title: A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure.
abstract: Continuous-flow left ventricular assist systems increase the rate of survival among patients with advanced heart failure but are associated with the development of pump thrombosis. We investigated the effects of a new magnetically levitated centrifugal continuous-flow pump that was engineered to avert thrombosis.
  
  
  
  We randomly assigned patients with advanced heart failure to receive either the new centrifugal continuous-flow pump or a commercially available axial continuous-flow pump. Patients could be enrolled irrespective of the intended goal of pump support (bridge to transplantation or destination therapy). The primary end point was a composite of survival free of disabling stroke (with disabling stroke indicated by a modified Rankin score >3; scores range from 0 to 6, with higher scores indicating more severe disability) or survival free of reoperation to replace or remove the device at 6 months after implantation. The trial was powered for noninferiority testing of the primary end point (noninferiority margin, -10 percentage points).
  
  
  
  Of 294 patients, 152 were assigned to the centrifugal-flow pump group and 142 to the axial-flow pump group. In the intention-to-treat population, the primary end point occurred in 131 patients (86.2%) in the centrifugal-flow pump group and in 109 (76.8%) in the axial-flow pump group (absolute difference, 9.4 percentage points; 95% lower confidence boundary, -2.1 [P<0.001 for noninferiority]; hazard ratio, 0.55; 95% confidence interval [CI], 0.32 to 0.95 [two-tailed P=0.04 for superiority]). There were no significant between-group differences in the rates of death or disabling stroke, but reoperation for pump malfunction was less frequent in the centrifugal-flow pump group than in the axial-flow pump group (1 [0.7%] vs. 11 [7.7%]; hazard ratio, 0.08; 95% CI, 0.01 to 0.60; P=0.002). Suspected or confirmed pump thrombosis occurred in no patients in the centrifugal-flow pump group and in 14 patients (10.1%) in the axial-flow pump group.
  
  
  
  Among patients with advanced heart failure, implantation of a fully magnetically levitated centrifugal-flow pump was associated with better outcomes at 6 months than was implantation of an axial-flow pump, primarily because of the lower rate of reoperation for pump malfunction. (Funded by St. Jude Medical; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755 .).
authors.affiliation: From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (M.R.M.); Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital (Y.N., P.C.C.) and Montefiore Einstein Center for Heart and Vascular Care (D.J.G., U.P.J.) - all in New York; University of Chicago School of Medicine and Medical Center, Chicago (N.U.); University of Colorado School of Medicine, Denver (J.C.C.); St. Vincent Heart Center, Indianapolis (M.N.W., C.S.); Duke Heart Center, Duke University, Durham, NC (C.A.M., C.B.P.); University of Michigan Health System, Ann Arbor (F.D.P., K.D.A.); Piedmont Hospital, Atlanta (D.A.D., K.M.); Washington University School of Medicine, St. Louis (A.I., G.A.E.); and Integris Baptist Medical Center, Oklahoma City (D.H., J.W.L.).
authors.forename: Mandeep R
authors.initials: MR
authors.lastname: Mehra
authors.affiliation: From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (M.R.M.); Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital (Y.N., P.C.C.) and Montefiore Einstein Center for Heart and Vascular Care (D.J.G., U.P.J.) - all in New York; University of Chicago School of Medicine and Medical Center, Chicago (N.U.); University of Colorado School of Medicine, Denver (J.C.C.); St. Vincent Heart Center, Indianapolis (M.N.W., C.S.); Duke Heart Center, Duke University, Durham, NC (C.A.M., C.B.P.); University of Michigan Health System, Ann Arbor (F.D.P., K.D.A.); Piedmont Hospital, Atlanta (D.A.D., K.M.); Washington University School of Medicine, St. Louis (A.I., G.A.E.); and Integris Baptist Medical Center, Oklahoma City (D.H., J.W.L.).
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Naka
authors.affiliation: From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (M.R.M.); Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital (Y.N., P.C.C.) and Montefiore Einstein Center for Heart and Vascular Care (D.J.G., U.P.J.) - all in New York; University of Chicago School of Medicine and Medical Center, Chicago (N.U.); University of Colorado School of Medicine, Denver (J.C.C.); St. Vincent Heart Center, Indianapolis (M.N.W., C.S.); Duke Heart Center, Duke University, Durham, NC (C.A.M., C.B.P.); University of Michigan Health System, Ann Arbor (F.D.P., K.D.A.); Piedmont Hospital, Atlanta (D.A.D., K.M.); Washington University School of Medicine, St. Louis (A.I., G.A.E.); and Integris Baptist Medical Center, Oklahoma City (D.H., J.W.L.).
