Objective Women with cardiac disease becoming pregnant have an increased risk of obstetric and fetal events. The aim of this study was to study the incidence of events, to validate the modified WHO (mWHO) risk classification and to search for event-specific predictors.
Methods The Registry Of Pregnancy And Cardiac disease is a worldwide ongoing prospective registry that has enrolled 2742 pregnancies in women with known cardiac disease (mainly congenital and valvular disease) before pregnancy, from January 2008 up to April 2014.
Results Mean age was 28.2±5.5 years, 45% were nulliparous and 33.3% came from emerging countries. Obstetric events occurred in 231 pregnancies (8.4%). Fetal events occurred in 651 pregnancies (23.7%). The mWHO classification performed poorly in predicting obstetric (c-statistic=0.601) and fetal events (c-statistic=0.561). In multivariable analysis, aortic valve disease was associated with pre-eclampsia (OR=2.6, 95%CI=1.3 to 5.5). Congenital heart disease (CHD) was associated with spontaneous preterm birth (OR=1.8, 95%CI=1.2 to 2.7). Complex CHD was associated with small-for-gestational-age neonates (OR=2.3, 95%CI=1.5 to 3.5). Multiple gestation was the strongest predictor of fetal events: fetal/neonatal death (OR=6.4, 95%CI=2.5 to 16), spontaneous preterm birth (OR=5.3, 95%CI=2.5 to 11) and small-for-gestational age (OR=5.0, 95%CI=2.5 to 9.8).
Conclusion The mWHO classification is not suitable for prediction of obstetric and fetal events in women with cardiac disease. Maternal complex CHD was independently associated with fetal growth restriction and aortic valve disease with pre-eclampsia, potentially offering an insight into the pathophysiology of these pregnancy complications. The increased rates of adverse obstetric and fetal outcomes in women with pre-existing heart disease should be highlighted during counselling.
- Congenital heart disease
- Valvular heart disease
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Acknowledgements The authors thank all ROPAC investigators, who are listed in the online supplement. The authors also thank the EORP team for their contribution, in particular: Elin Folkesson Lefrancq (project officer) and Viviane Missiamenou (data manager).
Contributors JWR-H and RH were responsible for planning, study design, data collection, drafting the manuscript and critical revision of the manuscript.
IMvH, VD, CL, MM, DJM, LG, NMB, JC and MRJ contributed to data collection, drafting the manuscript and critical revision of the manuscript.
Funding Since the start of EORP, the following companies have supported the programme: Abbott Vascular Int. (2011-2014), Amgen Cardiovascular (2009-2018), AstraZeneca (2014-2017), Bayer (2009-2018), Boehringer Ingelheim (2009-2016), Boston Scientific (2009-2012), The Bristol Myers Squibb and Pfizer Alliance (2011-2016), The Alliance Daiichi Sankyo Europe GmbH and Eli Lilly and Company (2011-2017), Edwards (2016-2019), Gedeon Richter Plc. (2014-2017), Menarini Int. Op. (2009-2012), MSD-Merck & Co. (2011-2014), Novartis Pharma AG (2014-2017), ResMed (2014-2016), Sanofi (2009-2011), SERVIER (2010-2018). The companies that support EORP were not involved in any part of the study or this report.
Competing interests None declared.
Patient consent Obtained.
Ethics approval Local IRBs.
Provenance and peer review Not commissioned; externally peer reviewed.