Pregnancy with a prosthetic heart valve, thrombosis, and bleeding: the ESC EORP Registry of Pregnancy and Cardiac disease III
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Key result
Mechanical valves linked to ~32% lower chance of uncomplicated pregnancy with live birth vs biological valves.
- P<0.001
- n=613
Why the study?
Pregnancy in women with a prosthetic heart valve is high risk due to anticoagulation requirements, but data on the relationship between anticoagulation practices and pregnancy outcomes are very limited.
Does the type of prosthetic heart valve and anticoagulation regimen affect pregnancy outcomes and thromboembolic complications in pregnant women?
Population
613 pregnancies in women with a prosthetic heart valve
Comparison
Mechanical vs biological valves and different anticoagulation practices
Design
Global prospective registry
Authors
Discussion
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“On the basis of our findings, we conclude that it is reasonable to maintain the status quo as contained in the current guidelines and continue to recommend anti-Xa monitoring of LMWH treatment if possible, on the basis that it is highly unlikely to be harmful, and there is a definite possibility that in some individual cases, it may be beneficial in avoiding anticoagulation levels falling too low or being excessive”
Implication
May inform valve selection counseling for women planning pregnancy; leaves open need for prospective confirmation.
Key Points
- The aim is to understand how anticoagulation practices affect pregnancy outcomes in women with prosthetic heart valves.
- Global registry enrolling pregnancies from January 2018 to April 2023
- Collected data on anticoagulation regimens, pregnancy, and perinatal outcomes
- Total of 613 pregnancies included, with differentiation between mechanical and biological valves.
- 54% of women with mechanical valves had uncomplicated pregnancies, 79% for biological valves (P < .001)
- Thromboembolic complications were higher with LMWH regimens
- Mitral prosthetic valve linked to increased risk of valve thrombosis (OR 3.3; 95% CI 1.9-8.0).
Study Design
Type
Observational (n=613)
Multicenter
Yes
Structured PICO
Does the type of prosthetic heart valve and anticoagulation regimen affect pregnancy outcomes and thromboembolic complications in pregnant women?
P
Population
613 pregnant women with a prosthetic heart valve (411 mechanical, 202 biological) followed through pregnancy and up to a median of 6.5 months postpartum.
E
Exposure
Anticoagulation regimens during pregnancy (vitamin K antagonist [VKA] throughout, low-molecular weight heparin [LMWH] throughout, unfractionated heparin [UFH] switched to VKA, or LMWH switched to VKA) and anti-Xa level monitoring.
C
Comparator
Biological vs mechanical valves; different anticoagulation regimens compared to each other; anti-Xa monitoring vs no monitoring.
O
Outcome
Uncomplicated pregnancy with a live birth, thromboembolic complications, and haemorrhagic complications.hard clinical
Main Result
Absolute Event Rate: 54% vs 79%
p-value: p=<0.001
In pregnant women with prosthetic heart valves, biological valves are associated with significantly better pregnancy outcomes than mechanical valves, and LMWH use in mechanical valves increases thromboembolic risk.
Limitations
- Observational study design
- Potential for unmeasured confounding in anticoagulation regimens
Cite This Study
Zande et al. (2025) conducted an observational in Pregnancy with a prosthetic heart valve (n=613). Mechanical prosthetic heart valve vs. Biological prosthetic heart valve was evaluated on Uncomplicated pregnancy with a live birth (p=<0.001). The chance of an uncomplicated pregnancy with a live birth was 54% in women with a mechanical valve compared to 79% in women with a biological valve.
Topics
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