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Closure Devices for Patent Foramen Ovale and Atrial Septal Defects

The percutaneous transcatheter closure of a patent foramen ovale using a device that has been approved by the U.S. Food and Drug Administration for that purpose  may be considered medically necessary to reduce the risk of recurrent ischemic stroke if patient meets all of the following:
Between 18 and 60 years of age
Diagnosed with patent foramen ovale with a right-to-left interatrial shunt confirmed by echocardiography with at least one of the following characteristics:

PFO with large shunt, defined as >30 microbubbles in the left atrium within 3 cardiac cycles, after opacification of the right atrium.
PFO associated with atrial septal aneurysm on transesophageal examination: septum primum excursion >10 mm

Documented history of cryptogenic ischemic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude any other identifiable cause of stroke, including large vessel atherosclerotic disease and small vessel occlusive disease

AND none of the following are present:

Uncontrolled vascular risk factors, including uncontrolled diabetes or uncontrolled hypertension
Other sources of right-to-left shunts, including an atrial septal defect and/or fenestrated septum.
Active endocarditis or other untreated infections
Inferior vena cava filter.

Transcatheter closure of secundum atrial septal defects may be considered medically necessary when using a device that has been approved by the U.S. Food and Drug Administration for that purpose and used according to the labeled indications including:

Patients with echocardiographic evidence of ostium secundum atrial septal defect;

AND either of the following

Clinical evidence of right ventricular volume overload (ie, 1.5:1 degree of left-to-right shunt or right ventricular enlargement); OR
Clinical evidence of paradoxical embolism.

Transcatheter closure of secundum atrial septal defects is considered investigational for all other indications not meeting criteria outlined above.

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