Registry for Pregnancy and Heart Disease

Go to the EuroHeartSurvey site: www.euroheartsurvey.org

Objective
This registry aims to improve our knowledge of complications of pregnancy in women with structural heart disease and to identify best treatment strategies. A special focus of this registry is on anticoagulation in pregnant women and on delivery options and outcomes (cesarean section versus vaginal delivery).

Primary objectives

Determine the variation over Europe of structural 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.

Secondary objectives

Assess prospectively the changes in maternal cardiac function as a consequence of pregnancy using echocardiography.

Compare different types of anticoagulant therapy strategies used during pregnancy.

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 models on pregnancy outcome in patients with heart disease.

Study design

This registry is an international multicenter study, embedded in the EuroHeart Survey Program and is completely web-based. You can enter your data from your own computer after receiving and using your password and login code. 

You can get a better sense of how this will work by going to the website: www.euroheartsurvey.org.   A demo version is available.  Use the login code: pregnancy and the password: pregnancy to try the demo version.  You will find at the upper left side a button “survey”.  Use the drop-down menu and choose “pregnancy” and you can look at the data forms under the tabs.

Study population

Data inclusion has started and all consecutive patients with structural heart disease (valve disease, congenital heart disease, or myocardial disease), who delivered after January 1, 2007 can be enrolled in the registry. Until now, over 500 patients have been enrolled in 18 countries. Planned enrollment is at least 1000 patients in this database.

Inclusion criteria

Consecutive inclusion of all patients with structural heart disease (valvular, congenital (when presenting after 20 weeks of pregnancy), 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.

Exclusion Criteria

Non-structural heart disease e.g. arrhythmias occurring in the context of a normal Heart

Dutch pregnant women with congenital heart disease presenting before the 20th week of pregnancy. (These women should be included in the ZAHARA II study; contact a.balci@thorax.umcg.nl)

Ethical Approval

The data of all enrolled patients will be transferred to the central database at the European Heart House without any patient identification and no intervention will be performed. Therefore, there is no need for ethical approval in the Netherlands.

International Projectleaders
Prof. Roger Hall (Great Britain)

Prof. Jörg Stein (Austria)

Dr. Jolien Roos-Hesselink (Netherlands)

National Coordinators

JW Roos-Hesselink, Dept. Of cardiology Erasmus MC, Rotterdam

PG Pieper, Dept. of Cardiology, UMCG, Groningen

Subsidy

Web-support from the EuroHeartSurvey, of the European Society of Cardiology

Contact

JW Roos-Hesselink

Departement of Cardiology

ErasmusMC Rotterdam

Tel: 010-7032432

Mobile: 06 53114078

E-mail: j.roos@erasmusmc.nl