A Fully Magnetically Levitated Left Ventricular Assist Device — Final Report

Mehra, Mandeep R. M.D.
Uriel, Nir M.D.
Naka, Yoshifumi M.D.
Cleveland, Joseph C. Jr. M.D.
Yuzefpolskaya, Melana M.D.
Salerno, Christopher T. M.D.
Walsh, Mary N. M.D.
Milano, Carmelo A. M.D.
Patel, Chetan B. M.D.
Hutchins, Steven W. M.D.
Ransom, John M.D.
Ewald, Gregory A. M.D.
Itoh, Akinobu M.D.
Raval, Nirav Y. M.D.
Silvestry, Scott C. M.D.
Cogswell, Rebecca M.D.
John, Ranjit M.D.
Bhimaraj, Arvind M.D.
Bruckner, Brian A. M.D.
Lowes, Brian D. M.D., Ph.D.
Um, John Y. M.D.
Jeevanandam, Valluvan M.D.
Sayer, Gabriel M.D.
Mangi, Abeel A. M.D.
Molina, Ezequiel J. M.D.
Sheikh, Farooq M.D.
Aaronson, Keith M.D.
Pagani, Francis D. M.D., Ph.D.
Cotts, William G. M.D.
Tatooles, Antone J. M.D.
Babu, Ashok M.D.
Chomsky, Don M.D.
Katz, Jason N. M.D.
Tessmann, Paul B. M.D., Pharm.D.
Dean, David M.D.
Krishnamoorthy, Arun M.D.
Chuang, Joyce Ph.D.
Topuria, Ia M.P.H.
Sood, Poornima M.D.
Goldstein, Daniel J. M.D.

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.).

^*A complete list of the investigators in the MOMENTUM 3 trial is provided in the Supplementary Appendix, available at NEJM.org.

Address reprint requests to Dr. Mehra at the Brigham and Women's Hospital Heart and Vascular Center, Center for Advanced Heart Disease, 75 Francis St., Boston, MA 02115 or at [email protected].

Supported by Abbott.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

Drs. Mehra and Goldstein contributed equally to this article.

This article was published on March 17, 2019, at NEJM.org.

A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.

We thank the trial coordinators and clinical team coordinators for their dedication to the trial and patients during the conduct of this trial, and Kai Koo, Ph.D., and Gerald Heatley, M.S., from the biometrics team of Abbott.

New England Journal of Medicine 380(17):p 1618-1627, April 25, 2019. | DOI: 10.1056/NEJMoa1900486

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.)