Background
Over the past decade, major advances have occurred in surgery and interventional techniques for patients with congenital heart disease or valvular heart disease. These advances have resulted not only in a better diagnosis and selection of patients for intervention but also in an increased survival of patients with these disorders. Survival into adulthood changed from 20-50% in the era before open-heart surgery to over 90% in recent years.
Information from which to make a clinical management decision has been greatly expanded in recent years, yet in many situations management issues remain controversial or uncertain. It should also be noted that many factors ultimately determine the counseling and guidance during pregnancy and mode of delivery of individual patients with heart disease in a given community. These include the availability of diagnostic equipment and expert diagnosticians as well as the expertise of obstetrics and (pediatric) cardiologists.
Our current knowledge of the risks associated with pregnancy and delivery in patients with heart disease is limited; in particular, we do not know what the impact of pregnancy is on the cardiac state, whether any deterioration is reversible or whether any type of heart disease is associated with a specific risk, nor do we know whether the medication used, such as anticoagulants, affects fetal and maternal outcomes. Collectively, these women have a spectrum of heart disease including congenital heart disease, rheumatic heart disease, pulmonary hypertension, cardiomyopathy and coronary artery disease. The heterogeneous nature of this group means that the information we use to develop our management protocols is incomplete and fragmented.
To be able to practice to the standard demanded by an “Evidence Based Medicine” approach it is imperative that we establish a large prospective registry. The information provided by the registry will enable us to give accurate advice and to formulate evidence-based protocols and so optimise the care this group of women receive during pregnancy.
Objective European Registry on Pregnancy and Heart Disease
The objectives of the European Registry on Pregnancy and Heart Disease are as follows:
- Determine the variation over Europe of heart disease in pregnant patients
- Type of heart disease (valvular, congenital, ischemic, cardiomyopathy)
- Age during pregnancy
- Medication use before/during pregnancy
- Mode of delivery
- Assess the maternal and fetal mortality and morbidity during pregnancy and 6 months after pregnancy.
- Assess the recurrence rate of congenital heart disease.
- Assess prospectively the changes in maternal cardiac function as a consequence of pregnancy using echocardiography.
- Assess medical resource utilisation (caesarean section, epidural anaesthesia) and its impact on outcome in different countries.
- Assess the results and complication rate of interventions performed during pregnancy
- Test the value of the existing risk model on pregnancy outcome in patients with heart disease.
- Compare different types of anticoagulant therapy strategies used during pregnancy.
- Assess the use of endocarditis prophylaxis and the incidence of endocarditis during and directly after pregnancy (until 6 months after pregnancy)
Participating Centres
The Euro Heart Survey Programme invites every centre in the ESC and AEPC Member Countries to actively participate in the European Registry on Pregnancy and Heart Disease.The National Societies and its Working Groups on Congenital Heart Disease and Valve Disease are invited to help in the recruitment of participating centres.
5. Study population
Consecutive patients with structural heart disease becoming pregnant should be enrolled into the registry.
5.1 Inclusion criteria
Consecutive inclusion of all patients with structural heart disease (valvular, congenital, or ischemic heart disease or cardiomyopathy) becoming pregnant. In the European Registry on Pregnancy and Heart Disease all consecutive patients with structural heart disease presenting with pregnancy, independent of age, any concomitant diseases and type of heart disease should be enrolled. Those patients who already participate in (e.g. randomised) trials or other registries should also be included into the European Registry on Pregnancy and Heart Disease.
5.2 Exclusion Criteria:
Not structural heart disease eg arrhythmias
6.1 Enrolment-Period
The recruitment of consecutive pregnant patients into the European Registry on Pregnancy and Heart Disease starts on November 1, 2007 (provisional date) and is planned to continue for two years.
6.2 Follow-up
A follow-up of all patients will be performed 6 months after delivery using telephone contact or information of the treating physician.
To participate please contact by email: ehs@escardio.org