title: Watchful Waiting in Continuous-Flow Left Ventricular Assist Device Patients With Ongoing Hemolysis Is Associated With an Increased Risk for Cerebrovascular Accident or Death.
abstract: Management of hemolysis in the setting of suspected device thrombosis in continuous-flow left ventricular assist device patients varies widely, ranging from watchful waiting with intensified antithrombotic therapy to early surgical device exchange. The aim of this study was to compare the outcomes of hemolysis events treated with surgical interventions versus medical management alone.
  
  
  
  A retrospective review of Heartmate II continuous-flow left ventricular assist device patients at 2 centers from January 2009 to September 2014 was completed. Patients were categorized as surgical management if hemolysis refractory to intensification of standard antithrombotic therapy was treated surgically. The primary end point was the first occurrence of cerebrovascular accident (CVA) or death. Sixty-four hemolysis events occurred in 49/367 patients implanted with Heartmate II continuous-flow left ventricular assist devices. Of 49 primary hemolysis events, 24 were treated with surgical interventions. After surgical treatment, 1 patient died and 2 experienced CVAs, as compared with 3 deaths and 9 CVAs in the 25 patients who remained on intensified antithrombotic therapy alone. The 1-year freedom from CVA or death was 87.5% and 49.5% in the surgical and medical cohorts, respectively (P=0.027). Resolution of a primary hemolysis event without CVA or death occurred in 21/24 patients treated with surgical interventions and in 13/25 who remained on medical therapy alone. A similar association between treatment and outcome was noted in the 15 recurrent hemolysis events.
  
  
  
