Watchful waiting in continuous-flow left ventricular assist device patients with ongoing hemolysis is associated with an increased risk for cerebrovascular accident or death

Allison P. Levin, Omar Saeed, Joshua Z. Willey, Charles J. Levin, Justin A. Fried, Snehal R. Patel, Daniel B. Sims, Jenni D. Nguyen, Jooyoung (Julia) Shin, Veli K. Topkara, Paolo C. Colombo, Daniel J. Goldstein, Yoshifumi Naka, Hiroo Takayama, Nir Uriel, Ulrich P. Jorde

Research output: Contribution to journalArticle

27 Citations (Scopus)

Abstract

Background - 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. Methods and Results - 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. Conclusions - 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.

Original languageEnglish (US)
Article numbere002896
JournalCirculation: Heart Failure
Volume9
Issue number5
DOIs
StatePublished - May 1 2016

Fingerprint

Watchful Waiting
Heart-Assist Devices
Hemolysis
Stroke
Equipment and Supplies
Therapeutics
Thrombosis

Keywords

  • analysis
  • heart failure
  • hemolysis
  • hemorrhage
  • thrombosis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Watchful waiting in continuous-flow left ventricular assist device patients with ongoing hemolysis is associated with an increased risk for cerebrovascular accident or death. / Levin, Allison P.; Saeed, Omar; Willey, Joshua Z.; Levin, Charles J.; Fried, Justin A.; Patel, Snehal R.; Sims, Daniel B.; Nguyen, Jenni D.; Shin, Jooyoung (Julia); Topkara, Veli K.; Colombo, Paolo C.; Goldstein, Daniel J.; Naka, Yoshifumi; Takayama, Hiroo; Uriel, Nir; Jorde, Ulrich P.

In: Circulation: Heart Failure, Vol. 9, No. 5, e002896, 01.05.2016.

Research output: Contribution to journalArticle

Levin, Allison P. ; Saeed, Omar ; Willey, Joshua Z. ; Levin, Charles J. ; Fried, Justin A. ; Patel, Snehal R. ; Sims, Daniel B. ; Nguyen, Jenni D. ; Shin, Jooyoung (Julia) ; Topkara, Veli K. ; Colombo, Paolo C. ; Goldstein, Daniel J. ; Naka, Yoshifumi ; Takayama, Hiroo ; Uriel, Nir ; Jorde, Ulrich P. / Watchful waiting in continuous-flow left ventricular assist device patients with ongoing hemolysis is associated with an increased risk for cerebrovascular accident or death. In: Circulation: Heart Failure. 2016 ; Vol. 9, No. 5.
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abstract = "Background - 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. Methods and Results - 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. Conclusions - 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.",
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T1 - Watchful waiting in continuous-flow left ventricular assist device patients with ongoing hemolysis is associated with an increased risk for cerebrovascular accident or death

AU - Levin, Allison P.

AU - Saeed, Omar

AU - Willey, Joshua Z.

AU - Levin, Charles J.

AU - Fried, Justin A.

AU - Patel, Snehal R.

AU - Sims, Daniel B.

AU - Nguyen, Jenni D.

AU - Shin, Jooyoung (Julia)

AU - Topkara, Veli K.

AU - Colombo, Paolo C.

AU - Goldstein, Daniel J.

AU - Naka, Yoshifumi

AU - Takayama, Hiroo

AU - Uriel, Nir

AU - Jorde, Ulrich P.

PY - 2016/5/1

Y1 - 2016/5/1

N2 - Background - 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. Methods and Results - 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. Conclusions - 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.

AB - Background - 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. Methods and Results - 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. Conclusions - 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.

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