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Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure
Mandeep R Mehra1, Daniel J Goldstein1, Nir Uriel1
1From 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.).
A new magnetically levitated centrifugal-flow pump significantly improved survival free of disabling stroke or reoperation compared to axial-flow pumps in advanced heart failure patients. This centrifugal-flow pump offers superior outcomes for heart failure management.
Area of Science:
- Cardiovascular Medicine
- Biomedical Engineering
- Medical Devices
Background:
- Early analysis indicated improved clinical outcomes with magnetically levitated centrifugal continuous-flow pumps versus mechanical-bearing axial continuous-flow pumps at 6 months in advanced heart failure patients.
- Advanced heart failure necessitates mechanical circulatory support, with continuous-flow pumps being a key therapeutic option.
Purpose of the Study:
- To compare the efficacy and safety of a centrifugal-flow pump against an axial-flow pump in patients with advanced heart failure.
- To evaluate the composite primary end point of survival free of disabling stroke or reoperation at 2 years.
Main Methods:
- A randomized noninferiority and superiority trial comparing centrifugal-flow and axial-flow pumps in advanced heart failure patients.
- The primary composite end point was survival at 2 years free of disabling stroke (modified Rankin score >3) or reoperation for device malfunction.
- A noninferiority margin of -10 percentage points for the risk difference was established.
Main Results:
- The centrifugal-flow pump group demonstrated superior performance, with the primary end point occurring in 79.5% of patients versus 60.2% in the axial-flow pump group (absolute difference 19.2 percentage points; P<0.001 for noninferiority and superiority).
- Reoperation for pump malfunction was significantly lower in the centrifugal-flow pump group (1.6% vs. 17.0%; P<0.001).
- The overall stroke rate was lower in the centrifugal-flow pump group (10.1% vs. 19.2%; P=0.02), although rates of death and disabling stroke were similar.
Conclusions:
- The fully magnetically levitated centrifugal-flow pump is superior to the mechanical-bearing axial-flow pump in advanced heart failure patients.
- This superiority is demonstrated by improved survival free of disabling stroke or reoperation for device malfunction.
- The study (MOMENTUM 3 trial) was funded by Abbott and registered under NCT02224755.
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