Percutaneous device closure of the patent foramen ovale during pregnancy.

OBJECTIVE: To review the procedures, results and follow-up of patients who underwent percutaneous device closure of a patent foramen ovale (PFO) during pregnancy. We report modifications made to the established technique that allowed absolute minimization of radiation exposure. Relevant management issues of this unusual presentation of cardiac disease in pregnancy are discussed. BACKGROUND: Stroke during or immediately prior to pregnancy is a catastrophic event. Paradoxical embolism may be more frequent due to the hypercoagulable state and increased incidence of venous thromboembolism. Treatment strategies must take into account the competing risks to mother and fetus. METHODS: Three patients, aged 34, 27, and 39, presented with ischemic neurological events during or immediately preceding pregnancy. Due to evidence of recurrent events or relative contraindication to anticoagulation they proceeded to percutaneous device closure during the second trimester. The Helex device (WL Gore and Associates) was used in all patients. Procedures were performed with local anesthesia under intra-cardiac echocardiography guidance. RESULTS: Successful closure was achieved with the Helex device in all three patients. Radiation doses, as assessed by dose area product, were 260, 58, and 19 cGy/cm(2), with estimated uterine (fetal) dose of <0.005 mGy, <0.001 mGy, and <0.0005 mGy. There were no peri-procedural complications. Despite one patient subsequently developing pre-eclampsia and another major post-partum hemorrhage all pregnancies were successful and free of further neurologic events. CONCLUSIONS: Percutaneous device closure of the PFO is a feasible option for selected patients with cryptogenic stroke believed secondary to paradoxical embolism. The procedure can be performed safely and effectively under local anesthesia using intra-cardiac echocardiography and with trivial fetal radiation exposure.