Center, Washington, DC (E.J.M., F.S.); University of Michigan, Ann Arbor (K.A., F.D.P.); St. Thomas Hospital, Nashville (A. Babu, D.C.); and Piedmont Hospital, Atlanta (D.D., A.K.).

Abstract

BACKGROUND:

In two interim analyses of this trial, patients with advanced heart failure who were treated with a fully magnetically levitated centrifugal-flow left ventricular assist device were less likely to have pump thrombosis or nondisabling stroke than were patients treated with a mechanical-bearing axial-flow left ventricular assist device.

METHODS:

We randomly assigned patients with advanced heart failure to receive either the centrifugal-flow pump or the axial-flow pump irrespective of the intended goal of use (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke or reoperation to replace or remove a malfunctioning device. The principal secondary end point was pump replacement at 2 years.

RESULTS:

This final analysis included 1028 enrolled patients: 516 in the centrifugal-flow pump group and 512 in the axial-flow pump group. In the analysis of the primary end point, 397 patients (76.9%) in the centrifugal-flow pump group, as compared with 332 (64.8%) in the axial-flow pump group, remained alive and free of disabling stroke or reoperation to replace or remove a malfunctioning device at 2 years (relative risk, 0.84; 95% confidence interval [CI], 0.78 to 0.91; P<0.001 for superiority). Pump replacement was less common in the centrifugal-flow pump group than in the axial-flow pump group (12 patients [2.3%] vs. 57 patients [11.3%]; relative risk, 0.21; 95% CI, 0.11 to 0.38; P<0.001). The numbers of events per patient-year for stroke of any severity, major bleeding, and gastrointestinal hemorrhage were lower in the centrifugal-flow pump group than in the axial-flow pump group.

CONCLUSIONS:

Among patients with advanced heart failure, a fully magnetically levitated centrifugal-flow left ventricular assist device was associated with less frequent need for pump replacement than an axial-flow device and was superior with respect to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755.).

PMID:
30883052
DOI:
10.1056/NEJMoa1900486

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