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Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) analysis of pump thrombosis in the HeartMate II left ventricular assist device.

Publication ,  Journal Article
Kirklin, JK; Naftel, DC; Kormos, RL; Pagani, FD; Myers, SL; Stevenson, LW; Acker, MA; Goldstein, DL; Silvestry, SC; Milano, CA; Baldwin, JT ...
Published in: J Heart Lung Transplant
January 2014

BACKGROUND: Pump thrombosis remains an uncommon but potentially catastrophic complication of durable continuous-flow left ventricular assist devices (LVAD). A perceived increase in the incidence of pump thrombosis in the HeartMate II (HMII) LVAD (Thoratec, Pleasanton, CA) by clinicians prompted this analysis of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database. METHODS: Between 2006 and June 2013, 8,988 United States patients aged older than 18 years received a durable LVAD. Of these, 6,910 adult patients from 132 institutions who received a HMII LVAD were entered in the INTERMACS database and constitute the study group for this analysis. RESULTS: Overall survival (with censoring at transplant or explant for recovery) with the HMII LVAD was 80% at 1 year and 69% at 2 years and was not significantly different when stratified by era of implant. Freedom from device exchange or death due to thrombosis decreased from 99% at 6 months in 2009 to 94% in 2012 (p < 0.0001). Multivariable hazard function analysis showed risk factors for pump thrombosis included later implant year (p < 0.0001), younger age (p < 0.0001), higher creatinine (p = 0.002), larger body mass index (p = 0.004), white race (p = 0.0004), left ventricular ejection fraction above 20% (p = 0.02), and higher lactate dehydrogenase level at 1 month (p < 0.0001). Survival (p < 0.0001) and freedom from infection (p = 0.008) and cerebrovascular accident (p < 0.0001) were lower after pump exchange than after primary implant. CONCLUSIONS: Pump exchange or death due to pump thrombosis increased during 2011 and 2012, but the magnitude of the increase remained relatively small. Survival remains high (80% at 1 year) with the HMII LVAD. Risk factor analysis suggests that a number of patient-related factors contribute to the risk of thrombosis. Markedly elevated lactate dehydrogenase in the first month is a predictor of pump thrombosis. This analysis could not examine the potential role of technical factors during implant, such as sub-optimal pump or graft positioning, changes in patient management paradigms with pump speed settings, improved recognition and change in the threshold for pump exchange, or design or production changes with the pump, as contributors to the risk of pump thrombosis.

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Published In

J Heart Lung Transplant

DOI

EISSN

1557-3117

Publication Date

January 2014

Volume

33

Issue

1

Start / End Page

12 / 22

Location

United States

Related Subject Headings

  • Ventricular Dysfunction, Left
  • United States
  • Thrombosis
  • Survival Rate
  • Surgery
  • Retrospective Studies
  • Registries
  • Predictive Value of Tests
  • Multivariate Analysis
  • Middle Aged
 

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Kirklin, J. K., Naftel, D. C., Kormos, R. L., Pagani, F. D., Myers, S. L., Stevenson, L. W., … Miller, M. A. (2014). Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) analysis of pump thrombosis in the HeartMate II left ventricular assist device. J Heart Lung Transplant, 33(1), 12–22. https://doi.org/10.1016/j.healun.2013.11.001
Kirklin, James K., David C. Naftel, Robert L. Kormos, Francis D. Pagani, Susan L. Myers, Lynne W. Stevenson, Michael A. Acker, et al. “Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) analysis of pump thrombosis in the HeartMate II left ventricular assist device.J Heart Lung Transplant 33, no. 1 (January 2014): 12–22. https://doi.org/10.1016/j.healun.2013.11.001.
Kirklin JK, Naftel DC, Kormos RL, Pagani FD, Myers SL, Stevenson LW, et al. Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) analysis of pump thrombosis in the HeartMate II left ventricular assist device. J Heart Lung Transplant. 2014 Jan;33(1):12–22.
Kirklin, James K., et al. “Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) analysis of pump thrombosis in the HeartMate II left ventricular assist device.J Heart Lung Transplant, vol. 33, no. 1, Jan. 2014, pp. 12–22. Pubmed, doi:10.1016/j.healun.2013.11.001.
Kirklin JK, Naftel DC, Kormos RL, Pagani FD, Myers SL, Stevenson LW, Acker MA, Goldstein DL, Silvestry SC, Milano CA, Baldwin JT, Pinney S, Eduardo Rame J, Miller MA. Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) analysis of pump thrombosis in the HeartMate II left ventricular assist device. J Heart Lung Transplant. 2014 Jan;33(1):12–22.
Journal cover image

Published In

J Heart Lung Transplant

DOI

EISSN

1557-3117

Publication Date

January 2014

Volume

33

Issue

1

Start / End Page

12 / 22

Location

United States

Related Subject Headings

  • Ventricular Dysfunction, Left
  • United States
  • Thrombosis
  • Survival Rate
  • Surgery
  • Retrospective Studies
  • Registries
  • Predictive Value of Tests
  • Multivariate Analysis
  • Middle Aged