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A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure.
Mehra, Mandeep R; Naka, Yoshifumi; Uriel, Nir; Goldstein, Daniel J; Cleveland, Joseph C; Colombo, Paolo C; Walsh, Mary N; Milano, Carmelo A; Patel, Chetan B; Jorde, Ulrich P; Pagani, Francis D; Aaronson, Keith D; Dean, David A; McCants, Kelly; Itoh, Akinobu; Ewald, Gregory A; Horstmanshof, Douglas; Long, James W; Salerno, Christopher.
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  • Mehra MR; 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 N
  • Naka Y; 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 N
  • Uriel N; 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 N
  • Goldstein DJ; 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 N
  • Cleveland JC; 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 N
  • Colombo PC; 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 N
  • Walsh MN; 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 N
  • Milano CA; 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 N
  • Patel CB; 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 N
  • Jorde UP; 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 N
  • Pagani FD; 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 N
  • Aaronson KD; 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 N
  • Dean DA; 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 N
  • McCants K; 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 N
  • Itoh A; 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 N
  • Ewald GA; 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 N
  • Horstmanshof D; 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 N
  • Long JW; 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 N
  • Salerno C; 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 N
N Engl J Med ; 376(5): 440-450, 2017 02 02.
Article en En | MEDLINE | ID: mdl-27959709
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 .).
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Contexto en salud: 6_ODS3_enfermedades_notrasmisibles Problema de salud: 6_cardiovascular_diseases / 6_cerebrovascular_disease / 6_other_circulatory_diseases Asunto principal: Corazón Auxiliar / Insuficiencia Cardíaca Tipo de estudio: Clinical_trials / Etiology_studies Límite: Adult / Aged / Aged80 / Humans / Middle aged Idioma: En Revista: N Engl J Med Año: 2017 Tipo del documento: Article
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Contexto en salud: 6_ODS3_enfermedades_notrasmisibles Problema de salud: 6_cardiovascular_diseases / 6_cerebrovascular_disease / 6_other_circulatory_diseases Asunto principal: Corazón Auxiliar / Insuficiencia Cardíaca Tipo de estudio: Clinical_trials / Etiology_studies Límite: Adult / Aged / Aged80 / Humans / Middle aged Idioma: En Revista: N Engl J Med Año: 2017 Tipo del documento: Article