  Hemolysis refractory to intensification of antithrombotic therapy identifies continuous-flow left ventricular assist device patients at major risk for CVA and death. Early device exchange should be considered to minimize these risks.
authors.affiliation: From the Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (A.P.L., O.S., S.R.P., D.B.S., J.D.N., J.J.S., U.P.J.); Division of Cardiology, Department of Medicine, Columbia University, New York, NY (A.P.L., J.Z.W., C.J.L., J.A.F., V.K.T., P.C.C.); Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (D.J.G.); Department of Cardiothoracic Surgery, Columbia University, New York, NY (Y.N., H.T.); and Division of Cardiology, University of Chicago, IL (N.U.).
authors.forename: Allison P
authors.initials: AP
authors.lastname: Levin
authors.affiliation: From the Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (A.P.L., O.S., S.R.P., D.B.S., J.D.N., J.J.S., U.P.J.); Division of Cardiology, Department of Medicine, Columbia University, New York, NY (A.P.L., J.Z.W., C.J.L., J.A.F., V.K.T., P.C.C.); Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (D.J.G.); Department of Cardiothoracic Surgery, Columbia University, New York, NY (Y.N., H.T.); and Division of Cardiology, University of Chicago, IL (N.U.).
authors.forename: Omar
authors.initials: O
authors.lastname: Saeed
authors.affiliation: From the Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (A.P.L., O.S., S.R.P., D.B.S., J.D.N., J.J.S., U.P.J.); Division of Cardiology, Department of Medicine, Columbia University, New York, NY (A.P.L., J.Z.W., C.J.L., J.A.F., V.K.T., P.C.C.); Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (D.J.G.); Department of Cardiothoracic Surgery, Columbia University, New York, NY (Y.N., H.T.); and Division of Cardiology, University of Chicago, IL (N.U.).
authors.forename: Joshua Z
authors.initials: JZ
authors.lastname: Willey
authors.affiliation: From the Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (A.P.L., O.S., S.R.P., D.B.S., J.D.N., J.J.S., U.P.J.); Division of Cardiology, Department of Medicine, Columbia University, New York, NY (A.P.L., J.Z.W., C.J.L., J.A.F., V.K.T., P.C.C.); Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (D.J.G.); Department of Cardiothoracic Surgery, Columbia University, New York, NY (Y.N., H.T.); and Division of Cardiology, University of Chicago, IL (N.U.).
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Levin
authors.affiliation: From the Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (A.P.L., O.S., S.R.P., D.B.S., J.D.N., J.J.S., U.P.J.); Division of Cardiology, Department of Medicine, Columbia University, New York, NY (A.P.L., J.Z.W., C.J.L., J.A.F., V.K.T., P.C.C.); Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (D.J.G.); Department of Cardiothoracic Surgery, Columbia University, New York, NY (Y.N., H.T.); and Division of Cardiology, University of Chicago, IL (N.U.).
authors.forename: Justin A
authors.initials: JA
authors.lastname: Fried
authors.affiliation: From the Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (A.P.L., O.S., S.R.P., D.B.S., J.D.N., J.J.S., U.P.J.); Division of Cardiology, Department of Medicine, Columbia University, New York, NY (A.P.L., J.Z.W., C.J.L., J.A.F., V.K.T., P.C.C.); Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (D.J.G.); Department of Cardiothoracic Surgery, Columbia University, New York, NY (Y.N., H.T.); and Division of Cardiology, University of Chicago, IL (N.U.).
authors.forename: Snehal R
authors.initials: SR
authors.lastname: Patel
authors.affiliation: From the Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (A.P.L., O.S., S.R.P., D.B.S., J.D.N., J.J.S., U.P.J.); Division of Cardiology, Department of Medicine, Columbia University, New York, NY (A.P.L., J.Z.W., C.J.L., J.A.F., V.K.T., P.C.C.); Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (D.J.G.); Department of Cardiothoracic Surgery, Columbia University, New York, NY (Y.N., H.T.); and Division of Cardiology, University of Chicago, IL (N.U.).
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Sims
authors.affiliation: From the Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (A.P.L., O.S., S.R.P., D.B.S., J.D.N., J.J.S., U.P.J.); Division of Cardiology, Department of Medicine, Columbia University, New York, NY (A.P.L., J.Z.W., C.J.L., J.A.F., V.K.T., P.C.C.); Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (D.J.G.); Department of Cardiothoracic Surgery, Columbia University, New York, NY (Y.N., H.T.); and Division of Cardiology, University of Chicago, IL (N.U.).
authors.forename: Jenni D
authors.initials: JD
authors.lastname: Nguyen
authors.affiliation: From the Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (A.P.L., O.S., S.R.P., D.B.S., J.D.N., J.J.S., U.P.J.); Division of Cardiology, Department of Medicine, Columbia University, New York, NY (A.P.L., J.Z.W., C.J.L., J.A.F., V.K.T., P.C.C.); Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (D.J.G.); Department of Cardiothoracic Surgery, Columbia University, New York, NY (Y.N., H.T.); and Division of Cardiology, University of Chicago, IL (N.U.).
authors.forename: Julia J
authors.initials: JJ
authors.lastname: Shin
authors.affiliation: From the Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (A.P.L., O.S., S.R.P., D.B.S., J.D.N., J.J.S., U.P.J.); Division of Cardiology, Department of Medicine, Columbia University, New York, NY (A.P.L., J.Z.W., C.J.L., J.A.F., V.K.T., P.C.C.); Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (D.J.G.); Department of Cardiothoracic Surgery, Columbia University, New York, NY (Y.N., H.T.); and Division of Cardiology, University of Chicago, IL (N.U.).
authors.forename: Veli K
authors.initials: VK
authors.lastname: Topkara
authors.affiliation: From the Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (A.P.L., O.S., S.R.P., D.B.S., J.D.N., J.J.S., U.P.J.); Division of Cardiology, Department of Medicine, Columbia University, New York, NY (A.P.L., J.Z.W., C.J.L., J.A.F., V.K.T., P.C.C.); Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (D.J.G.); Department of Cardiothoracic Surgery, Columbia University, New York, NY (Y.N., H.T.); and Division of Cardiology, University of Chicago, IL (N.U.).
authors.forename: Paolo C
authors.initials: PC
authors.lastname: Colombo
authors.affiliation: From the Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (A.P.L., O.S., S.R.P., D.B.S., J.D.N., J.J.S., U.P.J.); Division of Cardiology, Department of Medicine, Columbia University, New York, NY (A.P.L., J.Z.W., C.J.L., J.A.F., V.K.T., P.C.C.); Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (D.J.G.); Department of Cardiothoracic Surgery, Columbia University, New York, NY (Y.N., H.T.); and Division of Cardiology, University of Chicago, IL (N.U.).
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Goldstein
authors.affiliation: From the Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (A.P.L., O.S., S.R.P., D.B.S., J.D.N., J.J.S., U.P.J.); Division of Cardiology, Department of Medicine, Columbia University, New York, NY (A.P.L., J.Z.W., C.J.L., J.A.F., V.K.T., P.C.C.); Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (D.J.G.); Department of Cardiothoracic Surgery, Columbia University, New York, NY (Y.N., H.T.); and Division of Cardiology, University of Chicago, IL (N.U.).
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Naka
authors.affiliation: From the Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (A.P.L., O.S., S.R.P., D.B.S., J.D.N., J.J.S., U.P.J.); Division of Cardiology, Department of Medicine, Columbia University, New York, NY (A.P.L., J.Z.W., C.J.L., J.A.F., V.K.T., P.C.C.); Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (D.J.G.); Department of Cardiothoracic Surgery, Columbia University, New York, NY (Y.N., H.T.); and Division of Cardiology, University of Chicago, IL (N.U.).
authors.forename: Hiroo
authors.initials: H
authors.lastname: Takayama
authors.affiliation: From the Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (A.P.L., O.S., S.R.P., D.B.S., J.D.N., J.J.S., U.P.J.); Division of Cardiology, Department of Medicine, Columbia University, New York, NY (A.P.L., J.Z.W., C.J.L., J.A.F., V.K.T., P.C.C.); Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (D.J.G.); Department of Cardiothoracic Surgery, Columbia University, New York, NY (Y.N., H.T.); and Division of Cardiology, University of Chicago, IL (N.U.).
authors.forename: Nir
authors.initials: N
authors.lastname: Uriel
authors.affiliation: From the Division of Cardiology, Department of Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (A.P.L., O.S., S.R.P., D.B.S., J.D.N., J.J.S., U.P.J.); Division of Cardiology, Department of Medicine, Columbia University, New York, NY (A.P.L., J.Z.W., C.J.L., J.A.F., V.K.T., P.C.C.); Department of Cardiothoracic Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, New York, NY (D.J.G.); Department of Cardiothoracic Surgery, Columbia University, New York, NY (Y.N., H.T.); and Division of Cardiology, University of Chicago, IL (N.U.). ujorde@montefiore.org.
authors.forename: Ulrich P
authors.initials: UP
authors.lastname: Jorde
mesh_terms: D000328:Adult; D000368:Aged; D020878:Device Removal / Q000009:adverse effects / Q000401:mortality; D018572:Disease-Free Survival; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006333:Heart Failure / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006353:Heart-Assist Devices / Q000009:adverse effects*; D006461:Hemolysis; D006801:Humans; D008297:Male; D008875:Middle Aged; D009519:New York City; D011474:Prosthesis Design; D012189:Retrospective Studies; D012307:Risk Factors; D020521:Stroke / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D013927:Thrombosis / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left; D057832:Watchful Waiting
chemical_list: D005343:Fibrinolytic Agents
keywords: analysis; heart failure; hemolysis; hemorrhage; thrombosis