Top

Published in:

Open Access 01-12-2015 | Research article

Thromboembolic stroke in patients with a HeartMate-II left ventricular assist device – the role of anticoagulation

Authors: Walter M. van den Bergh, Annemieke Oude Lansink-Hartgring, Abram L. van Duijn, Annemarie E. Engström, Jaap R. Lahpor, Arjen JC Slooter

Published in: Journal of Cardiothoracic Surgery | Issue 1/2015

Abstract

Background and purpose

It is unknown what the optimal anticoagulant level is to prevent thromboembolic stroke in patients with left ventricular assist device (LVAD) support. We aimed to evaluate the relation between coagulation status and the occurrence of thromboembolic stroke in HeartMate-II LVAD assisted patients.

Methods

Thirty-eight consecutive patients with a HeartMate-II LVAD were included. Coagulation status was classified according to INR and aPTT ratio at: 1) the moment of first thromboembolic stroke; and 2) during the two weeks preceding the first thromboembolic stroke to assess long-term coagulation status. In patients without stroke, coagulation status was determined just before heart transplant, VAD explantation or death, whichever came first, and at two weeks preceding these surrogate endpoints. Based on coagulation status, patients were divided in two groups: Group I (reference group) was defined as INR below 2 and aPTT ratio below 1.5; Group II (adequate anticoagulation) as INR above 2 or aPTT ratio above 1.5. Logistic regression analysis was performed to assess the odds ratio for developing stroke for patients with adequate anticoagulation compared to the reference Group.

Results

Thromboembolic stroke occurred in six (16 %) patients, none within 2 weeks after LVAD implantation. Considering coagulation status at the time of event, patients in coagulation Group II had no decreased risk for thromboembolic stroke (OR 0.78; 95 % CI 0.12–5.0). Results for coagulation status 2 weeks prior of event could not be calculated as all six strokes occurred in Group II.

Conclusion

In our experience anticoagulation within predefined targets is not associated with a reduced thromboembolic stroke risk in patients with a HeartMate-II LVAD on antiplatelet therapy. However, no firm statement about the effect of either anticoagulant or antiaggregant therapy can be made based on our study. A larger randomized study is needed to support the hypothesis that there may be no additional benefit of coumarin or heparin therapy compared with antiplatelet therapy alone.

Frazier OH, Rose EA, Oz MC, Dembitsky W, McCarthy P, Radovancevic B, et al. Multicenter clinical evaluation of the HeartMate vented electric left ventricular assist system in patients awaiting heart transplantation. J Thorac Cardiovasc Surg. 2001;122(6):1186–95.PubMedCrossRef

Kirklin JK, Naftel DC, Kormos RL, Stevenson LW, Pagani FD, Miller MA, et al. Second INTERMACS annual report: more than 1,000 primary left ventricular assist device implants. J Heart Lung Transplant. 2010;29(1):1–10.PubMedPubMedCentralCrossRef

Rose EA, Gelijns AC, Moskowitz AJ, Heitjan DF, Stevenson LW, Dembitsky W, et al. Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med. 2001;345(20):1435–43.PubMedCrossRef

Slaughter MS, Rogers JG, Milano CA, Russell SD, Conte JV, Feldman D, et al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009;361(23):2241–51.PubMedCrossRef

John R, Kamdar F, Liao K, Colvin-Adams M, Miller L, Joyce L, et al. Low thromboembolic risk for patients with the Heartmate II left ventricular assist device. J Thorac Cardiovasc Surg. 2008;136(5):1318–23.PubMedCrossRef

Boyle AJ, Russell SD, Teuteberg JJ, Slaughter MS, Moazami N, Pagani FD, et al. Low thromboembolism and pump thrombosis with the HeartMate II left ventricular assist device: analysis of outpatient anti-coagulation. J Heart Lung Transplant. 2009;28(9):881–7.PubMedCrossRef

Schmid C, Weyand M, Nabavi DG, Hammel D, Deng MC, Ringelstein EB, et al. Cerebral and systemic embolization during left ventricular support with the Novacor N100 device. Ann Thorac Surg. 1998;65(6):1703–10.PubMedCrossRef

Slater JP, Rose EA, Levin HR, Frazier OH, Roberts JK, Weinberg AD, et al. Low thromboembolic risk without anticoagulation using advanced-design left ventricular assist devices. Ann Thorac Surg. 1996;62(5):1321–7.PubMedCrossRef

Crow S, Chen D, Milano C, Thomas W, Joyce L, Piacentino III V, et al. Acquired von Willebrand syndrome in continuous-flow ventricular assist device recipients. Ann Thorac Surg. 2010;90(4):1263–9.PubMedCrossRef

10.

Uriel N, Pak SW, Jorde UP, Jude B, Susen S, Vincentelli A, et al. Acquired von Willebrand syndrome after continuous-flow mechanical device support contributes to a high prevalence of bleeding during long-term support and at the time of transplantation. J Am Coll Cardiol. 2010;56(15):1207–13.PubMedCrossRef

11.

