Anticoagulation in pregnant women with a mechanical heart valve

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ID: 321271
2026
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Abstract
This commentary refers to ‘Pregnancy with a prosthetic heart valve, thrombosis, and bleeding: the ESC EORP Registry of Pregnancy and Cardiac disease III’, by J.A. van der Zande et al., https://doi.org/10.1093/eurheartj/ehaf265 and the discussion piece ‘Mechanical Valves in Pregnancy: Interpreting LMWH Risk Through Monitoring Adequacy’, by Z. Liu et al., https://doi.org/10.1093/eurheartj/ehag539. We thank Liu et al.1 for their response concerning our ROPAC paper on anticoagulation in women with a mechanical heart valve. They raise two issues, one, about the adequacy of our assessment of the antifactor Xa measurements and two, the lack of information about the thrombogenicity of the mechanical valves used in the patients included in ROPAC. We agree that these are important questions and further agree that the discussion, regarding the most appropriate anticoagulation regimen in pregnant women with a mechanical valve, is ongoing and not settled yet. In fact, we initiated the ROPAC III study after ROPAC I and II to prospectively study women with a mechanical valve to finally determine the optimal anticoagulation regimen and to investigate complications associated with the different regimens.2 We were very happy to have been able to enroll so many women with a mechanical heart valve and hoped that we would have been able to provide a clear and straightforward answer to the question of which was the optimal regimen. Unfortunately, having analysed all the data, we are still not clear whether the optimal regimen is one based on Low Molecular weight Heparins (LMWH), Vitamin K Antagonists (VitK) or their combination. The ROPAC study was a large, multicentre, real-life prospective registry and not a randomized controlled trial. At this moment, ROPAC is the best study design that we have available. Inherently, there are limitations to this study design, which are clearly pointed out in our original paper and highlighted further by Liu et al.1,2 Indeed, in an ideal world, we would have data on trough levels in all patients at all timepoints and these data might have made the results clearer, but this is not guaranteed as studies that included both peak and trough levels still failed to achieve optimal outcomes. In fact, our study gathered more information on INR and Anti-Xa levels than any earlier study, but we could not collect data in all women and consequently, we were unable to define which regimen is better. Liu et al.1 suggested that the higher thrombosis risk could be related to the high proportion of women with mechanical valves originating from LMICs. However, when we analyzed outcomes between LMIC and HIC patients, we actually observed more thrombotic events in HIC, highlighting that other factors beyond valve origin may contribute to risk We had data on valve position but not valve type and did not ascribe a thrombogenic risk score, although agree this would have been interesting as valve position and prosthesis type make a significant difference to thrombogenic risk. Indeed, we are convinced the outcomes for newer valves, especially in the aorta position, will be better. However, ROPAC presents real life data and included our current patient population. The situation is constantly evolving as newer valves are designed and implanted, and outcomes are likely to improve, perhaps with better data for LMWH-based regimens. All studies in this field are useful and needed; but the comments of Liu et al emphasize the need for a large randomized controlled trial and such a study is our ambition. In addition, more research should focus on the development of better heart valves, with greater durability and without the need for anticoagulation.
Reference Key
openalex_W7168654660 Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Johanna A van der Zande, Mark R. Johnson, Jolien W. Roos‐Hesselink
Journal european heart journal
Year 2026
DOI
10.1093/eurheartj/ehag540
URL
https://doi.org/10.1093/eurheartj/ehag540
Keywords Keywords not found

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