authors.forename: Nir
authors.initials: N
authors.lastname: Uriel
authors.affiliation: From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (M.R.M.); Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital (Y.N., P.C.C.) and Montefiore Einstein Center for Heart and Vascular Care (D.J.G., U.P.J.) - all in New York; University of Chicago School of Medicine and Medical Center, Chicago (N.U.); University of Colorado School of Medicine, Denver (J.C.C.); St. Vincent Heart Center, Indianapolis (M.N.W., C.S.); Duke Heart Center, Duke University, Durham, NC (C.A.M., C.B.P.); University of Michigan Health System, Ann Arbor (F.D.P., K.D.A.); Piedmont Hospital, Atlanta (D.A.D., K.M.); Washington University School of Medicine, St. Louis (A.I., G.A.E.); and Integris Baptist Medical Center, Oklahoma City (D.H., J.W.L.).
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Goldstein
authors.affiliation: From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (M.R.M.); Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital (Y.N., P.C.C.) and Montefiore Einstein Center for Heart and Vascular Care (D.J.G., U.P.J.) - all in New York; University of Chicago School of Medicine and Medical Center, Chicago (N.U.); University of Colorado School of Medicine, Denver (J.C.C.); St. Vincent Heart Center, Indianapolis (M.N.W., C.S.); Duke Heart Center, Duke University, Durham, NC (C.A.M., C.B.P.); University of Michigan Health System, Ann Arbor (F.D.P., K.D.A.); Piedmont Hospital, Atlanta (D.A.D., K.M.); Washington University School of Medicine, St. Louis (A.I., G.A.E.); and Integris Baptist Medical Center, Oklahoma City (D.H., J.W.L.).
authors.forename: Joseph C
authors.initials: JC
authors.lastname: Cleveland
authors.affiliation: From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (M.R.M.); Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital (Y.N., P.C.C.) and Montefiore Einstein Center for Heart and Vascular Care (D.J.G., U.P.J.) - all in New York; University of Chicago School of Medicine and Medical Center, Chicago (N.U.); University of Colorado School of Medicine, Denver (J.C.C.); St. Vincent Heart Center, Indianapolis (M.N.W., C.S.); Duke Heart Center, Duke University, Durham, NC (C.A.M., C.B.P.); University of Michigan Health System, Ann Arbor (F.D.P., K.D.A.); Piedmont Hospital, Atlanta (D.A.D., K.M.); Washington University School of Medicine, St. Louis (A.I., G.A.E.); and Integris Baptist Medical Center, Oklahoma City (D.H., J.W.L.).
authors.forename: Paolo C
authors.initials: PC
authors.lastname: Colombo
authors.affiliation: From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (M.R.M.); Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital (Y.N., P.C.C.) and Montefiore Einstein Center for Heart and Vascular Care (D.J.G., U.P.J.) - all in New York; University of Chicago School of Medicine and Medical Center, Chicago (N.U.); University of Colorado School of Medicine, Denver (J.C.C.); St. Vincent Heart Center, Indianapolis (M.N.W., C.S.); Duke Heart Center, Duke University, Durham, NC (C.A.M., C.B.P.); University of Michigan Health System, Ann Arbor (F.D.P., K.D.A.); Piedmont Hospital, Atlanta (D.A.D., K.M.); Washington University School of Medicine, St. Louis (A.I., G.A.E.); and Integris Baptist Medical Center, Oklahoma City (D.H., J.W.L.).
authors.forename: Mary N
authors.initials: MN
authors.lastname: Walsh
authors.affiliation: From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (M.R.M.); Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital (Y.N., P.C.C.) and Montefiore Einstein Center for Heart and Vascular Care (D.J.G., U.P.J.) - all in New York; University of Chicago School of Medicine and Medical Center, Chicago (N.U.); University of Colorado School of Medicine, Denver (J.C.C.); St. Vincent Heart Center, Indianapolis (M.N.W., C.S.); Duke Heart Center, Duke University, Durham, NC (C.A.M., C.B.P.); University of Michigan Health System, Ann Arbor (F.D.P., K.D.A.); Piedmont Hospital, Atlanta (D.A.D., K.M.); Washington University School of Medicine, St. Louis (A.I., G.A.E.); and Integris Baptist Medical Center, Oklahoma City (D.H., J.W.L.).
authors.forename: Carmelo A
authors.initials: CA
authors.lastname: Milano
authors.affiliation: From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (M.R.M.); Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital (Y.N., P.C.C.) and Montefiore Einstein Center for Heart and Vascular Care (D.J.G., U.P.J.) - all in New York; University of Chicago School of Medicine and Medical Center, Chicago (N.U.); University of Colorado School of Medicine, Denver (J.C.C.); St. Vincent Heart Center, Indianapolis (M.N.W., C.S.); Duke Heart Center, Duke University, Durham, NC (C.A.M., C.B.P.); University of Michigan Health System, Ann Arbor (F.D.P., K.D.A.); Piedmont Hospital, Atlanta (D.A.D., K.M.); Washington University School of Medicine, St. Louis (A.I., G.A.E.); and Integris Baptist Medical Center, Oklahoma City (D.H., J.W.L.).
