CLINICAL STUDIES
Dose-dependent fetal complications of warfarin in pregnant women with mechanical heart valves
Nicola Vitale, MD*,
Marisa De Feo, MD*,
Luca Salvatore De Santo, MD*,
Alessio Pollice, PhD ,
Nicola Tedesco, PhD and
Maurizio Cotrufo, MD*
* Department of Cardiac Surgery, Medical School, Monaldi Hospital, Second University of Naples, Naples, Italy
Department of Statistical Sciences, University of Bari, Bari, Italy
Manuscript received March 25, 1998;
revised manuscript received October 9, 1998,
accepted January 14, 1999.
Reprint requests and correspondence: Nicola Vitale, MD, Regional Cardiothoracic Centre, Freeman Hospital, High Heaton, Newcastle-upon-Tyne, NE7 7DN United Kingdom.
Nicola.Vitale{at}ncl.ac.uk
OBJECTIVES
The purpose of this study was to assess the incidence of warfarin fetal complications and whether they are dose-dependent.
BACKGROUND
Gravid patients with mechanical heart valves require long-term anticoagulant therapy. Controversy exists concerning the appropriate treatment of these patients.
METHODS
Forty-three women on warfarin carrying out 58 pregnancies were studied. For each patient with full-term pregnancy a caesarian section was scheduled for the 38th week during brief warfarin discontinuation. Maternal and fetal complications were evaluated. Fetal complications were divided according to the warfarin dosage  5 mg and >5 mg necessary to keep an international normalized ratio (INR) of 2.5 to 3.5, and analyzed subsequently.
RESULTS
A total of 58 pregnancies were observed: 31 healthy babies (30 full term, 1 premature) and 27 fetal complications (22 spontaneous abortions, 2 warfarin embryopathies, 1 stillbirth, 1 ventricular septal defect, 1 growth retardation) were recorded. Two maternal valve thromboses occurred. No fetal or maternal bleeding was observed during caesarian sections or premature vaginal delivery. Patients whose warfarin doses during pregnancy were >5 mg had 22 fetal complications, whereas those taking a dose 5 mg had only five fetal complications (p = 0.0001). For an increase of the warfarin dose there was a substantially increased probability of fetal complications (p < 0.0001;  < 0.7316).
CONCLUSIONS
There is a close dependency between warfarin dosage and fetal complications. Patients on warfarin anticoagulation may be delivered by planned caesarian section at the 38th week while briefly interrupting anticoagulation.
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