EURObservational Research Programme

Report
Pregnancy in Women with
Prosthetic Heart Valves
Registry Of Pregnancy And Cardiac
disease: ROPAC
Jolien Roos-Hesselink
Roger Hall
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
On behalf of the ROPAC investigators
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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
Mechanical valve
Tissue valve
CHD
CHD*
VHD
VHD*
Aortic disease
Aortic disease
No prosthetic valve
CHD*
VHD*
IHD*
CMP*
Aortic disease*
PAH
* p<0.05 vs mechanical valve
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Results Baseline
Mechanical
212
Tissue
134
No prosthesis
2620
AF
%
10
0*
2*
NYHA class I
%
74
77
73
Signs of CHF
%
15
4*
7*
* p<0.05 vs mechanical valve
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Results Complications
Maternal mortality
Thrombotic event
Haemorrhagic event
Miscarriage <24 wks
Fetal mortal >24 wks
Mechanical valve
212
Cardiac patients
No prosthesis
2620
1.4%
0.2%*
6.1%
0.4%*
23%
5%*
15.6%
1.7%*
2.8%
0.6%*
* p<0.05
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Mode of delivery
Planned
Mechanical
212
No prosthesis
2620
Vaginal
61%
64%
Caesarean Section
39%
36%
Performed
Mechanical
212
No prosthesis
2620
Vaginal
54%
52%
Caesarean Section
46%
48%
9%
15%
Emergency CS
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Results Live births
p=0.571
p<0.001
100
90
80
70
60
% 50
40
30
20
10
0
Mechanical valve
Tissue valve
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No prosthetic valve
Results Mechanical valve thrombosis
Incidence: 10 patients (4.7%)
Total
VKA
Heparin
1st trimester
5
0
5
2nd trimester
2
1
1
3rd trimester
3
3
0
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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 antagonists
UH = Unfractionated Heparin
LMWH = Low Molecular Weight Heparin
Results Regimes
120
p = 0.272
p = 0.366
p = 0.013
100
VKA-VKA-VKA
80
VKA-VKA-LMWH/UH
LMWH-LMWH-LMWH
60
UH-UH-UH
40
LMWH-VKA-LMWH/UH
20
UH-VKA-LMWH/UH
Other regimes
0
Hemorrhagic
events
Thrombotic
events
Live Birth
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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