authors.forename: Chetan B
authors.initials: CB
authors.lastname: Patel
authors.affiliation: From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (M.R.M.); Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital (Y.N., P.C.C.) and Montefiore Einstein Center for Heart and Vascular Care (D.J.G., U.P.J.) - all in New York; University of Chicago School of Medicine and Medical Center, Chicago (N.U.); University of Colorado School of Medicine, Denver (J.C.C.); St. Vincent Heart Center, Indianapolis (M.N.W., C.S.); Duke Heart Center, Duke University, Durham, NC (C.A.M., C.B.P.); University of Michigan Health System, Ann Arbor (F.D.P., K.D.A.); Piedmont Hospital, Atlanta (D.A.D., K.M.); Washington University School of Medicine, St. Louis (A.I., G.A.E.); and Integris Baptist Medical Center, Oklahoma City (D.H., J.W.L.).
authors.forename: Ulrich P
authors.initials: UP
authors.lastname: Jorde
authors.affiliation: From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (M.R.M.); Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital (Y.N., P.C.C.) and Montefiore Einstein Center for Heart and Vascular Care (D.J.G., U.P.J.) - all in New York; University of Chicago School of Medicine and Medical Center, Chicago (N.U.); University of Colorado School of Medicine, Denver (J.C.C.); St. Vincent Heart Center, Indianapolis (M.N.W., C.S.); Duke Heart Center, Duke University, Durham, NC (C.A.M., C.B.P.); University of Michigan Health System, Ann Arbor (F.D.P., K.D.A.); Piedmont Hospital, Atlanta (D.A.D., K.M.); Washington University School of Medicine, St. Louis (A.I., G.A.E.); and Integris Baptist Medical Center, Oklahoma City (D.H., J.W.L.).
authors.forename: Francis D
authors.initials: FD
authors.lastname: Pagani
authors.affiliation: From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (M.R.M.); Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital (Y.N., P.C.C.) and Montefiore Einstein Center for Heart and Vascular Care (D.J.G., U.P.J.) - all in New York; University of Chicago School of Medicine and Medical Center, Chicago (N.U.); University of Colorado School of Medicine, Denver (J.C.C.); St. Vincent Heart Center, Indianapolis (M.N.W., C.S.); Duke Heart Center, Duke University, Durham, NC (C.A.M., C.B.P.); University of Michigan Health System, Ann Arbor (F.D.P., K.D.A.); Piedmont Hospital, Atlanta (D.A.D., K.M.); Washington University School of Medicine, St. Louis (A.I., G.A.E.); and Integris Baptist Medical Center, Oklahoma City (D.H., J.W.L.).
authors.forename: Keith D
authors.initials: KD
authors.lastname: Aaronson
authors.affiliation: From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (M.R.M.); Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital (Y.N., P.C.C.) and Montefiore Einstein Center for Heart and Vascular Care (D.J.G., U.P.J.) - all in New York; University of Chicago School of Medicine and Medical Center, Chicago (N.U.); University of Colorado School of Medicine, Denver (J.C.C.); St. Vincent Heart Center, Indianapolis (M.N.W., C.S.); Duke Heart Center, Duke University, Durham, NC (C.A.M., C.B.P.); University of Michigan Health System, Ann Arbor (F.D.P., K.D.A.); Piedmont Hospital, Atlanta (D.A.D., K.M.); Washington University School of Medicine, St. Louis (A.I., G.A.E.); and Integris Baptist Medical Center, Oklahoma City (D.H., J.W.L.).
authors.forename: David A
authors.initials: DA
authors.lastname: Dean
authors.affiliation: From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (M.R.M.); Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital (Y.N., P.C.C.) and Montefiore Einstein Center for Heart and Vascular Care (D.J.G., U.P.J.) - all in New York; University of Chicago School of Medicine and Medical Center, Chicago (N.U.); University of Colorado School of Medicine, Denver (J.C.C.); St. Vincent Heart Center, Indianapolis (M.N.W., C.S.); Duke Heart Center, Duke University, Durham, NC (C.A.M., C.B.P.); University of Michigan Health System, Ann Arbor (F.D.P., K.D.A.); Piedmont Hospital, Atlanta (D.A.D., K.M.); Washington University School of Medicine, St. Louis (A.I., G.A.E.); and Integris Baptist Medical Center, Oklahoma City (D.H., J.W.L.).
