Jolien Roos-Hesselink Roger Hall
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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
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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 - PowerPoint PPT Presentation
Transcript of Jolien Roos-Hesselink Roger Hall
Pregnancy in Women with Prosthetic Heart Valves
Registry Of Pregnancy And Cardiac disease: ROPAC
Jolien Roos-HesselinkRoger Hall
On behalf of the ROPAC investigators
Iris van HagenTitia Ruijs
Waltraut MerzSorel Goland
Harald GabrielMalgorzata Lelonek
Olga Trojnarska
Wael Al MahmeedHajnalka BalintZeinab Ashour
Helmut BaumgartnerEric Boersma
EURObservational Research Programme
I have nothing to disclose.
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Background
Pregnancy• Haemodynamic burden• Hypercoagulable state
Is a mechanical valve a risk factor for adverse outcome?
Anticoagulation
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Methods
• ROPAC Registry Of Pregnancy And Cardiac disease
• ESC: EURObservational Research Programme (EORP)
• 2007 – 2014
• Ongoing worldwide Registry
• Online CRF
• Prospective
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48 countries, 132 centers, 2966 pregnancies
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Results Baseline
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Results Baseline
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Mechanical valve
CHDVHDAortic disease
Tissue valve
CHD*VHD*Aortic disease
No prosthetic valve
CHD*VHD*IHD*CMP*Aortic disease*PAH
* p<0.05 vs mechanical valve
Results Baseline
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Mechanical212
Tissue134
No prosthesis2620
AF % 10 0* 2*
NYHA class I % 74 77 73
Signs of CHF % 15 4* 7*
* p<0.05 vs mechanical valve
Results Complications
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Mechanical valve212
Cardiac patients No prosthesis
2620
Maternal mortality1.4% 0.2%*
Thrombotic event6.1% 0.4%*
Haemorrhagic event23% 5%*
Miscarriage <24 wks15.6% 1.7%*
Fetal mortal >24 wks2.8% 0.6%*
* p<0.05
Mode of delivery
Performed Mechanical212
No prosthesis2620
Vaginal 54% 52%
Caesarean Section 46% 48%
Emergency CS 9% 15%
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Planned Mechanical212
No prosthesis2620
Vaginal 61% 64%
Caesarean Section 39% 36%
Results Live births
Mechanical valve Tissue valve No prosthetic valve0
10
20
30
40
50
60
70
80
90
100
%
p<0.001
p=0.571
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Results Mechanical valve thrombosis
Incidence: 10 patients (4.7%)
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Total VKA Heparin
1st trimester 5 0 5
2nd trimester 2 1 1
3rd trimester 3 3 0
Results Anticoagulation
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Results Regimes
<14 wks 14-36 wks 36 wks - delivery n %
1 VKA VKA VKA 6 3
2 VKA VKA LMWH/UH 37 20
3 LMWH LMWH LMWH 18 10
4 UH UH UH 21 11
5 LMWH VKA LMWH/UH 32 17
6 UH VKA LMWH/UH 48 25
7 Other regimes 24 12
VKA= Vitamin K antagonistsUH = Unfractionated HeparinLMWH = Low Molecular Weight Heparin
Results Regimes
Hemorrhagic events
Thrombotic events
Live Birth0
20
40
60
80
100
120
VKA-VKA-VKAVKA-VKA-LMWH/UHLMWH-LMWH-LMWHUH-UH-UHLMWH-VKA-LMWH/UHUH-VKA-LMWH/UHOther regimes
p = 0.272
p = 0.366
p = 0.013
Discussion
• Choice of valve type in a young woman
• Interregional differences
• Guidelines for anticoagulation
• The (in)feasibility of an RCT
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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
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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
Acknowledgements: EORP Team and ROPAC investigators
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