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............................................................................................................................................................................. 13. Gaps in evidence

Epidemiological data European epidemiological (e.g. registers such as ROPAC) data on women with CVDs and their outcomes, and the foetal risk during pregnancy and in the peripartum period, are important sources of information. However, there is also a clear need for randomized controlled trials. In women with specific aortic diseases, the outcome is not well studied and the impact of treatment with beta-blockers during pregnancy is lacking. The impact of pregnancy in a woman with congenital or aortic disease on the long-term maternal and foetal outcome is not well studied. The impact of fertility treatment on pregnancy complications and maternal outcomes remains unknown.

Mechanical valve prostheses In women with mechanical valve prostheses, no prospective studies are available that compare different anticoagulation regimens. There are unresolved questions concerning LMWH, including optimal anti- Xa levels, the importance of peak vs. pre-dose levels, the best time intervals for anti-Xa monitoring, and the duration of use (first trimester or throughout pregnancy).

Coronary artery disease In women with CAD, the required delay of a subsequent pregnancy following MI is unknown. Furthermore, optimal management and follow-up of patients with P-SCAD is a burning clinical problem. This includes the decision for interventional therapy as well as counselling on the recurrence risk for repeated pregnancies.

Drugs The safety of antiplatelet agents used after PCI in pregnancy is not well known. There is a lack of randomized trials on the use of antiarrhythmic drugs and interventions during pregnancy. Data based on prospective randomized clinical trials in pregnant women to assess drug efficacy and safety are very limited. They will stay limited in some areas due to accepted ethical limitations. However, greater efforts can be made by prospective registries to answer burning treatment questions. Studies investigating the pharmacokinetic changes during pregnancy that modify clinical drug efficacy are required.

Cardiomyopathies The pathophysiology of PPCM has still to be explored in more detail. PPCM includes LV dysfunction due to several different causes and thus PPCM is not a well-described entity. The potential for recovery is often unclear and the risks of subsequent pregnancies are not well defined. For acute HF in the context of pregnancy there are almost no evidence-based treatments. More research is clearly needed.

Cardiac transplantation Evidence is also limited for pregnancies in patients post-cardiac transplantation. Delivery Trials evaluating the level of surveillance at delivery and the warranted monitoring level after delivery are needed. Furthermore, the optimal mode of delivery is not clear for high-risk situations.

Hypertension It is still unclear whether mild–moderate hypertension in pregnancy should be pharmacologically treated. The current guidelines are based on expert consensus regarding thresholds to initiate antihypertensive medication. Prospective studies, even observational, in this area are needed.

Diagnostic pathways More data are needed on diagnostic pathways, specifically the place of D-dimers, in VTE. The value of monitoring anti-Xa values in patients with VTE (treatment) is unknown. Studies are needed on the benefit of using the combination of peak and trough levels. The lack of data regarding the length of anticoagulation after delivery is an unmet need.

14 Key messages

• Risk estimation should be individualized depending on the underlying cardiac diagnosis, ventricular and valvular function, functional class, presence of cyanosis, PAPs, and other factors. • Indications for intervention (surgical or catheter) in the majority of patients do not differ in women who consider pregnancy compared with other patients. There are a few exceptions, such as some degree of aortic dilatation and severe asymptomatic MS. • In women with a moderate or high-risk of complications during pregnancy (mWHO II–III, III, and IV), pre-pregnancy counselling and management during pregnancy and around delivery should be performed in an expert centre by a multidisciplinary team: the pregnancy heart team. • All women with congenital or other possibly genetic heart disease should be offered foetal echocardiography in weeks 19–22 of pregnancy. • A delivery plan should be made between 20–30 weeks of pregnancy detailing induction, management of labour, delivery, and post-partum surveillance. • Induction of labour should be considered at 40 weeks of gestation in all women with cardiac disease. • Vaginal delivery is the first choice for the majority of patients. • Indications for caesarean section are: – pre-term labour in patients on OACs – aggressive aortic pathology – acute intractable HF – severe forms of PH (including Eisenmenger’s syndrome) • Pregnancy termination should be discussed if there is a high-risk of maternal morbidity or mortality, and/or of foetal abnormality. • Pregnancy, and consequently fertility treatment, is contraindicated in women with mWHO class IV. • All patients with known cardiac or aortic disease need investigations and counselling about the risks of pregnancy pre-pregnancy or before assisted reproductive therapy. • The following patients should be counselled against pregnancy: – with a Fontan operation and additional comorbidities (ventricular

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