Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy

Soon J. Park, Carmelo A. Milano, Antone J. Tatooles, Joseph G. Rogers, Robert M. Adamson, D Eric Steidley, Gregory A. Ewald, Kartik S. Sundareswaran, David J. Farrar, Mark S. Slaughter

Research output: Contribution to journalArticle

229 Citations (Scopus)

Abstract

Background-The HeartMate II (HMII) destination therapy (DT) trial demonstrated significant improvements in outcomes in continuous-flow left ventricular assist devices compared with patients implanted with the pulsatile-flow HeartMate XVE. The primary hypothesis of the current study is that trial patients enrolled after the initial data cohort would have better clinical outcomes. Methods and Results-Two hundred eighty-one patients who underwent HMII for DT from May 2007 to March 2009 (Mid Trial [MT] group) were compared with the initial 133 HMII patients from March 2005 to May 2007 (Early Trial [ET] group). Patient entry criteria were the same during the 2 time periods. Survival, adverse events, and quality of life were compared between the 2 groups. Baseline characteristics were similar between the groups. Compared with the ET group, patients in the MT group had reduced adverse event rates for bleeding requiring transfusions (1.66 versus 1.13 events per patient-year, P<0.001), sepsis (0.38 versus 0.27, P=0.025), device-related infections (0.47 versus 0.27, P<0.001), and hemorrhagic stroke (0.07 versus 0.03, P=0.01). Other event rates were similar between groups including ischemic stroke (0.06 versus 0.05 events per patient-year, P=0.57). Survival at 1 year in the MT group was 73% versus 68% in the ET group (P=0.21). Additionally, there was a significant reduction in deaths caused by hemorrhagic stroke (P=0.01). Quality of life improvements were significant in both the groups (P<0.001). Conclusions-The benefit of DT therapy with the HMII is confirmed in subsequent trial patients, with improved adverse event rates and a strong trend for improvements in survival. Clinical Trial Registration-URL: http://www. clinicaltrials.gov. Unique identifier: NCT00121485.

Original languageEnglish (US)
Pages (from-to)241-248
Number of pages8
JournalCirculation: Heart Failure
Volume5
Issue number2
DOIs
StatePublished - Mar 2012

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Heart-Assist Devices
Heart Failure
Therapeutics
Stroke
Survival
Quality of Life
Pulsatile Flow
Quality Improvement
Sepsis
Clinical Trials
Hemorrhage
Equipment and Supplies

Keywords

  • Heart failure
  • HeartMate II
  • Mechanical circulatory support
  • Ventricular assist device

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy. / Park, Soon J.; Milano, Carmelo A.; Tatooles, Antone J.; Rogers, Joseph G.; Adamson, Robert M.; Steidley, D Eric; Ewald, Gregory A.; Sundareswaran, Kartik S.; Farrar, David J.; Slaughter, Mark S.

In: Circulation: Heart Failure, Vol. 5, No. 2, 03.2012, p. 241-248.

Research output: Contribution to journalArticle

Park, SJ, Milano, CA, Tatooles, AJ, Rogers, JG, Adamson, RM, Steidley, DE, Ewald, GA, Sundareswaran, KS, Farrar, DJ & Slaughter, MS 2012, 'Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy', Circulation: Heart Failure, vol. 5, no. 2, pp. 241-248. https://doi.org/10.1161/CIRCHEARTFAILURE.111.963991
Park, Soon J. ; Milano, Carmelo A. ; Tatooles, Antone J. ; Rogers, Joseph G. ; Adamson, Robert M. ; Steidley, D Eric ; Ewald, Gregory A. ; Sundareswaran, Kartik S. ; Farrar, David J. ; Slaughter, Mark S. / Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy. In: Circulation: Heart Failure. 2012 ; Vol. 5, No. 2. pp. 241-248.
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AU - Milano, Carmelo A.

AU - Tatooles, Antone J.

AU - Rogers, Joseph G.

AU - Adamson, Robert M.

AU - Steidley, D Eric

AU - Ewald, Gregory A.

AU - Sundareswaran, Kartik S.

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AU - Slaughter, Mark S.

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N2 - Background-The HeartMate II (HMII) destination therapy (DT) trial demonstrated significant improvements in outcomes in continuous-flow left ventricular assist devices compared with patients implanted with the pulsatile-flow HeartMate XVE. The primary hypothesis of the current study is that trial patients enrolled after the initial data cohort would have better clinical outcomes. Methods and Results-Two hundred eighty-one patients who underwent HMII for DT from May 2007 to March 2009 (Mid Trial [MT] group) were compared with the initial 133 HMII patients from March 2005 to May 2007 (Early Trial [ET] group). Patient entry criteria were the same during the 2 time periods. Survival, adverse events, and quality of life were compared between the 2 groups. Baseline characteristics were similar between the groups. Compared with the ET group, patients in the MT group had reduced adverse event rates for bleeding requiring transfusions (1.66 versus 1.13 events per patient-year, P<0.001), sepsis (0.38 versus 0.27, P=0.025), device-related infections (0.47 versus 0.27, P<0.001), and hemorrhagic stroke (0.07 versus 0.03, P=0.01). Other event rates were similar between groups including ischemic stroke (0.06 versus 0.05 events per patient-year, P=0.57). Survival at 1 year in the MT group was 73% versus 68% in the ET group (P=0.21). Additionally, there was a significant reduction in deaths caused by hemorrhagic stroke (P=0.01). Quality of life improvements were significant in both the groups (P<0.001). Conclusions-The benefit of DT therapy with the HMII is confirmed in subsequent trial patients, with improved adverse event rates and a strong trend for improvements in survival. Clinical Trial Registration-URL: http://www. clinicaltrials.gov. Unique identifier: NCT00121485.

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