Patent Foramen Ovale Treatment & Management
- Author: Sandy N Shah, DO, MBA, FACC, FACOI; Chief Editor: Park W Willis IV, MD more...
Medical Care
Most patients with a patent foramen ovale (PFO) as an isolated finding receive no special treatment. No consensus exists on treatment of PFO in patients with transient ischemic attack or stroke.
- When PFO is associated with an otherwise unexplained neurologic event,[16] traditional treatment has been antiplatelet (ie, aspirin) therapy alone in low-risk patients or combined with warfarin in high-risk individuals to prevent cryptogenic stroke. With administration of warfarin, the international normalized ratio (INR) is maintained at 2-3. Consultation with a neurologist is mandatory to direct this treatment.
- The recurrence rate of stroke or transient ischemic attack has been reported to be as high as 3.4-3.9% per year.
- In patients with atrial septal aneurysm and PFO, the risk of first recurrent stroke within 2 years has been reported to be as high as 9%, while the rate of subsequent stroke or transient ischemic attack recurrence within 2 years increases to 22%.
Surgical Care
Surgical closure of PFO with double continuous suture has resulted in elimination of residual shunt across the PFO.
- Indication
- PFO more than 25 mm in size
- Inadequate rim of tissue around the defect
- Percutaneous device failure
- Advantages
- Permanent closure of the defect
- Prevents future paradoxical emboli
- No long-term anticoagulation and its risks
- Disadvantages
- General anesthesia
- Open-heart surgery
- Hospital stay for a few days
- The usual risks of cardiac surgery
Percutaneous care
Percutaneous closure of PFO during cardiac catheterization is an emerging therapeutic option.
- Indications
- Recurrent cryptogenic stroke due to presumed paradoxical embolism through PFO failure of conventional drug therapy
- Contraindications to anticoagulant treatment
- Alternative to medical therapy or surgical closure - Cryptogenic TIA due to presumed paradoxical embolism through a PFO
- Presumed paradoxical peripheral or coronary embolism through PFO
- Cryptogenic stroke, TIA, or peripheral or coronary embolism due to presumed paradoxical embolism through a PFO that is associated with hypercoagulability state
- Divers with a PFO who are at risk of clinical events that are related to paradoxical embolism through a PFO during decompression
- Systemic deoxygenation due to right-to-left shunting through a PFO in the absence of severe pulmonary hypertension (eg, platypnea orthodeoxia, right ventricular infarction)
- Migraine headache accompanied by aura
- Posttraumatic fat embolism syndrome with cerebral embolism by way of PFO
- The Federal Drug Administration (FDA) has approved 2 percutaneous devices for PFO closure.
- CardioSEAL Septal Occlusion System (NMT Medical Inc, Boston, MA) is a double umbrella-shaped permanent implant. It is made up of metal framework to which polyester fabric is attached. The CardioSEAL implant is available in sizes 17 mm, 23 mm, 28 mm, and 33 mm.
- Amplatzer PFO Occluder (AGA Medical Corp, Golden Valley, Minn) is a self-expanding wire mesh with double discs. It contains inner polyester fabric patches that, along with the wire mesh, cause the formation and accumulation of a blood clot, which seals the opening. After the device is in place, tissue will grow over it, and the device then becomes a part of the atrial septum.
- The procedure requires a hospital stay of 24-48 hours and prophylactic aspirin or warfarin for 6 months following the procedure. After more than 5 years of follow-up observation, the results are promising.
- Although hypertrophy and lipomatosis of the interatrial septum have been considered contraindications for transcatheter PFO closures, a study by Rigatelli et al suggests that this is not always the case.[17] The authors investigated outcomes in 10 patients with PFO who, owing to multiple recurrent stroke events (9 patients) or to the need for a posterior cerebral operation (1 patient), underwent transcatheter PFO closure, despite the presence of hypertrophy or lipomatosis of the rim of the fossa ovalis.
- Following intracardiac echocardiography assessment and measurements, a 25-mm Amplatzer device was implanted in 2 patients in the Rigatelli study, and a 25-mm Premere Occlusion System device was implanted in 8 patients. On mean follow-up (36.6 months), 2 patients were found to have a small residual shunt. During this period, however, none of the patients experienced stroke recurrence, aortic erosion, or device thrombosis. The investigators concluded that in patients with hypertrophy or lipomatosis of the fossa ovalis rim, safe and effective PFO closure may be attainable, at least in the absence of severe atrial septal aneurysm, if rim thickness is carefully evaluated with intracardiac echocardiography, and if soft and asymmetrical opening devices are used.
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