Skip to main content
Log in

Thromboembolic events after major bleeding events in patients with mechanical heart valves: a 13-year analysis

  • Published:
Journal of Thrombosis and Thrombolysis Aims and scope Submit manuscript

Abstract

Anticoagulation in patients with mechanical heart valves (MHV) is associated with a risk of major bleeding episodes (MBE). In case of MBE, anticoagulant interruption is advocated. However, there is lack of data regarding the thrombo-embolic events (TE) risk associated with anticoagulant interruption. The main objective of the study was to evaluate the rate and risk factors of 6-months of TEs in patients with MHV experiencing MBE. This observational study was conducted over a 13-year period. Adult patients with a MHV presenting with a MBE were included. The main study endpoint was 6-month TEs, defined by clinical TEs or an echocardiographic documented thrombosis, occurring during an ICU stay or within 6-months. Thromboembolic events were recorded at ICU discharge, and 6 months after discharge. Seventy-nine MBEs were analysed, the rate of TEs at 6-months was 19% CI [11-29%]. The only difference of presentation and management between 6-month TEs and free-TE patients was the time without effective anticoagulation (TWA). The Receiver Operator Characteristic curve identified the value of 122 h of TWA as a cut-off. The multivariate analysis identified early bleeding recurrences (OR 3.62, 95% CI [1.07–12.25], p = 0.039), and TWA longer than 122 h (OR 4.24, 95% CI [1.24–14.5], p = 0.021), as independent risk factors for 6-month TEs. A higher rate of TE was associated with anticoagulation interruption longer than 5 days and early bleeding recurrences. However, the management should still be personalized and discussed for each case given the heterogeneity of causes of MBE and possibilities of haemostatic procedures.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

  1. Members WC, Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP et al (2021) 2020 ACC/AHA Guideline for the management of patients with Valvular Heart Disease: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice guidelines. J Am Coll Cardiol 77:e25–197

    Article  Google Scholar 

  2. Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J et al (2021) 2021 ESC/EACTS guidelines for the management of valvular heart disease. Eur J Cardio-Thorac Surg off J Eur Assoc Cardio-Thorac Surg 60:727–800

  3. Toole JM, Stroud MR, Kratz JM, Crumbley AJ, Bradley SM, Crawford FA et al (2010) Twenty-five year experience with the St. Jude medical mechanical valve prosthesis. Ann Thorac Surg 89:1402–1409

  4. Cannegieter SC, Rosendaal FR, Wintzen AR, van der Meer FJ, Vandenbroucke JP, Briët E (1995) Optimal oral anticoagulant therapy in patients with mechanical heart valves. N Engl J Med 333:11–17

  5. Hylek EM, Singer DE (1994) Risk factors for intracranial hemorrhage in outpatients taking warfarin. Ann Intern Med 120:897–902

  6. Pernod G, Godiér A, Gozalo C, Tremey B, Sié P, French National Authority for Health (2010) French clinical practice guidelines on the management of patients on vitamin K antagonists in at-risk situations (overdose, risk of bleeding, and active bleeding). Thromb res 126:e167–174

  7. Tomaselli GF, Mahaffey KW, Cuker A, Dobesh PP, Doherty JU, Eikelboom JW et al (2020) 2020 ACC expert consensus decision pathway on management of bleeding in patients on oral anticoagulants: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol 76:594–622

  8. Crawley F, Bevan D, Wren D (2000) Management of intracranial bleeding associated with anticoagulation: balancing the risk of further bleeding against thromboembolism from prosthetic heart valves. J Neurol Neurosurg Psychiatry 69:396–398

  9. Hawryluk GWJ, Furlan JC, Austin JW, Fehlings MG (2014) Individual characteristics and management decisions affect outcome of anticoagulated patients with intracranial hemorrhage. World Neurosurg 81:742–751

  10. Flint AC, Lingamneni R, Rao VA, Chan SL, Ren X, Pombra J et al (2015) Risks of thrombosis and rehemorrhage during early management of intracranial hemorrhage in patients with mechanical heart valves. J Am Coll Cardiol 66:1738–1739

  11. Phan TG, Koh M, Wijdicks EF (2000) Safety of discontinuation of anticoagulation in patients with intracranial hemorrhage at high thromboembolic risk. Arch Neurol 57:1710–1713

  12. Ananthasubramaniam K, Beattie JN, Rosman HS, Jayam V, Borzak S (2001) How safely and for how long can warfarin therapy be withheld in prosthetic heart valve patients hospitalized with a major hemorrhage? Chest 119:478–484

