Pregnancy in Women with Prosthetic Heart Valves Registry Of Pregnancy And Cardiac disease: ROPAC...

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.


Background

Pregnancy• Haemodynamic burden• Hypercoagulable state

Is a mechanical valve a risk factor for adverse outcome?

Anticoagulation


https://www.google.nl/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&docid=tW0Dyx5351dOhM&tbnid=JmPzgGDiKQudCM:&ved=0CAUQjRw&url=https://woolworthsbabyandtoddlerclub.com.au/baby/bringing-baby-home/how-to-bath-your-baby/&ei=Hhz7U-jyNcnmOoeygeAL&bvm=bv.73612305,d.ZWU&psig=AFQjCNHmCOXJDm2l1_WcX_vNUXZZ3mUvRw&ust=1409051874309334

http://www.google.nl/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&docid=xUgPEuwgiIyv9M&tbnid=mB5Rm8jtgc6BpM:&ved=0CAUQjRw&url=http://www.wvw-fotografie.nl/page_1309455975955.html&ei=Xxz7U4TROcLfOqX6gZgH&bvm=bv.73612305,d.ZWU&psig=AFQjCNELhZrevYvsKbv6JHCi73f3HpOUBw&ust=1409052125117941

Methods

• ROPAC Registry Of Pregnancy And Cardiac disease

• ESC: EURObservational Research Programme (EORP)

• 2007 – 2014

• Ongoing worldwide Registry

• Online CRF

• Prospective


48 countries, 132 centers, 2966 pregnancies


Results Baseline


Results Baseline


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


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


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%


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


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

Results Anticoagulation


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


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


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


Please join [email protected]

Pregnancy in Women with Prosthetic Heart Valves Registry Of Pregnancy And Cardiac disease: ROPAC...

Documents

Transcript of Pregnancy in Women with Prosthetic Heart Valves Registry Of Pregnancy And Cardiac disease: ROPAC...