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Impact of time in therapeutic range after left ventricular assist device placement: a comparison between thrombus and thrombus-free periods

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Abstract

The association between time in therapeutic range (TTR) and clinical outcomes in patients with left ventricular assist devices (LVADs) on chronic warfarin therapy is not well understood. This study assessed TTR using the Rosendaal Method prior to suspected or confirmed pump thrombosis or ischemic stroke. Each patient served as their own control. Characteristics and TTR in 1, 2, and 3 months prior to thrombus (thrombus period) were compared to a thrombus-free period during 6 months to 3 months prior to thrombus (control period). There were 30 thrombus events observed in 25 patients for a rate of 0.06 events per LVAD day. Average TTR (target INR = 2–3) over 3 months for patients combined in both the thrombus and control time period was 53.4%. TTR (target INR = 2–3) was 11.4% lower 1 month prior to thrombus than the comparable month in the control period (p = 0.029). The TTR (target INR = 1.8–2.5) was 11.8% lower in the thrombus time period compared to the control time period 2 months prior to thrombus (p = 0.032). Our study found an increased risk of thrombosis with lower TTR in months leading up to thrombus compared to a thrombus-free period.

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References

  1. Kirklin JK, Naftel DC, Kormos RL et al (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 33:12–22

    Article  PubMed  Google Scholar 

  2. Starling RC, Moazami N, Silvestry SC et al (2014) Unexpected abrupt increase in left ventricular assist device thrombosis. N Engl J Med 370:33–40

    Article  CAS  PubMed  Google Scholar 

  3. Lenneman AJ, Combs P, Rhode S et al (2013) Management and outcomes of ventricular assist device patients with suspected pump thrombosis. J Heart Lung Transplant 32:S186–S187

    Article  Google Scholar 

  4. Mehra MR, Stewart GC, Uber PA (2014) The vexing problem of thrombosis in long-term mechanical circulatory support. J Heart Lung Transplant 33(1):1–11

    Article  PubMed  Google Scholar 

  5. Hohner E, Crow J, Moranville MP (2015) Medication management for left ventricular assist device thrombosis. Am J Heal Pharm 72(13):1104–1113

    Article  Google Scholar 

  6. Blitz A (2014) Pump thrombosis—a riddle wrapped in a mystery inside an enigma Keynote Lecture Series. Ann Cardiothorac Surg 3(5):450–471

    PubMed  PubMed Central  Google Scholar 

  7. Van den Bergh WM, Lansink-Hartgring AO, van Duijn AL, Engström AE, Lahpor JR, Slooter AJC (2015) Thromboembolic stroke in patients with a HeartMate-II left ventricular assist device—the role of anticoagulation. J Cardiothorac Surg 10:128

    Article  PubMed  PubMed Central  Google Scholar 

  8. Morgan J, Brewer R, Nemeh H et al (2014) Stroke while on long-term left ventricular assist device support: incidence, outcome, and predictors. ASAIO J 60(3):284–289

    Article  PubMed  Google Scholar 

  9. Feldman D, Pamboukian SV, Teuteberg JJ et al (2013) The 2013 International Society for Heart and Lung Transplantation Guidelines for mechanical circulatory support: executive summary. J Heart Lung Transplant 32:157–187

    Article  PubMed  Google Scholar 

  10. Rosendaal FR, Cannegieter SC, van der Meer FJ, Briët E (1993) A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost 69(3):236–239

    Article  CAS  PubMed  Google Scholar 

  11. Veeger NJGM, Piersma-Wichers M, Tijssen JGP, Hillege HL, Van Der Meer J (2005) Individual time within target range in patients treated with vitamin K antagonists: main determinant of quality of anticoagulation and predictor of clinical outcome. A retrospective study of 2300 consecutive patients with venous thromboembolism. Br J Haematol 128(4):513–519

    Article  PubMed  Google Scholar 

  12. Najjar SS, Slaughter MS, Pagani FD, Starling RC, McGee EC, Eckman P, Tatooles AJ, Moazami N, Kormos RL, Hathaway DR, Najarian KB, Bhat G, Aaronson KD, Boyce SW (2014) An analysis of pump thrombus events in patients in the HeartWare ADVANCE bridge to transplant and continued access protocol trial. J Heart Lung Transplant 33(1):23–34

    Article  PubMed  Google Scholar 

  13. Ravichandran AK, Parker J, Novak E, Joseph SM, Schilling JD, Ewald G, Silvestry S (2014) Hemolysis in left ventricular assist device: a retrospective analysis of outcomes. J Heart Lung Transplant 33(1):44–50

