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A Fully Magnetically Levitated Left Ventricular Assist Device - Final Report.
Mehra, Mandeep R; Uriel, Nir; Naka, Yoshifumi; Cleveland, Joseph C; Yuzefpolskaya, Melana; Salerno, Christopher T; Walsh, Mary N; Milano, Carmelo A; Patel, Chetan B; Hutchins, Steven W; Ransom, John; Ewald, Gregory A; Itoh, Akinobu; Raval, Nirav Y; Silvestry, Scott C; Cogswell, Rebecca; John, Ranjit; Bhimaraj, Arvind; Bruckner, Brian A; Lowes, Brian D; Um, John Y; Jeevanandam, Valluvan; Sayer, Gabriel; Mangi, Abeel A; Molina, Ezequiel J; Sheikh, Farooq; Aaronson, Keith; Pagani, Francis D; Cotts, William G; Tatooles, Antone J; Babu, Ashok; Chomsky, Don; Katz, Jason N; Tessmann, Paul B; Dean, David; Krishnamoorthy, Arun; Chuang, Joyce; Topuria, Ia; Sood, Poornima; Goldstein, Daniel J.
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  • Mehra MR; From 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.) - al
  • Uriel N; From 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.) - al
  • Naka Y; From 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.) - al
  • Cleveland JC; From 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.) - al
  • Yuzefpolskaya M; From 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.) - al
  • Salerno CT; From 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.) - al
  • Walsh MN; From 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.) - al
  • Milano CA; From 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.) - al
  • Patel CB; From 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.) - al
  • Hutchins SW; From 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.) - al
  • Ransom J; From 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.) - al
  • Ewald GA; From 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.) - al
  • Itoh A; From 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.) - al
  • Raval NY; From 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.) - al
  • Silvestry SC; From 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.) - al
  • Cogswell R; From 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.) - al
  • John R; From 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.) - al
  • Bhimaraj A; From 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.) - al
  • Bruckner BA; From 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.) - al
  • Lowes BD; From 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.) - al
  • Um JY; From 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.) - al
  • Jeevanandam V; From 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.) - al
  • Sayer G; From 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.) - al
  • Mangi AA; From 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.) - al
  • Molina EJ; From 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.) - al
  • Sheikh F; From 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.) - al
  • Aaronson K; From 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.) - al
  • Pagani FD; From 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.) - al
  • Cotts WG; From 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.) - al
  • Tatooles AJ; From 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.) - al
  • Babu A; From 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.) - al
  • Chomsky D; From 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.) - al
  • Katz JN; From 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.) - al
  • Tessmann PB; From 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.) - al
  • Dean D; From 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.) - al
  • Krishnamoorthy A; From 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.) - al
  • Chuang J; From 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.) - al
  • Topuria I; From 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.) - al
  • Sood P; From 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.) - al
  • Goldstein DJ; From 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.) - al
N Engl J Med ; 380(17): 1618-1627, 2019 04 25.
Article en En | MEDLINE | ID: mdl-30883052
ABSTRACT

BACKGROUND:

In two interim analyses of this trial, patients with advanced heart failure who were treated with a fully magnetically levitated centrifugal-flow left ventricular assist device were less likely to have pump thrombosis or nondisabling stroke than were patients treated with a mechanical-bearing axial-flow left ventricular assist device.

METHODS:

We randomly assigned patients with advanced heart failure to receive either the centrifugal-flow pump or the axial-flow pump irrespective of the intended goal of use (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke or reoperation to replace or remove a malfunctioning device. The principal secondary end point was pump replacement at 2 years.

RESULTS:

This final analysis included 1028 enrolled patients 516 in the centrifugal-flow pump group and 512 in the axial-flow pump group. In the analysis of the primary end point, 397 patients (76.9%) in the centrifugal-flow pump group, as compared with 332 (64.8%) in the axial-flow pump group, remained alive and free of disabling stroke or reoperation to replace or remove a malfunctioning device at 2 years (relative risk, 0.84; 95% confidence interval [CI], 0.78 to 0.91; P<0.001 for superiority). Pump replacement was less common in the centrifugal-flow pump group than in the axial-flow pump group (12 patients [2.3%] vs. 57 patients [11.3%]; relative risk, 0.21; 95% CI, 0.11 to 0.38; P<0.001). The numbers of events per patient-year for stroke of any severity, major bleeding, and gastrointestinal hemorrhage were lower in the centrifugal-flow pump group than in the axial-flow pump group.

CONCLUSIONS:

Among patients with advanced heart failure, a fully magnetically levitated centrifugal-flow left ventricular assist device was associated with less frequent need for pump replacement than an axial-flow device and was superior with respect to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device. (Funded by Abbott; MOMENTUM 3 ClinicalTrials.gov number, NCT02224755.).
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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Diseño de Prótesis / Corazón Auxiliar / Insuficiencia Cardíaca Tipo de estudio: Clinical_trials / Etiology_studies Idioma: En Revista: N Engl J Med Año: 2019 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Base de datos: MEDLINE Asunto principal: Diseño de Prótesis / Corazón Auxiliar / Insuficiencia Cardíaca Tipo de estudio: Clinical_trials / Etiology_studies Idioma: En Revista: N Engl J Med Año: 2019 Tipo del documento: Article