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Original Article

Impact of Empiric Nesiritide or Milrinone Infusion on Early Postoperative Recovery After Fontan SurgeryCLINICAL PERSPECTIVE

A Randomized, Double-Blind, Placebo-Controlled Trial

John M. Costello, Carolyn Dunbar-Masterson, Catherine K. Allan, Kimberlee Gauvreau, Jane W. Newburger, Francis X. McGowan, David L. Wessel, John E. Mayer, Joshua W. Salvin, Roger E. Dionne, Peter C. Laussen
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https://doi.org/10.1161/CIRCHEARTFAILURE.113.001312
Circulation: Heart Failure. 2014;7:596-604
Originally published June 6, 2014
John M. Costello
From the Departments of Cardiology (J.M.C., C.D.-M., C.K.A., K.G., J.W.N., R.E.D., P.C.L.), Anesthesia (F.X.M.), and Cardiac Surgery (J.E.M.), Boston Children’s Hospital, Harvard Medical School, MA; and Children’s National Medical Center, George Washington University, Washington, DC (D.L.W.).
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Carolyn Dunbar-Masterson
From the Departments of Cardiology (J.M.C., C.D.-M., C.K.A., K.G., J.W.N., R.E.D., P.C.L.), Anesthesia (F.X.M.), and Cardiac Surgery (J.E.M.), Boston Children’s Hospital, Harvard Medical School, MA; and Children’s National Medical Center, George Washington University, Washington, DC (D.L.W.).
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Catherine K. Allan
From the Departments of Cardiology (J.M.C., C.D.-M., C.K.A., K.G., J.W.N., R.E.D., P.C.L.), Anesthesia (F.X.M.), and Cardiac Surgery (J.E.M.), Boston Children’s Hospital, Harvard Medical School, MA; and Children’s National Medical Center, George Washington University, Washington, DC (D.L.W.).
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Kimberlee Gauvreau
From the Departments of Cardiology (J.M.C., C.D.-M., C.K.A., K.G., J.W.N., R.E.D., P.C.L.), Anesthesia (F.X.M.), and Cardiac Surgery (J.E.M.), Boston Children’s Hospital, Harvard Medical School, MA; and Children’s National Medical Center, George Washington University, Washington, DC (D.L.W.).
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Jane W. Newburger
From the Departments of Cardiology (J.M.C., C.D.-M., C.K.A., K.G., J.W.N., R.E.D., P.C.L.), Anesthesia (F.X.M.), and Cardiac Surgery (J.E.M.), Boston Children’s Hospital, Harvard Medical School, MA; and Children’s National Medical Center, George Washington University, Washington, DC (D.L.W.).
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Francis X. McGowan
From the Departments of Cardiology (J.M.C., C.D.-M., C.K.A., K.G., J.W.N., R.E.D., P.C.L.), Anesthesia (F.X.M.), and Cardiac Surgery (J.E.M.), Boston Children’s Hospital, Harvard Medical School, MA; and Children’s National Medical Center, George Washington University, Washington, DC (D.L.W.).
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David L. Wessel
From the Departments of Cardiology (J.M.C., C.D.-M., C.K.A., K.G., J.W.N., R.E.D., P.C.L.), Anesthesia (F.X.M.), and Cardiac Surgery (J.E.M.), Boston Children’s Hospital, Harvard Medical School, MA; and Children’s National Medical Center, George Washington University, Washington, DC (D.L.W.).
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John E. Mayer
From the Departments of Cardiology (J.M.C., C.D.-M., C.K.A., K.G., J.W.N., R.E.D., P.C.L.), Anesthesia (F.X.M.), and Cardiac Surgery (J.E.M.), Boston Children’s Hospital, Harvard Medical School, MA; and Children’s National Medical Center, George Washington University, Washington, DC (D.L.W.).
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Joshua W. Salvin
From the Departments of Cardiology (J.M.C., C.D.-M., C.K.A., K.G., J.W.N., R.E.D., P.C.L.), Anesthesia (F.X.M.), and Cardiac Surgery (J.E.M.), Boston Children’s Hospital, Harvard Medical School, MA; and Children’s National Medical Center, George Washington University, Washington, DC (D.L.W.).
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Roger E. Dionne
From the Departments of Cardiology (J.M.C., C.D.-M., C.K.A., K.G., J.W.N., R.E.D., P.C.L.), Anesthesia (F.X.M.), and Cardiac Surgery (J.E.M.), Boston Children’s Hospital, Harvard Medical School, MA; and Children’s National Medical Center, George Washington University, Washington, DC (D.L.W.).
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Peter C. Laussen
From the Departments of Cardiology (J.M.C., C.D.-M., C.K.A., K.G., J.W.N., R.E.D., P.C.L.), Anesthesia (F.X.M.), and Cardiac Surgery (J.E.M.), Boston Children’s Hospital, Harvard Medical School, MA; and Children’s National Medical Center, George Washington University, Washington, DC (D.L.W.).
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Abstract