authors.forename: Kelly
authors.initials: K
authors.lastname: McCants
authors.affiliation: From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (M.R.M.); Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital (Y.N., P.C.C.) and Montefiore Einstein Center for Heart and Vascular Care (D.J.G., U.P.J.) - all in New York; University of Chicago School of Medicine and Medical Center, Chicago (N.U.); University of Colorado School of Medicine, Denver (J.C.C.); St. Vincent Heart Center, Indianapolis (M.N.W., C.S.); Duke Heart Center, Duke University, Durham, NC (C.A.M., C.B.P.); University of Michigan Health System, Ann Arbor (F.D.P., K.D.A.); Piedmont Hospital, Atlanta (D.A.D., K.M.); Washington University School of Medicine, St. Louis (A.I., G.A.E.); and Integris Baptist Medical Center, Oklahoma City (D.H., J.W.L.).
authors.forename: Akinobu
authors.initials: A
authors.lastname: Itoh
authors.affiliation: From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (M.R.M.); Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital (Y.N., P.C.C.) and Montefiore Einstein Center for Heart and Vascular Care (D.J.G., U.P.J.) - all in New York; University of Chicago School of Medicine and Medical Center, Chicago (N.U.); University of Colorado School of Medicine, Denver (J.C.C.); St. Vincent Heart Center, Indianapolis (M.N.W., C.S.); Duke Heart Center, Duke University, Durham, NC (C.A.M., C.B.P.); University of Michigan Health System, Ann Arbor (F.D.P., K.D.A.); Piedmont Hospital, Atlanta (D.A.D., K.M.); Washington University School of Medicine, St. Louis (A.I., G.A.E.); and Integris Baptist Medical Center, Oklahoma City (D.H., J.W.L.).
authors.forename: Gregory A
authors.initials: GA
authors.lastname: Ewald
authors.affiliation: From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (M.R.M.); Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital (Y.N., P.C.C.) and Montefiore Einstein Center for Heart and Vascular Care (D.J.G., U.P.J.) - all in New York; University of Chicago School of Medicine and Medical Center, Chicago (N.U.); University of Colorado School of Medicine, Denver (J.C.C.); St. Vincent Heart Center, Indianapolis (M.N.W., C.S.); Duke Heart Center, Duke University, Durham, NC (C.A.M., C.B.P.); University of Michigan Health System, Ann Arbor (F.D.P., K.D.A.); Piedmont Hospital, Atlanta (D.A.D., K.M.); Washington University School of Medicine, St. Louis (A.I., G.A.E.); and Integris Baptist Medical Center, Oklahoma City (D.H., J.W.L.).
authors.forename: Douglas
authors.initials: D
authors.lastname: Horstmanshof
authors.affiliation: From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (M.R.M.); Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital (Y.N., P.C.C.) and Montefiore Einstein Center for Heart and Vascular Care (D.J.G., U.P.J.) - all in New York; University of Chicago School of Medicine and Medical Center, Chicago (N.U.); University of Colorado School of Medicine, Denver (J.C.C.); St. Vincent Heart Center, Indianapolis (M.N.W., C.S.); Duke Heart Center, Duke University, Durham, NC (C.A.M., C.B.P.); University of Michigan Health System, Ann Arbor (F.D.P., K.D.A.); Piedmont Hospital, Atlanta (D.A.D., K.M.); Washington University School of Medicine, St. Louis (A.I., G.A.E.); and Integris Baptist Medical Center, Oklahoma City (D.H., J.W.L.).
authors.forename: James W
authors.initials: JW
authors.lastname: Long
authors.affiliation: From the Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston (M.R.M.); Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital (Y.N., P.C.C.) and Montefiore Einstein Center for Heart and Vascular Care (D.J.G., U.P.J.) - all in New York; University of Chicago School of Medicine and Medical Center, Chicago (N.U.); University of Colorado School of Medicine, Denver (J.C.C.); St. Vincent Heart Center, Indianapolis (M.N.W., C.S.); Duke Heart Center, Duke University, Durham, NC (C.A.M., C.B.P.); University of Michigan Health System, Ann Arbor (F.D.P., K.D.A.); Piedmont Hospital, Atlanta (D.A.D., K.M.); Washington University School of Medicine, St. Louis (A.I., G.A.E.); and Integris Baptist Medical Center, Oklahoma City (D.H., J.W.L.).
authors.forename: Christopher
authors.initials: C
authors.lastname: Salerno
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018572:Disease-Free Survival; D006333:Heart Failure / Q000401:mortality / Q000628:therapy*; D006353:Heart-Assist Devices / Q000009:adverse effects; D006801:Humans; D057194:Intention to Treat Analysis; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D011474:Prosthesis Design; D011475:Prosthesis Failure; D020521:Stroke / Q000209:etiology; D013927:Thrombosis / Q000209:etiology; D055815:Young Adult