Nakajima I, Kato TS, Komamura K, Takahashi A, Oda N, Sasaoka T, et al. Pre- and post-operative risk factors associated with cerebrovascular accidents in patients supported by left ventricular assist device. -Single center's experience in Japan-. Circ J. 2011;75(5):1138–46.PubMedCrossRef

12.

Whitson BA, Eckman P, Kamdar F, Lacey A, Shumway SJ, Liao KK, et al. Hemolysis, pump thrombus, and neurologic events in continuous-flow left ventricular assist device recipients. Ann Thorac Surg. 2014;97(6):2097–103.PubMedCrossRef

13.

Morgan JA, Brewer RJ, Nemeh HW, Gerlach B, Lanfear DE, Williams CT, et al. Stroke while on long-term left ventricular assist device support: incidence, outcome, and predictors. ASAIO J. 2014;60(3):284–9.PubMedCrossRef

14.

Menon AK, Götzenich A, Sassmannshausen H, Haushofer M, Autschbach R, Spillner JW. Low stroke rate and few thrombo-embolic events after HeartMate II implantation under mild anticoagulation. Eur J Cardiothorac Surg. 2012;42(2):319–23.PubMedCrossRef

15.

Greenland S, Finkle WD. A critical look at methods for handling missing covariates in epidemiologic regression analyses. Am J Epidemiol. 1995;142(12):1255–64.PubMed

16.

Harrell Jr FE, Lee KL, Mark DB. Multivariable prognostic models: issues in developing models, evaluating assumptions and adequacy, and measuring and reducing errors. Stat Med. 1996;15(4):361–87.PubMedCrossRef

17.

Donders AR, van der Heijden GJ, Stijnen T, Moons KG. Review: a gentle introduction to imputation of missing values. J Clin Epidemiol. 2006;59(10):1087–91.PubMedCrossRef

18.

Koene RJ, Win S, Naksuk N, Adatya SN, Rosenbaum AN, John R, et al. HAS-BLED and CHA₂DS₂-VASc scores as predictors of bleeding and thrombotic risk after continuous-flow ventricular assist device implantation. J Card Fail. 2014;20(11):800–7.PubMedCrossRef

19.

Sorensen R, Hansen ML, Abildstrom SZ, Hvelplund A, Andersson C, Jorgensen C, et al. Risk of bleeding in patients with acute myocardial infarction treated with different combinations of aspirin, clopidogrel, and vitamin K antagonists in Denmark: a retrospective analysis of nationwide registry data. Lancet. 2009;374(9706):1967–74.PubMedCrossRef

20.

Backes D, van den Bergh WM, van Duijn AL, Lahpor JR, van Dijk D, Slooter AJ. Cerebrovascular complications of left ventricular assist devices. Eur J Cardiothorac Surg. 2012;42(4):612–20.PubMedCrossRef

21.

Critoph C, Chih S, Baumwol J. The World's Longest-Supported HeartWare Ventricular Assist Device Patient: 6 Years and Counting on Minimal Anticoagulation. Artif Organs. 2014;38(5):434–5.PubMedCrossRef

22.

Starling RC, Moazami N, Silvestry SC, Ewald G, Rogers JG, Milano CA, et al. Unexpected abrupt increase in left ventricular assist device thrombosis. N Engl J Med. 2014;370(1):33–40.PubMedCrossRef

23.

Bluestein D, Girdhar G, Einav S, Slepian MJ. Device thrombogenicity emulation: a novel methodology for optimizing the thromboresistance of cardiovascular devices. J Biomech. 2013;46(2):338–44.PubMedCrossRef

Title: Thromboembolic stroke in patients with a HeartMate-II left ventricular assist device – the role of anticoagulation
Authors: Walter M. van den Bergh
Annemieke Oude Lansink-Hartgring
Abram L. van Duijn
Annemarie E. Engström
Jaap R. Lahpor
Arjen JC Slooter
Publication date: 01-12-2015
Publisher: BioMed Central
Published in: Journal of Cardiothoracic Surgery / Issue 1/2015
Electronic ISSN: 1749-8090
DOI: https://doi.org/10.1186/s13019-015-0333-7

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Thromboembolic stroke in patients with a HeartMate-II left ventricular assist device – the role of anticoagulation

Abstract

Background and purpose

Methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background and purpose

Methods

Results

Conclusion

Please log in to get access to this content

Other articles of this Issue 1/2015

Different duration strategies of perioperative antibiotic prophylaxis in adult patients undergoing cardiac surgery: an observational study

Case report: Pacemaker lead perforation of a papillary muscle inducing severe tricuspid regurgitation

“V” aortoplasty of the proximal descending aorta in the elephant trunk procedure

An ex-vivo quantitative assessment to determine the optimal aortotomy closure technique

Fifteen-year experience with the Bicarbon heart valve prosthesis in a single center

Early- and intermediate-term results of surgical correction in 122 patients with total anomalous pulmonary venous connection and biventricular physiology