Medline ® Abstract for Reference 13
of 'Intermediate- and long-term mechanical circulatory support'
A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure.
Mehra MR, Naka Y, Uriel N, Goldstein DJ, Cleveland JC Jr, Colombo PC, Walsh MN, Milano CA, Patel CB, Jorde UP, Pagani FD, Aaronson KD, Dean DA, McCants K, Itoh A, Ewald GA, Horstmanshof D, Long JW, Salerno C, MOMENTUM 3 Investigators
N Engl J Med. 2017;376(5):440. Epub 2016 Nov 16.
BACKGROUND: 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.
METHODS: 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).
RESULTS: 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.
CONCLUSIONS: 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 .).
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.).