Pregnancy with a prosthetic heart valve, thrombosis, and bleeding: the ESC EORP Registry of Pregnancy and Cardiac disease III
Johanna A van der Zande, Karishma P. Ramlakhan, Karen Sliwa, Justin P Gnanaraj, Hasan Al Farhan, Isabelle Malhamé, Catherine M Otto, R Vasallo Peraza, Ariane Marelli, Aldo P. Maggioni, Jérôme Cornette, Mark R. Johnson, Jolien W. Roos‐Hesselink, Roger Hall, the ROPAC investigators, Jolien Roos-Hesselink, Roger Hall, William Parsonage, Werner Budts, Julie de Backer, Jasmin Grewal, Ariane Marelli, Guillaume Jondeau, Mark Johnson, Catherine Otto, Karen Sliwa, Aldo P Maggioni, K Vardanyan, A Melkonyan, H Lachikyan, K Hakobyan, M Mazmanian, H Hayrapetyan, A Tavaracyan, H Poghosyan, R Hovhannisyan, S Sahakyan, S Martirosyan, J Harris, A Pasquet, M Morissens, T Besse-Hammer, B Dumoulin, J De Backer, L Campens, L Demulier, M De Hosson, W Budts, A Van de Bruaene, A Rampelberg, E Troost, L Roggen, P De Meester, J C Mwita, E Tefera, L Kontle, A Marelli, I Malhamé, J Grewal, M Janzen, P A Román Rubio, R Vasallo Peraza, G Vázquez Hernández, J E Pérez Torga, Y Gil Jiménez, M Meluzá Martín, R Almaleh, G Youssef, K Sorour, S Abebe, D Mekonnen, C Fekadu, D Yadeta, S Dupuis-Girod, L Delagrange, M Richardson, L Ghesquiere, O Domanski, M Gonzalez Estevez, Y Ould Hamoud, S Gautier, L Marsili, L Bal-Theoleyre, S Palazzolo, M Ladouceur, G Jondeau, A Bourgeois Moine, L Eliaou, O Milleron, M Tchitchinadze, Y Dulac, C Karsenty, N Souletie, F Bajanca, C Rickers, S Blankenberg, C Sinning, C Magnussen, E Zengin, G Mueller
Abstract
BACKGROUND AND AIMS: Pregnancy in women with a prosthetic heart valve is considered high risk, primarily due to the need for effective anticoagulation. However, data on the relationship between anticoagulation practices and pregnancy outcomes are very limited. METHODS: The Registry of Pregnancy and Cardiac disease is a global registry that prospectively enrolled pregnancies in women with a prosthetic heart valve between January 2018 and April 2023. Detailed data on anticoagulation, including dosage and monitoring, and cardiovascular, pregnancy, and perinatal outcomes were collected. RESULTS: In total, 613 pregnancies were included of which 411 pregnancies were in women with a mechanical valve and 202 were in women with a biological valve. The chance of an uncomplicated pregnancy with a live birth in women with a mechanical valve was 54%, compared with 79% in women with a biological valve (P < .001). Thromboembolic and haemorrhagic complications most frequently occurred when low-molecular weight heparin (LMWH)-based regimens were used. Valve thrombosis occurred in 24 (6%) women, and a prosthetic valve in mitral position was associated with valve thrombosis (odds ratio 3.3; 95% confidence interval 1.9-8.0). A thromboembolic event occurred in 12 (10%) women with anti-Xa monitoring and in 9 (21%) women without (P = .060). Foetal death occurred in 20% of all pregnancies. CONCLUSIONS: More favourable outcomes were found in women with a biological valve compared with a mechanical valve. In women with a mechanical valve, the use of LMWH was associated with an increased risk of thromboembolic complications. A mitral prosthetic valve was identified as a predictor for valve thrombosis. The benefit could not be confirmed nor refuted, in terms of reduced thromboembolic events, from using anti-Xa level monitoring in women on LMWH.