1. Pregnancy in Women with Prosthetic Heart Valves Registry Of Pregnancy And Cardiac disease: ROPAC Jolien Roos-Hesselink Roger Hall On behalf of the ROPAC investigators Iris van Hagen Titia Ruijs Waltraut Merz Sorel Goland Harald Gabriel Malgorzata Lelonek Olga Trojnarska Wael Al Mahmeed Hajnalka Balint Zeinab Ashour Helmut Baumgartner Eric Boersma EURObservational Research Programme

2. I have nothing to disclose. EURObservational Research Programme

3. Background Pregnancy Haemodynamic burden Hypercoagulable state Is a mechanical valve a risk factor for adverse outcome? Anticoagulation EURObservational Research Programme

4. Methods ROPAC Registry Of Pregnancy And Cardiac disease ESC: EURObservational Research Programme (EORP) 2007 – 2014 Ongoing worldwide Registry Online CRF Prospective EURObservational Research Programme

5. 48 countries, 132 centers, 2966 pregnancies EURObservational Research Programme

6. Results Baseline EURObservational Research Programme

7. Results Baseline EURObservational Research Programme * p<0.05 vs mechanical valve

8. Results Baseline EURObservational Research Programme Mechanical 212 Tissue 134 No prosthesis 2620 AF%100*2* NYHA class I%747773 Signs of CHF%154*7* * p<0.05 vs mechanical valve

9. Results Complications EURObservational Research Programme Mechanical valve 212 Cardiac patients No prosthesis 2620 Maternal mortality 1.4%0.2%* Thrombotic event 6.1%0.4%* Haemorrhagic event 23%5%* Miscarriage <24 wks 15.6%1.7%* Fetal mortal >24 wks 2.8%0.6%* * p<0.05

10. Mode of delivery Performed Mechanical 212 No prosthesis 2620 Vaginal 54%52% Caesarean Section 46%48% Emergency CS 9%15% EURObservational Research Programme Planned Mechanical 212 No prosthesis 2620 Vaginal 61%64% Caesarean Section 39%36%

11. Results Live births EURObservational Research Programme

12. Results Mechanical valve thrombosis Incidence: 10 patients (4.7%) EURObservational Research Programme TotalVKAHeparin 1 st trimester505 2 nd trimester211 3 rd trimester330

13. Results Anticoagulation EURObservational Research Programme

14. Results Regimes <14 wks14-36 wks36 wks - deliveryn% 1VKA 63 2 LMWH/UH3720 3LMWH 1810 4UH 2111 5LMWHVKALMWH/UH3217 6UHVKALMWH/UH4825 7 Other regimes 2412 VKA= Vitamin K antagonists UH = Unfractionated Heparin LMWH = Low Molecular Weight Heparin

15. Results Regimes

16. Discussion Choice of valve type in a young woman Interregional differences Guidelines for anticoagulation The (in)feasibility of an RCT EURObservational Research Programme

17. Conclusion Pregnant women with a mechanical valve prosthesis are at high risk: Event-free pregnancy resulting in a live birth was 58% versus 78% in other cardiac patients. There is a wide variety in used regimes for anticoagulation Vitamin k antagonists seem associated with high offspring mortality (miscarriages) Heparin in the first trimester was associated with valve thrombosis Not one regime turned out to be clearly optimal EURObservational Research Programme

18. Clinical implications Pre-pregnancy counseling performed by an experienced specialist is mandatory explaining the different treatment options and their complication rates. After providing extensive information, a shared-decision should be searched for towards the best regime for the individual patient. All patients with a mechanical valve are at high risk during pregnancy and therefore the care for these patients should be concentrated in a few specialized centers Speaker

19. Acknowledgements: EORP Team and ROPAC investigators EURObservational Research Programme Please join us! eorp@escardio.org