Background—We sought to determine whether empirical nesiritide or milrinone would improve the early postoperative course after Fontan surgery. We hypothesized that compared with milrinone or placebo, patients assigned to receive nesiritide would have improved early postoperative outcomes.

Methods and Results—In a single-center, randomized, double-blinded, placebo-controlled, multi-arm parallel-group clinical trial, patients undergoing primary Fontan surgery were assigned to receive nesiritide, milrinone, or placebo. A loading dose of study drug was administered on cardiopulmonary bypass followed by a continuous infusion for ≥12 hours and ≤5 days after cardiac intensive care unit admission. The primary outcome was days alive and out of the hospital within 30 days of surgery. Secondary outcomes included measures of cardiovascular function, renal function, resource use, and adverse events. Among 106 enrolled subjects, 35, 36, and 35 were randomized to the nesiritide, milrinone, and placebo groups, respectively, and all were analyzed based on intention to treat. Demographics, patient characteristics, and operative factors were similar among treatment groups. No significant treatment group differences were found for median days alive and out of the hospital within 30 days of surgery (nesiritide, 20 [minimum to maximum, 0–24]; milrinone, 18 [0–23]; placebo, 20 [0–23]; P=0.38). Treatment groups did not significantly differ in cardiac index, arrhythmias, peak lactate, inotropic scores, urine output, duration of mechanical ventilation, intensive care or chest tube drainage, or adverse events.

Conclusions—Compared with placebo, empirical perioperative nesiritide or milrinone infusions are not associated with improved early clinical outcomes after Fontan surgery.

Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00543309.

  • cardiopulmonary bypass
  • Fontan procedure
  • heart defects, congenital
  • milrinone
  • natriuretic peptides
  • Received November 30, 2013.
  • Accepted June 5, 2014.
  • © 2014 American Heart Association, Inc.
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Circulation: Heart Failure
July 2014, Volume 7, Issue 4
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    Impact of Empiric Nesiritide or Milrinone Infusion on Early Postoperative Recovery After Fontan SurgeryCLINICAL PERSPECTIVE
    John M. Costello, Carolyn Dunbar-Masterson, Catherine K. Allan, Kimberlee Gauvreau, Jane W. Newburger, Francis X. McGowan, David L. Wessel, John E. Mayer, Joshua W. Salvin, Roger E. Dionne and Peter C. Laussen
    Circulation: Heart Failure. 2014;7:596-604, originally published June 6, 2014
    https://doi.org/10.1161/CIRCHEARTFAILURE.113.001312

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    Impact of Empiric Nesiritide or Milrinone Infusion on Early Postoperative Recovery After Fontan SurgeryCLINICAL PERSPECTIVE
    John M. Costello, Carolyn Dunbar-Masterson, Catherine K. Allan, Kimberlee Gauvreau, Jane W. Newburger, Francis X. McGowan, David L. Wessel, John E. Mayer, Joshua W. Salvin, Roger E. Dionne and Peter C. Laussen
    Circulation: Heart Failure. 2014;7:596-604, originally published June 6, 2014
    https://doi.org/10.1161/CIRCHEARTFAILURE.113.001312
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