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Pregnancy in Women with Prosthetic Heart Valves R egistry O f P regnancy A nd C ardiac disease: ROPAC. Iris van Hagen Titia Ruijs Waltraut Merz Sorel Goland Harald Gabriel Malgorzata Lelonek Olga Trojnarska Wael Al Mahmeed Hajnalka Balint Zeinab Ashour Helmut Baumgartner
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Pregnancy in Women with Prosthetic Heart ValvesRegistry Of Pregnancy And Cardiac disease: ROPAC Iris van Hagen Titia Ruijs WaltrautMerz SorelGoland Harald Gabriel Malgorzata Lelonek Olga Trojnarska Wael Al Mahmeed Hajnalka Balint ZeinabAshour Helmut Baumgartner Eric Boersma Jolien Roos-Hesselink Roger Hall On behalf of the ROPAC investigators • EURObservationalResearch Programme
I have nothingtodisclose. • EURObservationalResearch Programme
Background Pregnancy • Haemodynamic burden • Hypercoagulable state Is a mechanical valve a risk factor for adverse outcome? Anticoagulation • EURObservationalResearch Programme
Methods • ROPAC RegistryOfPregnancyAnd Cardiac disease • ESC: EURObservational Research Programme (EORP) • 2007 – 2014 • Ongoing worldwide Registry • Online CRF • Prospective • EURObservationalResearch Programme
48 countries, 132 centers, 2966 pregnancies • EURObservationalResearch Programme
Results Baseline • EURObservationalResearch Programme
Results Baseline * p<0.05 vs mechanical valve • EURObservationalResearch Programme
Results Baseline * p<0.05 vs mechanical valve • EURObservationalResearch Programme
Results Complications * p<0.05 • EURObservationalResearch Programme
Mode of delivery • EURObservationalResearch Programme
Results Live births • EURObservationalResearch Programme
ResultsMechanicalvalve thrombosis Incidence: 10 patients (4.7%) • EURObservationalResearch Programme
Results Anticoagulation • EURObservationalResearch Programme
ResultsRegimes VKA= Vitamin K antagonists UH = UnfractionatedHeparin LMWH = Low MolecularWeightHeparin
Discussion • Choice of valve type in a youngwoman • Interregionaldifferences • Guidelinesfor anticoagulation • The (in)feasibility of an RCT • EURObservationalResearch Programme
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 associatedwithvalvethrombosis • Not one regime turned out to be clearly optimal • EURObservationalResearch Programme
Clinicalimplications • 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
Acknowledgements: EORP Team and ROPAC investigators Pleasejoinus! eorp@escardio.org • EURObservationalResearch Programme