The Journal of Thoracic and Cardiovascular Surgery
Volume 139, Issue 5 , Pages 1316-1324, May 2010

Right ventricular failure in patients with the HeartMate II continuous-flow left ventricular assist device: Incidence, risk factors, and effect on outcomes

  • Robert L. Kormos, MD

      Affiliations

    • Heart, Lung & Esophageal Institute, University of Pittsburgh Medical Center, Pittsburgh, Pa
    • Corresponding Author InformationAddress for reprints: Robert L. Kormos, MD, FRCS, FACS, FAHA, Artificial Heart Program, Co-Director Heart Transplantation, 200 Lothrop St, Suite C-800, Pittsburgh, PA 15213.
    • ,
  • Jeffrey J. Teuteberg, MD

      Affiliations

    • Cardiovascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pa
    • ,
  • Francis D. Pagani, MD

      Affiliations

    • Section of Cardiac Surgery, University of Michigan, Ann Arbor, Mich
    • ,
  • Stuart D. Russell, MD

      Affiliations

    • Department of Medicine, Johns Hopkins Hospital, Baltimore, Md
    • ,
  • Ranjit John, MD

      Affiliations

    • Division of Cardiothoracic Surgery, University of Minnesota, Minneapolis, Minn
    • ,
  • Leslie W. Miller, MD

      Affiliations

    • Department of Cardiovascular Medicine, Washington Hospital Center, Washington, DC
    • ,
  • Todd Massey, MD

      Affiliations

    • Division of Cardiac Surgery, University of Rochester, Rochester, NY
    • ,
  • Carmelo A. Milano, MD

      Affiliations

    • Division of Cardiovascular and Thoracic Surgery, Duke University Medical Center, Durham, NC
    • ,
  • Nader Moazami, MD

      Affiliations

    • Division of Cardiothoracic Surgery, Washington University School of Medicine, St Louis, Mo
    • ,
  • Kartik S. Sundareswaran, PhD

      Affiliations

    • Thoratec Corporation, Pleasanton, Calif
    • ,
  • David J. Farrar, PhD

      Affiliations

    • Thoratec Corporation, Pleasanton, Calif
    • ,
  • HeartMate II Clinical Investigators

Received 30 July 2009; received in revised form 17 October 2009; accepted 12 November 2009. published online 04 February 2010.

Objective

The aim of this study was to evaluate the incidence, risk factors, and effect on outcomes of right ventricular failure in a large population of patients implanted with continuous-flow left ventricular assist devices.

Methods

Patients (n = 484) enrolled in the HeartMate II left ventricular assist device (Thoratec, Pleasanton, Calif) bridge-to-transplantation clinical trial were examined for the occurrence of right ventricular failure. Right ventricular failure was defined as requiring a right ventricular assist device, 14 or more days of inotropic support after implantation, and/or inotropic support starting more than 14 days after implantation. Demographics, along with clinical, laboratory, and hemodynamic data, were compared between patients with and without right ventricular failure, and risk factors were identified.

Results

Overall, 30 (6%) patients receiving left ventricular assist devices required a right ventricular assist device, 35 (7%) required extended inotropes, and 33 (7%) required late inotropes. A significantly greater percentage of patients without right ventricular failure survived to transplantation, recovery, or ongoing device support at 180 days compared with patients with right ventricular failure (89% vs 71%, P < .001). Multivariate analysis revealed that a central venous pressure/pulmonary capillary wedge pressure ratio of greater than 0.63 (odds ratio, 2.3; 95% confidence interval, 1.2–4.3; P = .009), need for preoperative ventilator support (odds ratio, 5.5; 95% confidence interval, 2.3–13.2; P < .001), and blood urea nitrogen level of greater than 39 mg/dL (odds ratio, 2.1; 95% confidence interval, 1.1–4.1; P = .02) were independent predictors of right ventricular failure after left ventricular assist device implantation.

Conclusions

The incidence of right ventricular failure in patients with a HeartMate II ventricular assist device is comparable or less than that of patients with pulsatile-flow devices. Its occurrence is associated with worse outcomes than seen in patients without right ventricular failure. Patients at risk for right ventricular failure might benefit from preoperative optimization of right heart function or planned biventricular support.

Abbreviations and Acronyms: BiVAD, biventricular assist device, BTT, bridge to transplantation, BUN, blood urea nitrogen, CI, confidence interval, CVP, central venous pressure, IABP, intra-aortic balloon pump, LVAD, left ventricular assist device, MRVFRS, University of Michigan right ventricular failure risk score, OR, odds ratio, PCWP, pulmonary capillary wedge pressure, RV, right ventricular, RVAD, right ventricular assist device, RVF, right ventricular failure, RVSWI, right ventricular stroke work index, VAD, ventricular assist device, WBC, white blood cell count

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 Disclosures: Jeffrey Teuteberg, Stuart Russell, Leslie Miller, and Todd Massey report consulting/lecture fees and grant support from Thoratec. Francis Pagani reports grant support from Thoratec. David Farrer reports grant support, equity, and employment by Thoratec.

PII: S0022-5223(09)01475-5

doi:10.1016/j.jtcvs.2009.11.020

The Journal of Thoracic and Cardiovascular Surgery
Volume 139, Issue 5 , Pages 1316-1324, May 2010

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