  13. Amin AG, Ng J, Hsu W, Pradilla G, Raza S, Quinones-Hinojosa A et al (2013) Postoperative anticoagulation in patients with mechanical heart valves following surgical treatment of subdural hematomas. Neurocrit Care 2013 19:90–94

  14. Wang CL, Wu VC, Huang YT, Chen YL, Chu PH, Kuo CF et al (2021) Incidence and consequences of resuming oral anticoagulant therapy following hematuria and risks of ischemic stroke and major bleeding in patients with atrial fibrillation. J Thromb Thrombolysis 51:58–66

  15. Staerk L, Fosbøl EL, Lip GYH, Lamberts M, Bonde AN, Torp-Pedersen C, Ozenne B, Gerds TA, Gislason GH, Olesen JB (2017) Ischaemic and haemorrhagic stroke associated with non-vitamin K antagonist oral anticoagulants and warfarin use in patients with atrial fibrillation: a nationwide cohort study. Eur Heart J38:907–915

  16. Halvorsen S, ESC Working Group on Thrombosis (2017) Management of antithrombotic therapy after bleeding in patients with coronary artery disease and/or atrial fibrillation: expert consensus paper of the European Society of Cardiology Working Group on thrombosis. Eur Heart J38:1455–1462

  17. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP et al (2007) The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med 147:573–577

  18. Schulman S, Angerås U, Bergqvist D, Eriksson B, Lassen MR, Fisher W et al (2010) Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients. J Thromb Haemost 8:202–204

  19. Horstkotte D, Lengyel M, Mistiaen WP, Piper C, Völler H Working Group on Infection, Thrombosis, Embolism and Bleeding of the Society of et al. (2005) Recommendations for reporting morbid events after heart valve surgery. J Heart Valve Dis 14:1–7

  20. Members WC, Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP et al (2021) 2020 ACC/AHA guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines. J Am Coll Cardiol 77:e25–197

  21. Lancellotti P, Pibarot P, Chambers J, Edvardsen T, Delgado V, Dulgheru R et al (2016) Recommendations for the imaging assessment of prosthetic heart valves: a report from the European Association of Cardiovascular Imaging endorsed by the Chinese Society of Echocardiography, the Inter-American Society of Echocardiography, and the Brazilian Department of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging 17:589–590

  22. Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J et al (2021) 2021 ESC/EACTS guidelines for the management of valvular heart disease. Eur J Cardio-Thorac Surg 60:727–800

    Article  Google Scholar 

  23. Butchart EG, Ionescu A, Payne N, Giddings J, Grunkemeier GL, Fraser AG (2003) A new scoring system to determine thromboembolic risk after heart valve replacement. Circulation 108:II68–74

  24. Kumano O, Akatsuchi K, Amiral J (2021) Updates on anticoagulation and laboratory tools for therapy monitoring of heparin, vitamin K antagonists and direct oral anticoagulants. Biomedicines 9:264

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  25. Wu C, Zhang M, Gu W, Wang C, Zheng X, Zhang J et al (2023) Study group of central venous catheter-related thrombosis. Daily point-of-care ultrasound-assessment of central venous catheter-related thrombosis in critically ill patients: a prospective multicenter study. Intensive Care Med 49:401–410

  26. Buttard P, Bonnefoy E, Chevalier P, Marcaz PB, Robin J, Obadia JF et al (1997) Mechanical cardiac valve thrombosis in patients in critical hemodynamic compromise. Eur J Cardio-Thorac Surg 11:710–713

  27. Dürrleman N, Pellerin M, Bouchard D, Hébert Y, Cartier R, Perrault LP et al (2004) Prosthetic valve thrombosis: twenty-year experience at the Montreal Heart Institute. J Thorac Cardiovasc Surg 127:1388–1392

Download references

Acknowledgements

None.

Funding

No external funding was received for study design, data acquisition, data interpretation, manuscript preparation or revision. The study received no specific financial support.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Pascal Augustin.

Ethics declarations

Ethics approval and consent to participate

The study protocol was approved by the local independent ethics committee, which waived the need for informed consent because of the observational nature of the study: CPP Ile de France I, IRB n° 00008522. The study protocol respected the principles of the 1964 Declaration of Helsinki.

Competing interests

The authors declare that they have no competing interests.

Additional information

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary Material 1

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Augustin, P., Andrei, S., Iung, B. et al. Thromboembolic events after major bleeding events in patients with mechanical heart valves: a 13-year analysis. J Thromb Thrombolysis (2024). https://doi.org/10.1007/s11239-024-02964-5

Download citation

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1007/s11239-024-02964-5

Keywords

Navigation