    Article  PubMed  Google Scholar 

  14. Goldstein DJ, John R, Salerno C, Silvestry S, Moazami N, Horstmanshof D, Adamson R, Boyle A, Zucker M, Rogers J, Russell S, Long J, Pagani F, Jorde U (2013) Algorithm for the diagnosis and management of suspected pump thrombus. J Heart Lung Transplant 32(7):667–670

    Article  PubMed  Google Scholar 

  15. Boehme AK, Pamboukian SV, George JF, Dillon C, Levitan EB, Griffin R, Beasley TM, McGwin G, Kirklin JK, Limdi NA (2015) Predictors of thromboembolic events in patients with ventricular assist device. ASAIO J 61(6):640–647

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  16. Interagency Registry for Mechanically Assisted Circulatory Support, National Heart Lung and Blood Instituted. Adverse event definitions. https://www.uab.edu/medicine/intermacs/intermacs-documents. Accessed 10 Dec 2017

  17. Halder LC, Richardson LB, Garberich RF, Zimbwa P, Bennett MK (2017) Time in therapeutic range for left ventricular assist device patients anticoagulated with warfarin. ASAIO J 63(1):37–40

    Article  CAS  PubMed  Google Scholar 

  18. Jennings D, McDonnell J, Schillig J (2011) Assessment of long-term anticoagulation in patients with a continuous-flow left-ventricular assist device: a pilot study. J Thorac Cardiovasc Surg 142:e1–e2

    Article  PubMed  Google Scholar 

  19. Gallagher AM, Setakjs E, Plumb JM, Clemens A, van Staa TP (2011) Risks of stroke and mortality associated with suboptimal anticoagulation in atrial fibrillation patients. Thromb Haemost 106:968–977

    Article  CAS  PubMed  Google Scholar 

  20. Williams BA, Evans MA, Honushefsky AM, Berger PB (2017) Clinical prediction model for time in therapeutic range while on warfarin in newly diagnosed atrial fibrillation. J Am Heart Assoc 12:6(10)

    Google Scholar 

  21. Bishop MA, Streiff MB, Ensor CR, Tedford RJ, Russell SD, Ross PA (2014) Pharmacist-managed international normalized ratio patient self-testing is associated with increased time in therapeutic range in patients with left ventricular assist devices at an academic medical center. ASAIO J 60:193–198

    Article  PubMed  Google Scholar 

  22. HeartWare (2012) HeartWare Ventricular Assist System. Instructions for use

  23. Thoratec Corporation (2014) HeartMate II post-approval updates: destination therapy study and overview of risk of thrombosis. Addendum to the HeartMate II LVAS instructions for use

  24. Rose AJ, Hylek EM, Ozonoff A, Ash AS, Reisman Jl, Berlowitz DR (2010) Patient characteristics associated with oral anticoagulation control: results of the Veteran Affairs study to improve anticoagulation (VARIA). J Thromb Haemost 8:2182–2191

    Article  CAS  PubMed  Google Scholar 

  25. Rose AE, Robinson EN, Premo JA, Hauschild LJ, Trapskin PJ, McBride AM (2017) Improving warfarin management within the medical home: a health-system approach. Am J Med 130(3):365.e7–365.e12

    Article  Google Scholar 

  26. Reiffel JA (2017) Time in the therapeutic range for patients taking warfarin in clinical trials. Circulation 135(16):1475–1477

    Article  PubMed  Google Scholar 

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Authors and Affiliations

  1. Department of Pharmacy, Virginia Commonwealth University Health, Richmond, VA, USA

    Julia C. Lea

  2. Department of Pharmacy, Sentara Leigh Hospital, 830 Kempsville Rd, Norfolk, VA, 23502, USA

    Catherine K. Floroff

  3. Department of Pharmacy, Sentara Norfolk General Hospital, Norfolk, VA, USA

    Amanda I. Ingemi

  4. Advanced Heart Failure, Sentara Norfolk General Hospital, Norfolk, VA, USA

    Gary R. Zeevi

Authors
  1. Julia C. Lea
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  2. Catherine K. Floroff
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  3. Amanda I. Ingemi
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  4. Gary R. Zeevi
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Correspondence to Catherine K. Floroff.

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This article does not contain any studies with human participants or animals performed by any of the authors.

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Lea, J.C., Floroff, C.K., Ingemi, A.I. et al. Impact of time in therapeutic range after left ventricular assist device placement: a comparison between thrombus and thrombus-free periods. J Thromb Thrombolysis 47, 361–368 (2019). https://doi.org/10.1007/s11239-018-01800-x

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  • DOI: https://doi.org/10.1007/s11239-018-01800-x

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