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

Mandeep R Mehra1, Nir Uriel1, Yoshifumi Naka1

  • 1From 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.).

The New England Journal of Medicine
|March 19, 2019
PubMed
Summary
This summary is machine-generated.

The fully magnetically levitated centrifugal-flow left ventricular assist device (LVAD) demonstrated superior outcomes in advanced heart failure patients. This LVAD reduced pump thrombosis and stroke events compared to axial-flow devices, improving survival rates.

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Area of Science:

  • Cardiology
  • Biomedical Engineering
  • Medical Devices

Background:

  • Advanced heart failure necessitates mechanical circulatory support.
  • Left ventricular assist devices (LVADs) are crucial for managing advanced heart failure.
  • Comparing different LVAD technologies is vital for optimizing patient outcomes.

Purpose of the Study:

  • To compare the safety and efficacy of a fully magnetically levitated centrifugal-flow LVAD against a mechanical-bearing axial-flow LVAD.
  • To evaluate the primary composite end point of survival at 2 years free of disabling stroke or reoperation.
  • To assess secondary end points including pump replacement rates and adverse events.

Main Methods:

  • A randomized trial comparing centrifugal-flow and axial-flow LVADs in patients with advanced heart failure.
  • Patients were assigned to either device irrespective of intended use (bridge to transplantation or destination therapy).
  • The primary end point was a composite of survival free of disabling stroke or reoperation at 2 years.

Main Results:

  • The centrifugal-flow LVAD group showed a significantly higher rate of survival free of disabling stroke or reoperation at 2 years (76.9% vs. 64.8%).
  • Pump replacement was substantially lower in the centrifugal-flow LVAD group (2.3% vs. 11.3%).
  • Lower rates of stroke, major bleeding, and gastrointestinal hemorrhage were observed with the centrifugal-flow LVAD.

Conclusions:

  • The fully magnetically levitated centrifugal-flow LVAD is superior to the axial-flow LVAD in patients with advanced heart failure.
  • This centrifugal-flow device is associated with improved survival and reduced need for pump replacement.
  • The findings support the use of magnetically levitated centrifugal-flow LVADs for advanced heart failure management.