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Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure.
Mehra, Mandeep R; Goldstein, Daniel J; Uriel, Nir; Cleveland, Joseph C; Yuzefpolskaya, Melana; Salerno, Christopher; Walsh, Mary N; Milano, Carmelo A; Patel, Chetan B; Ewald, Gregory A; Itoh, Akinobu; Dean, David; Krishnamoorthy, Arun; Cotts, William G; Tatooles, Antone J; Jorde, Ulrich P; Bruckner, Brian A; Estep, Jerry D; Jeevanandam, Valluvan; Sayer, Gabriel; Horstmanshof, Douglas; Long, James W; Gulati, Sanjeev; Skipper, Eric R; O'Connell, John B; Heatley, Gerald; Sood, Poornima; Naka, Yoshifumi.
Afiliación
  • Mehra MR; From 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; Unive
  • Goldstein DJ; From 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; Unive
  • Uriel N; From 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; Unive
  • Cleveland JC; From 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; Unive
  • Yuzefpolskaya M; From 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; Unive
  • Salerno C; From 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; Unive
  • Walsh MN; From 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; Unive
  • Milano CA; From 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; Unive
  • Patel CB; From 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; Unive
  • Ewald GA; From 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; Unive
  • Itoh A; From 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; Unive
  • Dean D; From 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; Unive
  • Krishnamoorthy A; From 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; Unive
  • Cotts WG; From 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; Unive
  • Tatooles AJ; From 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; Unive
  • Jorde UP; From 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; Unive
  • Bruckner BA; From 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; Unive
  • Estep JD; From 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; Unive
  • Jeevanandam V; From 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; Unive
  • Sayer G; From 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; Unive
  • Horstmanshof D; From 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; Unive
  • Long JW; From 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; Unive
  • Gulati S; From 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; Unive
  • Skipper ER; From 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; Unive
  • O'Connell JB; From 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; Unive
  • Heatley G; From 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; Unive
  • Sood P; From 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; Unive
  • Naka Y; From 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; Unive
N Engl J Med ; 378(15): 1386-1395, 2018 Apr 12.
Article en En | MEDLINE | ID: mdl-29526139
ABSTRACT

BACKGROUND:

In an early analysis of this trial, use of a magnetically levitated centrifugal continuous-flow circulatory pump was found to improve clinical outcomes, as compared with a mechanical-bearing axial continuous-flow pump, at 6 months in patients with advanced heart failure.

METHODS:

In a randomized noninferiority and superiority trial, we compared the centrifugal-flow pump with the axial-flow pump in patients with advanced heart failure, irrespective of the intended goal of support (bridge to transplantation or destination therapy). The composite primary end point was survival at 2 years free of disabling stroke (with disabling stroke indicated by a modified Rankin score of >3; scores range from 0 to 6, with higher scores indicating more severe disability) or survival free of reoperation to replace or remove a malfunctioning device. The noninferiority margin for the risk difference (centrifugal-flow pump group minus axial-flow pump group) was -10 percentage points.

RESULTS:

Of 366 patients, 190 were assigned to the centrifugal-flow pump group and 176 to the axial-flow pump group. In the intention-to-treat population, the primary end point occurred in 151 patients (79.5%) in the centrifugal-flow pump group, as compared with 106 (60.2%) in the axial-flow pump group (absolute difference, 19.2 percentage points; 95% lower confidence boundary, 9.8 percentage points [P<0.001 for noninferiority]; hazard ratio, 0.46; 95% confidence interval [CI], 0.31 to 0.69 [P<0.001 for superiority]). Reoperation for pump malfunction was less frequent in the centrifugal-flow pump group than in the axial-flow pump group (3 patients [1.6%] vs. 30 patients [17.0%]; hazard ratio, 0.08; 95% CI, 0.03 to 0.27; P<0.001). The rates of death and disabling stroke were similar in the two groups, but the overall rate of stroke was lower in the centrifugal-flow pump group than in the axial-flow pump group (10.1% vs. 19.2%; hazard ratio, 0.47; 95% CI, 0.27 to 0.84, P=0.02).

CONCLUSIONS:

In patients with advanced heart failure, a fully magnetically levitated centrifugal-flow pump was superior to a mechanical-bearing axial-flow pump with regard 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: 2018 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: 2018 Tipo del documento: Article