Pregnancy in women with a mechanical heart valve : Data of the European society of cardiology registry of pregnancy and cardiac disease (ROPAC))

Background— Pregnant women with a mechanical heart valve (MHV) are at a heightened risk of a thrombotic event, and
their absolute need for adequate anticoagulation puts them at considerable risk of bleeding and, with some anticoagulants,
fetotoxicity.

Methods and Results— Within the prospective, observational, contemporary, worldwide Registry of Pregnancy and Cardiac
disease (ROPAC), we describe the pregnancy outcome of 212 patients with an MHV. We compare them with 134 patients
with a tissue heart valve and 2620 other patients without a prosthetic valve. Maternal mortality occurred in 1.4% of the
patients with an MHV, in 1.5% of patients with a tissue heart valve (P=1.000), and in 0.2% of patients without a prosthetic
valve (P=0.025). Mechanical valve thrombosis complicated pregnancy in 10 patients with an MHV (4.7%). In 5 of these
patients, the valve thrombosis occurred in the first trimester, and all 5 patients had been switched to some form of heparin.
Hemorrhagic events occurred in 23.1% of patients with an MHV, in 5.1% of patients with a tissue heart valve (P<0.001),
and in 4.9% of patients without a prosthetic valve (P<0.001). Only 58% of the patients with an MHV had a pregnancy free
of serious adverse events compared with 79% of patients with a tissue heart valve (P<0.001) and 78% of patients without
a prosthetic valve (P<0.001). Vitamin K antagonist use in the first trimester compared with heparin was associated with a
higher rate of miscarriage (28.6% versus 9.2%; P<0.001) and late fetal death (7.1% versus 0.7%; P=0.016).

Conclusions— Women with an MHV have only a 58% chance of experiencing an uncomplicated pregnancy with a live
birth. The markedly increased mortality and morbidity warrant extensive prepregnancy counseling and centralization of
care

© 2015 American Heart Association, Inc

Funding - The ROPAC is a registry within the EORP. At the time of the registry, the following companies were supporting the EORP: Abbott Vascula Intl, Amgen, Bayer Pharma AG, Boehringer Ingelheim, Boston Scientific, the Bristol Myers Squibb/Pfizer alliance, Alliance Daiichi Sankyo Europe GmbH, Eli Lilly and Co, Menarini International Operations, Merck & Co Intl, Novartis Pharma, ResMed, Sanofi, and
Servier.