A Fully Magnetically Levitated Left Ventricular Assist Device — Final Report

Tuesday, March 26, 2019

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Source

Source Name: The New England Journal of Medicine

Source URL: https://www.nejm.org/doi/full/10.1056/NEJMoa1900486

Author(s)

Mandeep R. Mehra, Nir Uriel, Yoshifumi Naka, Joseph C. Cleveland, Jr., Melana Yuzefpolskaya, Christopher T. Salerno, Mary N. Walsh, Carmelo A. Milano, Chetan B. Patel, Steven W. Hutchins, John Ransom, Gregory A. Ewald, Akinobu Itoh, Nirav Y. Raval, Scott C. Silvestry, Rebecca Cogswell, Ranjit John, Arvind Bhimaraj, Brian A. Bruckner, Brian D. Lowes, John Y. Um, Valluvan Jeevanandam, Gabriel Sayer, Abeel A. Mangi, Ezequiel J. Molina, Farooq Sheikh, Keith Aaronson, Francis D. Pagani, William G. Cotts, Antone J. Tatooles, Ashok Babu, Don Chomsky, Jason N. Katz, Paul B. Tessmann, David Dean, Arun Krishnamoorthy, Joyce Chuang, Ia Topuria, Poornima Sood, Daniel J. Goldstein, for the MOMENTUM 3 Investigators

The investigators published the final analysis of the MOMENTUM 3 trial comparing the fully magnetically levitated centrifugal continuous-flow HeartMate 3 pump to the mechanical-bearing axial continuous-flow HeartMate II pump. The composite primary end point was survival at two years free of disabling stroke or reoperation to replace or remove a malfunctioning device. The principal secondary end point was pump replacement at two years.

HeartMate 3 and HeartMate II were implanted in 516 and 512 patients, respectively. In the analysis of the primary end point, 397 patients (76.9%) with HeartMate 3, as compared with 332 (64.8%) with HeartMate II, remained alive and free of disabling stroke or reoperation to replace or remove a malfunctioning device at two 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 HeartMate 3 group than in the HeartMate II group (12 patients [2.3%] versus 57 patients [11.3%]; relative risk, 0.21; 95% CI, 0.11 to 0.38; P<0.001). The number of events per patient-year for stroke of any severity, major bleeding, and gastrointestinal hemorrhage were lower in patients with HeatMate 3 comparted to patients with HeartMate II.

These data show that among patients with advanced heart failure, the fully magnetically levitated centrifugal-flow HeartMate 3 was associated with less frequent need for pump replacement and superior survival free of disabling stroke or reoperation to replace or remove a malfunctioning device.